louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03161171: Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III
Official title: Behavioral Challenges in Children With Mucopolysaccharidosis Type I-III and Parental Coping Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucopolysaccharidosis Type I
Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type III
Behavior Disorders
Coping Behavior
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 34
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mucopolysaccharidosis type I-III below 18 years of age registered at the German Society for Mucopolysaccharidosis

Brief summary: The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental coping strategies

Detailed description: This is a prospective, cross-sectional, observational study quantitatively assessing

1. challenging behavior in children with MPS, an orphan, progressive, neurodegenerative metabolic disorder, and
2. parental coping strategies for this challenging behavior.

Patients registered at the German Society for Mucopolysacchardoses giving written informed consent are eligible. The study is based on questionnaires. IRB approval was obtained.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mucopolysaccharidosis type I, II or III
* Written informed consent
* Patient is registered at the German Society for Mucopolysaccharidosis

Exclusion Criteria:

* Patient / Family does not give written informed consent.

Primary outcomes:
measure: Coping strategies for challenging behavior and for family burden in mucopolysaccharidosis type I-III
timeFrame: 10 minutes
Secondary outcomes:
measure: Quantity of behavioral abnormalities in children with mucopolysaccharidosis type I-III
timeFrame: 10 minutes
measure: Intensity of behavioral abnormalities in children with mucopolysaccharidosis type I-III
timeFrame: 10 minutes
measure: Psychosocial burden in families with mucopolysaccharidosis type I-III
timeFrame: 10 minutes
measure: Psychosocial burden in families with mucopolysaccharidosis type I-III
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: markus.ries@med.uni-heidelberg.de
name: Markus Ries, MD PhD MHSc FCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffmann F, Hoffmann S, Kunzmann K, Ries M. Challenging behavior in mucopolysaccharidoses types I-III and day-to-day coping strategies: a cross sectional explorative study. Orphanet J Rare Dis. 2020 Oct 2;15(1):275. doi: 10.1186/s13023-020-01548-9.
Clinical trial NCT01913171: Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression
Official title: Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene Expression
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: o determine effects of hula-hooping on android obesity, metabolic parameters and adipose tissue (AT) gene expression.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years
* central adiposity as measured by the waist circumference (\>80 cm in females and \>94 cm in males) (9)
* ability to hula-hoop for a minimum of 2 minutes and to have the necessary space available for this activity either at home or at work
* ability to communicate meaningfully with the investigator and legal competence to provide written informed consent

Exclusion Criteria:

* clinical or biochemical evidence of disease other than obesity as judged by history, physical examination and standard laboratory tests
* excessive use of alcohol, i.e., over 20 g/day
* use of medications known to affect glucose or lipid metabolism and
* pregnancy or lactation

Primary outcomes:
measure: Android obesity
timeFrame: 6weeks
Secondary outcomes:
measure: metabolic parameters
timeFrame: 6weeks
Other outcomes:
measure: adipose tissue inflammation
timeFrame: 6weeks
Locations:
city: Helsinki
country: Finland
facility: Department of Medicine, University of Helsinki
Study officials:
References:
citation: Lahelma M, Sadevirta S, Lallukka-Bruck S, Sevastianova K, Mustelin L, Gylling H, Rockette-Wagner B, Kriska AM, Yki-Jarvinen H. Effects of Weighted Hula-Hooping Compared to Walking on Abdominal Fat, Trunk Muscularity, and Metabolic Parameters in Overweight Subjects: A Randomized Controlled Study. Obes Facts. 2019;12(4):385-396. doi: 10.1159/000500572. Epub 2019 Jun 19.
Clinical trial NCT02821871: the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or any of the excipients of the formulation of SP2086

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 12
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 12
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 12
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 12
measure: Cumulative percentage drainage of SP2086 in urine
timeFrame: up to Day 12
measure: Cumulative percentage drainage of SP2086 in fecal
timeFrame: up to Day 12
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 12
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT01296971: A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
Official title: Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C
* Measurable serum HVC RNA levels
* Compensated liver disease (Child-Pugh class A)
* Treatment-naive for standard or pegylated interferons, or non-responder or relapsing

Exclusion Criteria:

* Concomitant hepatitis A or B
* History of chronic liver disease not caused by hepatitis C virus
* Hepatocellular carcinoma
* History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
* Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
* Pregnant or lactating women, or men whose partners are pregnant

Primary outcomes:
measure: Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
timeFrame: up to 96 weeks
measure: Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
timeFrame: up to 96 weeks
Secondary outcomes:
measure: Virological response/sustained virological response (serum HCV RNA levels)
timeFrame: 24 weeks after treatment completion
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06629571: The Effect of Preoperative Education on Anxiety
Official title: The Effect of Education Given to Patients Before Abdominal Surgery on Anxiety: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anxiety
Keywords: SurgeryAnxiety
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. After power analysis, patients were divided into experimental (n=40) and control (n=41) groups. The experimental group received preoperative information, while the control group received standard care. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI). Data were analyzed with SPSS, using tests such as the Mann-Whitney U and Wilcoxon Sign tests.

Detailed description: As a result of this study, the anxiety levels of patients who received preoperative information training in the prevention or reduction of anxiety were found to be lower than patients who received routine care. The lower score indicated that they experienced less anxiety or were able to manage their anxiety in the experimental group.

Eligibility criteria: Inclusion Criteria:

* Admission to the general surgery clinic for abdominal surgery in category A-B-C
* must be over the age of 18
* To be literate- to be a writer
* Being conscious
* Who does not have a psychiatric disorder

Exclusion Criteria:

* Exit the research during the study,
* Group D and E abdominal surgery has been performed
* don't be under the age of 18
* Unconscious patient,
* Who has a psychiatric disorder
* Patients with communication disabilities or who cannot speak Turkish were determined as patients.

Primary outcomes:
measure: STAI Form TX I,STAI Form TX II
timeFrame: 1 Day before the operation and 1 day after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: MarmaraU
Study officials:
References:
Clinical trial NCT02838771: Validation and Clinical Application of Dysphagia Screening Questionnaire
Official title: Validation and Clinical Application of Dysphagia Screening Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Swallowing Disorders
Keywords: Swallowing Disorder
Dysphagia
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Klaipėda University
First posted: 2016-07-20
Enrollment: 293
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this research was to develop a dysphagia screening measure and evaluate the prevalence of dysphagia and its clinical manifestation in different in age population groups.

Detailed description: The dysphagia screening questionnaire had the stages of validation - translation and back translation, a review of the translation and back translation committee, pre-test study (36 persons) with monolingual individuals and the test re-test study (67 subjects included).

The case - control study groups were tested using dysphagia screening questionnaire and clinical screening - water drinking test. Barthel index and nutrition questionnaire were used to identify the nutritional and functional state. M. D. Anderson dysphagia inventory questionnaire, sf-12 questionnaire were used to assess dysphagia effects on the quality of life.

The research group consisted of two subgroups - 171 nursing home residents from 3 different nursing homes and 82 outpatients of the Hospital of Lithuanian University of Health Sciences. The control group consisted of randomly selected 40 community-dwelling elderly healthy individuals.

Eligibility criteria: Inclusion Criteria:

* Adults
* Consent for participating in the research
* No cognitive disorders or mental illnesses

Exclusion Criteria:

* Refusal to participate in the research
* Serious mental or cognitive conditions

Primary outcomes:
measure: Dysphagia screening questionnaire
timeFrame: At the baseline
Secondary outcomes:
measure: Clinical water drinking test
timeFrame: At the baseline
measure: Barthel index
timeFrame: At the baseline
measure: Nutrition questionnaire
timeFrame: At the baseline
measure: M. D. Anderson dysphagia inventory (MDADI)
timeFrame: At the baseline
measure: The 12-Item Short Form Health Survey (SF-12 questionnaire)
timeFrame: At the baseline
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences Otorhinolaryngology department
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Klaipėda University
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528371: Effect of Midazolam on White-coat Hypertensive Dental Patients
Official title: The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in White-coat Hypertensive Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Hypertension
Keywords: Intravenous sedation
Midazolam
Dental treatment
White-coat hypertension
STAI
Dental patients
Transient hypertension
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intravenous sedation was used for dealing with transient hypertension, so-called white-coat hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.


Eligibility criteria: Inclusion Criteria:

SBP\>=140mmHg or DBP\>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes among dental outpatients scheduling intravenous sedation with American Society of Anesthesiologists physical status I or II.

Exclusion Criteria:

1. Uncontrolled or unstable hypertension
2. Secondary hypertension such as hyperthyroidism and pheochromocytoma
3. Taking sympathomimetic drugs
4. Contraindication of midazolam such as myasthenia gravis and acute narrow-angle glaucoma
5. A pregnant woman or during lactation period
6. Psychiatric disorder such as schizophrenia
7. Not having intelligence enough to read, understand and write a Japanese version of STAI
8. Judged unsuitable by a researcher

Primary outcomes:
measure: Blood pressure
timeFrame: Until 10 minutes after drug administration
measure: Heart rate
timeFrame: Until 10 minutes after drug administration
measure: Oxygen saturation
timeFrame: Until 10 minutes after drug administration
Secondary outcomes:
measure: Visual analog scale about anxiety to dental treatment
timeFrame: 10 minutes after drug administration
measure: Sedation level
timeFrame: 10 minutes after drug administration
measure: Japanese version of STAI
timeFrame: 10 minutes after drug administration
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Study officials:
affiliation: Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
name: Yoshihisa Watanabe, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776371: Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Eradication Rate
Keywords: Helicobacter pylori
Sequential therapy
Modified non-clarithromycin triple therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.


Eligibility criteria: Inclusion Criteria:

* Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.

Exclusion Criteria:

* negative in rapid urease test (RUT)
* previous standard eradication therapy for H. pylori;
* history of esophagectomy or gastrectomy;
* gastrointestinal malignancy;
* contraindications or allergic to study drugs;
* user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
* cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
* pregnant or lactating women;
* participants of other trial within the past 3 months;
* unwilling or unable to participate in the study.

Primary outcomes:
measure: the difference of eradication rates between 2 groups
timeFrame: 5 months
Secondary outcomes:
measure: the different rates of adverse events between 2 groups
timeFrame: 5 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200471: Cosmetic Dermatology Study
Official title: Evaluation of VeinViewer in Cosmetic Dermatology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetic Procedures
Keywords: Cosmetic dermatology
near-infrared
patient preference
physician preference
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.

Detailed description: This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and up
* Male or Female
* Receiving cosmetic dermatological injection
* Willing to participate

Exclusion Criteria:

* Aged younger than 18 years
* Prior history of known light sensitivity
* Other reasons as determined by investigator

Primary outcomes:
measure: Patient perception of the use of the device
timeFrame: Day 1
Secondary outcomes:
measure: Physician perception of the use of the device
timeFrame: Day 1
Other outcomes:
measure: Detection of adverse events related to the standard of care procedure
timeFrame: 2nd day
Locations:
city: La Jolla
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
state: California
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein Institute
state: Maryland
Study officials:
References: