louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03255525: Deep Friction Massage Effects: Asymptomatic
Official title: Deep Friction Massage Effects on Analgesia of the Asymptomatic Patellar Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Friction Massage
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms and, consequently how it affects the time needed promote an analgesic response.

Having this, our general objective is to establish a dose-response relationship between the pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar tendon.


Eligibility criteria: Inclusion Criteria:

* the participants should have an asymptomatic patellar tendon

Exclusion Criteria:

* history of previous injury of the lower limbs;
* intake of medication that could interfere with pain mechanisms;
* presence of any factors or conditions that could interfere with the tendinous tissue as well as with the awareness and sensibility to pain.

Primary outcomes:
measure: Time until analgesia
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gandra
country: Portugal
facility: Cooperativa Ensino Superior Politécnico e Universitário
state: Paredes
Study officials:
affiliation: Cooperativa Ensino Superior Politécnico e Universitário
name: Maria A Paço, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06275425: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia
Official title: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia : a Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasm
Cough
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-blinded randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.

The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.


Eligibility criteria: Inclusion Criteria:

Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.

Exclusion Criteria:

* Patients with American society of anesthesiologists physical status classification IV or higher.
* Patients who are hypersensitive to remimazolam or inhalational anesthetic.
* Patients with structural abnormalities in the upper airway or respiratory diseases.
* Patients with a history of upper respiratory tract infection within the past 2 weeks.
* Current smoker
* Pregnant
* Patients who have difficulty reading and understanding the informed consent form

Primary outcomes:
measure: Proportion of patients not coughing during postoperative extubation
timeFrame: Until discharge (3days on average)
Secondary outcomes:
measure: Cough score
timeFrame: Until discharge (3days on average)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, Seoul
name: Hyun-Joung No
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685825: Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness
Official title: Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Surgeon experience
Endothelial cell loss
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 160
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: One hundred sixty eyes underwent phacoemulsification-based cataract surgery performed by an experienced surgeon or a less surgically experienced ophtalmic assistant, using the divide-and-conquer or tilt-and-tumble technique for cataractous lens extraction.

Brief summary: To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.

Detailed description: Cataract surgery is the most commonly performed surgical procedure. Although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ECL) remains.

Given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ECL, as reflected by the presence of corneal edema.

Eligibility criteria: Inclusion Criteria:

* Presence of senile cataract
* Age above 50 years
* History of visual acuity regression

Exclusion Criteria:

* Presence of white or Brown cataract
* History of previous ophtalmic surgery
* preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)
* Patients who developed intraoperative complications

Primary outcomes:
measure: Early postoperative corneal edema
timeFrame: hour 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01629225: GRK4 Polymorphisms Blood Pressure Response to Candesartan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: men and women
in southwestern Han Chinese
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the association between GRK4 polymorphisms and essential hypertension in southwestern Han Chinese and test whether these polymorphisms were associated with the changes in blood pressure in patients with essential hypertension treated with angiotensin II Type antagonist candesartan.

Detailed description: All antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20mg once daily as monotherapy in a single-blind fashion. The doses were doubled after 1 weeks if DBP was ≥ 90 mmHg.

Eligibility criteria: Inclusion Criteria:

* men and women with mild to moderate essential hypertension in southwestern Han Chinese

Exclusion Criteria:

* subjects unwilling to participate or subjects did not have all measurement required,
* subjects who were on medications, which affect blood pressure or
* whose DNA failed to amplify and 8 with errors in Mendelian segregation

Primary outcomes:
measure: The subjects with GRK4 varirants may exert different response during 4 weeks of treatment with candesartan in patients with essential hypertension
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Cardiology, Daping Hospital, The Third Military Medical University
Study officials:
affiliation: TMMU
name: Zeng Chunyu, Doctor
role: STUDY_DIRECTOR
References:
citation: Cai Y, Yang Y, Chen X, He D, Zhang X, Wen X, Hu J, Fu C, Qiu D, Jose PA, Zeng C, Zhou L. Circulating "LncPPARdelta" From Monocytes as a Novel Biomarker for Coronary Artery Diseases. Medicine (Baltimore). 2016 Feb;95(6):e2360. doi: 10.1097/MD.0000000000002360.
citation: Yang Y, Cai Y, Wu G, Chen X, Liu Y, Wang X, Yu J, Li C, Chen X, Jose PA, Zhou L, Zeng C. Plasma long non-coding RNA, CoroMarker, a novel biomarker for diagnosis of coronary artery disease. Clin Sci (Lond). 2015 Oct 1;129(8):675-85. doi: 10.1042/CS20150121. Epub 2015 Jun 11.
Clinical trial NCT05808725: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Official title: Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Coronary Artery Disease
Lead sponsor: Brillian Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Accutest Research Laboratories (I) Pvt. Ltd.
First posted: 2023-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical study is to assess the relative bioavailability of Amlodipine for Oral Solution 5 mg of Brillian Pharma Inc. under fasting and fed conditions versus reference product Norvasc 5 mg tablets of Pfizer Labs under fasting in normal, healthy, adult, male,

Primary Objective:

1. To compare the relative bioavailability.
2. To assess the food effect in Test product (T1) (Fast) vs Test product (T2) (Fed) Amlodipine Oral Solution 5 mg of Brillian Pharma Inc.

Secondary Objective:

To monitor the safety and tolerability of a single oral dose of investigational medicinal products (IMPs).

Detailed description: A total of 24 healthy, adult, male and female human volunteers will be enrolled.

Excluding the screening period, the duration of the clinical phase will be approximately 50 days including a washout period of at least 21 days for each study period.

This study is being conducted in healthy, adult, human subjects under fasting and fed conditions as per USFDA and NMPA guidelines. The present study will be conducted to assess the relative bioavailability of the test product versus the reference product under fasting conditions. The study also assesses the effect of food on the bioavailability of Amlodipine FD-POS 5 mg (Powder in a Unit-dose container) product.

Eligibility criteria: Inclusion Criteria:

* Adult, Healthy

Primary outcomes:
measure: Cmax
timeFrame: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
measure: AUC0-t
timeFrame: 50 days
measure: AUC0-inf
timeFrame: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
Secondary outcomes:
measure: Tmax
timeFrame: 6 days
measure: AUC0-t/AUC0-inf
timeFrame: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
measure: Residual Area
timeFrame: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
measure: Kel
timeFrame: 6 days
measure: t1/2
timeFrame: 6 days
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Accutest Research Laboratories (I) Pvt. Ltd.
state: Gujarat
Study officials:
affiliation: Accutest Research Laboratories (I) Pvt. Ltd.
name: Pratikkumar Dilipbhai Asari, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01642225: Desensitization Protocol for Deceased Donor List
Official title: Desensitization Protocol for Deceased Donor List
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant; Failure, Kidney
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 100 subjects are expected to participate from 2007 to current, and another 100 subjects are expected to participate during the next 12-month period.

Brief summary: Purpose of the study:

The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Detailed description: Background:

Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates \[1, 2\]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Eligibility criteria: Inclusion Criteria:

* Recent (\< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%).
* Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.

Exclusion Criteria:

* Female subject is pregnant or lactating.
* Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.
* Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.
* Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.
* Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.

Primary outcomes:
measure: Anti HLA antibody level
timeFrame: after IVIG infusion
Secondary outcomes:
measure: Number of patients transplanted
timeFrame: at the end of study
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Junichiro Sageshima, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04292548: Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Passive Smoking
Oxidative Stress
Dental Caries
Children
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
Collaborators: name: Kırıkkale University
First posted: 2020-03-03
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, referring for dental examination to the Department of Pediatric Dentistry of Kirikkale University, were selected.

Brief summary: The aim of the present study was to determine the effect of passive smoking on the levels of salivary TAS, TOS, LL-37 and dental status in children.In the study the parents of children were asked to fill out a complete survey about smoking habits. After filling out the questionnaire, according to the survey results, a total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalance of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial peptide LL-37' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.


Eligibility criteria: Inclusion Criteria:

-Systemically healthy children

Exclusion Criteria:

* The presence of orthodontic / intraoral appliance
* Any disease or condition known to affect defense system
* Uncooperative children

Primary outcomes:
measure: salivary oxidative stress values: TAS level
timeFrame: 1 day (once after the dental examination)
measure: salivary oxidative stress values: TOS level
timeFrame: 1 day (once after the dental examination)
measure: salivary LL-37 level
timeFrame: 1 day (once after the dental examination)
measure: salivary cotinine levels
timeFrame: 1 day (once after the dental examination)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03304548: Qualitative Research to Explore Treatment Preference in Pulmonary Arterial Hypertension (PAH) Subjects
Official title: Qualitative Research to Explore Patient Preference for Modes of Administration in Pulmonary Arterial Hypertension Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Telephone interviews
Subcutaneous
Low-interventional
Qualitative research
PAH
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Adelphi Values
First posted: 2017-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sample of 8 to 10 US-English speaking subjects will be recruited. Recruitment will be facilitated by a third-party vendor in the US. A purposive approach to sampling will be employed to ensure subjects with a range of demographic and clinical characteristics are recruited.

Brief summary: GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. Hence, GSK would like to conduct this qualitative interview study with PAH subjects to explore subject's perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). This will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age.
* Subject is willing and able to provide written informed consent.
* Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as per the World Health Organization (WHO) clinical classification system.
* Subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes.

Exclusion Criteria:

* Subject has a diagnosis of other cardiac or pulmonary disease.
* Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
* Subject is currently receiving treatment for PAH via modes of administration other than intravenously or orally.

Primary outcomes:
measure: Number of subjects who preferred subcutaneous injection versus current treatment options
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01062048: Januvia Re-examination Study (MK-0431-181)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 3483
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean participants with Type 2 Diabetes Mellitus being treated with Januvia

Brief summary: The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Treated With Januvia within local label for the first time

Exclusion Criteria:

* Contraindication to Januvia according to the local label
* Treated with Januvia before contract and out of enrollment period

Inclusion criteria for long-term surveillance

* Treated with Januvia for more than or equal to 24 weeks

Primary outcomes:
measure: Percentage of participants with any adverse experience
timeFrame: up to 14 days following cessation of treatment
measure: Mean change in Hemoglobin A1c (HbA1c)
timeFrame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
measure: Mean change in fasting plasma glucose (FPG)
timeFrame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
measure: Mean change in 2hr-postprandial glucose (PPG)
timeFrame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: