louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04076293: Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Official title: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacology
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects


Eligibility criteria: Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
* Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit

Exclusion Criteria:

* Subject with a history or presence of clinically significant active diseases.
* Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events of HM15912
timeFrame: after single subcutaneous (SC) doses for 44 days
measure: Number of Participants With Significant Findings Observed for Hematology
timeFrame: after single subcutaneous (SC) doses for 44 days
Secondary outcomes:
measure: Concentration Max Profile of HM15912
timeFrame: after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT04065893: Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Official title: Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systolic Heart Failure
Ventricular Premature Complexes
Ventricular Tachycardia
Cardiac Resynchronization Therapy
Reduced Biventricular Pacing
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pts. with systolic heart failure, wide QRS complex and CRT with reduced biventricular pacing due to ventricular arrhythmia (PVC/VT)

Brief summary: Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%.

Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.


Eligibility criteria: Inclusion Criteria:

* reduced biventricular pacing \<98% due to ventricular arrhythmia

Exclusion Criteria:

* reduced biventricular pacing \<98% due to other cause
* age \<18
* pregnancy

Primary outcomes:
measure: Percentage of Biventricular pacing
timeFrame: 3 month after intervention biventricular pacing (%) is routinely monitored
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
References:
citation: van den Bruck JH, Middeldorp M, Sultan A, Scheurlen C, Seuthe K, Wormann J, Filipovic K, Kadhim K, Sanders P, Steven D, Luker J. Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2023 Mar;66(2):353-361. doi: 10.1007/s10840-022-01259-0. Epub 2022 Jun 14.
Clinical trial NCT01770093: Preferences of Parents for Pediatric Inpatient Ward Physicians' Attire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parents
Physicians
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-17
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents whose children have been hospitalized

Brief summary: Several studies have been conducted throughout the world to evaluate patients' and parents' preferences regarding physicians' attire. Most studies have shown that the attire influences their feelings trust and confidence regarding their care. In most countries the preference is for formal attire. In other places a more casual attire is generally accepted. Israel is a country where casual dress is acceptable in most settings. Israeli physician's dress code has been discussed in the past, but has never been systematically studied. The aim of this study is to systematically examine the attitudes of parents of children who have been admitted to the pediatric ward towards physicians' attire.


Eligibility criteria: Inclusion Criteria:

* Parents whose children have been hospitalized

Exclusion Criteria:

* All others

Primary outcomes:
measure: Number of parents preferring formal physician attire
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT06499493: Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius
Official title: Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius: A Prepost Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Trigger Point
Gastrocnemius Muscle
Manual Therapy
Pain Threshold
Keywords: gastrocnemius muscle
range of motion
lower limb
therapeutics
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the present study we will test the effects of myofascial induction technique in the muscles close to the application in the gastrocnemius muscle.

Detailed description: In the present study we will test the effects of myofascial induction technique on nearby muscles. The calf maneuver proposed by Pilat for myofascial induction will be applied and the effects on the pain pressure threshold of the trigger points of the flexor digitorum brevis biceps femoris extensor digitorum longus muscles will be observed.

Eligibility criteria: Inclusion criteria:

* Subjects aged 18-39 years.
* Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs.

Exclusion criteria;

* Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement and/or fasciitis.
* History of lower limb surgery or history of lower limb injury with residual symptoms (pain or sensation of sensation) within the last year.
* Participants could not have undergone ankle stretching or any other treatment.
* Diabetes due to possible impaired distal arterial circulation.
* Foot deformity, cavus and flat feet.
* Foot deformities such as hammertoes and hallux valgus,
* plantar calluses.
* Dysfunction of the lower extremities or chronic injuries.

Primary outcomes:
measure: 1.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles before intervention
timeFrame: Immediately before intervention.
measure: 2.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles after intervention
timeFrame: Immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: San Sebastián De Los Reyes
country: Spain
facility: Mayuben Clinic
state: Madrid
Study officials:
References:
Clinical trial NCT03344393: Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery
Official title: Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: .The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.

Detailed description: I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.

II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.

Eligibility criteria: Inclusion Criteria:

* - Patient's status ASA status-I and II.
* Patients age above 18 years old.
* Patients scheduled for intestinal surgery.

Exclusion Criteria:

* Patient refusal.
* Patients with known allergy to ketamine or morphine.
* Patients with significant hepatic dysfunction.
* Patients with severe renal disease.
* Significant Heart disease.
* Patients with chronic pain.
* Regular use analgesics, antidepressants or opioids in last 2 months.
* Any known convulsive disorder.
* Morbid obesity (BMI\>35).
* Patients with autoimmune disease
* Patients on corticosteroid therapy
* Pregnancy.
* Breast feeding.
* Woman under hormonal treatment.
* Oral disease.

Primary outcomes:
measure: morphine consumption
timeFrame: 2 days postoperative
Secondary outcomes:
measure: cortisol level
timeFrame: 2 days postoperative
measure: alpha amylase level
timeFrame: 2 days postoperative
Other outcomes:
Locations:
Study officials:
References:
citation: Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.
Clinical trial NCT01081093: Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Official title: Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction
Biventricular Pacemaker cardiac surgery aortic valve replacement
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.

A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.

The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.


Eligibility criteria: Inclusion Criteria:

* 18 years
* Hypertrophic Cardiomyopathy
* Aortic valve replacement

Exclusion Criteria:

* Atrial fibrillation
* Pericarditis
* postoperative low output
* Preoperative permanent pacemaker placement

Primary outcomes:
measure: Cardiac output
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe Universitätsklinikum
Study officials:
References:
Clinical trial NCT03283293: Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT
Official title: Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Neoadjuvant Chemotherapy
Intensity-modulated Radiation Therapy
Target Volume Delineation
Locoregional Failure Pattern
Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 112
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality. Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.


Eligibility criteria: Inclusion Criteria:

1. histologically confirmed NPC;
2. no evidence of distant metastasis;
3. no previous treatment for NPC;
4. stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
5. adequate liver, renal and bone marrow function;
6. Karnofsky Performance Status (KPS) ≥80 scores.

Exclusion Criteria:

1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT;
2. disease progression during NACT;
3. presence of distant metastasis;
4. pregnancy or lactation;
5. previous malignancy or other concomitant malignant disease.

Primary outcomes:
measure: 5-year loco-regional recurrence free survival (LRRFS)
timeFrame: Five years
Secondary outcomes:
measure: 5-year local recurrence free survival (LRFS)
timeFrame: Five years
measure: 5-year regional recurrence free survival (RRFS)
timeFrame: Five years
measure: 5-year distant metastasis free survival (DMFS)
timeFrame: Five years
measure: 5-year disease specific survival (DSS)
timeFrame: Five years
measure: 5-year overall survival (OS)
timeFrame: Five years
measure: Locoregional failure patterns
timeFrame: Five years
measure: Late toxicities
timeFrame: Five years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01667393: Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
Official title: Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.


Eligibility criteria: Inclusion Criteria:

* Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

Exclusion Criteria:

* Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: MAE-free survival rate.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04435093: Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Official title: Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Keywords: Neuromuscular Diseases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve children with a neuromuscular disease, aged 6 to 11 years old

Brief summary: The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items assessing motor functional abilities in a person with neuromuscular disease.

By exploring the potential of digital technologies applied to MFM, for each item completion we want to create digital animations containing different playful and informative scenarios. This digital evolution aims to standardize assessment on the therapist's side, but also to improve acceptance of scale and patient participation.

Despite the modification of the MFM completion by digital animation, the study hypothesis is that the metrological qualities of the scale are retained.

Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale before carrying out a validation study of the total MFM-Play.


Eligibility criteria: Inclusion Criteria:

* Girls and boys with a neuromuscular disease
* Aged 6 to 11 years old
* With parental assent

Exclusion Criteria:

* Patients participating to a therapeutic trial
* Patients without compartmental capacities to participate normally to the MFM.

Primary outcomes:
measure: MFM scores item 18 to 22
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
city: La Tronche
country: France
facility: CHU de Grenoble
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Dominique Vincent-Genod
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05541393: Engaging Church Health Ministries to Decrease Coronavirus Disease-19 Vaccine Hesitancy in Underserved Populations
Official title: Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities.

Detailed description: This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities. A total of 98 participants from three-to-five churches will be randomized to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated, boosted, and tested, or to a delayed intervention control group. The effects of the intervention on the primary outcome, change in vaccine/booster hesitancy, will be assessed by a questionnaire that will be administered to both groups at baseline and after three weeks. Following the three-week control period, the delayed intervention control group will also receive the intervention and again be administered the questionnaire. Questionnaires will be used to obtain more granular information on sources of vaccine/booster hesitancy and for their vaccine-related decisions.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 y
* Not having received an initial COVID-19 vaccine or a booster vaccine at the recommended interval
* Having vaccine or booster hesitancy
* Able to understand and speak English
* Willing to engage with the church's health ministry via in-person or virtual/phone sessions

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks
timeFrame: Baseline and three weeks
Secondary outcomes:
measure: Change in Vaccine/Booster Uptake from Baseline to 3 Weeks
timeFrame: Baseline and three weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: