louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04148040: Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
Official title: Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infantile Hypertrophic Pyloric Stenosis
Pyloromyotomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 20
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.

Exclusion Criteria:

* Comorbid conditions that could affect postoperative recovery.
* Needed an additional procedure during the same anaesthetic.

Primary outcomes:
measure: episodes of postoperative vomiting
timeFrame: 6 months after surgery
measure: major complication
timeFrame: 6 months after surgery
Secondary outcomes:
measure: operating and anaesthetic time
timeFrame: 6 months after surgery
measure: myotomy length
timeFrame: 6 months after surgery
measure: other complications
timeFrame: 6 months after surgery
measure: postoperative pain assessment by "Pain assessment for children under four years"
timeFrame: 6 months after surgery
measure: analgesia requirements
timeFrame: 6 months after surgery
measure: time to full enteral feed
timeFrame: 6 months after surgery
measure: postoperative length of stay
timeFrame: 6 months after surgery
measure: need for re-operation
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Pinghong Zhou
role: STUDY_CHAIR
References:
Clinical trial NCT00279240: Life Style Modifications Prevents Type 2 Diabetes in Asian Indians
Official title: The Indian Diabetes Prevention Programme Shows That Lifestyle Modification and Metformin Prevent Type 2 Diabetes in Asian Indian Subjects With Impaired Glucose Tolerance (IDPP1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Impaired glucose tolerance
Intervention
Prevention
Lead sponsor: M.V. Hospital for Diabetes
Sponsor class: OTHER
First posted: 2006-01-19
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: Three year prospective randomised controlled trial in IGT subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes

Detailed description: Lifestyle modification helps in primary prevention of diabetes in multiethnic Americans, Finnish and Chinese populations. In a prospective community based study, we tested if the conversion to diabetes could be influenced by interventions in native Asian Indians with impaired glucose tolerance (IGT) who were younger, leaner and more insulin resistant than the above populations.

We randomized 531 (Men : Women, 421 : 110) subjects with IGT \[mean age of 45.9 + 5.7 years and body mass index (BMI) of 25.8 + 3.5 kg/m2 into four groups. Group 1 was the control (CON), Group 2 was advised lifestyle modification (LSM), Group 3 was treated with metformin (MET) and Group 4 with LSM plus MET. Primary outcome measure was type 2 diabetes diagnosed by the WHO criteria.

In a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in group 1 to 4 respectively. The relative risk reduction was 28.5% with LSM (95 % confidence interval (CI), (20.5 - 37.3), (p=0.018), 26.4% with MET (95% CI, 19.1 - 35.1) (p = 0.029) and 28.2% with LSM plus MET (95% CI, 20.3 - 37.0), (P=0.022) versus control group. The numbers needed to treat to prevent one incident case of diabetes were 6.4 for LSM, 6.9 for MET and 6.5 for LSM+MET.

Conversion of IGT to diabetes is high in native Asian Indians. LSM and metformin significantly reduced the incidence of diabetes in Asian Indians with IGT. There was no added benefit by combining both.

Eligibility criteria: Inclusion Criteria:

* Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study.

Exclusion Criteria:

* Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs.

Primary outcomes:
measure: Reduction in conversion of IGT to diabetes
Secondary outcomes:
measure: Benefits of the drug on anthropometric variables and biochemical parameters
Other outcomes:
Locations:
city: Chennai
country: India
facility: Diabetes Research Centre & MV Hospital for Diabetes
state: Tamilnadu
Study officials:
affiliation: Director
name: Ambady Ramachandran, MD,PhD,DSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560040: Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon
Official title: Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Troponin
Natriuretic Peptide, Brain
Exercise
Echocardiography
Keywords: Troponin
Natriuretic Peptide, Brain
Exercise
Echocardiography
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Abbott Point of Care
First posted: 2007-11-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To determine if pre-race training effects heart damage induced by marathon running.

Detailed description: Investigations have shown increases in cardiac markers consistent with myocardial injury and left ventricular dysfunction in both recreational and elite athletes after endurance exercise. Pre-race training is an important component of endurance events, yet its effect on cardiovascular injury is unclear. The present study aimed to evaluate the correlation between myocardial injury and training level in recreational marathon runners utilizing both objective and subjective measures.

Eligibility criteria: Inclusion Criteria:

* Any healthy male or female aged 18-65 planning to run the 2006 Silicon Valley Marathon.

Exclusion Criteria:

* Hypertension
* Hyperlipidemia
* Diabetes
* History of myocardial infarction or acute coronary syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford Hospital and Clinics
name: Suzanne M Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01684540: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
Official title: Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility criteria: Inclusion Criteria:

* Female or male individuals ≥ 18 years
* Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period

Exclusion Criteria:

* Contra indications according to the label

Primary outcomes:
measure: Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
timeFrame: day 1, day 7, day 14
Secondary outcomes:
measure: Quality of Life questionnaire (Rhino QoL)
timeFrame: day 1, day 7, day 14
measure: Rhinoscopy
timeFrame: day 1, day 7, day 14
measure: Patient's and physician's judgment of efficacy
timeFrame: day 7, day 14
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Dr. med. Georg Krueckels
city: Aachen
country: Germany
facility: Dr. med. Martin Sondermann
city: Aachen
country: Germany
facility: Dr. med. Norbert Pasch
city: Juelich
country: Germany
facility: Dr. med. Wilhelm Schuetz
city: Koeln
country: Germany
facility: Peter Hinterkausen
city: Koeln
country: Germany
facility: Taufik Shahab
Study officials:
affiliation: Institut für Med. Informatik, Statistik und Epidemiologie
name: Ralph Mösges, Prof.
role: STUDY_DIRECTOR
References:
citation: Eichel A, Wittig J, Shah-Hosseini K, Mosges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragees) in patients with acute rhinosinusitis. Curr Med Res Opin. 2013 Jul;29(7):739-46. doi: 10.1185/03007995.2013.800474. Epub 2013 May 14.
Clinical trial NCT06638840: Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
Official title: Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ponto sound processor users

Brief summary: The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution. The purpose of this study is to assess subjective benefit by evaluating performance and overall satisfaction of the Ponto on a Ponto Softband in pediatric users.


Eligibility criteria: Inclusion Criteria:

* currently using Oticon Medical Ponto sound processor on Oticon Medical Softband

Exclusion Criteria:

* not

Primary outcomes:
measure: PEACH Overall Score
timeFrame: Single timepoint for completion of survey
measure: Quiet PEACH
timeFrame: Single timepoint for completion of survey
measure: Noise PEACH
timeFrame: Single timepoint for completion of survey
measure: Total GCBI Score
timeFrame: Single time point for completing survey
measure: Psycho Social GCBI Score
timeFrame: Single timepoint for completion of survey
measure: Physical Health GCBI Score
timeFrame: Single timepoint for completion of survey
measure: Behavior GCBI Score
timeFrame: Single timepoint for completion of survey
measure: Vitality GCBI Score
timeFrame: Single timepoint for completion of survey
measure: Use of Sound Processor
timeFrame: Single timepoint for completion of survey
measure: Hearing Benefit
timeFrame: Single timepoint for completion of survey
measure: Overall Satisfaction - Ponto Experience
timeFrame: Single timepoint for completion of survey
measure: Satisfaction With Softband
timeFrame: Single timepoint for completion of survey
Secondary outcomes:
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Oticon Medical
state: New Jersey
Study officials:
References:
Clinical trial NCT03323840: Pilot for a Community Pharmacy Service Model: Impact of a Pharmacist Monitored Patient Blood Pressure Readings
Official title: Pilot for a Community Pharmacy Service Model: Impact of a Pharmacist Monitored Patient Blood Pressure Readings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to explore whether routine measurement of blood pressure by community pharmacists can improve patient adherence to blood pressure medications. The study will utilize an incentivized care approach, in which patients receive a $10 gift card for every time they come to the pharmacy for blood pressure management (up to 2 times/month). The investigators hypothesize that the simple process of coming in for a blood pressure measurement (without any other scripted interventions, counseling, or consultation) will be feasible and sufficient to improve adherence to medications. The investigators will also collect preliminary data to help estimate how these hypothetical improvements in adherence might result in improved blood pressure control, fewer office visits, and (ultimately) fewer adverse cardiovascular outcomes (i.e. heart attacks, strokes, etc).


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of hypertension
* Current prescription for ≥2 antihypertensive medications for primary diagnosis of hypertension
* Prior use of ≥1 antihypertensive medication for ≥6 months at the same Kroger's Pharmacy (#523)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Age \<18 years
* New diagnosis of hypertension within the prior 6 months
* Current pregnancy or lactation
* Limited English Proficiency
* Use of antihypertensive medications for secondary prevention of cardiovascular events. Patients with history of acute myocardial infarction, stroke, heart failure will be excluded, however, patients with diabetes will be eligible for participation.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Benjamin Van Tassell, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00088140: A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
Official title: A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Conatus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Idun Pharmaceuticals
First posted: 2004-07-21
Enrollment: 204
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: The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C infection
* Unsuccessful prior HCV treatment
* Liver impairment (either AST or ALT 1.5-10.0 x ULN)
* Alpha-fetoprotein \<= 50 ng/mL
* Adequate hematologic parameters

Exclusion Criteria:

* Decompensated or severe liver disease
* Hepatocellular carcinoma
* HIV infection
* Co-infection with hepatitis B virus (HBV)
* Renal impairment
* Pancreatitis
* Use of illicit or drugs of abuse
* History of alcohol abuse
* Presence of clinically significant cardiac arrhythmias
* If female, pregnant or lactating

Primary outcomes:
measure: Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
measure: Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: New York City
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT06415240: Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates
Official title: Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Pharmacological Pain Management
Keywords: Non Pharmacological Pain Management
Neonates
Procedural Pain
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 159
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.

Detailed description: The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.

Eligibility criteria: Inclusion Criteria:

1. Both term and preterm neonates.
2. APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
3. Admitted to the Neonatal Intensive Care Unit
4. Undergoing arterial prick for the first time.

Exclusion Criteria:

1. Documented birth asphyxia
2. Congenital anomalies
3. Neurological diagnosis,
4. ventilated with paralysis
5. Extremely premature newborns (Gestational age \< 28 weeks)

Primary outcomes:
measure: Neonatal Infant Pain Scale
timeFrame: Before,During Arterial Prick and after three minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences
city: Islamabad
country: Pakistan
facility: Shifa Tameer E Millat University
Study officials:
affiliation: Shifa Tameer E Millat Univesrity
name: Nazma Hamid, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381640: A Study to Compare Two Paracetamol Tablets
Official title: A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: paracetamol
healthy volunteer
pharmacoscintography
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects who are in good general health
* Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

Primary outcomes:
measure: Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition
timeFrame: Baseline to 12 hours post dosing
Secondary outcomes:
measure: To assess the gastrointestinal transit by qualitative scintigraphic analysis
timeFrame: Baseline to 12 hours post dosing
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: BIO-IMAGES Research Ltd.
state: Scotland
city: Glasgow
country: United Kingdom
facility: Bio-Images
state: Scotland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: