louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401123: Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand
Official title: Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Human Milk
Keywords: breast milk
breastfeeding
milk contents
human milk
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: breasting pump
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The researchers planned this study to compare the effects of breast pumps, which are frequently used today, and manual milking after manual massage on the change in milk content when breast and breastfeeding problems develop.

Detailed description: Comparison of the methods used to solve the milk secretion and breastfeeding problems of the participants in the postpartum period; effective and uncomplicated methods should be put forward. Today, breast milk is expressed by hand using massage or pumps. Both milking techniques used have positive and negative aspects. While there are studies showing that breast milk content is affected by the milking techniques used, there are also studies showing that it does not. This study by the researchers was planned to compare the effects of post-massage pumps and manual milking on the change in milk content. For this reason, it is thought that the researchers will contribute to the literature scientifically and, since it is a doctoral thesis, it can be a guide for future studies on the subject.

Eligibility criteria: Inclusion Criteria:

Between the ages of 20-35

* Postpartum 1-5. between the day
* Those who gave birth after the 37th week of pregnancy
* The baby does not have any condition that prevents sucking
* Those whose baby is not hospitalized in the neonatal intensive care unit
* Those who do not have literacy problems, mental disabilities and communication problems
* Mothers who agreed to participate in the study voluntarily

Exclusion Criteria:

Those who want to quit working voluntarily

* Inaccessible, cut off communication during operation
* Mothers whose babies were hospitalized during the study
* Hospitalized during the study
* Not completing study post-tests
* Who does not do any milking for a day
* Mothers who express only once a day for two consecutive days

Primary outcomes:
measure: The protein contents will be analyzed by Miris®️ HMA
timeFrame: 12 week
measure: The ph contents will be analyzed by Miris®️ HMA
timeFrame: 12 week
measure: The carbohydrate contents will be analyzed by Miris®️ HMA
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00169923: Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
Official title: Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease
Inflammation
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
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 in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.

Detailed description: This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.

At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.

Eligibility criteria: Inclusion Criteria:

* Written consent
* Over 18 years of age
* Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines

Exclusion Criteria:

* Life span of less than one year
* Alcohol abuse
* Transaminases \> 2.5 times the upper limit
* Diabetes mellitus
* Pregnancy
* Cardiac disease with marked limitation of functional capacity (NYHA III or IV)
* Use of immunosuppressant agents

Primary outcomes:
measure: intima media thickness
timeFrame: 48 weeks
Secondary outcomes:
measure: carotid artery calcifications
timeFrame: 48 weeks
measure: inflammation
timeFrame: 48 weeks
measure: lipid profile
timeFrame: 48 weeks
measure: metabolic profile
timeFrame: 48 weeks
measure: pulse wave velocity
timeFrame: 48 weeks
measure: nutritional status
timeFrame: 48 weeks
measure: bone density
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
state: Z-Holland
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
state: Z-Holland
Study officials:
affiliation: Leiden University Medical Center
name: andré gaasbeek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04017923: Measurement of Age and Sex Related Changes in Nasal Tip Support Using Digital Newton Meter
Official title: Age and Sex Related Changes in Nasal Tip Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Valve Incompetence
Alar Collapse
Keywords: Nasal tip
Tip support
Rhinoplasty
Nasal cartilage
Age
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older

Brief summary: Background:

It is predicted that the nasal tip support will decrease with aging due to weakening of cartilage and connective tissues. However, there is no consensus on the age at which this change began. It is quite difficult to evaluate the nasal tip support, while the ideal nasal tip support pressure is also not known. The aim of this study is to determine the nasal tip support pressure alterations in various age groups, by measuring nasal tip support with a Newton meter, according to age and gender.

Methods:

This prospective clinical study was conducted between January 2019 and April 2019 at a tertiary health facility. Nasal tip resistances in 4 different age groups, as 20-29, 30-39, 40-64 and 65 years and older, were measured with a digital Newton meter. A total number of 159 patients with a minimum of 36 patients in each age group were included in the study. Nasal tip resistance measurements were compared among nasal tip displacement distances of 2mm, 3mm and 4mm, according to age groups and gender.


Eligibility criteria: Inclusion Criteria:

* Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older. A total of 159 patients with a minimum of 36 patients in each group were included in the study.

Exclusion Criteria:

* Patients with a history of nasal trauma, previous nasal surgery (septoplasty, rhinoplasty, tumor surgery), severe deviation of the caudal septum, visible external nasal deviation, and systemic disease affecting the connective tissue were excluded from the study.

Primary outcomes:
measure: Measurement of nasal tip resistance
timeFrame: All measurements were obtained within 2 months. (march 01-May 01)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Alper Koycu
state: Cankaya
Study officials:
References:
Clinical trial NCT00156923: ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Official title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcoholism
Keywords: Alcohol dependence
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 108
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 was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Detailed description: Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Eligibility criteria: Primary Inclusion Criteria:

* Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
* Willing and able to return for scheduled clinic visits and study assessments
* Noncustodial, stable address and phone
* Written, informed consent

Primary Exclusion Criteria:

* Pregnancy or lactation
* Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

Primary outcomes:
measure: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to 3.5 years of monthly treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References:
citation: O'Brien CP, Gastfriend DR, Forman RF, Schweizer E, Pettinati HM. Long-term opioid blockade and hedonic response: preliminary data from two open-label extension studies with extended-release naltrexone. Am J Addict. 2011 Mar-Apr;20(2):106-12. doi: 10.1111/j.1521-0391.2010.00107.x. Epub 2010 Dec 28.
Clinical trial NCT02825823: The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
Official title: The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Ketones
Dietary Supplements
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.


Eligibility criteria: Inclusion Criteria:

* Males aged 18-40
* Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
* Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)

Exclusion Criteria:

* Diagnosed with diabetes or any other medical conditions that could affect metabolism.
* Diagnosed with heart disease or taking anti-hypertensive medications.
* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
* Current consumption of ketone supplements
* Any other contraindication to vigorous exercise (identified via physical activity readiness questionnaire \[PAR-Q\])

Primary outcomes:
measure: Respiratory Exchange Ratio (RER) during cycling exercise
timeFrame: 0-18 minutes
Secondary outcomes:
measure: 10 km Cycling Time Trial Performance
timeFrame: Following 18 minutes of steady-state exercise
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
References:
Clinical trial NCT02430623: Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder Neoplasms
Keywords: irreversible electroporation
Unresectable Urinary Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Urinary Bladder Neoplasms.

Detailed description: By enrolling patients with unresectable Urinary Bladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Urinary Bladder Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Head and Urinary Bladder diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05169723: Respiratory Emissions in Healthy Participants
Official title: Respiratory Emissions in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is an randomised cross over trial in healthy participants measuring respiratory emissions during different respiratory activities.


Eligibility criteria: Inclusion Criteria:

* Adults, over the age of 18 and able to give informed consent
* Symptom free from any respiratory illness in the last 48 hours

Exclusion Criteria:

* Pregnant (where the participant feels that their pregnancy will make participation uncomfortable)
* Inability to give consent
* Current respiratory disease. Participants with well controlled asthma will be included (defined as asthma that the participant self-rates their asthma as being under control and that does not limit exercise, work)

Primary outcomes:
measure: Count of total number of respiratory particles emitted during respiratory activities in the range of 0.3 to 25 microns
timeFrame: Emission of particles will be collected and analysed for 2 minutes during each experimental condition
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare
Study officials:
References:
Clinical trial NCT05960123: Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Official title: Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Complication,Postoperative
Keywords: Distal and midpenile hypospadias
TIPU
Spongioplasty-dartosoraphy
pediatric HOSE
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 220
Sex: MALE
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).


Eligibility criteria: Inclusion Criteria:

* lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

Exclusion Criteria:

* recurrent cases Proximal; hypospadias

Primary outcomes:
measure: Urethrocutaneous fistula
timeFrame: 12 months
measure: meatal stenosis
timeFrame: 12 months
measure: glans dehiscence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Cosmetic results
timeFrame: 12 months
Locations:
city: Cairo
country: Egypt
facility: Mohammad Daboos
state: Select
Study officials:
References:
Clinical trial NCT01297023: Human Intervention Study With Calcium Phosphate and Vitamin D
Official title: The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: calcium phosphate
vitamin d3
bone metabolism
human study
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* pregnancy, lactation
* intake of dietary supplements

Primary outcomes:
measure: bone resorption and bone formation markers in blood and urine
timeFrame: 8 weeks
Secondary outcomes:
measure: concentration of minerals in blood, stool and urine
timeFrame: 8 weeks
measure: blood lipids
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trautvetter U, Neef N, Leiterer M, Kiehntopf M, Kratzsch J, Jahreis G. Effect of calcium phosphate and vitamin D(3) supplementation on bone remodelling and metabolism of calcium, phosphorus, magnesium and iron. Nutr J. 2014 Jan 17;13:6. doi: 10.1186/1475-2891-13-6.
Clinical trial NCT00350623: Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
Official title: A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: AIDS
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.


Eligibility criteria: Inclusion Criteria:

* Demonstrates good general health
* Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
* Low risk of acquiring HIV infection
* ALT lab value within normal range

Exclusion Criteria:

* Previously received an investigational HIV vaccine
* Has a known or suspected impairment of immunologic function
* Has a clinically significant chronic medical condition that is considered progressive
* Has a major psychiatric illness
* Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
* Weighs less than 105 lbs.
* Has a recent (within two years) history of chronic alcohol abuse
* Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
* Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
* Male subject is planning to impregnate or provide sperm donation during the study

Primary outcomes:
measure: Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: