louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02548247: Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation
Official title: Effect of Consumption of Inulin on Bowel Motor Function in Subjects With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Constipation
Keywords: Stool frequency
Bowel motor function
Orafti® Inulin
Dietary Fiber
Lead sponsor: Beneo GmbH
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
* Age ≥ 20 and ≤ 75

Exclusion Criteria:

* Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
* Subjects with stool frequency of \<1 stool every 7 days or more than 3 stools per week.

Primary outcomes:
measure: Stool frequency determined by daily questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool consistency rated according to the Bristol Stool Form Scale
timeFrame: 4 weeks
measure: Questionnaire on Gastrointestinal characteristics
timeFrame: 4 weeks
measure: Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)
timeFrame: 4 weeks
measure: Faecal microbiota composition determined by illumina sequencing
timeFrame: 4 weeks
measure: Stool metabolite profiling determined by GC/LC-MS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandeputte D, Falony G, Vieira-Silva S, Wang J, Sailer M, Theis S, Verbeke K, Raes J. Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Gut. 2017 Nov;66(11):1968-1974. doi: 10.1136/gutjnl-2016-313271. Epub 2017 Feb 17.
citation: Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5.
Clinical trial NCT01486147: Effect of a Visual Nutrient Profiling System on Recall of Nutrition Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Food labeling
Nutrition
Memory
Diet
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the study is to validate a visual method of presenting nutritional information by determining if users of the visual method remember food properties better than users given the same information in a non-visual form with texts and tables.


Eligibility criteria: Inclusion Criteria:

* Current student at University of Illinois at Urbana-Champaign

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of correct responses for fiber and protein ratings of foods
timeFrame: 10 minutes after presentation of nutrition information
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois National Soybean Research Laboratory
state: Illinois
Study officials:
References:
Clinical trial NCT06319547: Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax
Official title: Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Hydrothorax
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022).


Eligibility criteria: Inclusion Criteria:

* Patients who met the following inclusion criteria were enrolled:
* Liver cirrhosis (with or without hepatocellular carcinoma).
* Hepatic hydrothorax (bilateral or unilateral).

Exclusion Criteria:

* patients with a pleural effusion due to a condition other than HH.
* who had a diagnosis of tuberculosis pleurisy, parapneumonic effusion, inflammatory pleuritis, other neoplasms, and congestive heart failure.

Primary outcomes:
measure: percentage of empyema in patients with hepatic hydrothorax after thoracocentesis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Chaaban T, Kanj N, Bou Akl I. Hepatic Hydrothorax: An Updated Review on a Challenging Disease. Lung. 2019 Aug;197(4):399-405. doi: 10.1007/s00408-019-00231-6. Epub 2019 May 25.
citation: Gilbert CR, Shojaee S, Maldonado F, Yarmus LB, Bedawi E, Feller-Kopman D, Rahman NM, Akulian JA, Gorden JA. Pleural Interventions in the Management of Hepatic Hydrothorax. Chest. 2022 Jan;161(1):276-283. doi: 10.1016/j.chest.2021.08.043. Epub 2021 Aug 12.
citation: Avula A, Acharya S, Anwar S, Narula N, Chalhoub M, Maroun R, Thapa S, Friedman Y. Indwelling Pleural Catheter (IPC) for the Management of Hepatic Hydrothorax: The Known and the Unknown. J Bronchology Interv Pulmonol. 2022 Jul 1;29(3):179-185. doi: 10.1097/LBR.0000000000000823. Epub 2021 Nov 10.
citation: Liu WL, Kuo PH, Ku SC, Huang PM, Yang PC. Impact of therapeutic interventions on survival of patients with hepatic hydrothorax. J Formos Med Assoc. 2010 Aug;109(8):582-8. doi: 10.1016/S0929-6646(10)60095-2.
Clinical trial NCT06591247: Membrane Stripping for Cervical Ripening
Official title: Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor, Induced
Cervical Ripening
Balloon Induction
Membrane Stripping
Pregnancy Related
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.

The study population consists of women undergoing labor induction.

The main questions it aims to answer are:

1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and above
* Patients with a cervical dilation of at least 1 cm
* Full-term pregnancy
* Cephalic presentation
* No contraindication to vaginal delivery

Exclusion Criteria:

* Patients with rupture of membranes
* Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin
* Patients for whom the use of a double-balloon catheter is contraindicated
* Twin pregnancies
* Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
* Vaginal deliveries after a cesarean section
* Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress

Primary outcomes:
measure: Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening
timeFrame: from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Rates of vaginal delivery within 24 hours
timeFrame: from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
Study officials:
References:
Clinical trial NCT05072847: Introduction of the ADAPT System in an Orthopedic Department
Official title: Introduction of the ADAPT System for Pertrochanteric Fractures in an Orthopedic Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertrochanteric Fracture
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail

Brief summary: The ADAPT system by Stryker is introduced in the orthopedic department (at Aarhus University Hospital). Following the introduction of the ADAPT system all pertrochanteric fractures operated with a gamma3 nail by stryker are operated with the use of the ADAPT system. Following surgery the operating surgeon fill out a questionaire on the use of ADAPT.

Detailed description: At the ortopedic department, Aarhus University Hospital pertrochanteric fractures are mostly operated with the gamma3 system by Stryker.

The ADAPT system is software based instrumentation designed for use in Gamma3 surgery. The software assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal targeting. ADAPT is the only augmented reality instrumentation of its kind.

From March 1, 2021 it becomes mandatory for all orthopedic surgeons at the department to use the ADAPT system when operating pertrochanteric fractures with a gamma3 nail. Following surgery the operating surgeon will fill out the System Usability Scale questionaire and an additional 3 questions.

Eligibility criteria: Inclusion Criteria:

* Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail

Exclusion Criteria:

* none

Primary outcomes:
measure: System Usability Scale
timeFrame: Questionaire including the "system usability scale" will be send to surgeons within 24 hours following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Orthopedic Department, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital, orthopedic department
name: per h gundtoft, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03795077: Effect of a Programme Based on Professional Ethics in Physiotherapy Students
Official title: Effect of a Higher Education Programme Based on Professional Ethics in Physiotherapy Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ethics
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 241
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students.

A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out.

The investigators compared a control group (traditonal lectures) with an intervention group (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional values, and opinions towards professional ethics were evaluated before and after the programme, in both groups. All participants were informed about the study and procedures, and provided written informed consent.

Detailed description: Participants. Second-year degree students of Physiotherapy Degree at the University, aged between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All enrolled participants were informed of the purpose of the study and procedures, and provided written informed consent. The study was carried out at the institution where the authors belong.

Research design. A prospective simple-blind trial was performed. After baseline assessment, participants were allocated to one of the two groups (control group and experimental group). An external assistant not involved in the study performed assignment.

Intervention. A Physiotherapy professor with over-10-year experience in Ethics and Physiotherapy performed the teaching methodology and opened the allocation envelopes and applied the teaching methodology to the EG according to the group assignment. The intervention consisted of a three-month program based in professional ethics, including two phases: A) syllabus and activities; and B) face to face group sessions including techniques such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.

Eligibility criteria: Inclusion Criteria:

* To study the physical therapy degree at the University of Valencia

Exclusion Criteria:

* Exclusion criterion was having prior training on Ethics subject

Primary outcomes:
measure: Knowledge of Professional Ethicss
timeFrame: 12 weeks
Secondary outcomes:
measure: Perception of knowledge regarding professional Ethics
timeFrame: 12 weeks
measure: Quality assessment
timeFrame: 12 weeks
measure: Satisfaction assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References:
Clinical trial NCT04902677: Parental Perception of Child's Weight and Childhood Obesity
Official title: Relationship Between Parental Perception of Child's Weight and Feeding Practices in the Context of Childhood Obesity: The PERCEPS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Diet Habit
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Hospital del Mar Research Institute (IMIM)
First posted: 2021-05-26
Enrollment: 1898
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists in children from the 22 schools in the Sant Boi municipality (Barcleona, Spain). There are 5000 children of age beween 4-8 in these schools.

Brief summary: The increasing prevalence of metabolic diseases requires new strategies in the treatment and prevention of obesity. Children exposed to a poor diet and a sedentary lifestyle are especially vulnerable and may therefore be at risk of obesity at a very early stage in their lives. Recent studies have indicated a notable misperception of children's weight by parents. The main objective of this project is to study the association between parental perception of child's body weight and 1) feeding practices (permissive, restrictive or model); and 2) child's degree of overweight.


Eligibility criteria: Inclusion Criteria:

* Willing to participate

Exclusion Criteria:

-

Primary outcomes:
measure: Infant feeding practices measured by the Child Feeding Practice questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Participant BMI z-score
timeFrame: Baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
References:
Clinical trial NCT06206577: Autogenous Grafts for Anterior Maxillary Horizontal Ridge Augmentation
Official title: Autogenous Inlay Versus Onlay Grafts for Anterior Maxillary Horizontal Ridge Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Augmentation
Keywords: onlay grafting
inlay grafting
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation.

Detailed description: Autogenous block graft has been used as onlay thin cortical shell and cortico-cancellous particles. The thin cortical shell acts as an autogenous biological membrane that will resist resorption and stabilize the small pieces of particulate bone. The bone block is screwed-in at a distance from the recipient site by means of titanium bone screws, and then the free space under the shell is filled with the particulate bone.

The resultant augmentation somehow resembles an iliac graft, with thick internal cancellous bone and a thin external cortical layer. This leads to an ideal graft, with a high regenerative capacity comparable to iliac bone and a stable regenerated volume with optimum osseointegration potential close to that of mandibular block grafts.

Interpositional grafts have been successfully established in restoring vertical bone height . However much less evidence is present on its use for horizontal augmentation. It is the purpose of this study to assess the efficacy of autogenous onlay corticocancellous block grafts for anterior maxillary horizontal ridge augmentation as compared to onlay block grafts.

Eligibility criteria: Inclusion Criteria:

1. Patients with missing upper anterior tooth / teeth with horizontal ridge dimension range from 2 to 5 mm (measured 2mm below alveolar crest).
2. Adequate vertical height.
3. Having good oral hygiene.
4. being healthy, with no systemic diseases that might contraindicate receiving a dental implant
5. Patients were able to comply with the follow-up and maintenance program

Exclusion Criteria:

1. Presence of local infection or lesions at site of interest.
2. Dental history of bruxism, or other parafunctional habits.
3. Uncooperative patients.
4. Current chemotherapy or radiotherapy.
5. Patients with aggressive periodontal disease

Primary outcomes:
measure: horizontal ridge augmentation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura U
Study officials:
References:
Clinical trial NCT03554577: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
* colour blinded

Primary outcomes:
measure: Sound quality ratings
timeFrame: 4 weeks
Secondary outcomes:
measure: Oldenburg sentence test in noise
timeFrame: 4 weeks
measure: Oldenburg sentence test & manual tracking task
timeFrame: 4 weeks
measure: Adaptive Categorial Listening Effort Scaling (ACALES)
timeFrame: 2 weeks
measure: Self-report form
timeFrame: One week
Other outcomes:
measure: Interaural Phase Difference (IPD) Detection thresholds
timeFrame: 1 week
measure: Non-verbal Trail Making Test A & B
timeFrame: 1 week
measure: color-word-interference test by J.R.Stroop
timeFrame: 1 week
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Juliane Raether
role: PRINCIPAL_INVESTIGATOR
References: