louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01718418: Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
Official title: Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.


Eligibility criteria: Inclusion Criteria:

* Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives

Exclusion Criteria:

* gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians

Primary outcomes:
measure: Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
timeFrame: Post-prandially after breakfast, 0-210 min
Secondary outcomes:
measure: voluntary energy intake
timeFrame: Post-prandially after breakfast, 0-210 min
measure: Subjective satiety
timeFrame: post-prandially after breakfast, 0-210 min
measure: Differences in gut microbiota
timeFrame: Faecal samples are collected after 14 days intake of test- and reference product
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Applied Nutrition and Food Chemistry, Lund University
Study officials:
affiliation: Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.
Clinical trial NCT02931318: The Knowledge Levels and Attitudes of the People Living in Nevşehir on Organ Donation and Transplantation
Official title: The Knowledge Levels and Attitudes of the People Living in the City Center of Nevşehir on Organ Donation and Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Finding
Keywords: Organ donation
brain death
public opinion
Lead sponsor: Nevsehir Public Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Nevsehir Haci Bektas Veli University
First posted: 2016-10-13
Enrollment: 414
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this descriptive study, the purpose was to determine the knowledge levels and attitudes of the people in Nevsehir, Turkey on organ donation.

It has been determined that the people living in Nevsehir do not have sufficient knowledge on organ donation, they had various concerns on the issue, and they wanted to receive information from Organ Donation Units. It can be used the exemplification and internalization in educational curricula about increasing the organ donation.

Detailed description: Purpose

In this descriptive study,the purpose was to determine the knowledge levels and attitudes of the people in Nevsehir on organ donation.

Methods

The data of the study were collected with the questionnaire applied to 414 people residing in Nevşehir between February and May 2016. In evaluating the data, the numbers, percentage calculations, Chi-Square Test,t-test, and One-Way tests were used.

Eligibility criteria: Inclusion Criteria:

* Anyone aged between 20-65
* The people living in the city center of Nevşehir, Turkey

Exclusion Criteria:

* \<20 years old

  * 65 years old
* The people who do not live the city center of Nevşehir, Turkey

Primary outcomes:
measure: Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: republic of turkey ministry of health
name: Mehmet Akif Yazar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haustein SV, Sellers MT. Factors associated with (un)willingness to be an organ donor: importance of public exposure and knowledge. Clin Transplant. 2004 Apr;18(2):193-200. doi: 10.1046/j.1399-0012.2003.00155.x.
citation: Sanner MA. A Swedish survey of young people's views on organ donation and transplantation. Transpl Int. 2002 Dec;15(12):641-8. doi: 10.1007/s00147-002-0474-1. Epub 2002 Nov 5.
Clinical trial NCT04153318: Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB
Official title: Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Diseases
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study

Brief summary: In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.

Detailed description: Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.

Eligibility criteria: Inclusion Criteria:

* Tissue samples can be obtained via EUS-FNB
* Signed informed consent letter

Exclusion Criteria:

* Unable or refuse to provide informed consent

Primary outcomes:
measure: Sensitivity of Light-CT
timeFrame: 1week after procedure
Secondary outcomes:
measure: Sensitivity of Light-CT
timeFrame: 1week after procedure
measure: The diagnostic efficacy of Light-CT for different pancreatic diseases
timeFrame: 1week after procedure
measure: coherence of FFOCT diagnoses by assistant and pathologist
timeFrame: 1week after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02252718: Amsterdam Stool Scale: Usefulness in Clinical Setting
Official title: Amsterdam Stool Scale: Usefulness in Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stool Assessment
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group will be selected from the children admitted to the Department of Pediatrics The Medical University of Warsaw

Brief summary: The aim of this study is to assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating in the study it will be assessed using the Amsterdam Stool Scale independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos that will be independently evaluated by another doctor.

Detailed description: INTRODUCTION:

Description of stool appearance is important in clinical practice. Parents are often asked to evaluate stool of their child. At present parents also take more frequently photos using smartphone camera when they are concerned with child's stool appearance and show it to their doctors. To make stool evaluation easier there have been stool form scales created. One of this is Amsterdam Stool Scale that enables stool assessment of children who are not yet toilet trained. This scale facilitates to describe amount, consistency and color of the stool.

AIM:

To assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice.

METHODS:

After passing a stool by the child participating in the study, within a short-time interval (\<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone camera. The photographs then will be independently evaluated by another doctor who will be unaware of both the "in vivo" stool appraisal and child condition.

STATISTICAL ANALYSIS:

Then the interobserver (between a parent, the doctor and the doctor assessing photograph) variability will be evaluated by calculating the kappa (κ) statistics for nominal data for the stool consistency, amount and color separately.

Eligibility criteria: Inclusion Criteria:

* Age 0-18 months of age
* Lack of ability to use the toilet

Exclusion Criteria:

* Lack of parental consent to participate in the study
* Parental inability to understand the study procedures

Primary outcomes:
measure: Interrater Variability (IV)
timeFrame: <5min after defecation
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
Study officials:
References:
Clinical trial NCT03685513: One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
Official title: One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Single Posterior Crowns
Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth
Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.

BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.

The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.


Eligibility criteria: Inclusion Criteria:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to withstand conventional dental procedures
4. Patients with teeth problems indicated for single posterior crowns:

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
   6. Spacing between posterior teeth
5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient less than 18 or more than 50 years
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest

Primary outcomes:
measure: Fracture
timeFrame: 1 year
Secondary outcomes:
measure: Marginal adaptation
timeFrame: 1 year
Other outcomes:
measure: Patient Satisfaction
timeFrame: 1 year
Locations:
Study officials:
References:
Clinical trial NCT00487513: Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials
Official title: Procurement of Follicular B Cell Lymphoma Cells From Blood, Tissue or Malignant Effusion for the Purpose of Possible Use in Future Clinical Trials: A Minimal Risk Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular B Cell lymphoma
vaccination
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2007-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are selected because they have Non-Hodgkin's lymphoma.

Brief summary: In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting samples from people with this diagnosis. We then hope to make a vaccine from this tissue to help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank indefinitely.

Detailed description: - The following tests and procedures will be performed: Approximately 50cc of peripheral blood will be drawn and stored in the tissue bank; patients who have follicular lymphoma cells circulating in the blood will have about 40cc's of blood drawn and stored for processing; patients undergoing a lymph node biopsy will have samples of the biopsy stored; patients having fluid drained from the abdomen or from around the lung will have some of their fluid saved to cell collection and processing; patients undergoing a bone marrow biopsy will have some of the sample stored for cell collection and processing.

Eligibility criteria: Inclusion Criteria:

* Relapsed, refractory or de novo histologically confirmed follicular B-cell lymphoma with accessible lymph nodes, tumor mass or malignant effusion or peripheral blood
* 35 years of age or older

Exclusion Criteria:

* Uncontrolled active infection
* HIV or viral Hepatitis infection
* Other current malignancies except any in situ cancer or basal or squamous cell carcinoma of the skin
* Autoimmune cytopenias

Primary outcomes:
measure: Tissue collection for vaccine generation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01874613: Clinical Study of FRC Implant to Treat Skull Bone Defects
Official title: Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cranial Bone Defect
Orbital Base Fracture
Keywords: Craniofacial bone reconstruction
Fibre-reinforced composite
Bioactive glass
Craniotomy
Skull bone defect
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
name: Turku Clinical Biomaterials Centre
First posted: 2013-06-11
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects.

Functional and aesthetic outcome is assessed by patient and doctor.

Detailed description: Development phase: Clinical trial Objectives: Assessment of functional and aesthetic outcome Methodology: Intervention study Sample size: 35+20+25 Main criteria for inclusion: Skull bone defect OR orbital floor fracture

Investigational drug/treatment, dose and mode of administration: FRC implant Comparative drug(s)/placebo/treatment, dose and mode of administration: -

Duration of treatment: 2 years of follow-up

Assessments:

Clinical outcome and radiologic assesment Functional and aesthetic outcome with Visual Analog Scale (VAS). Pain assessment with VAS.

Statistical methods:

Adequate statistical methods for publishing in international peer-reviewed journals.

Eligibility criteria: Inclusion Criteria:

Study arm 1:

* patients with skull bone defect
* reconstruction indications fullfilled

Study arm 2:

* patients with orbital floor defect
* reconstruction indication fullfilled

Exclusion Criteria:

* if informed consent cannot be obtained

Primary outcomes:
measure: Functional outcome (a composition of following measures)
timeFrame: 2 year follow-up
Secondary outcomes:
measure: Aesthetic outcome (a composition of following measures)
timeFrame: 2 years post-operatively
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Otorhinolaryngology
state: N/A = Not Applicable
Study officials:
affiliation: Turku University Hospital
name: Kalle J Aitasalo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00026013: Effects of St. John's Wort on the Effectiveness of Oral Contraceptives
Official title: Effects of Hypericum Perforatum on Effectiveness of Oral Contraceptives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: contraception
hormonal contraception
herbal remedies
hypericum perforatum
contraceptive effectiveness
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-11-06
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as well, it may increase the risk of contraceptive failure and unintended pregnancy. Study participants will be evaluated for risk of ovulation on oral contraceptives before and during simultaneous therapy with St. John's Wort.

Detailed description: See Brief Summary

Eligibility criteria: Inclusion Criteria:

* Women taking or willing to take low dose oral contraceptives for 5 months
* No contraindications to hormonal contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Department of Obstetrics & Gynecology
state: New York
Study officials:
affiliation: Columbia University
name: Patricia Murphy, DrPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041613: Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell
Keywords: Refractory Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Introgen Therapeutics
Sponsor class: INDUSTRY
First posted: 2002-07-12
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: There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.


Eligibility criteria: * 18 years or older
* Not eligible for surgery
* Must have had radiation and chemotherapy treatments
* No prior methotrexate treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Unversity of Colorado Cancer Center
state: Colorado
city: Louisville
country: United States
facility: Norton Healthcare Pavilion
state: Kentucky
city: Baltimore
country: United States
facility: Cancer Center of GBMC
state: Maryland
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
name: Kerstin Menander, MD
role: STUDY_DIRECTOR
name: Julie L Sicam, MT (ASCP) MSHS
role: STUDY_CHAIR
References: