louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04670341: The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks
Official title: Quality Improvement of Saliva by Chewing Tapioca Pearls in Bubble Tea Drinks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saliva
Keywords: bubble tea
salivary C-reactive protein
salivary calcium
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the first week of the experiment, subject chewing tapioca pearl inthe bubble tea. In the second week, the same subjects drink tea without chewing tapioca pearl
Primary purpose: BASIC_SCIENCE

Brief summary: Bubble tea drinks contain tea and tapioca pearls. Chewing tapioca pearls in bubble tea drinks may increase salivary components. Because of its proteins, inorganic components, and enzymes, saliva plays an important role in the body's defense against bacteria and viruses. This study aims to analyze the effect of chewing the tapioca pearls in bubble tea drinks on salivary C-reactive protein (CRP) and calcium (Ca) levels.

Detailed description: Sixty saliva samples were collected from 15 subjects. The inclusion criterion was 18-25 years of age. The exclusion criteria were receiving medication, using dentures, a history of dry mouth, smoking and systemic disease. In the first week of the experiment, subjects drank bubble tea as the intervention group. In the second week, the same subjects drank tea without pearls as the control group. Each subject drank the bubble tea for 5 minutes per day over 3 days. Saliva samples were collected on the first day before bubble tea consumption (pretest) and on the third day after tea consumption (posttest). Saliva collection was performed in the morning (09:00 a.m.-12:00 p.m.) for 1 minute. Salivary CRP levels were measured using an ELISA kit, and Ca levels were determined using a test kit.

Eligibility criteria: Inclusion Criteria:

* good Oral Hygiene Index-Simplified (OHI-S) score

Exclusion Criteria:

* taking medication
* a history of dry mouth
* smoking
* systemic disease

Primary outcomes:
measure: Salivary C-reactive protein (CRP) level
timeFrame: 3 days
Secondary outcomes:
measure: Calcium (Ca) level
timeFrame: 3 days
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Faculty of Dentistry, Universitas Gadjah Mada
Study officials:
affiliation: Faculty of Dentistry, Universitas Gadjah Mada
name: Juni Handajani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handajani J, Kusumajati D, Fathiyah H, Susilowati H, Tandelilin RTC. Quality improvement of saliva by chewing tapioca pearls in bubble tea drinks: a randomized experimental trial: (Study on salivary C-reactive protein (CRP) and calcium (Ca) levels). F1000Res. 2021 Feb 1;10:56. doi: 10.12688/f1000research.28028.2. eCollection 2021.
Clinical trial NCT02331641: Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.
Official title: Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases. A Propensity Score-matched Dual-institution Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Liver Metastases
Colon Cancer
Keywords: hepatectomy
hepatic resection
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2015-01-06
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal liver metastases (CLM) that underwent hepatectomy.

Brief summary: The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in patients with colorectal liver metastases (CLM) is object of debate. We build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.

Detailed description: The aim of this study is to investigate the outcome of patients with colorectal liver metastases (CLM) undergoing multiple minor hepatectomies (MMH) instead of major hepatectomies (MH). Indeed, the performance of MMH versus MH in patients with CLM is object of debate. For this purpose, the databases at two independent institutions were retrospectively reviewed. To control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used. Among 554 patients, 110 patients undergoing MMH and 110 undergoing MH were matched. They were similar in baseline characteristics, comorbidities, features of the primary tumors, and CLM. Primary outcomes were short- and long-term outcome.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLM

Exclusion Criteria:

* Uncertain diagnosis
* Lost at follow-up

Primary outcomes:
measure: Number of postoperative complications after MH or MMH, graded based on the Dindo's classification (Dindo et al. Ann Surg 2004;240:205-13)
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: Long-term outcome (overall and disease-free survival)
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04186741: Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy
Official title: Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Otitic Barotrauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Measument of middle ear pressure after exposure to hyper baric oxygen therapy

Brief summary: Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure

Detailed description: Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment

Eligibility criteria: Inclusion Criteria:

* patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot

Exclusion Criteria:

* patients who already had tympanostomy tubes

Primary outcomes:
measure: Changing in middle ear pressure
timeFrame: Through completion of study after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Enas S Mohamed, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamamoto Y, Noguchi Y, Enomoto M, Yagishita K, Kitamura K. Otological complications associated with hyperbaric oxygen therapy. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2487-93. doi: 10.1007/s00405-015-3845-9. Epub 2015 Dec 9.
Clinical trial NCT00363441: A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
Official title: A Randomized Phase II Study of Conventional 3D Radiation (3DCRT) Versus Intensity-Modulated Radiation (IMRT) in Squamous Cell Cancer of the Head and Neck (SCCHN): Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Head and Neck Neoplasms
Squamous Cell Cancer
Keywords: head and neck neoplasms
squamous cell cancer
intensity modulated radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.


Eligibility criteria: Inclusion Criteria:

* histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent

Exclusion Criteria:

* M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form

Primary outcomes:
measure: Prevalence and severity of side effects according to Radiation Therapy Oncology Group
measure: scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tom Baker Cancer Center
name: Harold P Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06875141: DM199 for Pregnancy Complications
Official title: DM199 for Pregnancy Complications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: DiaMedica Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This entry was submitted in error by DiaMedica Therapeutics, Inc. and was not authorized by any of the trial Investigators or study sponsor (Stellenbosch University).

The clinical trial, DM199 for Pregnancy Complications, was prospectively registered with the Pan African Clinical Trials Registry (PACTR202404895013782), in accordance with ICMJE and WHO requirements. This listing serves as the primary and authoritative registration record for this investigator-initiated study.


Eligibility criteria: Please refer to the Pan African Clinical Trials Registry (PACTR202404895013782).

Primary outcomes:
measure: Incidence of treatment adverse events
timeFrame: Until 6 weeks after the due date
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01256541: Kristalose as Bowel Evacuant Prior to Colonoscopy
Official title: A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bowel Evacuant Prior to Colonoscopy
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
name: Cumberland Pharmaceuticals
First posted: 2010-12-08
Enrollment: 20
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: To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant

Detailed description: This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel).

Eligibility criteria: Inclusion Criteria:

Patients requiring bowel evacuation for colonoscopy

Exclusion Criteria:

1. Patients with galactosemia (galactose-sensitive diet).
2. Patients known to be hypersensitive to any of the components of Kristalose.
3. Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
4. Patients less than 18 years of age.
5. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.
6. Be pregnant or nursing
7. Be otherwise unsuitable for the study, in the opinion of the Investigator

Primary outcomes:
measure: Hydrogen and Methane Gas Production
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT00005441: Lifestyle Management for Women With CHD and NIDDM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Diabetes Mellitus, Non-insulin Dependent
Postmenopause
Diabetes Mellitus
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat vegetarian diet, smoking cessation and stress management training) for postmenopausal women with coronary heart disease and Type II (non-insulin dependent) diabetes.

Detailed description: BACKGROUND:

Coronary heart disease is the leading cause of death among postmenopausal women. Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women, especially as a result of comprehensive lifestyle changes. A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women.

DESIGN NARRATIVE:

The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred. Its generalizability and applicability -- especially for high-risk women --was uncertain. The program was compared to a usual care condition in an initial randomized trial. Outcome measures included patient self-care behaviors and health outcomes (serum lipid profiles, blood pressure, relative weight, and glycemic control). Process measures included self-efficacy, personal health models, perceived stress, social support and problem-solving skills. Subjects participated in the intervention for three years, with gradual fading of the program in the third year to evaluate the long-term effects of the program. Analyses included assessments of between groups differences on physiological risk factors, behavioral (lifestyle) measures and process measures as well as maintenance over time. Based upon the results of this study, the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Toobert DJ, Glasgow RE, Nettekoven LA, Brown JE. Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease. Patient Educ Couns. 1998 Nov;35(3):177-88. doi: 10.1016/s0738-3991(98)00074-3.
Clinical trial NCT06590441: Investigation of Wearing Compliance of Spectacles for Myopia Control
Official title: A Multisite Investigation of the Wearing Compliance of Spectacles for Myopia Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Juvenile participants recruited directly from the patient bases of several UK optometry practices who currently wear spectacles prescribed for myopia

Brief summary: The goal of this observational study is to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.

Detailed description: This unmasked, multi-center, observational study will evaluate the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. Wearing pattern will be measured via the use of temperature sensors fitted to the sides of the participant's spectacles. Data from the final week of the 1-month study will be used for analysis to minimize 'unusual' wear patterns which may occur early in the study.

Eligibility criteria: Inclusion Criteria:

1. They are aged between six and 15 years old.
2. Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent.
3. They understand the study at a level appropriate for their age and are willing to sign a statement of assent.
4. They and their parents or guardians are willing and able to follow the protocol.
5. They currently use spectacle lenses for myopia control and have done so for at least three months.
6. They agree not to participate in other clinical research for the duration of this study.

Exclusion Criteria:

1. They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study.
2. They are amblyopic.

Primary outcomes:
measure: Wearing pattern of myopia control spectacles
timeFrame: Measured continuously over 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Sale
country: United Kingdom
facility: Eye2C Ltd
state: Cheshire
city: Darwen
country: United Kingdom
facility: Susan Hilton Ltd
state: England
city: Oakwood
country: United Kingdom
facility: Columbo Ltd
state: Leeds
city: Haslingden
country: United Kingdom
facility: David Gould Opticians Limited
state: Rossendale
Study officials:
affiliation: Eurolens Research
name: Philip Morgan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850119: Nanofat on Wound Healing and Scar Formation
Official title: Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scars
Delayed Wound Healing
Hypertrophic Scar
Post Inflammatory Hyperpigmentation
Donor Site Complication
Keywords: adipose derived stem cells
stromal vascular fraction
wound healing
scar formation
donor site morbidity
nanofat
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric randomized controlled double-blinded prospective interventional study
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.

Detailed description: In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control.

Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.

The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.

Eligibility criteria: Inclusion Criteria:

- scheduled for DIEP-flap breast reconstruction surgery at our department

Exclusion Criteria:

* smokers
* use of cortisone or other immunsuppressants
* diabetes mellitus type 1 or 2
* age
* connective tissue disease

Primary outcomes:
measure: Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
timeFrame: one year
measure: Clinical assessment of the time to healing of the abdominal wound
timeFrame: one month
measure: Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.
timeFrame: six months
measure: Pigmentation Index of the two sides of the scar, measured with a Mexameter
timeFrame: one year
measure: Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale
timeFrame: one year
measure: Rate of adverse events
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Moustapha Hamdi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01512719: POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders
Official title: POEM a Novel Endoscopic Treatment for Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.


Eligibility criteria: Inclusion Criteria:

* Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

* Perforation of LES during dilatation
* Pregnant women
* mentally ill patients

Primary outcomes:
measure: Resolution of dysphagia
timeFrame: up to 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization Ein-Kerem campus
Study officials:
affiliation: Hadassah Medical Organization
name: Yoav Mintz, MD
role: PRINCIPAL_INVESTIGATOR
References: