louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01607099: Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility
Official title: Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laxative Compatibility
Keywords: colonoscopy
bowel cleansing
bowel cleanness
efficiency
compatibility
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the examination). One handicap of using polyethylene glycol is the occurence of nausea and vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a pilot study the investigators have detected a high fraction of patients who consider the cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the colonoscopy procedure altogether is low.

Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness of the bowel was equal in both groups.

The investigators believe that a new protocol which contains sodium picosulfate/magnesium citrate instead of macrogol will benefit the patients by fewer abdominal side effects while cleanness of the bowel at the same time will be warranted. This presumption is the reason for the present study.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Scheduled for colonoscopy

Exclusion Criteria:

* No informed consent
* ASA IV or V
* Pregnancy

Primary outcomes:
measure: Valuation "very distressing"
timeFrame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours)
Secondary outcomes:
measure: Colon cleanness
timeFrame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Wolfgang Huber, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04572399: UVA Light Device to Treat COVID-19
Official title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Aytu BioPharma, Inc.
First posted: 2020-10-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intubated patients with confirmed SARS-CoV-2 will receive UV light treatment to potentially reduce bacterial and viral burden.
Primary purpose: TREATMENT

Brief summary: This pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19.

Detailed description: This is a single center, open label, pilot study. 5 adult patients, aged over 18, who are confirmed positive with SARS-CoV-2 and are newly intubed, will receive UV light treatment to reduce SARS-CoV-2 viral load.

Eligibility criteria: Inclusion Criteria:

* Confirmed positive test result for SARS-CoV-2
* Mechanically ventilated
* Endotracheal tube inner diameter of at least 7.5 mm

Exclusion Criteria:

* Unable to provide informed consent (or surrogate)
* Enrolled in a therapeutic clinical trial for same condition that does not allow recruitment in other trials
* Pregnant women

Primary outcomes:
measure: Negative Change in Viral Load
timeFrame: 5 days
Secondary outcomes:
measure: Change in Bacterial Load
timeFrame: 5 days
measure: Ventilated Associated Pneumonia
timeFrame: 1 month
measure: Days to Extubation
timeFrame: 1 month
measure: Days to Discharge
timeFrame: 1 month
measure: Change in C-reactive Protein
timeFrame: 5 days
measure: Change in the World Health Organization (WHO) Coronavirus Disease (COVID)-19 10-point Ordinal Severity Scale by 30 Days
timeFrame: 1 month
measure: Catheter Tip Assessment on the Last Day of Treatment
timeFrame: 5 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: George Chaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rezaie A, Melmed GY, Leite G, Mathur R, Takakura W, Pedraza I, Lewis M, Murthy R, Chaux G, Pimentel M. Endotracheal Application of Ultraviolet A Light in Critically Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2: A First-in-Human Study. Adv Ther. 2021 Aug;38(8):4556-4568. doi: 10.1007/s12325-021-01830-7. Epub 2021 Jun 26.
Clinical trial NCT06660199: Text-based Support for Parents of Adolescents Following an Emergency Department Visits
Official title: Effectiveness of Text-based Support for Parents of Suicidal Adolescents Following Emergency Department Visits
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Text
Suicidal Ideation
Suicide Attempt
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-28
Enrollment: 420
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

Detailed description: Participants will be 420 adolescents (ages 13-17) seen in ED with recent suicidal ideation and/or attempt and their parents recruited from two health system EDs in the Midwest.

Eligibility criteria: Inclusion Criteria:

* Adolescent (13-17 years old) who present to Emergency Department (ED) due to (1) last-week suicidal ideation and/or (2) last-month suicide attempt, and their caregiver.

Exclusion Criteria:

Adolescents who are:

* medically unstable
* presenting with severe cognitive impairment, altered mental status, severe aggression/agitation
* presenting without a legal guardian
* whose parent does not own a cell phone

Primary outcomes:
measure: Aim 1 (primary aim): likelihood of suicidal behavior (actual, interrupted, or aborted attempts)
timeFrame: 12-week follow-up
measure: Aim 2 (secondary aim) severity of parental stress
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Aim 1 (primary aim): -time- to- suicidal behavior (actual, interrupted, or aborted suicide attempts
timeFrame: 24-week follow-up
measure: Aim 1 (primary aim): time- to- return ED visit
timeFrame: 24-week follow-up.
measure: Aim 2 (secondary aim): parental negative affect
timeFrame: Up to 6 weeks
measure: Aim 2 (secondary aim) parental positive affect
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ewa Czyz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008499: High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
High-activity natural killer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of colorectal cancer.

Detailed description: By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06245499: Aging Brain Care Virtual Program
Official title: The Aging Brain Care Virtual Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: Telehealth
Virtual intervention
Aging brain care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Regenstrief Institute, Inc.
name: Indiana University Health
First posted: 2024-02-07
Enrollment: 860
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 program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.


Eligibility criteria: Patient Inclusion Criteria:

* 65 and older,
* active primary care patient (visit in past 14 months),
* diagnosis of Alzheimer's disease and related dementias (ADRD) based on ICD criteria in primary care problems list.

Patient Exclusion Criteria:

* enrolled in hospice at the study start (study screening)or
* living in a long term care nursing facility.

Care Partners Inclusion Criteria:

* 18 and older,
* able to access a phone or computer for intervention delivery in English, and
* identified in the EMR as the emergency contact or as the primary care partner.

Care Partners Exclusion Criteria:

- Individuals who decline to participate in the ABCV intervention

Primary outcomes:
measure: Emergency Department Utilization
timeFrame: During the 12 months of intervention
Secondary outcomes:
measure: New prescriptions for antipsychotic medications
timeFrame: During the 12 months of intervention
measure: New prescriptions for benzodiazepine medications
timeFrame: During the 12 months of intervention
measure: Anticholinergic Cognitive Burden Scale score
timeFrame: Before and 12 months after initial intervention
measure: Acceptability of the intervention score
timeFrame: During the 12 month intervention period
measure: Feasibility of the intervention score
timeFrame: During the 12 month intervention period
measure: Appropriateness of the intervention score
timeFrame: During the 12 month intervention period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute, Inc.
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Inc.
name: Alexia M Torke, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04096599: Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
Official title: Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With Moderate-to-high Caries Risk? - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 579
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will identify children at high caries risk and then advise/instruct their parents/caregivers in practicing evidence-based risk-based at home preventive measures for their infants with daily use of xylitol or fluoride toothpaste. This study plan to invite the children aged 12-15 months old with high caries risk to do the clinical trial. Every infants will be randomly allocated into two groups. Participants in the test group will be asked to use xylitol (20%) toothpaste to brush their teeth twice every day with the help of caregivers. Participants in the test control group will be asked to use fluoride (1000ppm) toothpaste to brush their teeth twice every day with the help of caregivers. The same oral health instruction and children' diet instruction will be done for every participant's caregivers.

For every dental examination, clinical chatting form for the children will be collected after filling in by examiner. Questionnaire will be collected after filling in by the caregivers. And infants' plaque and saliva will be collected to detect the S. mutans level. We plan to do the dental examination three times for one infant including the first time recruiting, one year follow-up, and two year follow-up.

The establishments of the good oral health-related habits will safeguard and have sustained benefits for the children. The study can provide evidence on the effectiveness of xylitol toothpaste and risk of high fluoride toothpaste among young children. In the long term, the findings of the study might serve as a foundation for establishing an effective oral health care promotion programme throughout Hong Kong and beyond. The framework, if shown to be effective, could help development of the oral health policies and promotion programmes to achieve better oral health among young children eventually.


Eligibility criteria: Inclusion Criteria:

Infants aged 12-15 months old with high caries risk

Exclusion Criteria:

Infants who has systematical disease

Primary outcomes:
measure: Clinical chatting form
timeFrame: 2 years
measure: Questionnaire
timeFrame: 2 years
measure: MS quantitation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Paediatric Dentistry
Study officials:
affiliation: The University of Hong Kong
name: Gillian Lee, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00180999: Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course
Official title: Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: - Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.


Eligibility criteria: Inclusion Criteria:

* Both sexes
* 18-70 yrs
* metastatic or locally advanced cancer
* Life expectancy \> 3 months
* hemoglobin between 7 and 10 g/100ml
* no contraindication to r-Hu-EPO
* with written informed consent at entry time

Primary outcomes:
measure: Quality of life, in particular when related to tiredness (FACT F)
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Valérie LAPIERRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06170099: Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial)
Official title: Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2023-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is:

• is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Researchers will compare laser group with control group to see if there is a difference in amount of distalization between groups.

Detailed description: The aim of the present study is to assess the effect of low level laser therapy on treatment outcomes of bony supported distal jet for correction of 20 orthodontic patients with angle class II malocclusion. enrolled patient is randomly divided into 2 groups laser group and distal screw group. for result assessment dental casts and CBCT are taken before and after completion of distalization. both groups receives Distal Jet supported on 2 paramedian screw with laser therapy for laser group only.

Eligibility criteria: Inclusion Criteria:

* bilateral Angle's Class II malocclusion minimum of 1/4 cusp discrepancy, normal or low mandibular plane (MP) angle cases and no history of serious medical illness

Exclusion Criteria:

* subjects with skeletal Class II with retrusion mandibular profile, vertical growth pattern and steep mandibular plane angle and subjects with shallow or anterior open bite.

Primary outcomes:
measure: amount of upper first molar distal movement
timeFrame: till achievement of class I molar relation, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar dental hospital
state: Nasr City
Study officials:
affiliation: Al-Azhar University
name: Rabab HF elhosseini, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101699: Effects of Soy Consumption on Symptoms of Menopause
Official title: Influence of Soy Consumption on Menopause
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: Women
Soy Foods
Middle Aged
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-01-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to examine the way soy consumption affects menopausal symptoms in middle-aged Japanese women.

Detailed description: For the past 20 years, Japanese women have reported fewer menopausal symptoms than their North American counterparts. One explanation for the disparity is the differences in diet. Evidence suggests that Japanese women consume large amounts of soy, a phytoestrogen that is structurally similar to the hormone estrogen. However, there is a lack of menopause-related research data from non-Western populations. This study will be a long-term observation of the effects of soy consumption in menopausal Japanese women.

This study will last 6 months. Participants will complete a dietary log and a menopausal symptom checklist daily. There will be three or four study visits. During these visits, participants will complete a diet questionnaire, have a blood sample collected, and be interviewed about their menopausal symptoms. Six months after study completion, participants will be sent a questionnaire about any recent menopausal symptoms they may have experienced.

Eligibility criteria: Inclusion Criteria:

* Japanese resident
* Menopausal

Exclusion Criteria:

* Hysterectomy, removal of ovaries, or tubal ligation with subsequent menstrual changes
* Hormones for menopause or birth control pills within 5 years of study entry
* Recent major illness
* Medication that could affect naturally-produced hormones

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Koriyama
country: Japan
facility: Loma Linda Clinic
state: Fukushima
city: Kamigyo-ku
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
Study officials:
affiliation: Emory University
name: Melissa K. Melby, MPhil, MA
role: PRINCIPAL_INVESTIGATOR
References: