louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04980599: Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
Official title: Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Adiposity
Keywords: obesity
lactobacillus paracasei
body fat
visceral fat area
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Inner Mongolia Yili Industrial Group Co., Ltd
First posted: 2021-07-28
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.

In this before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.


Eligibility criteria: Inclusion Criteria:

* BMI\>=30kg/m2,or percent of body fat(PBF) \>=25% for male, \>=30 for female.
* Age: 18 - 60 years old adults

Exclusion Criteria:

* patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
* History of intervention with fat-reducing drugs or health products in the past 2 months
* take weight control measures (diet, exercise, etc.) within the past month
* Those who cannot guarantee to maintain their current lifestyle during the trial period
* Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy

Primary outcomes:
measure: percent body fat
timeFrame: 60days
measure: visceral fat area
timeFrame: 60days
Secondary outcomes:
measure: Serum Lipid Profile
timeFrame: 60 days
measure: fasting blood glucose
timeFrame: 60 days
measure: Glycated hemoglobin
timeFrame: 60 days
measure: Glycosylated albumin
timeFrame: 60 days
measure: skeletal muscle mass
timeFrame: 60 days
measure: waist to hip ratio (WHR)
timeFrame: 60 days
measure: Body Mass Index BMI
timeFrame: 60 days
measure: body weight
timeFrame: 60 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hua Dong Hospital Affiliated to Fu Dan University
Study officials:
affiliation: Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
name: Ying Feng, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01635699: Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)
Official title: Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: DNA oxidation
obstructive sleep apnea
lipid peroxidation
oxidative stresses
Lead sponsor: Erzurum Regional Training & Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-07-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS) at the otolaryngology department of our hospital in Erzurum, Turkey.

Brief summary: The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on oxidative damage.

Detailed description: Obstructive sleep apnea syndrome (OSAS) is a sydrome which has characteristic upper way obstruction and a decrease in blood oxygen saturation as sleeping. uvulopalatopharngoplasty (UPPP)is one of the surgical approaches applied to the patients with OSAS, since the oxidative damage markers have been found high in patients with OSAS. Although antioxidant levels were higher in patients with OSAS than those in normal population, there is report about the effect of UPPP on antioxidant status in patients with OSAS. We performed this study to confirm whether is there a We performed the present study to confirm whether there is a relationship between the OSAS and oxidative damage before and after UPPP.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS)

Exclusion Criteria:

* Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Regional Educational Researh Hospital
Study officials:
affiliation: eskisehir yunus emre state hospital (still works here)
name: vural fidan, operating surgeon doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakan E, Fidan V, Alp HH, Baygutalp NK, Cokluk E. Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea Syndrome. J Craniofac Surg. 2015 Jul;26(5):e392-6. doi: 10.1097/SCS.0000000000001870.
Clinical trial NCT03170999: Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Keywords: China
Cognitive testing
COPD exacerbation
CERT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 199
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects having COPD attending the outpatient respiratory specialist clinics of tier 3 hospitals for their disease will be included in the study.

Brief summary: It has been observed that COPD exacerbations are under-reported in China. One of the reasons for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned in English. Hence this study aims to create a tool called CERT that will help Chinese physicians and subjects with COPD to recognize and report exacerbations. The study will be carried out in 4 stages: item identification, cognitive briefing, item reduction and creation of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for physicians. A total of approximately 200 subjects will be included in the study and each subject will contribute to only one step.


Eligibility criteria: Inclusion Criteria:

* Male or female of age greater than or equal to 40 years.
* Spirometrically confirmed COPD according to diagnostic criteria in Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.
* A treated exacerbation of COPD within 3 months prior to the study visit.
* Willing and able to provide informed consent, and able to participate in focus groups or cognitive interviews.
* Literacy is not a requirement for any of the groups.

Exclusion Criteria:

* Current diagnosis of asthma or clinically relevant bronchiectasis. Note: Subjects with Asthma COPD Overlap Syndrome (ACOS) are eligible.
* Subjects with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases; psychiatric condition; cognitive impairment or any other reasons that in the investigator's opinion, would place subjects at risk or interfere with study evaluation or affect participation in the study.

Primary outcomes:
measure: COPD symptom item set to identify common phrases of COPD exacerbation
timeFrame: Day 1
measure: Preparation of COPD Exacerbation Recognition tool (CERT)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Chongqing
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06072599: Use of Osteopathic Manipulative Treatment for Non-musculoskeletal Conditions
Official title: Use of Osteopathic Manipulative Treatment for Non-Musculoskeletal Conditions: A DO-Touch.NET Card Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Manipulation, Osteopathic
Keywords: Musculoskeletal Diseases
Non-Musculoskeletal Diseases
Osteopathic Manipulative Treatment
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: DO-Touch.NET
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving osteopathic manipulative treatment globally either in an outpatient or inpatient setting.

Brief summary: The goal of this observational study is to learn how clinicians use osteopathic manipulative treatment (OMT) for their patients who have problems only related to their muscles, bones, and joints (ie, musculoskeletal problems) compared to patients whose problems involve other body systems (eg, infections, breathing, bowel function). The main questions it aims to answer are:

* What percentage of patients receiving OMT have a non-musculoskeletal problem?
* Is there a difference in the OMT techniques when the patient's problems include a non-musculoskeletal problem compared to patients with only musculoskeletal problems?

Surveys will be completed by the clinicians about 20 unique adult (age 18 or older) patients who have received OMT.


Eligibility criteria: Inclusion Criteria:

* Adult patients receiving osteopathic manipulative treatment from a participating treatment provider

Exclusion Criteria:

-

Primary outcomes:
measure: Type of chief complaint
timeFrame: 24 hours
measure: Osteopathic manipulative treatment techniques
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: ATSU-KCOM OMM Clinic
state: Missouri
Study officials:
affiliation: A.T. Still University
name: Jane C Johnson, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302699: Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma
Official title: Clinical Utility of Ultrasensitive Chromosomal Aberrations Detection (UCAD) for Detecting Minimal Residual Disease (MRD) and Monitoring Clonal Evolution by Low-Pass Whole Genome Sequencing in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Minimal Residual Disease
Low-Pass Whole Genome Sequencing
Clonal Evolution
Ultrasensitive Chromosomal Aberrations Detection
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Suzhou Hongyuan Biotech Inc., Biobay, Suzhou, China.
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple myeloma patients with baseline and sequential next-generation flow-MRD data are included in this study.

Brief summary: The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with MM.
* With available baseline and sequential next-generation flow-MRD data.

Exclusion Criteria:

* Subjects without baseline and sequential next-generation flow-MRD data.

Primary outcomes:
measure: Detection of copy number variation
timeFrame: From May 1, 2023 to December 31, 2023
Secondary outcomes:
measure: Serial monitoring of treatment response
timeFrame: From January 1, 2024 to May 31, 20224
Other outcomes:
Locations:
city: Tianjin
country: China
facility: InsituteHBDH
state: Tianjin
Study officials:
References:
citation: Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.
Clinical trial NCT00256399: Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
Official title: A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH
Erectile Dysfunction
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-11-21
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

Detailed description: The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Eligibility criteria: Inclusion Criteria:

* Males 45-75 years of age
* Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
* Men with steady partner and who agree to attempt sex once a week.

Exclusion Criteria:

* Prostate cancer
* Prostatitis
* Penile disease
* Cardiac co-morbidity
* Pre-existing co-morbid conditions
* History of sensitivity to the drug or similar drugs
* Enrollment in another clinical trial
* Impaired hepatic function
* Impaired renal function
* Mental conditions rendering subject unable to understand the study
* Subjects not likely to comply with protocol

Primary outcomes:
measure: Evaluate the medication on erection maintenance
Secondary outcomes:
measure: Assess effect of Uroxatral on BPH and sexual function using questionnaires
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Urologists of Cleveland
name: Allen D Seftel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03194399: Development of Personalized Health Care Service in Patients With Breast Cancer
Official title: Development of Personalized Health Care Service in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lymphedema
Cancer-related Problem/Condition
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 11
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).


Eligibility criteria: Inclusion Criteria:

* Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user

Exclusion Criteria:

* Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who can not participate rehabilitation exercise program

Primary outcomes:
measure: Patient satisfaction change
timeFrame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Secondary outcomes:
measure: Physical activity change
timeFrame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
measure: Functional outcome change
timeFrame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
measure: Quality of care change
timeFrame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Eunjoo Yang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00737399: Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
Official title: Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Depression
Keywords: depression
anxiety
pain
insomnia
cancer
cholangiocarcinoma
EFT (Emotional Freedom Techniques)
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Anxiety and depression have been found to be significant co-occurring conditions in cancer patients. This study examines these and other psychological conditions in patients diagnosed with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of three to six months post-diagnosis. Participants are taught EFT in telephone and internet group coaching sessions, and have access to an online support forum. They complete the Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also provide medical records confirming their diagnosis, and markers, both before and after the study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a within-subjects, time series, repeated measures design. Symptoms are assessed prior to coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur in one month, three months, and one year. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cholangiocarcinoma
* Ability to complete forms and attend phone coaching sessions

Exclusion Criteria:

* None

Primary outcomes:
measure: depression
timeFrame: duration of study
Secondary outcomes:
measure: anxiety
timeFrame: duration of study
measure: pain
timeFrame: duration of study
measure: insomnia
timeFrame: duration of study
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Soul Medicine Institute
state: California
Study officials:
affiliation: Soul Medicine Institute
name: Dawson Church, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Endo I, Gonen M, Yopp AC, Dalal KM, Zhou Q, Klimstra D, D'Angelica M, DeMatteo RP, Fong Y, Schwartz L, Kemeny N, O'Reilly E, Abou-Alfa GK, Shimada H, Blumgart LH, Jarnagin WR. Intrahepatic cholangiocarcinoma: rising frequency, improved survival, and determinants of outcome after resection. Ann Surg. 2008 Jul;248(1):84-96. doi: 10.1097/SLA.0b013e318176c4d3.
Clinical trial NCT06206499: Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant
Official title: Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Tissue Failure
Dental Implant Failed
Peri-Implantitis
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Furthermore, a significant association was found between peri-implant mucositis, and smoking, implant maintenance and peri-implant soft tissue characteristics (Wada et al. 2019).

Soft tissue quality and volume of the peri-implant mucosa are considered important factors in the prognosis of osseointegrated implants. Linkevicius et al. showed that if its soft tissue thickness was less than 2 mm, crestal bone loss might occur (Linkevicius et al. 2009). In addition, when soft tissue width was evaluated, a wider soft tissue band was related to minimal bone remodeling (Linkevicius et al. 2015). Lin et al. reported in a systematic review and meta-analysis that a lack of keratinized tissue (KT) around osseintegrated implants was associated with plaque accumulation, peri-implant tissue inflammation, soft tissue recession and attachment loss (Lin et al. 2013). Moreover, recent studies established the need of a minimal band of 2 mm of KT around osseointegrated implants, and showed that a band less than 2 mm was associated with more brushing discomfort, plaque accumulation, tissue inflammation and marginal bone apical displacement, concluding that a KT\>2 mm had a protective effect on peri-implant tissues (Souza et al. 2015, Perussolo et al. 2018, Monje et al. 2019). Furthermore, peri-implant tissue diseases have also been related to an irregular compliance in situations of lack of KT (Monje et al. 2019).

In the presence of peri-implant horizontal and/or vertical soft tissue deficiencias, soft tissue augmentation has been considered a priority, even prior or instead of bone augmentation (Burkhardt et al. 2008, Zucchelli et al. 2013).


Eligibility criteria: Inclusion Criteria:

implant with soft tissue recession Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day)

Exclusion Criteria:

Pregnancy-Lactation Relevant systemic disease

Primary outcomes:
measure: Change in soft tissue 6months after procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: UNIVERSIDAD DE MURCAI
name: JOSE ANTONIO MORENO RODRÍGUEZ, DDS
role: PRINCIPAL_INVESTIGATOR
References: