louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02618239: Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
Official title: Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: intestinal gas
Healthy subjects
microbiota
prebiotics
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria have been shown to improve this type of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics.

Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* gastrointestinal symptoms
* recent (3 months) antibiotic intake
* recent (3 months) change of diet
* recent (3 months) gastroenteritis

Primary outcomes:
measure: Number of daily anal gas evacuations
timeFrame: Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)
Secondary outcomes:
measure: Volume of anal gas evacuation
timeFrame: Change from beginning of treatment (day 3) to end of treatment (day 21)
Other outcomes:
Locations:
Study officials:
affiliation: Vall d'Hebron Research Institute
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mego M, Manichanh C, Accarino A, Campos D, Pozuelo M, Varela E, Vulevic J, Tzortzis G, Gibson G, Guarner F, Azpiroz F. Metabolic adaptation of colonic microbiota to galactooligosaccharides: a proof-of-concept-study. Aliment Pharmacol Ther. 2017 Mar;45(5):670-680. doi: 10.1111/apt.13931. Epub 2017 Jan 12.
Clinical trial NCT04316039: Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Official title: Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Low-grade Glioma
Keywords: low-grade glioma
High-risk
Radiotherapy
Temozolomide
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 250
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: It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed supratentorial WHO grade II gliomas;
2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
3. Karnofsky performance score (KPS) ≥ 60;
4. No more than moderate neurologic symptoms and signs;
5. The interval between surgery and randomization is less than 12 weeks;
6. Have signed the consent form. -

Exclusion Criteria:

1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
2. Have received prior radiation therapy to the head and neck region;
3. Have received prior chemotherapy;
4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
5. Prior malignancy's disease-free survival less than 5 years;
6. Have active infection;
7. Patients are pregnant or breast-feeding. -

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Xingchen Peng
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xingchen Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00048139: A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Official title: An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced and/or metastatic colorectal cancer;
* \>=1 target lesion.

Exclusion Criteria:

* previous treatment with Xeloda or irinotecan;
* previous systemic therapy for metastatic disease;
* progressive disease during previous adjuvant therapy or within 6 months of completion.

Primary outcomes:
measure: Tumor measurement (RECIST criteria)
timeFrame: Event driven
Secondary outcomes:
measure: Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.
timeFrame: Event driven
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hutchinson
country: United States
state: Kansas
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Buffalo
country: United States
state: New York
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02151422: Breathing Exercises for Asthma
Official title: Breathing Exercises for Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Adults
age 18-65
physician-diagnosed
persistent asthma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite the advances in pharmacological therapy for asthma, there has been an increasing worldwide interest in alternative therapies for asthma. Treatments and therapies such as yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been used as complementary therapies however little evidence exists behind such practices.

Data from systemic reviews and randomized control trials provide evidence of benefit although additional confirmation is still needed. Among the most common techniques are the Buteyko breathing exercises that aim to reduce minute ventilation by instruct asthmatics patients to breathe shallowly and slowly through the nose. The second common technique is the Pranayama, or yoga breathing exercises which emphasizes deep respirations and exhalation prolongation.

Our goal is to assess the effectiveness of breathing exercises as a complementary therapy for asthma.


Eligibility criteria: Inclusion Criteria:

* Adults age 18-65 of either sex, with a physician-diagnosed history of persistent asthma.
* Access to internet

Exclusion Criteria:

* Subjects with history of COPD or any other lung disease, pregnant or lactating women, no access to internet and patients who cannot communicate in English.

Primary outcomes:
measure: Improvement of quality of life of asthmatic patients
timeFrame: equal or greater than 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Allergy and Immunology Clinic at University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alan Baptist, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02848222: Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Official title: Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Discomfort
Dry Eye Disease
Meibomian Gland Dysfunction
Keywords: contact lens discomfort
dry eye disease
meibomian gland dysfunction
Bruder mask
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Bruder Healthcare Company
First posted: 2016-07-28
Enrollment: 60
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 purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Provide informed consent and authorization to disclose protected health information
* Have habitual contact lens corrected visual acuity in each eye of at least 20/30
* Willing to comply with protocol
* Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 days a week on average over at least a 30 day period before enrollment

Exclusion Criteria:

* Have any uncontrolled systemic disease that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease
* Pregnant by self-report
* Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis

Primary outcomes:
measure: Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
timeFrame: Baseline through 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT05216822: Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
Official title: Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Watery Diarrhea
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.

Detailed description: Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.

Eligibility criteria: Inclusion Criteria:

* Age group for six months - 5 years.
* No or mild to moderate dehydration.
* Alert patient (to tolerate oral intake since the drug is only available in oral form).

Exclusion Criteria:

* Patients with severe dehydration (inability to drink because of drowsiness).
* Patients with any serious concomitant illness that needs antibiotic treatment.
* If severe adverse events occur at any time.
* Chronic diarrhea.

Primary outcomes:
measure: Diarrheal episode
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Professor
name: Hamada M Kamel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03088722: A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
Official title: Task-sharing to Expand Access to Contraceptive Implants: A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraceptive implant
Task sharing
Nigeria
Lead sponsor: Marie Stopes International
Sponsor class: OTHER
Collaborators: name: Population Council
name: GRM Futures Group
First posted: 2017-03-23
Enrollment: 7903
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION) will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and remove contraceptive implants to the same level of safety and quality as a nurse or midwife, and whether this is acceptable to their clients and colleagues. The study will also document feasibility issues which would be relevant to any future national programmatic scale-up.


Eligibility criteria: Inclusion Criteria:

* facilities are located with 20km of a referral facility
* facilities - facility staff are willing to participate, e.g. willingness to conduct family planning awareness-raising activities, willing to maintain project records
* facilities - selected provider at each facility expects to be in the facility for the 12-month period of client recruitment
* clients - women present to attending facilities and request a contraceptive implant

Exclusion Criteria:

* facilities - involved in overlapping interventions

Primary outcomes:
measure: Adverse events
timeFrame: Day of implant insertion
Secondary outcomes:
measure: Quality of implant provision
timeFrame: Day of implant insertion
measure: Acceptability of service provision
timeFrame: Day of implant insertion
measure: Adverse events
timeFrame: Up to 14 days post insertion
Other outcomes:
Locations:
Study officials:
References:
citation: Reiss K, Penfold S, Alabi O, Ali M, Hopkins K, Ngo TD, Odogwu K, Douthwaite M, Ezire O, Udoh U, Effiom E, Munroe ES. Safety, Quality, and Acceptability of Contraceptive Subdermal Implant Provision by Community Health Extension Workers Versus Nurses and Midwives in Nigeria: Protocol for a Quasi-Experimental, Noninferiority Study. JMIR Res Protoc. 2018 Mar 2;7(3):e67. doi: 10.2196/resprot.8721.
Clinical trial NCT02862522: Uric Acid Levels and Endothelial Functions
Official title: Clinical Follow-up of Patients With Assessment of Endothelial Dysfunction/Coronary Spasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: uric acid
microvascular dysfunction
inflammation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Aging (NIA)
First posted: 2016-08-11
Enrollment: 229
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients referred to Mayo Clinic's cardiac care clinic in Rochester, Minnesota.

Brief summary: Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED.


Eligibility criteria: Inclusion Criteria:

* Referred to Mayo Clinic for cardiac catheterization
* Postmenopausal

Exclusion Criteria:

* History of percutaneous coronary intervention
* Coronary artery bypass graft surgery
* Unstable angina pectoris
* Valvular heart disease
* Peripheral vascular disease
* Known congestive heart failure

Primary outcomes:
measure: Serum Uric Acid Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03364322: Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease
Official title: Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Ocular Surface Disease
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.

Brief summary: Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.


Eligibility criteria: Inclusion Criteria:

* Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.

Exclusion Criteria:

* Subjects who are elderly (≥80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.

Primary outcomes:
measure: Ocular surface disease index
timeFrame: 1 day
Secondary outcomes:
measure: Tear break-up time
timeFrame: 1 day
measure: Schirmer tear secretion test
timeFrame: 1 day
measure: Corneal fluorescence staining
timeFrame: 1 day
Other outcomes:
measure: Tear osmolarity
timeFrame: 1 day
measure: Eyelid hyperemia
timeFrame: 1 day
measure: Conjunctivochalasis
timeFrame: 1 day
measure: visual analogue pain score
timeFrame: 1 day
measure: modification of SPEED score
timeFrame: 1 day
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
References:
Clinical trial NCT04159922: Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds
Official title: Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Foot Wound
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with type 2 diabetes with foot wounds

Brief summary: Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.

It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.

Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.

It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.


Eligibility criteria: Inclusion Criteria:

* diagnosis of type 2 diabetes
* patient \> 18 years old
* with a diabetic foot wound
* person who has expressed non-opposiyion to participation in the study

Exclusion Criteria:

* a person who is not affiliated to national health insurance
* person subject to legal protection (curatorship, guardianship)
* person under limited judicial protection
* pregnant, parturient or breastfeeding woman
* adult unable to consent
* minor

Primary outcomes:
measure: Score of the Bortner self-questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: