louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02203812: Effect of Probiotic Lozenge on Gingivitis and Periodontitis
Official title: The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild and Moderate Chronic Periodontitis
Lead sponsor: CD Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
First posted: 2014-07-30
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.


Eligibility criteria: Inclusion Criteria

* Patients with chronic mild to moderate periodontitis.
* Having Pocket depth \> 4mm.
* Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket \> 4mm

Exclusion Criteria:

* Patients on probiotic supplements
* Patients who have allergy to lactose and fermented milk products
* Smokers
* Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
* Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
* Patient suffering from any systemic illness
* Patients who are deemed to be un-cooperative

Primary outcomes:
measure: Improvement in Clinical Periodontal Indices
timeFrame: 8 weeks
Secondary outcomes:
measure: Improvement in Biochemical Indices
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vijayawada
country: India
facility: Department of Periodontology, Government Dental College & Hospital
state: Andra Pradesh
Study officials:
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
name: Surya Jyotsna Kiran Kanchumurthy, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
name: Narendra Dev Jampani, MDS
role: STUDY_DIRECTOR
affiliation: Government Dental College and Hospital, Vijayawada, Andhra Pradesh
name: Vajra Madhuri S, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994512: Swedish Spinal Stenosis Study
Official title: Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal stenosis
Decompression
Fusion
Olisthesis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 245
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis \>3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.


Eligibility criteria: Inclusion Criteria:

* Pseudoclaudication in one or both legs and backpain (VAS\>30)
* MRI with 1-2 adjacent stenotic segments (area \<0.75 mm2)between L2 and sacrum
* Duration of symptoms \>6 months
* Informed consent

Exclusion Criteria:

* Spondylolysis
* Degenerative lumbar scoliosis (Cobb angle \>20 deg)
* History of lumbar spinal surgery for spinal stenosis or instability
* Stenosis not caused by degenerative changes
* Stenosis caused by herniated disc
* Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
* History of vertebral compression fractures in affected segments
* Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 2 years
Secondary outcomes:
measure: Back pain
timeFrame: 2 years
measure: Leg pain
timeFrame: 2 years
measure: EuroQol (EQ-5D)
timeFrame: 2 years
measure: Swiss Spinal Stenosis Questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
Clinical trial NCT04619212: Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
Official title: A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Pumping
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.

Detailed description: This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.

Eligibility criteria: Inclusion Criteria:

* Subject ≥ 18 years old
* Infant was born maximum 4 (96 hours) days ago
* Subject aims to provide breastmilk for the baby through breastfeeding.
* At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
* Subject has an indication to pump for reasons
* The subject signs the informed consent documentation

Exclusion Criteria:

* Woman is exclusively pumping
* Woman is experiencing a mastitis event
* Woman is still breastfeeding with the previous child
* Woman has been breastfeeding in the last 6 months
* Woman received morphine pain medication in the last 8 hours

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
measure: Comfort while pumping
timeFrame: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.
Secondary outcomes:
measure: Performance of the new software
timeFrame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG Amsterdam
Study officials:
affiliation: Study team
name: Fedde Scheele
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191512: Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
Official title: Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Continuous Positive Airway Pressure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients using upper airway stimulation or continuous positive airway pressure

Brief summary: To date, there has been no head to head comparison of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) utilizing a full night polysomnographic evaluation. With this study we aim to evaluate a pilot cohort of patients with OSA treated with CPAP or UAS using the WatchPAT polysomnography system.


Eligibility criteria: Inclusion Criteria:

* Age greater than 22 years old
* History of moderate to severe OSA (AHI 15-65)
* UAS implantation with postoperative titration and demonstrated successful use of therapy or has demonstrated the ability to tolerate CPAP for greater than 4 hours per night 5 days per week.

Exclusion Criteria:

* none

Primary outcomes:
measure: Difference in polysomnography (PSG) data between UAS and CPAP groups
timeFrame: 2 years
measure: Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups
timeFrame: 2 years
measure: Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03644212: Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
Official title: Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Vitamin D Deficiency
Keywords: Polycystic Ovary Syndrome
Vitamin D
Anti Mullerian Hormone
Soluble receptor for Advanced Glycation End Products
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 79
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.

Detailed description: Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate.

Main outcome measure: Changes in AMH concentrations following vit D3 replacement.

Eligibility criteria: Inclusion Criteria:

* Vitamin D deficient premenopausal women

Exclusion Criteria:

* Pregnant women
* Women during their postpartum period
* Breastfeeding women
* Women taking any kind of exogenous hormones
* Women receiving any form of oral vitamin D replacement

Primary outcomes:
measure: AMH Levels in Women With PCOS
timeFrame: 8 weeks after completing vitamin D treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center, OBGYN clinic
state: New York
Study officials:
affiliation: Maimonides Medical Center, Brooklyn, NY, USA
name: Mohamad Irani, MD
role: STUDY_DIRECTOR
affiliation: University of Vermont College of Medicine, Burlington, VT, USA
name: Zaher Merhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510312: Long-term Prognosis in Stroke Patients
Official title: Long-term Prognosis in Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with acute ischemic stroke/transient ischemic attack

Brief summary: A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.

Detailed description: This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea.

Stroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.

Eligibility criteria: Inclusion Criteria:

* All patients with acute ischemic stroke or transient ischemic attack

Exclusion Criteria:

* A patient who did not agree with enrollment of this study

Primary outcomes:
measure: Event of Stroke or transient ischemic attack
timeFrame: through study completion, up to 10 years
measure: Event of cardiovascular disease (include stroke/transient ischemic attack)
timeFrame: through study completion, up to 10 years
measure: All cause mortality
timeFrame: through study completion, up to 10 years
measure: Cardiovascular cause mortality (include stroke/transient ischemic attack mortality)
timeFrame: through study completion, up to 10 years
measure: The modified Rankin Scale (mRS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji Hoe Heo
Study officials:
affiliation: Yonsei University
name: Ji Hoe Heo, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02539212: Comparison of Microwave and Radiofrequency Ablation for Liver
Official title: A Randomized Controlled Trial of Microwave and Radiofrequency Ablation in the Treatment of Early-stage Hepatocellular Carcinoma Meeting Milan Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: microwave
radiofrequency
ablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 403
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.

Detailed description: According to following enrollment standard, about \>400 cases of biopsy-proved hepatocellular carcinoma(HCC) patients will be involved in the study. They will be treated with percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is selected for the patient according to the sequence of their visit to the hospital based on randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic effectiveness will be compared between two modalities.

Eligibility criteria: Inclusion Criteria:

* tumor size ≤5cm in diameter,
* tumor number ≤3,
* Child-Pugh class A or B classification,
* no evidence of extrahepatic metastasis,
* vein or bile duct tumor embolus, and
* no any other anti-cancer treatment

Exclusion Criteria:

* not meeting the inclusion criteria

Primary outcomes:
measure: Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
timeFrame: up to 79 months
Secondary outcomes:
measure: disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
timeFrame: up to 79 months
measure: Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.
timeFrame: up to 79 months
measure: An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.
timeFrame: up to 79 months
measure: Wilcoxon test was used for comparing liver function between MWA and RFA.
timeFrame: up to 79 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00034112: Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Official title: Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Emphysema
Keywords: chronic obstructive pulmonary disease
combination therapy,
emphysema
exercise
human therapy evaluation
rehabilitation
respiratory disease /disorder therapy
respiratory function
biomechanics
body movement
diaphragm
dyspnea
muscle tension
musculoskeletal system
outcomes research
quality of life
somatic reflex
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-04-23
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.

Detailed description: OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.

Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: Kirksville College of Osteopathic Medicine
state: Missouri
Study officials:
affiliation: Kirksville College of Osteopathic Medicine
name: Donald R. Noll
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942812: Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
Official title: A Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack(Comprising of Low Osmolality ORS, Zinc Tablets, Water Purification Tablets and Pictorial Chart) on Childhood Diarrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: Children
Recovery
Diarrhea Pack
Social Marketing
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
First posted: 2009-07-21
Enrollment: 7200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a lot to be done for this issue. Zinc supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk of developing infectious diseases which eventually lead to a high burden of mortality.

In order to prevent and effectively manage diarrheal episodes, it is important that water purification tablets, zinc and oral rehydration salt is always available in each household. Though, these products are easily available in the market separately, but are rarely available together in any household. If these products are made available in a single packet, it is likely to be an effective strategy in combating diarrheal diseases in the community.


Eligibility criteria: Inclusion Criteria:

* Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate

Exclusion Criteria:

* Failure to provide consent or children having debilitating illness or requiring emergency hospital care.

Primary outcomes:
measure: Reduction in Diarrhea related morbidity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Khairpur
country: Pakistan
facility: AKU Project Office
state: Sind
Study officials:
References: