louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04462341: Efficacy of an Oral Hygiene Implant Protocol
Official title: Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: Water Pik, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 6
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: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.

Detailed description: The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. This is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks. Photographs of the tissue and denture will be taken.

Eligibility criteria: Inclusion Criteria:

* have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
* Good general health, with no diseases which could impact periodontal health
* able to read and understand English
* willing to return for all appointments
* at least 30% BOP
* probing depths less or equal to 5mm

Exclusion Criteria:

* subjects who are currently pregnant
* mobility of implant
* subjects who have diabetes
* subjects who smoke
* subjects with any serious medical condition which the investigator feels may impact participation in the study

Primary outcomes:
measure: Bleeding on probing
timeFrame: 6 weeks
Secondary outcomes:
measure: Probing depth
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts School of Dental Medicine
name: Gerard Kugel, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT03717441: DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
Official title: DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Colorado Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos

Brief summary: Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center

Detailed description: The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.

Eligibility criteria: Inclusion Criteria:

* Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos

Exclusion Criteria:

-

Primary outcomes:
measure: DNA Analysis of discarded media drops form the clinical IVF Cycles
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
Study officials:
affiliation: Colorado Center for Reproductive Medicine
name: Mandy Katz-Jaffe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02325141: Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection
Official title: Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

Detailed description: Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

Eligibility criteria: Inclusion Criteria:

Body mass index \>40 or \>35 with hypertension or DM

Exclusion Criteria:

Previous bariatric surgery

Primary outcomes:
measure: number pf patients developing postoperative gastric leakage
timeFrame: 0ne year
Secondary outcomes:
measure: percent of patients with excess weight loss
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05692596: The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Official title: The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma
Pancreatic Cyst
Chronic Pancreatitis
Fatty Pancreas
Genetic Pancreatic Cancer
Genetic Pancreatitis
BRCA Mutation
Lynch Syndrome
FAP
Familial Atypical Multiple Mole-Melanoma
PALB2 Gene Mutation
Peutz-Jeghers Syndrome
Ataxia Telangiectasia
Keywords: pancreas
database
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at the Moffitt GI clinic

Brief summary: The long-term goal of our PIC is to develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect PDAC at an early stage, thereby reducing PDAC burden and saving lives.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Moffitt Cancer Center patients presenting with a pancreatic cyst, and/or inherited syndrome that predisposes them to pancreatic ductal adenocarcinoma (PDAC)
* Moffitt Cancer Center patients undergoing evaluation for localized/early stage PDAC.
* Moffitt Cancer Center patients with a combination of PDAC risk factors such as a history of chronic or new-onset diabetes, pancreatitis, obesity, tobacco exposure, toxin exposure and/or heavy alcohol consumption.

Primary outcomes:
measure: Database creation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Shaffer Mok, MD, MBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06806696: SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA
Official title: SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
COVID-19
Post-COVID / Long-COVID
Newborn Health
Miscarriages
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 60739
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the pregnant Estonian women who conceived and gave birth between February 27, 2020, and March 1, 2023

Brief summary: The main aim of the study is to describe the possible impacts of SARS-CoV-2 and its various genotypes on pregnancy and long-term outcomes among pregnant women and their newborns in Estonia.

Detailed description: All the pregnant women in Estonia who conceived and gave birth between February 27, 2020, and March 1, 2023 were included in the study. Pregnant women will be divided into 2 groups: 1. pregnant women who were diagnosed with COVID-19 during the study period, along with their newborns; 2. control group: pregnant women who did not have COVID-19 during pregnancy, along with their newborns. The following data is collected for each subject: prior vaccination, previous COVID-19 infection, underlying diseases/conditions, hospitalization, need for intensive care, need for mechanical ventilation and/or oxygen therapy, death cases, post-COVID-19 symptoms, pregnancy course and outcomes, possible virus transmission from mother to child, and the newborn's condition or accompanying health issues

Eligibility criteria: Inclusion Criteria:

* pregnancy (conceived and gave birth between February 27, 2020, and March 1, 2023) with COVID-19 or without and their newborns

Exclusion Criteria:

* NA

Primary outcomes:
measure: COVID-19 incidence
timeFrame: From enrollment to March 2023
measure: Post-COVID condition incidence
timeFrame: From enrollment to March 2023
measure: Chronic diseases incidence
timeFrame: From enrollment to March 2023
measure: Newborn condition
timeFrame: From enrollment to March 2023
measure: Mortality
timeFrame: From enrollment to March 2023
measure: Hospitalization rate due to COVID-19
timeFrame: From enrollment to March 2023
measure: Pregnancy complications incidence
timeFrame: From enrollment to March 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: University of Tartu
Study officials:
References:
Clinical trial NCT06164496: Evaluation of the Effectiveness of Different Toothbrushes in Children
Official title: Evaluating the Effectiveness of Different Toothbrushes in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Plaque
Plaque, Dental
Oral Hygiene
Gingivitis
Periodontal Indexes
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blinded randomized control trial
Primary purpose: PREVENTION

Brief summary: Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.

Study design: Experimental study

Detailed description: In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.

Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p \< 0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 2-12.
* Children without systemic disease or developmental dental anomalies.
* Children not undergoing orthodontic treatment.
* Children with no decay on the labial surfaces of upper anterior incisors.
* Patients or their parents accepting participation in the treatment.

Exclusion Criteria:

* Children with decay on the labial surfaces of upper anterior incisors.
* Children undergoing orthodontic treatment.
* Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.

Primary outcomes:
measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maltepe
country: Turkey
facility: Marmara University
state: İstanbul
Study officials:
References:
Clinical trial NCT05244096: COVID-19 & Psychiatry: A Retrospective Chart Review
Official title: A Retrospective Chart Review Study to Determine the Effects of Psychotropic Medications and Prior Psychiatric Diagnoses on COVID-19 Patients' Disease Progression, and Severity.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 65000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COVID-19

Brief summary: A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.

Detailed description: The goal of this study would be to study the association between use of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression and severity.

Eligibility criteria: Inclusion Criteria:

- Individuals with a positive COVID-19 test between March 15 2020 to November 30 2021 at Northwestern Medicine hospitals.

Exclusion Criteria:

-

Primary outcomes:
measure: Hazard Ratio
timeFrame: March 15 2020 to Nov 30 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwester Clinical Research Program
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jeffrey Rado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03113396: Baclofen for Rumination
Official title: A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rumination
Supra-gastric Belching
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.


Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of rumination syndrome and/or supra-gastric belching.
* Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
* 18 to 75 years old.
* Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

* Systemic diseases, known to affect esophageal motility.
* Surgery in thorax or in the upper part of the abdomen.
* Treatment with baclofen prior to the start of the study.
* Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
* Pregnancy or breast feeding.
* History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed).
* History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Primary outcomes:
measure: Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
timeFrame: 2 weeks treatment
Secondary outcomes:
measure: objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
timeFrame: 2 weeks treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Pauwels A, Broers C, Van Houtte B, Rommel N, Vanuytsel T, Tack J. A Randomized Double-Blind, Placebo-Controlled, Cross-Over Study Using Baclofen in the Treatment of Rumination Syndrome. Am J Gastroenterol. 2018 Jan;113(1):97-104. doi: 10.1038/ajg.2017.441. Epub 2017 Dec 5.
Clinical trial NCT06079996: Caffeinated Gum Softball Performance
Official title: Effects of Caffeinated Gum on a Batting and Pitching Performance of Female Softball Players: a Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of caffeinated chewing gum on female softball pitching and hitting performance. 24 trained female softball players (10 pitchers and 14 fielders) were divided into a caffeine chewing gum trial (CAF) or a placebo trial (PLA) in a single-blind, randomized, crossover experimental design. Two pieces of gum containing 100 mg of caffeine (CAF) or without caffeine (PLA) were chewed for 10 minutes and then spit out, followed by a 15-minute warm-up. The physical tests included grip strength and countermovement jump. The softball-specific tests included pitching (fast ball speed) or hitting (exit speed). The two trials were separated by seven days.

Detailed description: This study utilized a randomized, crossover, single-blind experimental design. At least two familiarization tests were conducted one week before the formal trial to ensure each participant was familiar with the experimental procedures. Before the first formal trial, participants were randomly assigned to either the caffeinated chewing gum trial (CAF) with 200 mg of caffeine or the placebo trial (PLA) without caffeine, seven days apart (Figure 1). The primary outcome was the pitching and hitting performance, and the secondary outcomes were hand grip strength and height of countermovement jump.

Eligibility criteria: Inclusion Criteria:

* 1. adult female; 2. at least six years of professional softball training and familiarity with all softball skills; 3. caffeine intake of less than 80 mg daily.

Exclusion Criteria:

* 1. not professionally trained; 2. having a medical condition for which exercise is not recommended, such as hypertension, hyperlipidemia, or heart disease; 3. having any musculoskeletal injuries within the last six months or not being able to complete a full trial; 4. having a history of caffeine allergy.

Primary outcomes:
measure: pitching performance
timeFrame: 15 min after intervention
measure: batting performance
timeFrame: 15 min after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
References:
Clinical trial NCT00491296: Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations Combined With Hyperthermia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: S/P Transuretral resection of bladder tumor
Recurrent tumor after BCG Treatment
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-06-26
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA determination will obtain before each synergo therapy application and at cystoscopy with each patient also serving as a control.

Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or pt. with recurrent tu of bladder post TURT with BCGtreatment.


Eligibility criteria: Inclusion Criteria:

* Recurrent transitional cell carcinoma of urinary bladder post endoscopic resection
* PSA Prior synergo therapy application\<10
* Normal rectal examination
* Patients willing to sign informed consent according

Exclusion Criteria:

* History of prostate cancer
* Previous history of TCC stage T2 or higher
* Invasive tu of bladder
* Prior pelvic radiotherapy or systemic chemotherapy
* Active prostatitis
* Active tuberculosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek MC
city: Afula
country: Israel
facility: Department of urology
Study officials:
affiliation: HAEMEK MEDICAL CENTER, UROLOGY DEPARTMENT
name: PEREZ DORON, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: haemek medical center
name: Perez Doron, M.D
role: PRINCIPAL_INVESTIGATOR
References: