louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05304338: Evaluation of the Effect of Oil Pulling
Official title: Evaluation of the Effect of Oil Pulling on Dental and Gingival Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Dental Plaque
Keywords: Chlorhexidine
Oil pulling
Plaque Regrowth model
Coconut oil
Digital spectrophotometer
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of this study were to evaluate the inhibitory effect on plaque and the tooth discoloration associated with agents used in the chemical plaque control of oil pulling in comparison with chlorhexidine-containing mouthwash and water in a four-day plaque regrowth model.

One hundred dentistry students were included in this randomized, parallel-group, placebo-controlled clinical study. In this study, participants were divided into 5 equal groups: Group 1: Gargling with 0.2% chlorhexidine; Group 2: Oil pulling with coconut oil; Group 3: Oil pulling with black cumin oil; Group 4: Oil pulling with terebinth oil; Group 4: Gargling with distilled water. Participants were instructed to refrain from mechanical oral hygiene and rinse only with the allocated mouth rinse during the four-day period. The differences in plaque index, gingival index, and tooth discoloration were evaluated in the study.


Eligibility criteria: Inclusion Criteria:

* Without systemic disease,
* Had at least 24 teeth, and
* Without fixed or removable prostheses or orthodontic appliances

Exclusion Criteria:

* Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months
* Individuals with an allergy to any ingredient used in the study
* Smokers
* Pregnant or breastfeeding women
* Individuals with ≥2 mm gingival recession

Primary outcomes:
measure: Dental Plaque
timeFrame: Day 4
Secondary outcomes:
measure: Tooth Color
timeFrame: Day 1- Day 4
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: None Selected
Study officials:
References:
Clinical trial NCT00763438: Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
Official title: A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Sertindole
Safety study
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.

Detailed description: Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.

Eligibility criteria: Inclusion Criteria:

* Participation in the previous SCoP study, 99824
* Still fulfils the EU SPC requirements for Sertindole

Exclusion Criteria:

* Withdrawn before the end of the SCoP study, 99824
* Become homeless
* Participation in another clinical trial at the same time
* Unlikely to comply with the clinical study protocol or is unsuitable for any reason

Primary outcomes:
measure: All serious adverse events reported; visits scheduled every 3 months
timeFrame: Every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Allonnes
country: France
facility: FR002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT00499538: Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects
Official title: A Single Dose Bioavailability Study of 3 New Formulations of SKI-606 (500 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.


Eligibility criteria: Criteria:

* Healthy male and female aged 18 to 50 years.
* Women of nonchildbearing potential (WONCBP).

Primary outcomes:
measure: The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for SKI-606 to support formulation development.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01062438: Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma
Official title: Genomic Study of Metastatic Osteosarcoma Using Next-Generation Sequencing Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: localized osteosarcoma
metastatic osteosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-04
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of localized or metastatic osteosarcoma

Brief summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.

Detailed description: OBJECTIVES:

* Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.
* Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.
* Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.
* Identify which mutations are associated with outcome.
* Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.

OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.

Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of localized or metastatic osteosarcoma
* Banked snap-frozen tumor tissue samples and paired blood DNA samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing
measure: Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing
measure: Mutations associated with outcome
measure: Mutations also found in germ line DNA that predispose the patient to osteosarcoma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NCI - Oncogenomics Section
name: Javed Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00225238: The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep
Official title: The Effect of Esomeprazole (Nexium) on the Incidence and Severity of Gastrointestinal Adverse Events Associated With a Colonoscopy Purgative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Abdominal Pain
Keywords: colonoscopy prep
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a colon prep for a colonoscopy will decrease the side effects that are associated with the colon preparation

Detailed description: The high incidence for colon cancer make it an ideal target for screening. In the United Staes there are approximately 100,00 new cases of colon cancer yearly. Typically the progression from polyps to cancer requires years. This permits a screening procedure to identify polyps befoere they are cancerous. Colon cleansing is required prior to colonoscopy. The gastrointestinal syptoms associted with colonic preps are common and oftn assoicated wwith upper gastrointestinal disorders including GERD, non-ulcer syspepsia, and gastric dysmotoility such as gastropareesis.

Eligibility criteria: Inclusion Criteria:

* Subject 18 or older undergoing out-patient colonoscopy

Exclusion Criteria:

* Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.

Primary outcomes:
measure: Outcome will be measured by use of a symptom survey utilizing an analog scale. This will be done at the screen visit and prior to colonoscopy.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David Kastenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149938: Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Official title: Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).


Eligibility criteria: Key Inclusion Criteria:

* Must be healthy based on medical history, laboratory work, and physical exam
* Be ≥18 and ≤65 years of age
* Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
* Must be free of any systemic or dermatologic disorder

Key Exclusion Criteria:

* Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
* Current use of opioids
* Known hypersensitivity or allergy to any of the components of the product formulations
* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization

Primary outcomes:
measure: Peak plasma concentration (Cmax) of lidocaine
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Apparent dose
timeFrame: 0 to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TKL Research, Inc.
name: Phillip LaStella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.
Clinical trial NCT00626938: Role of Proteomics in Diagnosing Sarcoidosis
Official title: Proteomics as a Tool for Biomarker Detection in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Keywords: sarcoidosis
protein profile
CYP-450
TNF-alpha polymorphisms
HLA
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting the out-patient clinic of the university hospital Maastricht.

Brief summary: Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the fact that its exact cause is still unknown. Consequently, diagnosing the disease is also rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical methods to evaluate the status of the lung including a chest X-ray, lung biopsy and bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather invasive and, even more important, non-conclusive. Therefore, the current study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results will be compared with other currently used laboratory parameters.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

* Non-smoking
* No treatment for extra-pulmonary symptoms of sarcoidosis

Primary outcomes:
measure: protein profile in blood
timeFrame: within 1 month after obtaining sample
Secondary outcomes:
measure: CYP and TNF polymorphisms
timeFrame: within 6 months after obtaining sample
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: University Hospital Maastricht, Departement of Respiratory Medicine
name: Marjolein Drent, Prof,MD,PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Maastricht, Departement of Clinical Chemistry
name: Otto Bekers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Maastricht, Departement of Tissue Typing
name: Christine Voorter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Maastricht, Departement of Clinical Chemistry
name: Marja P van Dieijen-Visser, Prof,MSc,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00304408: Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody
Official title: Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Enterocolitis
Pseudomembranous Colitis
Antibiotic-Associated Colitis
Keywords: Clostridium difficile
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: Baylor College of Medicine
First posted: 2006-03-17
Enrollment: 10
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: Patients positive for C. difficile.

Brief summary: The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.

Detailed description: Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.

Eligibility criteria: Inclusion Criteria:

* All patients at the Houston VA with documented C. difficile infection

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. Debakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Daniel M Musher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435108: A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Official title: A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: c-MET Positive Gastric Cancer
Keywords: MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
4. c-MET positive gastric cancer
5. ECOG PS 0-2
6. At least one measurable disease
7. Proper organ function

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
5. known history of hypersensitivity to study drugs

Primary outcomes:
measure: progression-free survival
timeFrame: expected average of 24 weeks
Secondary outcomes:
measure: overall response rate
timeFrame: up too 100 weeks
measure: overall survival
timeFrame: up too 100 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up too 100 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical center
Study officials:
affiliation: Samsung Medical Center
name: Jeeyun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: