louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03601585: Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal
Official title: Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal: A Randomized, Double Masked Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Self Cleaning
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study was to evaluate the efficacy of three methods for removal of dental biofilm when compared to dental toothbrushing control. Twenty patients were diagnosed and randomized into four groups according to the method tested: 1) apple 2) Rolly Brush 3) chewing gum and 4) brushing control. Subjects were evaluated four times according to the method used. All were evaluated before performing any method and after using each of the four methods separately. The patient's evaluation interval was 24 hours between the use of the methods. In the first stage, they underwent a clinical examination in which the needs of supragingival scraping or definitive restorations and prophylaxis were detected. After this step, all methods of oral hygiene and the consumption of fibrous foods and chewing gum were suspended for twenty-four hours. In the second stage, with a minimum of twenty-four hours after the first, volunteers received approximately 10 ml of basic fucsin to perform a mouthwash. The dental examination was then carried out for measurement on each dental surface and the plaque index was recorded on each surface. In the latter, four evaluations were performed with at least a 24-hour interval until the patients used the four methods


Eligibility criteria: Inclusion Criteria:

* Good periodontal health
* Minimum of eight occlusal surfaces of premolars and molars hygienic

Exclusion Criteria:

* Less than eight occlusal surfaces
* Use of orthodontic appliance
* Use of dental prosthesis

Primary outcomes:
measure: Plaque index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Periodontics Clinic, Department of Dentistry
state: Minas Gerais
Study officials:
References:
Clinical trial NCT02386085: Patient-reported Adverse Events From Osteopathic Manipulative Treatment
Official title: Patient-reported Adverse Events From Osteopathic Manipulative Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopathic Manipulative Treatment
Keywords: Osteopathic Manipulative Medicine
Osteopathic Manipulation
adverse effects
side effects
undesirable effects
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American Academy of Osteopathy
name: A.T. Still Research Institute
name: DO-Touch.NET
First posted: 2015-03-11
Enrollment: 1303
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: The study population is patients who receive osteopathic manipulative treatment from a licensed practitioner for any reason.

Brief summary: Currently, there is a significant deficiency in evidence regarding the safety of osteopathic manipulative treatments (OMT). To address this deficit, this study is designed to systematically evaluate the incidence and severity of OMT adverse events and examine the relationship of these adverse events to the technique(s) used and the body region(s) treated. The study is being conducted at the clinics of participating members of DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic manual medicine research. Eligible patients who receive OMT at one of the participating clinics will be asked to complete either a paper or online survey regarding any adverse events they experience within 1, 3, and 7 days following their treatment. Information regarding their diagnoses, which osteopathic techniques were used in their OMT, and which body regions were treated will be obtained from participant medical records. This data will be used to answer the following research questions:

1. What is the incidence of adverse events from osteopathic manipulative treatment?
2. What types of adverse events occur following osteopathic manipulative treatment?
3. Are there individual osteopathic techniques in particular body regions that have higher incidences of adverse events than other techniques or body regions?
4. Is the incidence of adverse events higher for some patient conditions than others?


Eligibility criteria: Inclusion Criteria:

* received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria:

* unable to communicate in English, Spanish, French, German, or Portuguese

Primary outcomes:
measure: Severity of adverse events related to osteopathic manipulative treatment (OMT)
timeFrame: Within 1 week after receiving OMT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: A.T. Still University of Health Sciences
name: Jane C Johnson, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: A.T. Still University of Health Sciences
name: Brian F Degenhardt, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590485: Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-treatment Pain Following Root Canal Therapy
Keywords: pain
root canal therapy
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.

Detailed description: Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. After root canal therapy each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be compared between 2 groups.

Eligibility criteria: Inclusion Criteria:

* patients who have at least one vital tooth with one root canal and moderate to severe pain

Exclusion Criteria:

1. teeth with periapical lesions
2. patients with history of:

   * allergy to saffron
   * diabetes mellitus
   * cardiovascular disorders
   * kidney and liver diseases
   * blood and hormonal disorders
   * electrolyte imbalance
3. women in pregnancy or breast feeding period and
4. use of analgesics or opioids during 4 hours before treatment

Primary outcomes:
measure: change in VAS score
timeFrame: Every 6 hours after treatment completion up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Zahedan university of medical sciences, Vice-chancellor for research
Study officials:
affiliation: Zahedan University of Medical Sciences
name: Kaveh Oloomi, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03357185: Prospective Evaluation of Femoral Tripod Eversion Technique
Official title: Prospective Evaluation of Femoral Tripod Eversion Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atheromatous
Keywords: Femoral bifurcation
Peripheral arterial disease
Vascular surgery
Eversion
Open surgery
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 37
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: Register including all patients who have been treated with the femoral eversion technique.

Brief summary: Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. The major advantage of the eversion technique is the absence of prosthetic material to be performed. However, its use has been scarcely evaluated in the literature to date. This work aims at evaluating the long term safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly described and participants were followed up for two years by serial clinical and doppler US examination.

Detailed description: Femoral bifurcation lesions is one of the most frequent lesion encountered in lower limb atheromatous occlusive disease. Current treatment options consists in femoral endarteriectomy or bypass. More recently, endovascular treatment of femoral tripod lesions has been reported. Inguinal area is prone to postoperative infection in up to 20% of the cases. Hence, the use of synthetic graft puts the participants at risk of dramatic consequences in case of postoperative infection. Besides, long term data are still required to validate the use of endovascular device in this very "surgical" area. The use of the eversion technique is possible in the majority of the lesions and offer the major advantage of open surgery in terms of durability, without the use of synthetic material in case of postoperative infection.

The investigators herein report the detailed technique, tips and variations of the eversion technique as well as the clinical follow up in terms of clinical benefit according to Rutherford classification and restenosis evaluated by serial doppler US.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Lower limb atheromatous occlusive disease.
* Stage 2 to 4 according to Rutherford's classification

Exclusion Criteria:

* Age\< 18
* Previous surgery or endovascular treatment of the ipsilateral limb
* Non atheromatous disease
* Pregnancy
* Life-expectancy estimated to be less than one year

Primary outcomes:
measure: Clinical follow-up
timeFrame: One year.
Secondary outcomes:
measure: Clinical complications
timeFrame: At one month, six months and twelve months.
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital NOVO
name: Jean-Michel DAVAINE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00335985: Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Official title: A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polymyositis
Dermatomyositis
Keywords: polymyositis, dermatomyositis
High-dose intravenous immunoglobulin
Venoglobulin-IH
Steroid-resistant polymyositis(PM) and dermatomyositis(DM)
Lead sponsor: Japan Blood Products Organization
Sponsor class: INDUSTRY
First posted: 2006-06-12
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.


Eligibility criteria: Inclusion Criteria:

* Patients who have been defined as "definite" based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
* Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.

Exclusion Criteria:

* Patients with malignant tumors.
* Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
* Patients with severe muscular atrophy for a long period.
* Patients with severe infectious disease.
* Patients who have the anamnesis of shock or hypersensitivity to this drug.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
* Patients who have been diagnosed as IgA deficiency in their past history.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
* Patients who were administered immunoglobulin dosage within 6 weeks before consent.

Primary outcomes:
measure: Changes in manual muscle strength (MMT) scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)
timeFrame: 8 weeks
measure: Adverse events and laboratory tests
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University
state: Tokyo
Study officials:
affiliation: Tokyo Medical and Dental University
name: Nobuyuki Miyasaka, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02651285: Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF
Official title: G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Embryo Development
IVF
Keywords: G-CSF
BLASTOCYST
IVF
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2016-01-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles.

Detailed description: In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients undergoing IVF. 180 infertile women undergoing IVF no more than 37 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered

Eligibility criteria: Inclusion Criteria:

* infertility
* healthy condition,
* good ovarian reserve (AMH levels more than 1microg/ml)

Exclusion Criteria:

* chromosomal defects in the couple,
* metabolic diseases (diabetes, etc),
* other genetic diseases (thalassemia, cystic fibrosis, etc.)

Primary outcomes:
measure: pregnancy rate
timeFrame: 12 months
measure: implantation rate
timeFrame: 12 months
Secondary outcomes:
measure: number of blastocyst developped
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Cerm-Hungaria
Study officials:
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
name: Francesco Morgia, MS
role: STUDY_CHAIR
References:
Clinical trial NCT02214537: Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?
Official title: Embryo Development Measure Depending on the DNA Sperm Fragmentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blastocyst Time
Pronuclear Appearance
Pronuclear Fading
Embryo Compaction
Cleavage Times
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 36
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.


Eligibility criteria: Inclusion Criteria:

* Patients 36 to 38 years
* Fresh sample semen
* Minimum 6 oocytes
* Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.

Exclusion Criteria:

* Patients younger than 36 or older than 38 years old
* Frozen semen sample
* Less tan 6 oocytes.
* Semen samples with less than 5 million / ml or less than 30% of motile sperm.

Primary outcomes:
measure: Time of pronuclear appearance in hours.
timeFrame: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
affiliation: IVI Madrid
name: Manuela Alonso
role: STUDY_DIRECTOR
affiliation: IVI Madrid
name: David Agudo, PhD
role: STUDY_DIRECTOR
affiliation: IVI Madrid
name: Maria Testillano
role: STUDY_CHAIR
affiliation: IVI Madrid
name: Alberto Pacheco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03760237: Cardiovascular Function in Acute Leukemia
Official title: Cardiovascular Function in Leukemia Patients: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoid, Acute
Cardiotoxicity
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are newly diagnosed with acute leukemia

Brief summary: An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.

Detailed description: Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age,
* New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).
* Signed the informed consent form

Exclusion Criteria:

• Unable to provide informed consent

Primary outcomes:
measure: Left Ventricular dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Cardiovascular Events
timeFrame: 1 year
measure: Incidence of Symptomatic Heart Failure
timeFrame: 1 year
measure: Incidence of Cardiac Death and all mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marielle Scherrer-Crosbie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567437: Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Official title: Utility of Exercise-induced NT-pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Stenosis
Keywords: aortic stenosis
prognosis
brain natriuretic peptide
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise. Changes in NT-pro-BNP levels will be correlated to outcomes at one year. In the pilot phase an additional 10 control subjects without AS will be enrolled to document the control response of NT-pro-BNP elevations with exercise.


Eligibility criteria: Inclusion Criteria:

1. valvular AS (Doppler velocity ≥ 3.0 m/s)
2. no baseline symptoms referable to valvular heart disease
3. able to perform ETT

Exclusion Criteria:

1. more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis
2. previous AVR
3. known coronary artery disease
4. creatinine clearance 50 mL/min
5. LVEF \< 50%
6. planned valve surgery prior to enrollment
7. significant pulmonary disease
8. unable to give informed consent
9. pregnancy

Primary outcomes:
measure: development of symptomatic aortic stenosis (new/progressive angina or dyspnea, pre-syncope/syncope, hospitalization for cardiac chest pain or heart failure, drop in LV ejection fraction, cardiovascular or sudden death, valve replacement surgery)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas M. Bashore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: John K. Harrison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Aslan T. Turer, MD
role: STUDY_DIRECTOR
References: