louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03527602: FE in Anterior Teeth
Official title: Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Apical Periodontitis
Keywords: Apical patency
Endodontics
Lead sponsor: Isparta Military Hospital
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.

Detailed description: Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

Eligibility criteria: Inclusion Criteria:

Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.

Exclusion Criteria:

Systemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.

Primary outcomes:
measure: 100-mm Visual Analog Scale (VAS).
timeFrame: 5 days
Secondary outcomes:
measure: The number of patients taking an analgesic following the endodontics treatment.
timeFrame: 5 days
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta Military Hospital
Study officials:
affiliation: Military Hospital, Isparta
name: ibrahim ethem yaylali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05359302: Effects of Ramadan Fasting on Sleeping and Quality of Life
Official title: Effects of Ramadan Fasting on Sleeping and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Quality of Life
Sleep Disorder
Keywords: Ramadan Fasting
SF-36 score
sleeping score
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable patients that intend to fast Ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.

Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Brief summary: Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Detailed description: All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.

The week before Ramadan (Pre-R). the last week of Ramadan (R). the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

All patients benifit of a routine examen and evaluation of the quality of life by Short Form 36 (SF36) test and sleeping by Pittsburg Sleep Quality Index (PQSI) score .

Eligibility criteria: Inclusion Criteria:

* Adult patient intending to fast Ramadan.

Exclusion Criteria:

* Age \< 18 years old
* Hemodynamic instability.
* Myocardial infarction requiring urgent revascularization.
* Parkinsonism: tremor problem.
* Refusal, communication problem.

Primary outcomes:
measure: the change in sleeping quality
timeFrame: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
measure: the change in the quality of life score
timeFrame: the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University hospital Fattouma Bourguiba
Study officials:
affiliation: University of Monastir
name: Semir Nouira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313802: A Study of LY3502970 in Healthy Overweight and Obese Participants
Official title: A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Obese
Keywords: Pharmacokinetics
Safety and Tolerability
LY3502970
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.


Eligibility criteria: Inclusion Criteria:

* Participants with stable body weight for at least one month prior to randomization.
* Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
* Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Predose up to 42 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
timeFrame: Predose up to 29 days postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 29 days postdose
measure: PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
timeFrame: Predose up to 29 days postdose
measure: Pharmacodynamics (PD): Change From Baseline in Body Weight
timeFrame: Predose through Day 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Lenexa
country: United States
facility: ICON Early Phase Services Lenexa Center
state: Kansas
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06281002: Trueness of Full Arch Scans and Generated Digital Implant Models
Official title: Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Denture
Complete Edentulism
Keywords: Intraoral scanning
Digital implant models
Edentulous mandible
Screw retained prosthesis
Geometric scanning aids
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 9
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.

Detailed description: The main issues to evaluate are:

* The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
* The trueness of the generated 3D-printed DIMs.

Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.

Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.

Eligibility criteria: Inclusion Criteria:

* Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
* Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
* Sufficient crown height space according to criteria of all-on-4.
* good oral hygiene and motivation

Exclusion Criteria:

* Patients with bad oral hygiene.
* Patients with limited mouth opening.
* Vulnerable groups.
* Uncooperative patients.
* Patients receiving or undergoing radiotherapy or chemotherapy.
* Patients with systemic diseases affecting bone metabolism.
* Smokers

Primary outcomes:
measure: Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
timeFrame: 2 months
Secondary outcomes:
measure: Trueness of the generated 3D-printed digital implant models.
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00212602: ONO-7436 Phase II Study in Japan
Official title: ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Tumor
Keywords: ONO-7436, Aprepitant, Vomiting, Nausea
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor


Eligibility criteria: Inclusion Criteria:

1. Patients age 20 years or older
2. Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours
3. Patients whose performance status is 0 to 2
4. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
2. Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study
3. Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
4. Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: Patient proportion of complete response (no vomiting and no rescue treatment).
Secondary outcomes:
measure: Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region Facility
city: Chugoku
country: Japan
facility: Chugoku Region Facility
city: Hokkaido
country: Japan
facility: Hokkaido Region Facility
city: Hokuriku
country: Japan
facility: Hokuriku Region Facility
city: Kanto
country: Japan
facility: Kanto Region Facility
city: Kinki
country: Japan
facility: Kinki Region Facility
city: Kyushu
country: Japan
facility: Kyushu Region Facility
city: Shikoku
country: Japan
facility: Shikoku Region Facility
city: Tohoku
country: Japan
facility: Tohoku Region Facility
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
citation: Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K. Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci. 2010 Nov;101(11):2455-61. doi: 10.1111/j.1349-7006.2010.01689.x.
Clinical trial NCT00256802: The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
Official title: The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
MR-Angiography
Healthy Volunteers
GTN
Middle Cerebral Artery
Keywords: Headache
migraine
MR-angiography
healthy volunteers
GTN
Middle cerebral artery
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular response during the GTN-induced headache in healthy volunteers.

Detailed description: The only intra cranial structures innervated by sensory nerves, and therefore a possible source of the headpain are the meninges and the large intracerebral arteries. The dilatation of the cerebral vessels may not be the origin of the head pain per se, but measurements of the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and has helped elucidate the basis for the migraine aura (Olesen, Friberg et al. 1990). The effects of different signal molecules on the intra cerebral vasculature continue to be an important field in the migraine research, in the search for possible pain causing signaling molecules.

Therefore we have set up at study to examine if MR-Angiography (MRA) can be used for monitoring of the vascular response after challenge with the known vasodilator GTN. This drug was chosen because it is well characterized and a large body of evidence from earlier studies could serve as background data (Thomsen 1997).

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to \>2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia.

Primary outcomes:
measure: The primary endpoints were the difference between the area under the curve of the MCA area and the difference between the area under the curve of the diameter of the MCA on an active day and on a placebo day recorded over 60 mins.
Secondary outcomes:
measure: The secondary endpoints were difference in the area under the curve for the relative changes in area in percent deviation from baseline, and the difference in headache response.
Other outcomes:
Locations:
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03328702: CPAP to Improve Swallow Function Post Total Laryngectomy
Official title: Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Laryngectomy; Status
Keywords: Dysphagia
Oropharyngeal dysphagia
Total Laryngectomy
Video Fluoroscopic Swallowing Exam (VFSE)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing

Detailed description: Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.

Eligibility criteria: Inclusion Criteria:

* Patients at least 2 months after total laryngectomy
* Undergoing Video Fluoroscopic Swallowing Examination

Exclusion Criteria:

* Patients with 100% neopharyngeal stenosis
* Patients with active cancer within 2 months of the study
* Patients with pharyngocutaneous fistula
* Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners

Primary outcomes:
measure: Total Pharyngeal Transit Time (With CPAP)
timeFrame: During VFSE (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT03582202: Organization of the Dietetic Service in a Hospital
Official title: Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Disease
Malnutrition
Keywords: dietitic service, organization of service
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized.

Methods: Randomized, unblinded, parallel design. The intervention group (IT) was nutritionally handled by the dietician, and the control group (C) by the nurses as previously with the possibility for dietetic help from the center.

Detailed description: All patients were screened by NRS-2002 and had their estimated needs calculated (equations in IT, tables in C). The IT was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. All patients were re-screened weekly and had their intake registered. Hand-grib-strength (HGS) was measured in both groups at admittance and discharge, and weight three times weekly.

The primary endpoint was re-admission rate to hospital within 2 months.

Eligibility criteria: Inclusion Criteria:

* adult
* acutely admitted to hospital

Exclusion Criteria:

* dementia
* unable to comply with the protocol

Primary outcomes:
measure: re-admission-rate after discharge (%)
timeFrame: 2 months
Secondary outcomes:
measure: intake of protein during hospital stay
timeFrame: 1 week
measure: intake of energy during hospital stay
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815202: Sun Protection Factor Assay (SPF Assay 19008)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References: