louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04999579: Digital Occlusal Analysis of Ultra Suction Retained Complete Denture
Official title: Digital Occlusal Analysis of Ultra Suction Retained Complete Denture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Edentulism
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.

Detailed description: Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed.

The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements.

The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004", 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.

Eligibility criteria: Inclusion Criteria:

* All implant indicated.

Exclusion Criteria:

* All implant contraindicated

Primary outcomes:
measure: Occlusal load analysis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr university in Cairo
Study officials:
affiliation: Badr university in Cairo
name: El Naagar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842879: Outpatient Foley Cervix Priming
Official title: Outpatient Versus Inpatient Cervix Priming With Foley Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatient Mechanical Cervix Priming
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score \< 6, gestational age \> 41 weeks or medical indication for induction of labor.

Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.

The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.


Eligibility criteria: Inclusion Criteria:

* women with a single fetus in cephalic presentation
* Bishop score \< 6
* Gestational age \> 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter

Exclusion Criteria:

* women with a fetus in noncephalic presentation
* an indication for elective cesarean delivery
* spontaneous labor
* hydramnios (amniotic fluid index ≥ 25)
* nonreassuring cardiotocogram
* multiple pregnancy
* rupture of membranes
* active vaginal bleeding
* indication for prophylaxis of Streptococcus group B infection
* HIV infection
* cervical injury
* previous cesarean section with recurrent indication

Primary outcomes:
measure: variation of bishop score (difference between bishop score before and after application of foley catheter)
timeFrame: up to 24 months
Secondary outcomes:
measure: mode of delivery
timeFrame: up to 24 months
measure: induction-to-delivery time
timeFrame: up to 24 months
measure: maternal pain evaluated by visual analog scale for pain
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
name: Catarina Policiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
citation: Policiano C, Pimenta M, Martins D, Clode N. Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:1-6. doi: 10.1016/j.ejogrb.2016.11.026. Epub 2016 Nov 27.
Clinical trial NCT00657579: Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension.
* Provided signed, written informed consent.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka, Japan
Study officials:
References:
Clinical trial NCT04939779: Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371(Batch#1650006)" and "LCB01-0371(Batch#3183817R)" in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 25
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject


Eligibility criteria: Inclusion Criteria:

1. A person who is a healthy adult aged between 19 and 45 years old with the result of BMI between 18.0 kg/m2 and 28.0 kg/m2
2. A healthy adult whose weight is over 50 kg
3. A person who is deemed suitable for a clinical trial subject in physical examination, vital sign tests, diagnostic examination, and 12-lead ECG by the medical doctor, etc.

Exclusion Criteria:

1. A person who has a clinically significant history of the disease, such as liver, kidney, gastrointestinal disease, respiratory tract disease, muscular-skeletal disease, endocrine disease, nervous system disease, blood ∙ tumor disease, cardiovascular disease, etc.
2. A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.

Primary outcomes:
measure: Pharmacokinetic evaluation: The observed maximum concentration(Cmax)
timeFrame: 0-12hours
measure: Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)
timeFrame: 0-12hours
Secondary outcomes:
measure: Pharmacokinetic evaluation: Time to reach Cmax(Tmax)
timeFrame: 0-12hours
measure: Pharmacokinetic evaluation: Elimination half-life(t1/2)
timeFrame: 0-12hours
measure: Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F)
timeFrame: 0-12hours
measure: Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F)
timeFrame: 0-12hours
measure: Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf)
timeFrame: 0-12hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae-Yong Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406679: Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Official title: Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: pain, postoperative
surgery, oral
surgery, dental
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).


Eligibility criteria: Inclusion Criteria:

* ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
* Moderate or severe pain within 4 hours after the completion of surgery.

Exclusion Criteria:

* Another acute or chronic painful physical condition
* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
* Inability to use and understand Visual Analog Scale and Verbal Rating Score

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University Dental Hospital of Manchester
state: England
city: Cardiff
country: United Kingdom
facility: University Dental Hospital NHS Trust Cardiff
state: Wales
Study officials:
affiliation: Baxter Healthcare Corporation
name: Keyvan Tadjalli-Mehr, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01345279: Indirect Comparison Topotecan Cervical Carcinoma
Official title: Indirect Comparison of the Efficacy Between Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 1
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The search was designed to identify all clinical data published since the Cancer Care Ontario systematic review in 2006. The Cancer Care Ontario systematic review searched MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006), the Cochrane Library (Cochrane Database of Systematic Reviews (2006 Issue 1), and Cochrane Controlled Trials Register (2006 Issue 1)), the Canadian Medical Association Infobase, and the National Guidelines Clearinghouse. The conference proceedings of the American Society of Clinical Oncology (1995-2005) and the European Society of Medical Oncology (2002-2005) were also searched. The search was completed on 18 December 2008

Brief summary: Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some differences between the respective study populations. Patients with prior chemotherapy were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in GOG-0169 (27%) than in GOG-0179 (\~60%) and these patients were unevenly distributed between treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated with the indirect meta-analysis.


Eligibility criteria: Inclusion Criteria:

* randomised clinical trials, or systematic reviews and meta-analyses
* treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04349579: Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine
Official title: Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine on Postoperative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: rifamycine
pain
edema
trismus
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and mouthwashes are prescribed for the treatment of complications encountered. When using postoperative antibiotics in surgery of impacted third molar teeth, lower surgical area infection, pain, swelling and trismus are seen. Based on this information, in this study, it is aimed to evaluate the effects of rifamycine intraoperatively on the postoperative pain, swelling and trismus.


Eligibility criteria: Inclusion Criteria:

* absence of any systemic disease
* having bilateral impacted mandibular third molar teeth in a similar position
* absence of allergy to any of the drugs used in the study,
* absence of pregnancy/lactating state,
* no history of any medication use during at least 2 week before the operation.

Exclusion Criteria:

* not regularly coming to the controls,
* not using their medicines regularly
* using any additional medication that may affect the outcome of the study

Primary outcomes:
measure: Postoperative Pain
timeFrame: Postoperatif 1st day
measure: Postoperative Pain
timeFrame: Postoperatif 2nd day
measure: Postoperative Swelling
timeFrame: Postoperative 2nd day
measure: Postoperative Trismus
timeFrame: Postoperative 2nd day
measure: Postoperative Pain
timeFrame: Postoperatif 3th day
measure: Postoperative Pain
timeFrame: Postoperatif 4th day
measure: Postoperative Pain
timeFrame: Postoperatif 5th day
measure: Postoperative Pain
timeFrame: Postoperatif 6th day
measure: Postoperative Pain
timeFrame: Postoperatif 7th day
measure: Postoperative Swelling
timeFrame: Postoperative 7th day
measure: Postoperative Trismus
timeFrame: Postoperative 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
state: Tuşba
Study officials:
affiliation: Cairo University
name: Serap KESKIN TUNC, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04404179: Setting up a COVID-19 Care Facility at a Prison in Pakistan
Official title: Setting up a COVID-19 Care Facility at a Prison in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Prison
Pakistan
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2020-05-27
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consisted of the prisoners who after being exposed to a suspected COVID-19 patient tested positive on screening. a total of 59 prisoners were detected by screening. They were included in the study. 10 COVID-19 prisoners shifted to Camp Jail were also latter included.

Brief summary: Presenting outline of the steps taken by our team to set up a Covid Care facility within the Prison setting. The facility was set up at Camp Jail (Lahore District Jail) located on Ferozpur Road, Lahore.

Detailed description: A prisoner brought to Camp Jail developed symptoms of and later tested positive for COVID-19. This lead to almost 527 contacts. An outbreak was expected. To manage the situation , a COVID-19 Care Facility was established within the prison. The study describes the steps taken by the team to set up this facility.

Eligibility criteria: Inclusion Criteria:

- All COVID-19 positive prisoners within the Camp Jail

Exclusion Criteria:

* Any patient being shifted to any other facility (except designated)

Primary outcomes:
measure: Recovery
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: ICU admission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Camp Jail / COVID-19 CARE FACILITY/ SIMS
Study officials:
References:
Clinical trial NCT01501279: Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Official title: Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: pudendal nerve block
postoperative pain
bladder spasm
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck and proximal urethra. Pain management during transurethral procedures is a major concern.Patients who have been catheterized under anesthesia complained of urgency in the postoperative period because of catheter-related bladder irritation. We want to investigate that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in transurethral prostatectomies

Detailed description: Outcome measures USG guided transperineal pudendal block success Postoperative pain score (VAS score) Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.

Postoperative patient's comfort (poor, sufficient, good)

Eligibility criteria: Inclusion Criteria:

* ASA I,II,III status
* Who were scheduled to have elective transurethral resection of the prostate

Exclusion Criteria:

* Chronic renal failure
* coagulopathy
* active anorectal disease
* active urinary tract infection
* uncontrolled diabetes

Primary outcomes:
measure: postoperative bladder spasm
timeFrame: postoperative 12 h
Secondary outcomes:
measure: postoperative pain
timeFrame: postoperative 12 h
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Study officials:
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Derya Özkan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
name: Taylan Akkaya, MD
role: STUDY_DIRECTOR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic
name: Nihat Karakoyunlu, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. AnesthesiologyClinic
name: Julide Ergil, MD
role: STUDY_CHAIR
affiliation: Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
name: Hamit Ersoy, MD
role: STUDY_CHAIR
References: