louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04368650: RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
Official title: Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Keywords: Sticky bone
Intrabony defects
Regeneration
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization involved the computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinding was ensured by assigning the block of sites to study groups according to the specified sequence by a second operator who coded the two treatment sites selected from every patient by the first operator into the following groups
Primary purpose: TREATMENT

Brief summary: This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).

Detailed description: It was done in 40 subjects who were evaluated for a period of 6 months. the results were evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients age 20-55 years with intrabony defects and probing pocket depth of ≥5mm after initial therapy were included in the study.

Exclusion Criteria:

* Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers were excluded.

Primary outcomes:
measure: bone fill
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
References:
Clinical trial NCT01391650: Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
Official title: Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: ACL
double-bundle
navigation system
Lead sponsor: Hospital Znojmo
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2011-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.

Detailed description: The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.

Methods Anterior-posterior translation, internal rotation, and external rotation were recorded in the deficient condition (without ACL), in the anteromedial-reconstructed, posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000 was used to evaluate anterior-posterior translation.

Eligibility criteria: Inclusion Criteria:

* isolated ACL lesion and primary ACL replacement

Exclusion Criteria:

* replacement of ACL with navigation system

Primary outcomes:
measure: measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL
timeFrame: one hour
Secondary outcomes:
measure: measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL
timeFrame: one hour
Other outcomes:
Locations:
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo
Study officials:
affiliation: Hospital Znojmo
name: Martin Komzák
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016950: Long-term Pacemaker Arrhythmia Analysis
Official title: East Sussex Long-term Pacemaker Arrhythmia Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 2551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with permanent pacemakers

Brief summary: Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.


Eligibility criteria: Inclusion Criteria:

* Pre-existing dual chamber permanent pacemaker

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Atrial fibrillation burden
timeFrame: 28 days to 1 year
Secondary outcomes:
measure: Atrial fibrillation episode frequency
timeFrame: 28 days to 1 year
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne General Hospital
state: E Sussex
Study officials:
affiliation: Eastbourne General Hospital
name: Neil Sulke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.
Clinical trial NCT02604550: Anterior Cruciate Ligament Pain Study
Official title: Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Detailed description: This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
* Patients willing and able to provide written informed consent
* Parents willing and able to provide written informed consent for minors

Exclusion Criteria:

* Patients who are pregnant or lactating
* Patients with liver dysfunction or renal failure
* Patients with a known allergy to ropivacaine
* Patients with a local infection
* Patients who take chronic pain medications
* Patients with an opioid tolerance
* Patients with known coagulopathy or bleeding risk.
* Patients who are getting neuraxial anesthesia for surgery

Primary outcomes:
measure: Pain Score
timeFrame: Post-surgery (day of surgery to 6 days post-surgery)
Secondary outcomes:
measure: Number of Percocet Tablets Consumed
timeFrame: Post surgery, Day 0 to Day 6
measure: Total Hours of Sleep
timeFrame: First Postoperative Night (up to 12 hours)
measure: Patient-Reported Nausea
timeFrame: Post-Surgery (up to 6 days)
measure: Patient-Reported Vomiting
timeFrame: Post-Surgery (up to 6 days)
measure: Patient-Reported Constipation
timeFrame: Post-Surgery (up to 6 days)
measure: Patient-Reported Sedation
timeFrame: Post-Surgery (up to 6 days)
measure: Patient-Reported Itching
timeFrame: Post-Surgery (up to 6 days)
measure: Time to Straight Less Raise
timeFrame: Post-Surgery (up to 6 days)
measure: Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"
timeFrame: 2 Weeks Post-Surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: John Xerogeanes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04601350: Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
Official title: Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benzodiazepine
Keywords: remimazolam
recovery
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.


Eligibility criteria: Inclusion Criteria:

* ASAⅠ-Ⅱ
* Patients undergoing elective surgery under general anesthesia.
* Age, sex, and weight were not limited.

Exclusion Criteria:

* Allergic or contraindication to remimazolam/midazolam/remifentanil;
* Abnormal liver and kidney function; Alcohol abuse;
* Long-term use of sedative, analgesic or anxiolytic drugs;
* Hearing and language communication disorders;
* Complicated with severe cardiovascular lesions or neurological diseases.

Primary outcomes:
measure: The average intraoperative power spectral density in the frontal alpha band
timeFrame: Preoperatively, During operation，End of operation
measure: Changes in the score of MMSE
timeFrame: The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
Secondary outcomes:
measure: Changes in IL-6, IL-10, and S100-β levels
timeFrame: The outcome above should be measured the day before surgery and 1，3 days after surgery
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04548050: Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine
Official title: Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Breastfeeding
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 82
Sex: FEMALE
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: All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the CHU - Félix GUYON .

Brief summary: Colostrum is an irreplaceable nutrient rich in protein and antibodies. Its taste and smell are similar to those of amniotic fluid (therefore rich for the senses of the baby separated from his mother). It should be offered to every newborn baby, regardless of term and the type of breastfeeding their mom wants. The early expression of colostrum, within the first 2 hours after childbirth, is an essential way to start lactation of a mother separated from her baby. The sooner and more often the mother stimulates her breasts, the more milk she will have for her baby in the weeks to come. Manual expression of milk is therefore an essential gesture to initiate lactation, maintain it, and giving colostrum to babies as early as possible is beneficial. Two studies carried out in the neonatal medicine department of Felix Guyon Hospital in premature infants \<33 week of amenorrhea (PRE'OLACT study in 2015-2016 by Dr RAJAOFERA and Diploma from university (DU) breastfeeding brief in 2018-2019 by Dr GRONDARD) found the same results: the desire for breastfeeding is 80% but manual expression of colostrum before H24 is only achieved by 30% of mothers and before H6 in only 6% of cases.

.


Eligibility criteria: Inclusion Criteria:

* All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the University Hospital Center (CHU) - Félix GUYON Hospital during the study period.
* Expressed no opposition from mothers to their participation and to the use of their data

Exclusion Criteria:

* Outborn
* Mother not hospitalized in the maternity ward of Félix Guyon Hospital
* Prognosis for the child engaged in the first 24 hours
* Difficult oral comprehension
* Medical contraindication to breastfeeding
* Unseen mother \<3D

Primary outcomes:
measure: 104/5000 Percentage of mothers who expressed colostrum before 24hours
timeFrame: 24hours after childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
References:
Clinical trial NCT01933750: Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
Official title: A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Presbyopia
Reading Glasses
Near Vision
Lead sponsor: Refocus Ocular Europe, B.V.
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses


Eligibility criteria: Inclusion Criteria:

* Age 45 or older at commencement of study
* Best Corrected Distance Visual Acuity of .80 (20/25) or better
* Patients must be alert, mentally competent, and able to comply with clinical study requirements

Exclusion Criteria:

* Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery
* Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
* Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

Primary outcomes:
measure: Near Visual Acuity
timeFrame: 12 Months
Secondary outcomes:
measure: Uncorrected Near Visual Acuity
timeFrame: 12 Months
measure: Presence of Significant Safety Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Midland Eye
Study officials:
References:
Clinical trial NCT04207450: Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment
Official title: Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Clinical trials
Dentin Sensitivity
glutaraldehyde
Desensitizing agents
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.


Eligibility criteria: Inclusion Criteria:

- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.

Exclusion Criteria:

* Systemic diseases;
* Pulpitis;
* Carious lesions;
* Presence of restorations in selected teeth;
* Cracked enamel;
* Noncarious cervical lesions;
* Use of medication with analgesics and/or anti-inflammatories;
* Pregnant or lactating women;
* Desensitizing treatment and periodontal treatment received during three months prior to study recruitment.

Primary outcomes:
measure: Dentin sensitivity
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Dentin hypersensitivity experience questionnaire
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Para
state: PA
Study officials:
References:
Clinical trial NCT03501550: Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Official title: An Open-Label Phase 2a Study Evaluating the Safety and Efficacy of Combination Treatment With 2 Weeks of the Non-Nucleoside Inhibitor CDI 31244 Plus 6 Weeks of Sofosbuvir/Velpatasvir in Subjects With Chronic Hepatitis C Genotype 1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: HCV
GT1
Lead sponsor: Cocrystal Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 12
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: Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection

Detailed description: The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.

Eligibility criteria: Key Inclusion Criteria:

Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis

Key Exclusion Criteria:

Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Adverse Events
timeFrame: Day 1 to Day 72
measure: Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
timeFrame: post-treatment Week 12
Secondary outcomes:
measure: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
timeFrame: post-treatment Week 24
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Institute of Human Virology University of Maryland
state: Maryland
Study officials:
affiliation: Institute of Human Virology, University of Maryland, Baltimore
name: Joel Chua, MD
role: PRINCIPAL_INVESTIGATOR
References: