louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04315532: The Effect of Periodontal Treatment on Stress and Pregnancy Relationship
Official title: Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Gingivitis
Keywords: Stress
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Abant Izzet Baysal University
First posted: 2020-03-19
Enrollment: 84
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided.

Detailed description: The aim of this clinical study was to determine the effect of non-surgical mechanical periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. A total of 84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group 3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4) participated in this study. Clinically, plaque index, gingival index, and probing pocket depth were measured at baseline and after therapy.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 24-50
* being pregnant for 23-30 weeks (for pregnant individuals)
* not smoking.

Exclusion Criteria:

* using antimicrobial or anti-inflammatory therapy within the previous 3 months,
* having systemic disease,
* having periodontitis,
* having deep caries lesions, and remnant roots and
* having lactation

Primary outcomes:
measure: Dehydroepiandrosterone (DHEA)
timeFrame: Baseline and after 8 weeks
measure: estrogen
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: Gingival index
timeFrame: Baseline and after 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abant Izzet Baysal
name: Ozge Gokturk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03647332: Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Official title: Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis of Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections


Eligibility criteria: Inclusion Criteria:

* Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
* Not an operative candidate as per RI joint replacement surgeon OR
* Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
* Male or non-pregnant female older than 18 years of age
* willing and able to sign the IRB-approved informed consent document.

Exclusion Criteria:

* Any steroid injection in hip within 90 days
* Local infection at injection site or active systemic infection
* Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
* AICD with inability to utilize magnet for RFA per treating cardiologist
* Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
* Allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol

Primary outcomes:
measure: Pain
timeFrame: 24 weeks following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03200132: Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)
Official title: Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Imaging
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving 18F-FDG for clinical diagnostic PET/MRI or PET/CT.

Brief summary: This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.


Eligibility criteria: Inclusion Criteria:

* 18F-FDG injection for clinical diagnostic PET/MRI or PET/CT

Exclusion Criteria:

* Diet-suppressed myocardial uptake of 18F-FDG
* General exclusion criteria for MRI (i.e. metallic implants, claustrophobia, pregnancy, etc.)
* Not willing to be informed about incidental findings

Primary outcomes:
measure: Target-to-background ratio (TBR)
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Signal-to-noise ratio (SNR)
timeFrame: 15-20 minutes
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
state: Limburg
Study officials:
affiliation: Maastricht University Hospital
name: Joachim Wildberger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04775732: Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
Official title: Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn Disease
Ulcerative Colitis
Keywords: therapeutic drug monitoring
inflammatory bowel disease
point of care testing
infliximab
Lead sponsor: Imelda GI Clinical Research Center
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic cluster trial
Primary purpose: TREATMENT

Brief summary: This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL \>7μg/mL: interval prolongation allowed; (C) TL \<3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL \<3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target \* Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.

The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.


Eligibility criteria: Inclusion Criteria:

* all adult IBD patients treated for at least 14 weeks with infliximab were included

Exclusion Criteria:

* induction treatment with infliximab (\<14 weeks)
* treatment with other biological for IBD

Primary outcomes:
measure: number of patients with infliximab failure
timeFrame: one year
Secondary outcomes:
measure: number of TL measurements per patient per year
timeFrame: one year
measure: percentage of interval changes (shortening, prolongation, bidirectional)
timeFrame: one year
measure: number of patients with infliximab discontinuation
timeFrame: one year
measure: percentage of patients with sustained clinical remission
timeFrame: one year
measure: number of patients with mucosal remission
timeFrame: one year
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda GI clinical research center
city: Gent
country: Belgium
facility: AZ Sint Lucas
Study officials:
References:
Clinical trial NCT01517932: Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
Official title: Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Restlessness
Pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 60
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: PREVENTION

Brief summary: Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.

In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.

Detailed description: Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
* undergoing selective thoracotomy
* weight between 45 and 75kg
* operation time 2-4 hours

Exclusion Criteria:

* history of neurologic disease
* history of chronic analgesics intake
* history of allergic reactions to the experimental durgs
* history of renal insufficiency
* history of hepatic dysfunction
* history of coagulation disorders
* women in lactation
* participating in other studies

Primary outcomes:
measure: Emergence agitation
timeFrame: during 0-3 postoperative hours
Secondary outcomes:
measure: Postoperative pain at rest
timeFrame: At 1,3 postoperative hours
measure: dosage Dosage of analgesics
timeFrame: during 3 postoperative hours
measure: Recovery time
timeFrame: At the moment of the eyes opend when calling the names
measure: Postoperative sedation
timeFrame: at 0,1,3 postoperative hours
measure: Extubation time
timeFrame: at the moment of extubation
measure: Breathing recovery time
timeFrame: when autonomous respiration recovered
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
name: Fang Luo, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235532: Effects of Aloe Vera Toothpaste on Periodontal Parameters
Official title: Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: clinical trial
oral hygiene
Gingivitis
Aloevera
Toothpaste
anti-inflammatory agents
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.

The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days . This order was reversed in group 2.

Detailed description: Toothpastes are used with tooth brushing to better control microbial plaque. Herbal toothpastes have recently gained attention. This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.

This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated Measure ANOVA tests were applied for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Subjects were selected among dental students with at least 20 natural teeth without systemic disease
* No periodontal treatment at least 6 months to the study
* No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months, nonsmokers, no pregnancy or lactating women
* Subjects with PD≤3mm, (clinical attachment level)CAL\<1mm, PI≥2 and gingival bleeding in more than 30% of the tested areas were enrolled with the diagnosis of plaque-related gingivitis.

Exclusion Criteria:

* Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study

Primary outcomes:
measure: measuring gingival index
timeFrame: 1-2days
Secondary outcomes:
measure: measuring gingival index
timeFrame: 1-2 days
measure: measuring plaque index
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Dental Branch, Islamic azad University
Study officials:
affiliation: Tehran Dental Branch, Islamic Azad University,Tehran/Iran
name: Ferena Sayar, DDS;MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996732: Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry
Official title: Studies on Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Fudan University Shanghai Cancer Center Registry（FUCaRe）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Survival
Surgery
Radiotherapy
Drug Therapy
Keywords: Cancer
Survivorship
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 500000
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: All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.

Brief summary: Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.

Detailed description: This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.

Eligibility criteria: Inclusion Criteria:

* All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.

Exclusion Criteria:

* Patients who have not been treated during hospitalization;
* Patients with non-malignant tumors.

Primary outcomes:
measure: Overall survival
timeFrame: 15 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 15 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT05259332: Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas
Official title: Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meningioma Atypical
Keywords: Transcriptome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-02-28
Enrollment: 85
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: Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).

Brief summary: Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).

Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.


Eligibility criteria: Inclusion Criteria:

* Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
* At least one postoperative follow-up visit.
* Adult patients (\>18 yo) at the time of the intervention.
* Surgical excision.

Exclusion Criteria:

* History of meningioma in the same location.
* Neo-adjuvant treatment.
* Absence of non-objection form.

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion an average of 5 years.
Secondary outcomes:
measure: Tumor volume assessed by imaging pre- and post-operative
timeFrame: before and within 3 months after surgery
measure: mRNA quantities of transcripts of interest
timeFrame: through study completion, an average of 1 year
measure: Radiotherapy-induced toxicity
timeFrame: within 5 years after radiotherapy
measure: Dose of corticosteroids before and after radiotherapy
timeFrame: within 6 months before and after radiotherapy
measure: Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Guillaume GAUCHOTTE
state: Lorraine
Study officials:
References:
Clinical trial NCT04782232: Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
Official title: Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Univentricular Heart
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Keywords: EXCOR Ventricular Assist Device
EXCOR Venous Cannula
Failing Fontan
Lead sponsor: Berlin Heart GmbH
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 20
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: Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.

Brief summary: The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.

Detailed description: The registry study has an observational, prospective, international, multi-center, non-randomized design.

The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.

Eligibility criteria: Inclusion Criteria:

* Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
* The indications on RVAD and BVAD use of the EXCOR VAD apply,
* Patient shall be on transplant list or at least eligible for HTx,
* BSA (body surface area) greater than or equal to 1.2 m².

Exclusion Criteria:

* Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
* The contraindications of EXCOR VAD apply.

Primary outcomes:
measure: Rate of mortality
timeFrame: 30 days
measure: Rate of major bleeding
timeFrame: 30 days
measure: Rate of thrombosis
timeFrame: 30 days
measure: Survival to heart transplantation
timeFrame: up to 12 months
Secondary outcomes:
measure: Rate of adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
Study officials:
References:
citation: Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11.