louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05211362: Sticky Bone and Repeated Injectable PRF (iPRF) Application in Management of Periodontal Intrabony Defects
Official title: Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sticky Bone
iPRF
Periodontal Defect
Keywords: iPRF
sticky bone graft
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.


Eligibility criteria: Inclusion Criteria:

* No systemic diseases which could influence the outcome of therapy.
* Good compliance with plaque control instructions following initial therapy.
* Teeth involved were all vital with no mobility.
* Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
* Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
* Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
* Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.

Exclusion Criteria:

• Pregnant females.

Primary outcomes:
measure: change in clinical attachment level
timeFrame: baseline, 3, and 6 months
Secondary outcomes:
measure: change in interseptal bone width
timeFrame: baseline, 3, and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mah
Study officials:
affiliation: al azhar universty
name: mahmoud eldestawy, associted profissor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06669962: Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
Official title: Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tako Tsubo Cardiomyopathy
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive consenting patients over the age of 18 years with a diagnosis of Takotsubo syndrome will be included in the study according to the position statement of the European Journal of Heart Failure (2016).

Brief summary: Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Diagnosis of Takotsubo syndrome
* Signing of informed consent

Exclusion Criteria:

* Age \<18 years;
* Refusal to sign written informed consent.

Primary outcomes:
measure: Incidence of coronary microcirculation dysfunction
timeFrame: one year
Secondary outcomes:
measure: Incidence of in-hospital mortality
timeFrame: up to thirty days
measure: Correlation between the levels of biomarkers analysed and microvascular dysfunction
timeFrame: at discharge (assessed up to 5 days)
measure: Perceived quality of life
timeFrame: one year
measure: Severity of angina
timeFrame: one year
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
References:
Clinical trial NCT05167591: Detection of Paracetamol Concentration in Patients Using Regular Medication- a Validation Study for a Novel Technique
Official title: Determination of Serum Paracetamol Concentration With an Electrochemical Measurement Tool From Blood and Saliva Samples in Patients Using Also Other Medication.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pharmacokinetics
Keywords: Electrochemical
Paracetamol
Saliva
Fingerprick
Capillary sample
Acetaminophen
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Paracetamol intoxication is common, and concentration measurements are performed regularly. This research group is developing a fast bedside electrochemical analysis tool for paracetamol concentration measurement. This study will find out how this novel method performs in patients using other, confounding medication in detecting paracetamol concentration in capillary blood, venous plasma and saliva samples.

Detailed description: Paracetamol concentration analysis is performed in 20 patients who will come to hospital for elective surgery. Inclusion criteria is a regular medication that continues over perioperative period.

Patients will be given standard premedication of paracetamol 1g perorally before surgery: this study does not affect standard surgical treatment.

Paracetamol concentration will be measured in venous plasma-, capillary blood-, and saliva samples before drug delivery and in recovery room after surgery using the novel electrochemical analysis tool and high-performance mass spectrometry analysis as a reference. If needed, confounding medication is identified with large toxicologic mass spectrometry screen (UPLC-QTOF).

Eligibility criteria: Inclusion Criteria:

* informed consent
* Age 18-75 years
* American society of anesthesiologist classification 2-4
* planned elective surgery with standard premedication with paracetamol 1g po.
* at least one regular medication ongoing perioperatively
* eligibility for elective surgery
* negative pregnancy test in fertile women

Exclusion Criteria:

* American society of anesthesiologists classification 1
* contraindication for use of paracetamol as standard premedication
* pregnancy or lactation
* less than 3 months from previous drug research
* less than 3 months from previous blood donation
* anticipated difficult puncture of veins
* Body Mass Index lower than 18.5 or higher than 35

Primary outcomes:
measure: No outcome for patients
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Helsinki
name: Eija Kalso
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05005091: Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients
Official title: Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Fasting
Postoperative Pneumonia
Keywords: Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
Lead sponsor: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients.

Detailed description: The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time.

SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time.

Eligibility criteria: Inclusion Criteria:

Stage I-Stage II all operable NSCLC patients -

Exclusion Criteria:

Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.

-

Primary outcomes:
measure: Mobilization time
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: health Science University, Sureyyapa Training and Research Hospital
Study officials:
References:
Clinical trial NCT01927991: Internet-based Self-help for Tinnitus: The Role of Support
Official title: Internet-based Self-help for Tinnitus: The Role of Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
cognitive behavioural therapy
internet treatment
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2013-08-23
Enrollment: 112
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: Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.


Eligibility criteria: Inclusion Criteria:

* tinnitus duration of more than 6 months
* severe or most severe tinnitus distress
* age of at least 18 years
* fluent in German

Exclusion Criteria:

* psychosis, severe psychological disorder, risk for suicide
* prior participation in associated study
* medical disorder as reason for tinnitus, i.e. morbus ménière

Primary outcomes:
measure: Change in tinnitus distress
timeFrame: 1 year; pre, post, 6-mo-follow-up
Secondary outcomes:
measure: Change in depressive Symptoms
timeFrame: 1 year; pre, post, 6mo-follow-up
measure: Change in tinnitus-related thoughts
timeFrame: 1 year; pre, post, 6mo-follow-up
measure: Change of tinnitus acceptance
timeFrame: 1 year; pre, post, 6mo-follow-up
Other outcomes:
measure: Screening of psychiatric symptoms
timeFrame: Pre-Treatment
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
state: Hessen
Study officials:
affiliation: Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
name: Cornelia Weise, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439291: Comparing Operative vs Non Operative Treatment for Pilonidal Disease
Official title: Comparing Operative vs Non Operative Treatment for Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilonidal Disease
Keywords: Pilonidal Surgery
Pilonidal Excision
Pilonidal recurrence
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision
Primary purpose: PREVENTION

Brief summary: The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

Detailed description: The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation. Patients with pilonidal disease can have significant pain and drainage at the gluteal cleft, and recurrent disease in this teenage and young adult population often leads to social embarrassment, isolation, and time off from work or school. Effective therapy to prevent recurrent disease is urgently needed.

The current standard of care is excision of pilonidal cyst. The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision. The research will consist of patient surveys and clinical notes. Surgical excision is not needed to be part of this research.

All patients will receive surveys and their charts will be reviewed. At the point of treatment decision making, the patients will be randomized to one of the two options.

Eligibility criteria: Inclusion Criteria:

* Patients at Stanford Healthcare with pilonidal disease.
* Patients over the age of 8yrs.

Exclusion Criteria:

* Inability to read, write or understand English \*\*\*or Spanish
* Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire

Primary outcomes:
measure: Number of participants with recurrent symptoms of pilonidal disease
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of participants requiring antibiotic treatment
timeFrame: Up to 1 year
measure: Time taken off from school or work due to pilonidal disease
timeFrame: Up to 1 year
measure: Effect on parent's daily activities
timeFrame: Baseline to 1 year
measure: Number of participants requiring additional surgical intervention
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Bill Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739891: Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors
Official title: Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors for Its Diagnosis and Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Cholecystitis
Choledocholithiasis
Keywords: Acute Cholecystitis
Choledocholithiasis
Urgent cholecystectomy
Risk factors
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent emergent cholecystectomy for acute calculous cholecystitis

Brief summary: The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

Detailed description: Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database.

The Ethics Committee approval has been obtained.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years

Exclusion Criteria:

* Non urgent cholecystectomy

Primary outcomes:
measure: CBDS risk
timeFrame: From diagnostic to surgery
Secondary outcomes:
measure: Intraoperative cholangiography
timeFrame: During the surgery
measure: Postoperative morbidity
timeFrame: From surgery to 1 year
measure: Readmission
timeFrame: From discharge to 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.
Clinical trial NCT00669591: A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
Official title: A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
docetaxel chemotherapy
bavituximab
monoclonal antibody
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Adult females over age 18 with life expectancy of at least 3 months
* Histologically or cytologically confirmed locally advanced or metastatic breast cancer
* One and only one prior chemotherapy regimen (no prior docetaxel)
* Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
* Adequate hematologic, renal, and hepatic function;

Exclusion Criteria:

* Known history of bleeding diathesis or coagulopathy
* Any current evidence of clinically significant bleeding
* Any history of thromboembolic events
* Concurrent hormone therapy
* Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy

Primary outcomes:
measure: Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
timeFrame: Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.
Secondary outcomes:
measure: Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Lisi Lake
country: Georgia
facility: JSC. National Cancer Centre
state: Tbilisi
city: Batumi
country: Georgia
facility: Ltd. Oncological Center
city: Tbilisi
country: Georgia
facility: Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str
city: Tblisi
country: Georgia
facility: Ltd. Tbilisi Oncological Dispensary
Study officials:
References:
Clinical trial NCT00280891: Review of Palliative Radiotherapy in the Management of Advanced Head and Neck Cancer
Official title: Review of Palliative Radiotherapy in the Management of Advanced Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: head and neck
cancer
palliation
radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: To describe the charactersitics of patients with advanced head and neck cancer treated with palliative intent and determine outcome in terms of symptom control and toxicity


Eligibility criteria: Inclusion Criteria:

* squamous cell carcinoma of the head and neck, primary treatment given with palliative intent

Exclusion Criteria:

* radical treatment, palliative treatment following local recurrence, adenocarcinoma, salivary gland carcinoma or melanoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancerboard
name: Harold Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: