louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04236115: Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth
Official title: Does Articaine, Rather Than Prilocaine, Increase the Success Rate of Anaesthesia for Extraction of Maxillary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overcoming the Failure of Anaesthesia
Maxillary Teeth
Dental Extraction
Keywords: Carticaine
dental extraction
injections
prilocaine
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 95
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded randomised trial
Primary purpose: TREATMENT

Brief summary: Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.

Detailed description: 85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).

Eligibility criteria: Inclusion Criteria:

* Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).

Exclusion Criteria:

* Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.

Primary outcomes:
measure: Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Taibah University
Study officials:
References:
citation: Gazal G. Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth. Saudi J Anaesth. 2020 Jul-Sep;14(3):297-301. doi: 10.4103/sja.SJA_94_20. Epub 2020 May 30.
Clinical trial NCT04839315: COVID-19 Vaccination in Rheumatic Disease Patients
Official title: Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus
Sjogren's Syndrome
Inflammatory Myositis
Psoriatic Arthritis
Gout
Ankylosing Spondylitis
Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis)
Osteoarthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.

Detailed description: Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.

Eligibility criteria: Inclusion Criteria:

* Rheumatologist confirmed diagnosis of one of the following diagnoses:
* Systemic lupus erythematosus;
* Sjogren syndrome;
* Inflammatory myositis;
* Psoriatic arthritis;
* Osteoarthritis;
* Gout;
* Ankylosing spondylitis;
* IBD-related arthritis.

Exclusion Criteria:

* Active infection or untreated malignancy (other than skin cancer) at enrollment.
* Pregnancy

Primary outcomes:
measure: Humoral responses towards mRNA COVID-19 vaccines
timeFrame: 2 weeks to 6 months after second dose of vaccine
Secondary outcomes:
measure: Cellular immune responses towards mRNA COVID-19 vaccines
timeFrame: 2 weeks to 6 months after second dose of vaccine
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hu Zeng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05129215: Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Official title: Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Radiotherapy
Rectal Cancer
Keywords: Bowel Dysfunction
Low Anterior Resection Syndrome
Radiotherapy
Rectal Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Beijing Friendship Hospital
First posted: 2021-11-22
Enrollment: 901
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent preoperative radiotherapy and curative low anterior resection for nonmetastatic rectal cancer.

Brief summary: Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.


Eligibility criteria: Inclusion Criteria:

* Curative low anterior resection for nonmetastatic rectal cancer
* Preoperative radiotherapy

Exclusion Criteria:

* Death
* Metastasis or recurrence
* Postoperative radiotherapy
* Cognitive disorder
* Intestinal stoma
* Rectal cancer resection for \<12 months
* Stoma reversal for \<6 months

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: Over one year after restorative rectal cancer resection
Secondary outcomes:
measure: Sensitivity
timeFrame: Over one year after restorative rectal cancer resection
measure: Specificity
timeFrame: Over one year after restorative rectal cancer resection
measure: Positive prediction value (PPV)
timeFrame: Over one year after restorative rectal cancer resection
measure: Negative prediction value (NPV)
timeFrame: Over one year after restorative rectal cancer resection
Other outcomes:
measure: Net reclassification index (NRI)
timeFrame: Over one year after restorative rectal cancer resection
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Qiyuan Qin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816085: Shoes on Balance, Muscular Endurance and Functional Skills
Official title: The Effects of Shoes With Different Heel Heights on Balance, Muscular Endurance and Functional Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: women
shoes
balance
muscles
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In daily life, stiletto heeled shoes which are popularly preferred by women have different heel heights. This study aims to investigate the effects of these differences on balance, muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done barefoot, 10 cm, and 4cm shoes.

Detailed description: The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg Standing for static balance, heel raising and squat-up test for muscular endurance of plantar flexor and quadriceps muscles, ascending stairs for functional skills.

Measuring distance will be used for Functional reach test and timing will be used for single leg standing test. Timing and repetition number will be used for muscular endurance tests. Timing will be used to climb up 10 stairs with and without heel contact.

Eligibility criteria: Inclusion Criteria:

* the shoe number will be 37
* women who do not regularly wear high heeled shoes
* women who are familiar with stiletto heeled shoes

Exclusion Criteria:

* any pain which prevents to participate in tests
* women with cardiovascular disease, metabolic disease, blood pressure disorders, diabetes diseases, neuromuscular diseases.

Primary outcomes:
measure: Functional Skill
timeFrame: at baseline
Secondary outcomes:
measure: Single Leg Standing
timeFrame: at baseline
Other outcomes:
measure: Repetition number of heel raising
timeFrame: at baseline
measure: Repetition number of squating
timeFrame: at baseline
measure: Duration of heel raising
timeFrame: at baseline
measure: Duration of squating
timeFrame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
measure: Functional Forward Reach Test
timeFrame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
Locations:
city: Famagusta
country: Cyprus
facility: Zehra Güçhan Topcu
Study officials:
affiliation: Eastern Mediterranean University
name: ZEHRA GÜÇHAN TOPCU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044785: Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors
Official title: A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil (5FU) Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: colorectal cancer
gastric cancer
breast cancer
Lead sponsor: Wellstat Therapeutics
Sponsor class: INDUSTRY
First posted: 2002-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.


Eligibility criteria: Inclusion Criteria

* Must be at least 18 years of age;
* Life expectancy: At least 3 months;
* Performance status: ECOG of 0 or 1;
* Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection;
* Evaluable or measurable disease documented within 4 weeks of the start of treatment;
* Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment;
* Adequate organ function:

Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) \< 3 x upper limit of normal (\< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine \< 2.0 mg/dL;

* Patient has the initiative, geographic proximity, and means to be compliant with the protocol;
* Fertile patients (male or female) must agree to use effective contraception;
* Must be able to swallow and retain tablets.

Exclusion Criteria

* Major surgery within the four weeks preceding the start of treatment;
* Serious medical or psychiatric illness that would prevent self-determined informed consent;
* Intensive chemotherapy treatment;
* Infection or antibiotics at the time of screening;
* Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction;
* Pregnant or nursing;
* Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome);
* Brain metastases that have not been stable for more than 3 months;
* Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.

Primary outcomes:
measure: Safety and Maximum Tolerated Dose
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
Study officials:
References:
Clinical trial NCT05010785: Ridge Splitting With Simultaneous Implant Placement Using i-PRF
Official title: Ridge Splitting With Simultaneous Implant Placement Using i-PRF With Guided Bone Regeneration: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Splitting
i-PRF
Dental Implant
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 22
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: Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. The present study was conducted to evaluate the clinical and radiographic outcomes following the application of the alveolar ridge splitting in combination with the use of guided bone regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant placement in patients with horizontally atrophic jaw bones.


Eligibility criteria: Inclusion Criteria:

* good general health at the time of surgery.
* at least 3 months of healing after tooth extraction.
* horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion Criteria:

* a vertical bone defect in the edentulous ridge.
* thick cortex in the labial/buccal with less cancellous bone inside
* obvious undercut on the labial/buccal side.
* uncontrolled periodontal conditions or other oral disorders.
* history of radiotherapy in the head and neck region.
* uncontrolled diabetes mellitus or other systematic disorders.
* smokers.
* Pregnancy.
* non-compliant patients.
* allergic reaction to the medications used

Primary outcomes:
measure: Measurements of the amount of bone formation in millimeters around immediately placed dental implants
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Dentistry, Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06035237: The Effect of Cold Spray Applied Before Local Anaesthesia
Official title: The Effect of Cold Spray Applied Before Local Anaesthesia on Pain and Anxiety in Coronary Angiography Procedure: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Coronary Artery Disease
Keywords: Pain, anxiety, cold spray, angiography
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Coronary angiography is a reliable and valid method used in the diagnosis of Coronary Artery Disease (CAD). Coronary angiography is defined as the process of obtaining cineangiographic images by administering radio-opaque material to the coronary vessels via arterial route. Coronary angiography is frequently performed from brachial, radial and femoral arteries. The aim of coronary angiography is to determine the presence, localisation and extent of cardiovascular lesions.

Invasive interventions cause anxiety and pain in the patient, increase the level of anxiety and cause a number of negative effects such as increased use of sedative drugs, development of post-procedure complications, prolongation of the recovery process and hospitalisation time. It is stated that there is a positive relationship between reducing the anxiety of the patients and meeting the needs of the patients.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18 and above.
* Not having used any anesthetic substance before the procedure.
* Not having undergone angiography before.
* Having no communication problems.

Exclusion Criteria:

* Having previously undergone angiography.
* Having taken analgesics before angiography.

Primary outcomes:
measure: Pain levels recorded with the Visual Analog Scale
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yüzüncü yıl university
Study officials:
References:
Clinical trial NCT02253537: Evaluation of the QuantiFERON-TB Test.
Official title: Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
TB
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bacteriologically confirmed and untreated TB disease.

Brief summary: To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Detailed description: To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.

Eligibility criteria: Inclusion Criteria:

* Clinical symptoms consistent with a high probability of having TB disease
* Receiving, or are likely to receive, therapy for active TB
* Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
* Between 18 and 70 years of age.

Exclusion Criteria:

* Taken therapy for active TB or latent TB for more than 14 days
* Culture confirmation of M. tuberculosis not obtained

Primary outcomes:
measure: Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity
timeFrame: At time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
Clinical trial NCT01723137: Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales
Official title: Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: Pain
Pain measurement
Visual analog scale
Anxiety
Stress
Opioid
Emergency department
Demographics
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 3630
Sex: ALL
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: Patients presenting to the emergency department at an urban county hospital.

Brief summary: Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.


Eligibility criteria: Inclusion Criteria:

* Reported pain greater than or equal to 3 out of 10

Exclusion Criteria:

* Less than 18 years of age
* Decreased level of consciousness
* Inability to answer questions
* Prisoner

Primary outcomes:
measure: Change in Patient Described Stress
timeFrame: Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
measure: Change in Patient described anxiety.
timeFrame: Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
measure: Change in patient described satisfaction with ongoing treatment.
timeFrame: Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
measure: Change in patient described pain.
timeFrame: Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References: