louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04533113: Carious Tissue Selective Removal on Permanent Posterior Teeth.
Official title: Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Dental Materials
Keywords: Dental caries
Dental materials
Outcome
Postoperative Pain
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.


Eligibility criteria: Inclusion Criteria:

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
* Understands and is willing to comply with all study procedures and restrictions.
* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
* Diagnosis of normal pulp or reversible pulpitis.
* No presence of periapical periodontitis
* Posterior teeth

Exclusion Criteria:

General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.

Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain

Primary outcomes:
measure: Clinical post-operative pain
timeFrame: Immediately post-treatment
measure: Clinical post-operative pain
timeFrame: 8 hours post-treatment
measure: Clinical post-operative pain
timeFrame: 24 hours post-treatment
measure: Clinical post-operative pain
timeFrame: 48 hours post-treatment
measure: Clinical signs or symptoms of pulp or periapical disease
timeFrame: 1 year
measure: Clinical signs or symptoms of pulp or periapical disease
timeFrame: 2 years
measure: Clinical signs or symptoms of pulp or periapical disease
timeFrame: 5 years
measure: Radiographic signs of periapical disease
timeFrame: 1 year
measure: Radiographic signs of periapical disease
timeFrame: 2 years
measure: Radiographic signs of periapical disease
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
Clinical trial NCT01133613: Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis of the Knee
Lead sponsor: Stryker Biotech
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria

* Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
* \>40 years
* Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion Criteria

* Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
* Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
* Received arthroscopic or open surgery to the index knee within 6 months of screening
* History of joint replacement surgery (index knee).
* Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
* Long acting hyaluronic acid injection of the index knee within 6 months of screening
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
* History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
* Female subject with reproductive capability.

Primary outcomes:
measure: Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
timeFrame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Secondary outcomes:
measure: WOMAC pain and function
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24
measure: Patient and physician global VAS
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
measure: Quality of life measurement (SF-36) and pain medication use
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT03591913: Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section
Official title: Comparison Between Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries


Eligibility criteria: Inclusion Criteria:

* All pregnant women who will undergo elective lower segment cesarean section
* term ( ≥ 37 weeks)
* normal fetal heart tracing.

Exclusion Criteria:

* Placenta previa-Rupture uterus
* Classical cesarean section
* Preterm delivery
* Hypertensive disorders of pregnancy
* Bleeding tendency
* Previous history of postpartum hemorrhage
* Concurrent anticoagulant therapy
* Concurrent long-term use of steroids
* Fetal distress
* Antepartum haemorrhage

Primary outcomes:
measure: mean intraoperative blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06203613: Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
Official title: Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Positron Emission Tomography
Pancreatic Neoplasms
Igestive System Neoplasms
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, we will investigate the diagnostic efficacy and safety of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

* (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.

  (3) Written informed consent signed by the subject or his/her legal guardian or caregiver.

  (4) Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.

(4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.

Primary outcomes:
measure: To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
timeFrame: 90mins from time of injection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: PET Center, Huashan Hospital, Fudan University
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03065413: It is a Prospective Study Aiming to Identify Incidence and Prevalence of Cardiovascular Diseases, Changes in Physical Activity, Dietary Habits and Anxiety Depression Levels Through a Period of Time in the Naval Personnel (PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases)
Official title: The PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases (OCEANUS Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Risk Factor, Cardiovascular
Lead sponsor: Naval Hospital, Athens
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals

Brief summary: Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies will be enrolled until the class of 2025.

Physical examination, food frequency questionnaire, physical activity questionnaire, anxiety/depression questionnaire, medical history will be filled out at first interview.

Specific blood tests will be performed. Every participant will be interviewed every three years and will complete the same questionnaires.

Follow up period is determined ten years after last class enrollment


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Non signed consent form

Primary outcomes:
measure: Incidence / prevalence of CVD
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens Naval Hospital
Study officials:
affiliation: Athens Naval Hospital
name: Aikaterini Roumpi, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803413: Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
Official title: Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Back School
Walking
Physical activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 119
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Do Back School and/or supervised walking improve reported pain and spine flexibility in sedentary women with chronic low back pain (LBP)?

Detailed description: From August 2002 to March 2004, one hundred nineteen volunteers sedentary women with chronic LBP and age ranging from 32 to 60 years old, randomly allocated to four groups of participants assigned as Back School (BS; N=28), Supervised Walking (W; N=32), Back School and Supervised Walking (BS+W; N=29), and Control Group (CG; N=30) were submitted to interventions once a week for 5 consecutive weeks and followed for up to 6 months. The groups BS, W, and BS+W received LBP-targeted lectures and on-place practical sessions of each respective intervention. CG received print information about LBP and 5 different lectures unrelated to LBP.

Eligibility criteria: Inclusion Criteria:

* Age range 30 to 60 years old
* LBP without any known organic cause for at least 3 months of duration
* Less than 90 minutes per week of regular physical activity of any intensity

Exclusion Criteria:

* Any known organic cause of LBP

Primary outcomes:
measure: Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Spine Flexibility (3rd Fingertip to Floor - 3FF).
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Center for Health Promotion - Hospital das Clínicas - FMUSP
Study officials:
affiliation: Hospital das Clínicas - São Paulo University School of Medicine
name: Mario Ferreira Junior, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464513: MSCT Angiography in Bleeding
Official title: Role of MSCT Angiography in Evaluation of Lower Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Gastrointestinal Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Lower gastrointestinal bleeding occurs distal to the ligament of treitz and may involve the small bowel, colon and rectum .

Active lower gastrointestinal bleeding is a common, potentially life threatening medical presentation that can be challenging to localize and treat .

There are many diseases that may cause lower gastrointestinal bleeding, including angiodysplasia, diverticulosis, benign or malignant bowel neoplasm, inflammatory bowel disease, ischemic bowel disease, and infectious bowel disease.

Often, gastrointestinal bleeding will stop spontaneously, but in approximately 25% of patients, bleeding is massive or recurrent, requiring imaging localization and directed therapy.

Detailed description: Accurate and prompt diagnosis of the bleeding source is crucial because mortality can be as high as 40%if there is hemodynamic instability in patients .

Because of the length of GI tract, the multitude of pathologic processes that can result in GI bleeding, imaging plays a primary role in the diagnosis .

Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding .

MSCTA is being increasingly used because it is a widely available, non-invasive and fast diagnostic technique that allows for the visualization of the entire intestinal tract and its lesions, the identification of the vascularity and possible vascular abnormalities. In addition, this technique does not require preparation in patients with acute bleeding.

Eligibility criteria: Inclusion Criteria:

* Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.

Exclusion Criteria:

* Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency

Primary outcomes:
measure: MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yoon W, Jeong YY, Shin SS, Lim HS, Song SG, Jang NG, Kim JK, Kang HK. Acute massive gastrointestinal bleeding: detection and localization with arterial phase multi-detector row helical CT. Radiology. 2006 Apr;239(1):160-7. doi: 10.1148/radiol.2383050175. Epub 2006 Feb 16.
Clinical trial NCT02191319: Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
Official title: Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 55
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: HIV treatment centres and HIV out-patient facilities

Brief summary: Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility criteria: Inclusion Criteria:

* Patients suffer from HIV type 1 infection
* Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
* Patient has shown a depression of viral load before limit of detection (\< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
* Patient is male or female with age greater than or equal to 18 years
* Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

Exclusion Criteria:

* Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> five times upper limit of normal (ULN))
* Patients is hypersensitive to Viramune® or to any of its excipients
* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
* Patients is breast-feeding
* Patient is pregnant
* Patient is a woman and does not use effective contraception

Primary outcomes:
measure: Change in viral load (HIV-RNA)
timeFrame: Baseline, up to 52 weeks
measure: Change in CD4 cell count
timeFrame: Baseline, up to 52 weeks
measure: Change in lipid parameters
timeFrame: Baseline, up to 52 weeks
measure: Change in glucose
timeFrame: Baseline, up to 52 weeks
Secondary outcomes:
measure: Assessment of subjective well-being
timeFrame: up to 52 weeks
measure: Assessment of tolerability by physician and patients
timeFrame: after 52 weeks
measure: Change in liver enzyme parameter
timeFrame: Baseline, up to 52 weeks
measure: Number of patients with adverse events
timeFrame: up to 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01409018: Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
Official title: Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric, Cancer
Keywords: pediatric
cancer
invasive fungal disease
antifungal agent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients who are under chemotherapy, and receive itraconazole.

Exclusion Criteria:

1. Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

   * Heart : fractional shortening \< 30%, ejection fraction \< 45%
   * Liver : total bilirubin ≥ 2 x upper limit of normal (ULN) ; aminotransferase ≥ 3 x ULN
   * Kidney : creatinine ≥ 2 x normal or GFR ≤ 60㎖/min/1.73㎡
2. Patients with hypersensitivity to azoles.
3. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
4. Pregnant or nursing women.
5. Psychiatric disorder that would preclude compliance.

Primary outcomes:
measure: To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients
timeFrame: 28 days
Secondary outcomes:
measure: To assess empirical antifungal efficacy and safety in pediatric cancer patients
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, M.D, ph.D
role: PRINCIPAL_INVESTIGATOR
References: