louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03037814: Clinical Performance of Restorative Materials in Primary Teeth
Official title: Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries; Dentin
Dental Caries
Keywords: restorative materials
primary teeth
children
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth

Detailed description: Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.

Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Eligibility criteria: Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth that have caries lesions extending no more than the outher half of dentin radiographically

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients who are uncooperative
* Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
* Patients who have bruxism, skeletal or dental malocclusion
* Teeth that have developmental defects or anomalies

Primary outcomes:
measure: Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zafer C Cehreli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06781814: Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function
Official title: Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Function
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of four high-activity compound probiotic freeze-dried powders on improving gastrointestinal function, observing their regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 4-week intervention period.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study
2. Able to complete the study according to the requirements of the trial protocol
3. Age between 18 and 65 years old
4. Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"
5. Symptoms: Irregular bowel movements, loose or hard stools, abdominal bloating, belching, flatulence, severe intestinal gas, abdominal pain, acid reflux, heartburn, pain in the stomach or abdomen when hungry, nausea
6. Signs: Abdominal pain and bloating, diarrhea and constipation, indigestion, gastric acid reflux, bad breath and foul-smelling flatulence, skin problems, changes in stool color and shape -

Exclusion Criteria:

1. Use of drugs affecting the intestinal flora (including antimicrobials, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week continuously within 1 month prior to screening
2. Short-term consumption of products similar to the test substance, which affects the judgment of the results
3. Use of antibiotics during illness
4. Participants with severe systemic diseases or malignant tumors
5. Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial
6. Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future
7. Participants who cannot participate in the trial due to personal reasons
8. Other participants deemed unsuitable for participation by the researcher -

Primary outcomes:
measure: Improvement of gastrointestinal function in study participants
timeFrame: 4 weeks
Secondary outcomes:
measure: Concentration of Short-Chain Fatty Acids in Fecal Samples
timeFrame: 4 weeks
measure: Metabolite Profile in Fecal Samples as an Indicator of Intestinal Microbiota Health
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Luoyang
country: China
facility: School of Food and Bioengineering, Henan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT06533514: Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis
Official title: Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Pneumonia
Biomarkers
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Meets the diagnostic criteria for severe pneumonia；

Brief summary: The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Detailed description: Methods: The relationship between relevant biomarkers and stratified diagnosis was analyzed by collecting laboratory and etiological examinations of patients with severe pneumonia.

Eligibility criteria: Inclusion Criteria:

* Meets the diagnostic criteria for severe pneumonia；
* Age≥18 years old and \< 80 years old；
* Willing to sign informed consent for the course of the study；

Exclusion Criteria:

* Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
* Pregnant and lactating patients;
* Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine \>0.5mg/kg/min);
* Those who do not consent to participate in this study；

Primary outcomes:
measure: The relationship between the patient's specific biomarker levels and clinical outcomes.
timeFrame: 1 mounth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05026255: Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre
Official title: Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intensive Care Patients
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective multicentre open-label study of mechanically ventilated intensive care patients.
Primary purpose: PREVENTION

Brief summary: Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.

Prospective multicentre open-label study of mechanically ventilated intensive care patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study
* Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation
* Equipped with a central venous line in the superior vena cava territory and an arterial catheter.
* Whose state of health justifies vascular filling

Exclusion Criteria:

* Patient under legal protection, guardianship or curatorship
* Pregnant or breastfeeding woman
* Patient not affiliated to the French social security system
* Contraindication to the realization of an alveolar recruitment maneuver

Primary outcomes:
measure: Primary outcome measure
timeFrame: through study completion, an average of 12 hours
Secondary outcomes:
measure: Secondary outcome measure
timeFrame: through study completion, an average of 12 hours
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
Study officials:
References:
Clinical trial NCT04787055: In Field Performance of a Hearing Aid Transducer
Official title: A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-03-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate sensorineural hearing loss
* Adult

Exclusion Criteria:

* Inability or unwillingness to wear study devices for extended period of time.

Primary outcomes:
measure: Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
timeFrame: Three months after initial appointment
measure: Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
timeFrame: Six months after initial appointment
measure: Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
timeFrame: Three months after initial appointment
measure: Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
timeFrame: Six months after initial appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT00712855: A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Official title: A Phase 1B, Multi-center, Open Label, Dose Escalation Study of Mapatumumab ([HGS1012], a Fully-human Monoclonal Antibody to TRAIL-R1) in Combination With Sorafenib as a First Line Therapy in Subjects With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Liver Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.


Eligibility criteria: Inclusion Criteria:

* Moderate liver disease
* Test positive for hepatitis B surface antigen or hepatitis C antibody
* Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
* Age 18 years or older

Exclusion Criteria:

* Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
* Received radiation therapy within 4 weeks before randomization
* Major surgery within 4 weeks before randomization
* Minor surgery within 2 weeks before randomization
* Systemic steroids within 1 week before randomization
* Hepatic encephalopathy, per the investigator's evaluation
* History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
* History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
* Known brain or spinal cord metastases
* History of other cancers within 5 years before enrollment
* Pregnant or breast-feeding women
* Known HIV infection

Primary outcomes:
measure: Type, frequency, and severity of adverse events.
timeFrame: Until disease progression or unacceptable toxicity develops
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Health System
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania- Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: Human Genome Sciences Inc.
name: Norma Lynn Fox, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01396655: PET in Breast Cancer Receiving Neoadjuvant Chemotherapy
Official title: Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant chemotherapy
molecular marker
FDG PET
locally advanced breast cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.

The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. pathologically-confirmed breast cancer by core needle biopsy,
2. initial clinical stage II or III,
3. objective measurable lesion,
4. ECOG performance 0\~2,
5. previously untreated,
6. adequate bone marrow, hepatic, cardiac, and renal functions
7. age 20\~70
8. agreement with this trial, and written informed consent

Exclusion Criteria:

1. history of other cancer
2. active infection
3. pregnancy
4. psychologic disease
5. uncontrolled heart diseases
6. male

Primary outcomes:
measure: pathologic complete response
timeFrame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
Secondary outcomes:
measure: survival (Relapse-free survival, overall survival)
timeFrame: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy
measure: early metabolic response
timeFrame: before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)
measure: predictive factors
timeFrame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
measure: hematologic toxicity
timeFrame: every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Bhumsuk Keam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Seock-Ah Im, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keam B, Im SA, Koh Y, Han SW, Oh DY, Cho N, Kim JH, Han W, Kang KW, Moon WK, Kim TY, Park IA, Noh DY, Chung JK, Bang YJ. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer. 2011 Oct 20;11:452. doi: 10.1186/1471-2407-11-452.
Clinical trial NCT03951155: Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.
Official title: Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
behavioral management
dental management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.

Detailed description: Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.

Eligibility criteria: Inclusion Criteria:

* Children: 6 to 9 years old ADHD children
* Teeth: Teeth requiring dental treatment or preventive measure.

Exclusion Criteria:

* Non ADHD children.
* ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
* Refusal of participation

Primary outcomes:
measure: Modified Frankl Scale for child cooperation
timeFrame: one day
Secondary outcomes:
measure: Completion of treatment
timeFrame: one day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04415255: Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy
Official title: Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Biopsy
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung biopsy.

Detailed description: The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture hole when the needle is removed after the biopsy. However, pneumothorax may occur during the needle insertion as the visceral pleura is punctured or during the biopsy procedure before needle removal. Prevent such leakage, the investigators planned to inject autologous blood into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on visceral pleura as a sealant. The investigators planned to test the EPABI method in a prospective single-center randomized controlled study design.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Referred for CT guided biopsy of lung lesion
* Target lesion of any size
* Target lesion located any away from visceral pleura based on the needle path
* Needle path without transgression of a pleural fissure, bleb, or bulla is possible
* Coaxial biopsy technique using Bard 19-Gauge introducer needle
* Needle length =16

Exclusion Criteria:

* Passage through non-aerated lung or tissue
* More than 1 biopsy on the same side requiring more than 1 pleural puncture
* History of prior ipsilateral lung interventions including:

Chest tube placement Surgery Pleurodesis Radiation treatment

Primary outcomes:
measure: To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Tekirdag Namik Kemal University Medical Faculty Radiology Department
Study officials:
affiliation: Namik Kemal University
name: Yasar Turk
role: PRINCIPAL_INVESTIGATOR
References: