louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06117189: Turkish Validity and Reliability of Oral Health Impact on Daily Life Questionnaire
Official title: Turkish Validity and Reliability of Oral Health Impact on Daily Life Questionnaire in Endodontic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health Related Quality of Life
Keywords: oral health
quality of life
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years and older who applied to the Department of Endodontics

Brief summary: This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.The questionnaire was translated and adapted into Turkish. Then, it was applied to two hundred twenty-two participants aged 18 years.

Detailed description: This study aimed to test Turkish validity and reliability of the Oral Health Impact on Daily Life Questionnaire (OHIDL) in adult endodontic patients.

The questionnaire was translated and adapted into Turkish. Two hundred twenty-two participants aged 18 years and over without systemic disease were included. The reliability was examined by internal consistency and test-retest reliability. The construct and criterion validity were examined by evaluating the correlation of each question with the domains, the correlation of the domains with the global questions, and the correlation of Turkish-OHIDL with the Turkish version of the Oral Health Impact Scale (OHIP-14-TR). Statistical analysis was performed with SPSS 21.0 (IBM Corp, Armonk, NY, USA). P \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older who applied to the Department of Endodontics

Exclusion Criteria:

* Patients who did not speak Turkish,
* Patients having cognitive impairment,
* Patients having communication difficulties

Primary outcomes:
measure: To asses Turkish validity and reliability of Oral Health Impact on Daily Life questionnaire
timeFrame: One month from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Ahter Şanal Çıkman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060889: Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Official title: Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Placenta Previa
Keywords: Cesarean section
placenta previa
Tranexamic acid
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Detailed description: Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss

Eligibility criteria: Inclusion Criteria:

* Term pregnancy (more than 37 weeks of gestation)
* Diagnosis of placenta previa was confirmed by ultrasound
* The patient hemoglobin percentage is more than 10 mg/dl

Exclusion Criteria:

* Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
* Emergency lower segment cesarean section
* Associated medical comorbidities

Primary outcomes:
measure: intra operative blood loss in ml
timeFrame: intraoperative during cesarean section
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02785289: A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Official title: A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

Detailed description: Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an efficient method cover hard-to reach populations in developing countries. While the recent cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection, recent studies have questioned their efficacy by reporting the superiority of the more expensive flocked swabs.

The objective of this study is to compare the performance of cotton vs flocked swabs for cellular retrieval and HPV DNA quantification after vaginal self-sampling.

A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of age or older, attending the colposcopy clinic, understanding the study procedures and able to comply with the study protocol. Pregnant women, those having previously had a total hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect two different vaginal self samples: one with the cotton swab and one with the flocked swab. Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic evaluation for specimen adequacy will be run on each sample. Agreement between the two methods will be calculated using the kappa statistic (κ).

Eligibility criteria: Inclusion Criteria:

* attending the colposcopy clinic
* accepts voluntarily to take part to the study and signs the informed consent form

Exclusion Criteria:

* pregnancy
* previous hysterectomy
* ongoing menstruations

Primary outcomes:
measure: Flow cytometric analysis
timeFrame: 1 week
measure: Real-time PCR analysis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
Clinical trial NCT04085029: Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Official title: Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oligometastasis
Metastatic Cancer
Keywords: Ablative radiotherapy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Duke University Health System Radiation Oncology treatment facilities or Durham VA Medical Center

Brief summary: The purpose of this study is to provide a registry of participants in order to assess the acute adverse event rates following ablative radiotherapy for metastatic disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment
* Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s)
* Patient must sign study-specific informed consent

Exclusion Criteria:

• None

Primary outcomes:
measure: Occurrence of acute adverse events following radiotherapy
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Cary
country: United States
facility: Duke Cancer Institute Cary
state: North Carolina
city: Durham
country: United States
facility: Durham Veterans Administration Health Care System (DVAHCS)
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Women's Cancer Care Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph Salama, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661929: The Association of Cognitive Distortions and NCDs Among Users of Medical Internet Resources
Official title: The Association of Cognitive Distortions and NCDs Among Users of Medical Internet Resources
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Biases
Non-infecious Chronic Disease
Lead sponsor: Limited Liability Company "Docstarclub"
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: User of medical Internet resources

Brief summary: Currently, medical Internet resources are popular among the population of most countries, including Russia. So its can be used as a platform for mass measures of prevention.

Now we can receive a lot of information about socio-demographic characteristics, risk factors and the presence of chronic non-infectious diseases among users of medical Internet resources. And these knowledges are necessary to create effective online interventions for prevention of the most common diseases.

We have enough resources to identify and control risk factors for chronic non-infectious diseases. But adherence to doctor's recommendations remains at a low level. Working with cognitive biases is one of the points of application for increasing adherence to treatment and the rules of a healthy lifestyle.

Certain groups of patients have special cognitive biases. We assume that creation a typical portrait of a patient can reveal relationships and factors the variant of cognitive biases. This information may help to more effectively carry out preventive work with users of medical Internet resources, forming the correct patterns of perception and thereby improving adherence to the doctor's recommendations.


Eligibility criteria: Inclusion Criteria:

* User of medical Internet resources older 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: The questionnaire "Cognitive Mistakes Questionnaire"
timeFrame: from 1 February to 1 March 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Sevastopol'
country: Russian Federation
facility: Limited Liability Company "Docstarclub"
Study officials:
affiliation: Limited Liability Company "Docstarclub"
name: Margarita Bezzubtseva
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568529: Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Official title: Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Advanced gastric cancer
Response rate
Side effects
time to progression
overall survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

Detailed description: The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years
* Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
* ECOG performance status ≤1
* Measurable diseases according to the RECIST
* Relapse or refractory after the first-line chemotherapy
* Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).

Exclusion Criteria:

* Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
* Have used any of drugs in the regimen in first-line chemotherapy
* Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Received other chemotherapy regimen after metastasis
* Participated in other clinical trials.

Primary outcomes:
measure: Response Rate
timeFrame: 2-6 months
Secondary outcomes:
measure: time to progression and overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04619329: Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)
Official title: Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huge Hepatocellular Carcinoma (HCC) (≥10cm)
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).


Eligibility criteria: Inclusion Criteria:

1. Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition).
2. Barcelona Clinic Liver Cancer (BCLC) stage A or B.
3. Remnant liver volume and liver function reserve are suitable for surgical resection.
4. Main lesion diameter ≥10cm.
5. Number of HCC lesions ≤5 and all located on one liver lobe.
6. Liver function Child-Pugh class A
7. ECOG Performance Status 0-1
8. Life expectancy ≥ 6 months
9. HCC is diagnosed for the first time.
10. Age 18 to 75 years
11. Able to sign and provide written informed consent.

Exclusion Criteria:

1. Severe active infection \>grade 2 (except for Hepatitis B and C infection).
2. Liver function Child-Pugh class C.
3. BCLC stage C.
4. Patients with unresectable HCC.
5. Platelet \<60×109/L.
6. Concomitant malignant tumors in other organs.
7. Patient with severe cardiac, lung or kidney disease, or severe diabetes.
8. Pregnant or breast-feeding woman.
9. Patients with severe neuropathy and unable to report therapeutic effects.
10. Patients with severe atherosclerosis.
11. Patients with AIDS.
12. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
13. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
14. Currently enrolled or going to enroll in any other clinical trials.
15. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).

Primary outcomes:
measure: Disease Free Survival（DFS）
timeFrame: 6 months
measure: Median Overall Survival (mOS)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of Intrahepatic Metastasis
timeFrame: 6 months
measure: Incidence of Extrahepatic Metastasis
timeFrame: 1 and 2 years
measure: Overall Survival (OS)
timeFrame: 1 and 2 years
measure: Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
Study officials:
References:
Clinical trial NCT00837629: Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)
Official title: An Open-label Non-interventional Evaluation of Efficacy of Symbicort® Forte Turbuhaler 320/9 µg (Budesonide / Formoterol) and Symbicort® Turbuhaler® 160/4,5 µg (Budesonide / Formoterol)in Functional Status Improvement of Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
Symbicort Turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients (outpatient or hospitalised) in whom Symbicort Turbuhaler is indicated according to the current Summary of product characteristics (SPC)

Brief summary: This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.


Eligibility criteria: Inclusion Criteria:

* non pregnant female
* COPD with persistent symptoms in spite of regular bronchodilator therapy
* Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler

Exclusion Criteria:

* Hypersensitivity to budesonide, formoterol or inhaled lactose

Primary outcomes:
measure: Reduction in overall Clinical COPD Questionnaire (CCQ) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 12 weeks
measure: Physicians' global clinical impression of the treatment
timeFrame: 12 weeks
measure: Evaluation of smoking habits
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Golnik Hospital
name: Matjaz Flezar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934929: Contribution of Residual Tumour DNA Testing on the Surgical Bed
Official title: Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of the Oral Cavity
Keywords: oral cavity
squamous cell carcinoma
residual tumor DNA
head and neck surgery
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

Detailed description: Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.

Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
* 18 years of age or older
* Member or beneficiary of a social security scheme.

Exclusion Criteria:

* Absence of signed informed consent
* Patient of protected age
* Psychosocial problems
* Not affiliated to or benefiting from a social security scheme
* Previous cervical irradiation
* Pregnant or breast-feeding women
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).

Primary outcomes:
measure: Residual tumro DNA on operating bed
timeFrame: during the surgery
Secondary outcomes:
measure: Survival without locoregional recurrence rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Lise-Marie Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067729: A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
Official title: A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Burn
Superficial burns
Partial thickness burns
Rate of healing
Infection rate
Pain perception
Non adherence
Scarring
Lead sponsor: Aubrey Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

Detailed description: The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

Eligibility criteria: Inclusion Criteria:

* Superficial partial thickness burns
* Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
* One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
* Burn wounds measuring \>2% - \<40% TBSA
* Patient age: \>1 - 70 years

Exclusion Criteria:

* Ventilator dependence
* Pregnancy/Lactation
* Mechanism of injury was electrical, chemical or frostbite
* Co-morbidity which may compromise healing
* Known allergy to porcine or porcine products

Primary outcomes:
measure: Rate of healing
timeFrame: Day 14
Secondary outcomes:
measure: Scarring
timeFrame: 6 months, 1 year, 18 months and 2 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Burn Center
state: California
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Galveston
country: United States
facility: Shriners Hospitals for Children
state: Texas
Study officials:
References: