louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05478148: TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
Official title: COMPARISON OF THE CONVENTIONAL AND MODERN TECHNIQUES USED IN CLINICAL EVALUATION AND CLASSIFICATION OF THE GINGIVAL PHENOTYPE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival phenotype
gingival thickness
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.

The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals,
* Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
* Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
* Absence of dental compensations of skeletal malocclusion.

Exclusion Criteria:

* Individuals who smoke and have a history of smoking,
* Individuals who have undergone orthodontic treatment,
* Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
* Individuals who are in pregnancy or lactation period,
* Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
* The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,

Primary outcomes:
measure: Feasibility and reliability of techniques
timeFrame: 1 day
Secondary outcomes:
measure: The amount of gingival thickness and the width of the keratinized tissue
timeFrame: 1 day
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05848648: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Official title: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Pamiparib
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients using pamipalil must sign a written informed consent before collecting blood samples.

Brief summary: This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.

Detailed description: In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation.

Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.

Eligibility criteria: Inclusion Criteria:

1. The age of the patient is ≥ 18 years old and less than 80 years old.
2. Receive treatment with pamipalil.
3. The patient signed a written informed consent form.

Exclusion Criteria:

1. The expected survival time may be less than the treatment cycle.
2. Is being treated with other systemic trial drugs.
3. There are other factors that the researchers think are not suitable for joining the group.

Primary outcomes:
measure: Blood drug concentration
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between blood drug concentration and adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xin Huang
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Huang Xin
role: STUDY_DIRECTOR
References:
Clinical trial NCT05777148: Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial
Official title: Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: hemodiafiltration
super high-flux hemodialysis
advanced glycation end products
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are

* Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF
* Safety profile : Dialysate albumin loss, Intradialytic complication

Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF


Eligibility criteria: Inclusion Criteria:

* Chronic HD \> 3 months
* Adequate small molecule uremic toxins removal
* Kt/v \> 1.8 in HD 2 times/week
* Kt/v \> 1.2 in HD 3 times/week
* BFR \> 300 mL/min
* RKF \< 100 ml/day
* Hemodynamically stable for \> 2 weeks

Exclusion Criteria:

* contraindicated to anticoagulant
* active malignancy
* advanced liver disease

Primary outcomes:
measure: skin autofluorescence for AGEs
timeFrame: 24 weeks
Secondary outcomes:
measure: serum beta 2 microglobulin
timeFrame: At first week, 8th week, 16th week and 24th week
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: ramathibodi hospital, faculty of medicine, Ramathibodi hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT05675748: Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients
Official title: A Non-interventional Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients With Mild/Normal COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
name: Huashan Hospital
First posted: 2023-01-09
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nursing homes patients with mild/common COVID-19 symptom

Brief summary: This study was a multicenter, non-intervention, real world study. To evaluate the efficacy and safety of azvudine in nursing homes with mild/common COVID-19 patients. The primary outcome measure was the proportion of patients with severe/critical illness within 28 days.


Eligibility criteria: Inclusion Criteria:

1. Living in a nursing home who has taken or intends to take azvudine tablets depending on their condition;
2. Mild/normal subjects who are SARS-CoV-2 RT-RCR positive or antigen-positive;
3. Subjects have at least one or more of the following clinical symptoms of COVID-19 in the 24 hours prior to initial administration, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, chills or chills;
4. Volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone.

Exclusion Criteria:

1. Subjects have received antiviral therapy, such as Paxlovid and SARS-CoV-2 monoclonal antibody therapy (except previous treatment for COVID-19 infection) before entering the study;
2. Shortness of breath, RR≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%;
3. Mechanical ventilation is required or expected to be urgently required;
4. Severe infections requiring systemic treatment within 14 days prior to initial medication;
5. Use of other antiviral drugs (such as anti-HIV, hepatitis B, and hepatitis C drugs) within 14 days prior to the first medication.

Primary outcomes:
measure: The proportion of patients with severe/critical illness within 28 days
timeFrame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
Secondary outcomes:
measure: all-cause mortality within 28 days
timeFrame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
measure: Proportion of hospitalization within 28 days and the duration of hospitalization
timeFrame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03407248: Dairy Product Consumption and Impact on Nutritional Adequacy, Environment and Diet Cost
Official title: What Are the Roles of Dairy Products in Sustainable Diets? Modelling Nutritional Adequacy, Financial and Environmental Impacts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Pattern Analysis
Environmental Impact
Nutrient Intakes
Cardio-metabolic Health
Dietary Cost
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Dairy Council, United Kingdom
First posted: 2018-01-23
Enrollment: 1655
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The data included food consumption and nutritional data for 1655 adults (males: n=710 and females: n=945) aged 19-64 years old, in 2008/09-2011/12 National Diet and Nutrition Survey (NDNS).

Brief summary: This is a secondary analysis of dietary, demographic and health parameter data collected in the 2008/09-2011/12 National Diet and Nutrition Survey (NDNS), UK to determine the roles of dairy products in sustainable diets by modelling nutritional adequacy, financial cost and environmental impact of UK diets containing varying amounts of dairy products.


Eligibility criteria: Inclusion Criteria:

* Eligible respondents were adults aged 19-64 years.

Exclusion Criteria:

* Younger than age 18 or older than age 65

Primary outcomes:
measure: Food intake
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
References:
citation: Hobbs DA, Durrant C, Elliott J, Givens DI, Lovegrove JA. Diets containing the highest levels of dairy products are associated with greater eutrophication potential but higher nutrient intakes and lower financial cost in the United Kingdom. Eur J Nutr. 2020 Apr;59(3):895-908. doi: 10.1007/s00394-019-01949-y. Epub 2019 Mar 29.
Clinical trial NCT01548248: Efficacy and Safety of Levemir® Used as Basal Insulin
Official title: An Observational 3-months Study to Evaluate Efficacy and Safety of Insulin Levemir® Used as Basal Insulin on the Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with type 1 or type 2 diabetes treated with human insulin NPH in whom at the discretion of the participating physicians it was decided to switch insulin treatment to the long-acting insulin analogue insulin detemir in combination with insulin aspart. The selection of the subjects was at the discretion of the participating physicians.

Brief summary: This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes treated with insulin NPH

Primary outcomes:
measure: Change in HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Change in weight
measure: Change in fasting plasma glucose (FPG)
measure: Change in 4-points glucose profiles
measure: Change in lipid profile
measure: Number of hypoglycaemic events
measure: Number of adverse events
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Zuzana N et al; Effect of Basal Insulin Detemir on Weight and Hypoglycemia in T1DM and T2DM; 2025-PO; 69th Scientific Sessions (2009); American Diabetes Association
Clinical trial NCT01375348: Relationship Between Cognitive Function and Pain
Official title: Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognitive Ability, General
Keywords: Cognitive function
Experimental pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Mech-Sense
First posted: 2011-06-17
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. The interaction between pain, treatment and cognitive function is very complex and is far from understood.

The hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.


Eligibility criteria: Inclusion Criteria:

* Healthy men aged 18-65 years
* Normal vision and hearing
* No disease associated with cognitive dysfunction

Exclusion Criteria:

* Allergic to remifentanil or patches
* Any use of pain killers or alcohol 48hours before study start
* Current participation in other clinical studies or participation within the last 14days before study start
* Prescribed medication
* Risk of developing
* Previously alcohol- or drug addict
* MMSE score \< 26

Primary outcomes:
measure: Cognitive function
timeFrame: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Mech-Sense, Department of Gastroenterology, Aalborg Hospital
Study officials:
affiliation: Mech-Sense
name: Asbjørn M Drewes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjogren P, Drewes AM. Altered frequency distribution in the electroencephalogram is correlated to the analgesic effect of remifentanil. Basic Clin Pharmacol Toxicol. 2015 May;116(5):414-22. doi: 10.1111/bcpt.12330. Epub 2014 Oct 21.
Clinical trial NCT01909648: HbA2 Leuven and Its Impact on HbA1c Results
Official title: HbA2 Leuven and Its Impact on HbA1c Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Study HbA2 Leuven Mutation.
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.

Detailed description: HbA2 Leuven mutation will be investigated using molecular diagnostic techniques.

Interference on HbA1c measurements will be assessed in HbA2 Leuven carriers using different methodologies.

Eligibility criteria: Inclusion Criteria:

* Family history of HbA2 Leuven mutation.

Exclusion Criteria:

* Any condition inhibiting simple blood withdrawal.

Primary outcomes:
measure: Demonstration of presence/absence of HbA2 Leuven mutation
timeFrame: 1 year
Secondary outcomes:
measure: Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Davy MJ Kieffer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Gillard, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Koen Desmet, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT05764148: Effectiveness of Behavioral Activation Treatment for Schizophrenia
Official title: Effectiveness of Non Face-to-face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia, Latent
Negative Symptoms in Schizophrenia
Behavioral Activation
Remote Medical Service
Keywords: Schizophrenia
Negative Symptoms in Schizophrenia
behavioral activation
Remote Medical Service
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: schizophrenia group and treatment as usual
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to implement a behavior activation remote program for negative symptoms of schizophrenia and to verify whether the behavior activation remote program for negative symptoms of schizophrenia has effects on negative symptoms, cognitive function, and social function of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients who have received a primary diagnosis of schizophrenia
* Patients who are at least 18 years old and under 65 years old
* Patients who show a score of 3 or higher on at least two negative symptom items in the Positive and Negative Syndrome Scale (PANSS)
* The subject selection period is until December 31, 2021, from the IRB approval date.

Exclusion Criteria:

* Patients with a history of organic brain syndrome, epilepsy, or traumatic brain injury
* Patients with comorbidities such as intellectual disability, current alcohol or other substance dependence
* Patients who show a score of 5 or higher on at least two positive symptom items in the Positive and Negative Syndrome Scale (PANSS)
* Patients who have received a diagnosis of major depressive disorder according to the DSM-V criteria by a specialist in psychiatry
* Patients who have received psychological services including components of behavioral activation therapy
* Patients who are at risk of self-harm or harm to others.

Primary outcomes:
measure: negative function
timeFrame: three month
Secondary outcomes:
measure: cognitive function
timeFrame: three month
measure: depressed mood
timeFrame: three month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha university hospital
state: Jung-Gu
Study officials:
References:
Clinical trial NCT06372548: Rehabilitation Training Games for Children With Amblyopia
Official title: The Effect of Cognitive Appraisal Theory on Adherence in Rehabilitation Training Games for Children With Amblyopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Amblyopia Occlusion
Child Behavior
Adherence, Treatment
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

Detailed description: The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed).
* The child has no significant IQ deficits and has no difficulty communicating with others.
* The children's teachers and parents gave their informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.

Exclusion Criteria:

* Severe amblyopia.
* Suffering from other psychological or physical disorders.
* Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.

Primary outcomes:
measure: 8-Item Morisky Medication Adherence Scale (MMAS-8):
timeFrame: baseline and study completion (after 8 weeks)
Secondary outcomes:
measure: User Experience Questionnaire (UEQ)
timeFrame: study completion (after 8 weeks)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Dian Zhu, Dr
role: PRINCIPAL_INVESTIGATOR
References: