louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03848936: Evaluation of Functional Status and Mental Functions of Adult Cerebral Palsy Patients
Official title: Evaluation of Functional Status and Mental Functions of Adult Cerebral Palsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: adult cerebral palsy
cerebral palsy
functional status
mental function
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult cerebral palsy patients

Brief summary: In adult cerebral palsy patients , a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned.

Detailed description: In adult patients diagnosed with cerebral palsy, a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned. There are studies about the functional status of adults with CP in the literature; However, there is no study conducted on this subject in our country. In this study, it was aimed to evaluate the functional status and mental functions of adults with CP who applied to our hospital.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Diagnosed with cerebral palsy
* Who voluntarily participate the study

Exclusion Criteria:

* \<18 years old
* Who does not give permission to participate the study

Primary outcomes:
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Functional status of adult cerebral palsy patients
timeFrame: 1 year
measure: Mental status of adult cerebral palsy patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Study officials:
References:
Clinical trial NCT05616936: Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin
Official title: Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Effect of Platelet Rich Fibrin With Different Tooth Movements
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 54
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Factorial Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: The present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases

Detailed description: Assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases

Eligibility criteria: Inclusion Criteria:An age range from 15-22 years. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.

All permanent teeth present, 3rd molars are excluded. Good oral and general health. No systemic disease/medication that could interfere with orthodontic tooth movement. No previous orthodontic treatment.

-

Exclusion Criteria:Patient diagnosed to have an indication for non-extraction approach.

Poor oral hygiene or periodontally compromised patient. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

-

Primary outcomes:
measure: effect of injectable platelet rich fibrin on different tooth movements
timeFrame: post interventional at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar university
Study officials:
References:
citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
citation: Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
Clinical trial NCT02376036: Phase 1 Study of MGD010 in Healthy Subjects
Official title: A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MGD010, a CD32B x CD79B Dual Affinity Re-Targeting (DART®) Bi-specific Antibody-Based Molecule, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Normal healthy volunteer
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers.

Detailed description: This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x CD79B DART bi-specific antibody-based molecule. This study will be conducted as a double-blind, randomized, placebo controlled, single ascending dose study among healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 50 years of age
* Body mass index (BMI) of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Women of child-bearing potential;
* Women who are pregnant or breast-feeding
* Any significant acute or chronic medical illness
* Any major surgery within 4 weeks of study drug administration
* Active or latent tuberculosis (TB)
* Active or latent Hepatitis B, Hepatitis C or HIV infection
* History of allergy to monoclonal antibodies, any significant drug allergy (such as anaphylaxis), or hypersensitivity to any components of the test or reference investigational product formulation.
* Evidence of organ dysfunction or any clinically significant deviation from normal
* Vaccination with any live vaccine, or use of any prescription drugs, within 4 weeks of study drug administration
* Known history of infection or exposure to Hepatitis A virus

Primary outcomes:
measure: Safety and Tolerability as assessed by AEs and SAEs
timeFrame: up to Day 57
Secondary outcomes:
measure: Serum concentration (pharmacokinetics) of MGD010
timeFrame: up to Day 57
measure: Incidence of MGD010 anti-drug antibodies (ADA)
timeFrame: up to Day 57
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: PAREXEL Baltimore Early Phase Clinical Unit
state: Maryland
Study officials:
affiliation: MacroGenics
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04518436: Diffusion MRI in Appendicitis
Official title: Diffusion-Weighted Magnetic Resonance Imaging on Surgical Decision-Making in Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: Acute appendicitis
Diffusion weighted magnetic resonance imaging
Diagnostic accuracy
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to the Department of General Surgery and Emergency Medicine with right lower quadrant pain of the abdomen, between January 2015 and May 2019, and scanned by diffusion weighted magnetic resonance imaging

Brief summary: In this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. Investigators believe that Diffusion-weighted magnetic resonance imaging is a valuable method in the diagnosis of acute appendicitis and in making the decision of surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected acute appendicitis and scanned by diffusion weighted magnetic resonance imaging

Exclusion Criteria:

* Patients evaluated by CT
* younger than 18 years

Primary outcomes:
measure: Diffusion weighted magnetic resonance imaging
timeFrame: preoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medical Park Hastanesi
Study officials:
affiliation: Asist. Prof.
name: Gül BORA MAKAL
role: STUDY_DIRECTOR
References:
Clinical trial NCT00871936: A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of SLx-4090 in Combination With Metformin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 82
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: The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

Detailed description: 1. HbA1c after 12 weeks
2. FPG after 12 weeks
3. Safety and tolerability
4. Plasma levels of SLx-4090

Eligibility criteria: Inclusion Criteria:

* HbA1c 7-11%
* On a stable dose of metformin for at least 6 weeks

Exclusion Criteria:

* Type 1 Diabetes
* Antidiabetic medication other than or in addition to metformin
* FPG \> 270 mg/dL

Primary outcomes:
measure: Reduction in HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Burbank
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: West Palm Beach
country: United States
state: Florida
city: Addison
country: United States
state: Illinois
city: Auburn
country: United States
state: Maine
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Greenville
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT02935036: Efficacy Study in Patients With Acne Vulgaris.
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 294
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and efficacy study in patients with acne vulgaris

Detailed description: randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Primary outcomes:
measure: Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
timeFrame: Baseline to week 12 (study day 84)
measure: Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
timeFrame: Baseline to week 12 (study day 84)
measure: The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
timeFrame: Baseline to Week 12 (study day 84)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT02693236: DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
Official title: Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophagus Cancer
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed diagnosis of esophagus cancer
* Age \>18 years at time of consent
* Received standardized treatment of Small-Cell Lung Cancer
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* No severe viral or bacterial infections
* Predicted survival \>3 months

Exclusion Criteria:

* Serious dysfunction of vital organs(heart, liver or kidney)
* History of autoimmune diseases
* Pregnant and breast-feeding patient
* Active or chronic infectious diseases
* History of allergy or hypersensitivity to study product excipients
* Currently participating in another clinical trial
* Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
* Clinically relevant diseases or infections (HBV, HCV, HIV)

Primary outcomes:
measure: objective rate response (CR+PR) as measured by RECIST criteria
timeFrame: Time Frame: 4 weeks after DC/CIK treatment
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: Time Frame: 3 days within DC/CIK treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
References:
Clinical trial NCT04709536: A Study of IBI306 in Participants With Hypercholesterolemia
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 306
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: This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.


Eligibility criteria: Inclusion criteria

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

1. Uncontrolled hypertension
2. Uncontrolled hyperthyroidism or hypothyroidism
3. Severe renal dysfunction
4. Known sensitivity to any of the products to be administered during dosing

Primary outcomes:
measure: 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
timeFrame: Baseline to week12
Secondary outcomes:
measure: The percent of subjects with LDL-C reduction no less than 50% from baseline
timeFrame: Baseline to week24
measure: The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
timeFrame: Baseline to week24
measure: The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
timeFrame: Baseline to week24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT02148536: Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome
Official title: Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatopulmonary Syndrome
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 64
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: Cirrhotic patients with hepatopulmonary syndrome undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital.

Brief summary: To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).


Eligibility criteria: Inclusion Criteria:

* Presence of cirrhosis
* Alveolar-arterial oxygen gradient ≥ 15 mm Hg (≥ 20 mm Hg for age \> 64 years)
* Positive contrast-enhanced echocardiography

Exclusion Criteria:

* Age of less than 18 years
* Intrinsic cardiopulmonary disease
* Malignancy
* Active infection
* Pregnancy
* Previous shunt therapy
* Refusal to participate

Primary outcomes:
measure: Alveolar-arterial oxygen gradient (PA-a,O2)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Macroaggregated albumin (MAA) shunt fraction
timeFrame: 12 Weeks
measure: Exhaled nitric oxide (eNO)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan university
state: Sichuan
Study officials:
References:
Clinical trial NCT05368636: Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence
Official title: Analyzing the Link Between Tongue Images and Gastric Cancer Cascade Response Using Artificial Intelligence Techniques
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Artificial Intelligence
Tongue
Gastric Cancer
Keywords: Artificial Intelligence
tongue
gastric cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 40-80 years who will undergo gastroscopy and fulfil the inclusion criteria who do not meet the exclusion criteria.

Brief summary: This study combines artificial intelligence with tongue images, by collating and collecting tongue images and diagnostic and pathological results of gastroscopic diseases, mining and analysing the correlation between tongue images and OLGA, OLGIM stages, Correa sequences and constructing prediction models, to deeply investigate the relationship between tongue images and precancerous diseases, precancerous lesions and gastric cancer.

Detailed description: Firstly, tongue pictures and patient information will be collected after the patient signed an informed consent form.

Secondly, after the patient undergoes gastroscopy, patient gastroscopy reports and pathology reports will be obtained.

Thirdly, the investigator will assess the patient's gastroscopy report for the Correa sequence of gastric cancer with OLGA and OLGIM staging.

Finally, the patient's tongue image, information and gastric cancer cascade response are matched to construct an artificial intelligence model and assess the quality of the model.

Eligibility criteria: Inclusion Criteria:

* Patients between 40 and 80 years of age who are scheduled for gastroscopy.
* Patients all gave their informed consent and signed the informed consent form.

Exclusion Criteria:

* Persons with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who are unable to participate in gastroscopy.
* Patients with previous surgical procedures on the gastrointestinal tract.
* Patients taking bismuth or other staining drugs.

Primary outcomes:
measure: Sensitivity
timeFrame: 3 years
measure: Specificity
timeFrame: 3 years
measure: Positive predictive values(PPV)
timeFrame: 3 years
measure: Negative predictive values(NPV)
timeFrame: 3 years
measure: AUC (95% CI)
timeFrame: 3 years
measure: Accuracy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: