louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03268512: Effect of L-PRF and A-PRF in Ridge Preservation
Official title: The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Maxilla
Ridge Preservation
Keywords: leucocyte- and platelet rich fibrin
ridge preservation
growth factors
platelet concentrates
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.


Eligibility criteria: Inclusion Criteria:

* 3 single-rooted teeth needed to be extracted in the upper jaw
* patient in good general health as documented by self-assessment
* patients must be committed to the study and must be willing to sing the informed consent.

Exclusion Criteria:

* any systemic medical condition that could interfere with the surgical procedure or planned treatment.
* current pregnancy or breast feeding
* radiotherapy or chemotherapy in head and neck area
* intravenous and oral bisphosphonate
* patients smoking \>20 cig/day
* unwillingness to return for the follow-up examination

Primary outcomes:
measure: Changes horizontal width at crest -1mm
timeFrame: 3 months
Secondary outcomes:
measure: Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill
timeFrame: 3 months
Other outcomes:
measure: Post-operative scores
timeFrame: 1 week
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Ana B Castro, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04458012: Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections
Official title: Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients With Age-related Macular Degeneration Treated With Intravitreal Injections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Tor Paaske Utheim
name: Vegard Asgeir Forsaa
name: Vilde Marie Thomseth
First posted: 2020-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with age related macular degeneration receiving intravitreal injections with anti-vegf.

Brief summary: To investigate prevalence of dry eye disease in Norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of DED in this population.

Detailed description: Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for objective ocular surface evaluation. Tear fluid samples will be collected for later biochemical analysis.

Eligibility criteria: Inclusion Criteria:

* AMD diagnosis
* Treated with intravitreal injection agents

Exclusion Criteria:

* Not able to cooperate

Primary outcomes:
measure: Dry eye disease in patients receiving intravitreal injections
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT00367146: MMF After Pediatric Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Chronic Kidney Disease
Keywords: liver transplantation
children
immunosuppression
mycophenolatmofetil
calcineurin inhibitor
kidney disease
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2006-08-22
Enrollment: 25
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.

The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.


Eligibility criteria: Inclusion Criteria:

* patients after pediatric liver transplantation
* no acute rejections for the last half year

Exclusion Criteria:

* concomitant malign disease (e.g. ptld)
* neutropenia (granulocytes \<1000/µl)
* systemic infection
* thrombopenia (\<80/nl)

Primary outcomes:
measure: safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
timeFrame: 1, 3, 6, 9, 12, 24 month
Secondary outcomes:
measure: incidence of chronic kidney disease
timeFrame: 12, 24 month
measure: incidence of infections
timeFrame: 1, 3, 6, 9, 12, 24 month
measure: incidence of ptld (post transplant lymphoproliferative disease)
timeFrame: 1, 3, 6, 9, 12, 24 month
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover medical School
Study officials:
affiliation: Hannover Medical School
name: Michael Melter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02800746: Intravenous Iron Pre-treatment in Prognathic Surgery
Official title: Preoperative Intravenous Iron Supplementation on Postoperative Hematocrit and Intraoperative Transfusion Amount in Prognathic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prognathic Surgery
Keywords: Prognathic surgery
intravenous iron
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with prognathism in undergoing elective prognathic surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative Hematocrit \> 39% (male) and \> 36% 9female)serum hemoglobin \>13 g/dL (male) and \>12 g/dL (female)

Exclusion Criteria:

* Patients with history of anaphylaxis, iron overload, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Primary outcomes:
measure: Serum-Hematocrit
timeFrame: Postoperative 2 hour
Secondary outcomes:
measure: Serum-Ferritin level
timeFrame: Postoperative 2 hour
measure: Changes of serum-Ferritin level
timeFrame: Postoperative 2 hour
measure: Transfusion amount
timeFrame: Postoperative 2 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06843746: Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint
Official title: Comparison of Usability Satisfaction of the Newly Developed Low-cost Thermoplastic Splint and Commercial Thermoplastic Splint in Orthopedic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Usability Satisfaction
Keywords: Splinting Materials
Low temperature thermoplastic
Hand splint
Occupational Therapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 groups: newly developed low-cost thermoplastic splint and commercial thermoplastic splint.
Primary purpose: TREATMENT

Brief summary: Low-temperature thermoplastic has been commonly used in the fabrication of hand splints. However, its high cost and limited accessibility pose challenges for both clinicians and clients. There is a need for innovative and cost-effective splinting materials that are convenient to use. This study aimed to investigate the satisfaction and opinions of patients regarding a newly developed low-cost thermoplastic material.


Eligibility criteria: Inclusion Criteria:

* Patient with musculoskeletal disorder
* Need to receive the splint from occupational therapist

Exclusion Criteria:

* History of neurological disorder
* Have the cognitive impairment
* Receive the splint already
* Have clinical diagnosis of the disease or symptoms that cannot use the splint

Primary outcomes:
measure: Patient satisfaction and opinions
timeFrame: After using the thermoplastic splint for 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Faculty of Physical Therapy, Mahidol University
state: Nakhon Pathom
Study officials:
References:
Clinical trial NCT06283446: Enhancing Prospective Thinking in Early Recovery (NERF)
Official title: Enhancing Prospective Thinking in Early Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-02-28
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:

Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.


Eligibility criteria: Inclusion Criteria:

* Abstinence between 30 days ≤ 1 year
* Verbal endorsement of commitment to recovery
* English comprehension

Exclusion Criteria:

* Unstable medical disorders
* Outside the age range of 18-60
* Habitual substance or alcohol use
* Smell/taste disorders
* Unstable psychiatric conditions

Primary outcomes:
measure: Increase Prospective Thinking
timeFrame: [Time Frame: Study Day Visit (Day 1)]
measure: Delayed Rewards
timeFrame: [Time Frame: Study Day Visit (Day 1)]
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Goodman Hall
state: Indiana
Study officials:
affiliation: Indiana University
name: Brandon G Oberlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03827746: The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
Official title: The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Kinesiophobia
Physical Activity
Balance
Falling
Keywords: Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
Collaborators: name: Marmara University
name: Istanbul University - Cerrahpasa
First posted: 2019-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of the study consisted of patients with Parkinson's disease who were in 1-3 stages according to Hoehn-Yahr Scale.

The sample consisted of 60 patients who applied to Istanbul University Cerrahpaşa Medical Faculty Neurology Department Movement Disorders Unit, complied with the inclusion criteria, read the information form and signed an informed consent form.

Brief summary: The kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. It develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. Studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. It is known that functional problems such as balance problems and decrease in physical activity level occur in patients with Parkinson's disease. However, in the literature, there is no study investigating the presence of kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Parkinson's disease according to the criteria of United Kingdom Brain Bank and diagnosed as Parkinson's disease by neurologist
* According to Hoehn-Yahr scale 1-3
* Mini-Mental Test score 24 and above

Exclusion Criteria:

* Another disease that will prevent walking
* Visual impairment and vestibular dysfunction
* Cognitive impairment

Primary outcomes:
measure: Tampa Kinesiophobia Scale (TSK)
timeFrame: 10 minutes
measure: Berg-Balance Test
timeFrame: 15-20 minutes
measure: Falls Efficacy Scale
timeFrame: 5-7 minutes
measure: International Physical Activity Questionnaire - Short form
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT01596946: Home-sampling in Partner Notification of Chlamydia
Official title: Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia
Keywords: contact tracing
home sampling
cluster randomisation
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Medical Research Council of Southeast Sweden
First posted: 2012-05-11
Enrollment: 633
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Though partner notification is mandatory to perform of Chlamydia trachomatis infected individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission. The investigators wanted to determine whether there was any difference in time between home-sampling and clinical testing as a tool of partner notification measured from eliciting of partners to date of testing.


Eligibility criteria: Inclusion Criteria:

* Sexual Partners to chlamydia infected index patients accepting to participate in the study.

Exclusion Criteria:

Index patients not living in Sweden or not speaking Swedish.

* MSM.
* Sexual partners living in another county or abroad.

Primary outcomes:
measure: Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners
timeFrame: 60 days or more were defined as an exclusion criterion
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: R&D department of Local Health Care
Study officials:
affiliation: Östergötland CC
name: Lars Falk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083446: A Nutritional Approach to Minimal Hepatic Encephalopathy
Official title: A Nutritional Approach to Minimal Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimal Hepatic Encephalopathy
Keywords: Encephalopathy
Cirrhotics
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* All consented adults (age \> 18), with the diagnosis of CHILD A cirrhosis with MELD score of \< 10.
* Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score \> 12 kpa) and / or fibrotest (score \> 0.74) and /or imaging.

Exclusion Criteria:

* History of \> grade II hepatic encephalopathy (HE).
* Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
* Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
* Current use of lactulose or neomycin.
* Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nachum Vaisman, Prof'
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaisman N, Katzman H, Carmiel-Haggai M, Lusthaus M, Niv E. Breakfast improves cognitive function in cirrhotic patients with cognitive impairment. Am J Clin Nutr. 2010 Jul;92(1):137-40. doi: 10.3945/ajcn.2010.29211. Epub 2010 May 5.
Clinical trial NCT05339646: A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
Official title: A Phase I, Single and Multiple Dose, to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 and SSD8432 Co-administrated in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects

Detailed description: 108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study.

This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Eligibility criteria: Inclusion Criteria:

* Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.

Exclusion Criteria:

* History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study.
* Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
* History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
* Take special diet and cannot abide by the provided food and corresponding requirements in this study.
* Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.

Primary outcomes:
measure: The Adverse events of SSD8432(Part A~D)
timeFrame: From signing ICF up to day 26
measure: PK parameters(Part E)
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: PK parameters(Part A~D)
timeFrame: Day 1 to Day 4
measure: The Adverse events of SSD8432(Part E)
timeFrame: From signing ICF up to day 26
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Jiangsu Simcere Pharmaceutical Co., Ltd.
name: Yumei Yang
role: STUDY_DIRECTOR
References: