louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04750967: Amitriptyline vs GON and SON Blocks in Migraine
Official title: Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Keywords: greater occipital nerve
supraorbital nerve
nerve blocks
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-11
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of efficacy and safety of amitriptyline and nerve blocks

Detailed description: This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Eligibility criteria: Inclusion Criteria:

* Diagnosed with migraine according to ICHD-3

Exclusion Criteria:

* Being over 50 years or under 18 years
* Malignancy and other systemic diseases

Primary outcomes:
measure: Number of Participants with 50% Reduction of Headache Frequency
timeFrame: 6 months
Secondary outcomes:
measure: Side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cem Bölük
state: Fatih
Study officials:
References:
Clinical trial NCT04276467: Development of the ICF Based Amputee Mobility Scale
Official title: Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lower Limb Amputee

Brief summary: Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.


Eligibility criteria: Inclusion Criteria:

* Unilateral and traumatic lower limb loss
* Prosthesis use for at least 6 months

Exclusion Criteria:

* Not speaking or understanding Turkish
* Not having cognitive skills to perform the tests

Primary outcomes:
measure: 2 Minute Walk Test
timeFrame: 3 March 2021
measure: Amputee Mobility Predictor
timeFrame: 3 March 2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03603067: The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery
Official title: A Prospective, Non-randomized, Controlled Study: To Evaluate the Psychological Status of Monophthalmic Patients Before and After Ocular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychology, Social
Surgery
Keywords: monophthalmos
social psychology
ocular surgery
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Shanghai Aier Eye Hospital and are intended to receive ocular surgery in one of two eyes.

Brief summary: This study is designed to evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision.

Detailed description: Monophthalmos means the best corrected visual acuity (BCVA) of the worse eye is less than 0.05 or the central visual field (CFOV) is less than 5°. The ocular surgery of the better eye in monophthalmic patients is of high risk. On the one hand the surgical failure will result in the patient falling into permanent darkness. On the other hand the monophthalmic patient may have the same disease in both two eyes such as high axial myopia, uveitis and glaucoma, which will increase the surgical risk. There is still no consensus on whether it is necessary to take risks to perform this kind of operation. In this study we will evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision. The necessity of the ocular surgery in monophthalmic patients will be evaluated from the point of social psychology.

Eligibility criteria: Inclusion Criteria:

* Intention to receive ocular surgery in one of two eyes.
* Free from prior mental disorders.
* Without general disease and can tolerate the operation.
* Communication without difficulty.

Exclusion Criteria:

* With prior mental disorders.
* Can not tolerate the operation.
* Communication with difficulty.

Primary outcomes:
measure: Level of anxiety
timeFrame: Change from Baseline HAMA score at 6 months.
measure: Level of depression
timeFrame: Change from Baseline HAMD score at 6 months.
Secondary outcomes:
measure: Level of social support
timeFrame: Change from Baseline SSRS score at 6 months.
Other outcomes:
measure: Visual function
timeFrame: One day before surgery and one day, one months, three months and six months after surgery.
Locations:
city: Shanghai
country: China
facility: Shanghai Aier Eye Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Aier Eye Hospital
name: Wensheng Li
role: STUDY_DIRECTOR
References:
citation: Hirneiss C, Neubauer AS, Herold TR, Kampik A, Hintschich C. Utility values in patients with acquired anophthalmus. Orbit. 2009;28(6):332-6. doi: 10.3109/01676830903104702.
Clinical trial NCT01870167: Antibiotic Prophylaxis for PEG in Children
Official title: Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection
Keywords: PEG
Percutaneous Endoscopic Gastrostomy
antibiotic prophylaxis
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Detailed description: Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.

Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.

Local infection is the most common complication following PEG.

Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.

The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Eligibility criteria: Inclusion Criteria:

* All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit

Exclusion Criteria:

* Controindications for PEG
* Ongoing antibiotic treatment
* Antibiotic use within the past 4 days
* Illness too severe to allow the patient to participate
* Allergy to penicillin

Primary outcomes:
measure: Efficacy
timeFrame: 24 hours after PEG insertion
measure: Efficacy
timeFrame: 14 days after PEG insertion
Secondary outcomes:
measure: Efficacy
timeFrame: 24 hours after PEG insertion
measure: Efficacy
timeFrame: 14 days after PEG insertion
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Pediatrics
Study officials:
References:
Clinical trial NCT00788567: CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants
Official title: A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 136
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 study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* recipients of a primary kidney transplant.

Exclusion Criteria:

* positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
* positive for hepatitis C virus, with moderate or severe liver disease;
* active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
* need for maintenance corticosteroids for another condition.

Primary outcomes:
measure: Proportion of patients achieving therapeutic window by Day 5\n
Secondary outcomes:
measure: Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24.
Clinical trial NCT03618667: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification
Official title: A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma, Adult
EGFR Amplification
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

Detailed description: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Eligibility criteria: Inclusion Criteria:

1. written informed consent
2. 19 years or older
3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
4. high EGFR amplification
5. available archive tumor sample(s)
6. Karnofsky performance status (KPS) \> 70
7. life expectancy \> 3 months
8. adequate end-organ function
9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)

Exclusion Criteria:

1. patients who had EGFR target agent(s) before screening
2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (\> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
4. patients who had investigation drug(s) within previous 4 weeks
5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
6. patients who had severe infection within previous 4 weeks
7. HIV infection
8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
10. pregnancy or breast-feeding

Primary outcomes:
measure: Progression-free survival
timeFrame: at 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months, 12 month
measure: overall response rate
timeFrame: up to 30months
measure: Exploration of predictive/prognostic biomarkers
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: sehoon lee, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03365167: Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
Official title: Clinical Evaluation of the Effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis( Randomized Clinical Trial Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Laser
Keywords: LANAP
Periodontitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth

Detailed description: this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.

Eligibility criteria: Inclusion Criteria:

* definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side

Exclusion Criteria:

* pregnant smoker systemic disease breast feeding

Primary outcomes:
measure: change of periodontal pocket depth
timeFrame: 0,1,2,3,4,5,6 months
Secondary outcomes:
measure: change of Bleeding on Probing
timeFrame: 0,1,2,3,4,5,6 month
measure: change of Full Mouth Bleeding Score
timeFrame: 0,1,2,3,4,5,6 month
measure: change of Clinical attachment loss
timeFrame: 0,1,2,3,4,5,6 month
measure: change of Full Mouth Plaque Score
timeFrame: 0,1,2,3,4,5,6 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Neda Moslemi
Study officials:
References:
citation: Dortaj D, Bassir SH, Hakimiha N, Hong H, Aslroosta H, Fekrazad R, Moslemi N. Efficacy of Nd:YAG laser-assisted periodontal therapy for the management of periodontitis: A double-blind split-mouth randomized controlled clinical trial. J Periodontol. 2022 May;93(5):662-672. doi: 10.1002/JPER.21-0242. Epub 2021 Sep 12.
Clinical trial NCT01148667: Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
Official title: Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gut Microbiota
Skin Microbiota
Humoral Immune Responses
Severity of Atopic Dermatitis
Keywords: atopic dermatitis
barrier function
gut
probiotics
skin
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Academy of Finland
name: Mead Johnson Nutrition
First posted: 2010-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.

Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.

Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of atopic dermatitis
* age 4 we - 18 mo

Exclusion Criteria:

* skin infection or severe infection at the time of enrollment

Primary outcomes:
measure: severity of atopic dermatitis
timeFrame: March 2007 - July 2008
Secondary outcomes:
measure: Maturation of humoral immune responses
timeFrame: March 2007 - July 2008
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
References:
citation: Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.
Clinical trial NCT04585867: Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy
Official title: Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain Management
Sternotomy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 80
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: Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.


Eligibility criteria: Inclusion Criteria:

* Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy.

Exclusion Criteria:

* Urgent and emergency procedures,
* preexisting sternal infections,
* prior sternotomy,
* preexisting pain syndromes,
* current chronic home opioid use,
* anterior rib or sternal masses,
* allergy to any of the components of liposomal bupivacaine and plain bupivacaine.

Primary outcomes:
measure: Opioid consumption in morphine equivalents
timeFrame: 0 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 12 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 24 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 36 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 48 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 60 hours post-surgery
measure: Opioid consumption in morphine equivalents
timeFrame: 72 hours post-surgery
Secondary outcomes:
measure: Time to extubation in minutes will be retrieved via the electronic medical record
timeFrame: 30 days post operative
measure: Presence of sternal wound infection
timeFrame: 4-6 weeks postoperative visit
measure: Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jared Staab, DO
role: PRINCIPAL_INVESTIGATOR
References: