louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02718859: Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
Official title: Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: advanced pancreatic cancer
nature killer cell
irreversible electroporation
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.

Detailed description: By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer.

The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS).

The safety will be evaluated by statistics of adverse reaction

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Diagnosis：advanced and active pancreatic cancer
3. The tumour is measurable
4. Eastern Cooperative Oncology Group(ECOG) score：0\~2；3 but has no relationship with tumour
5. Vital organ function is normal:

   total bilirubin(TB) \<68μmol/L aspartate aminotransferase(AST)\<90 IU/L Cre\<353μmol/L white blood cell count(WBC)\<9×10\^9/L,when WBC is close to or even greater than 9×10\^9/L，the recommended dose should be halved platelet count(PLT)\>80×10\^9/L Red blood cell specific volume(HCT)\>0.20 Non severe viral or bacterial infection
6. Non pregnant and lactating patients
7. Non allergic reactions to biological products
8. Informed and consent

Exclusion Criteria:

1. Patients with cardiac pacemaker
2. Patients with severe cardiac and pulmonary dysfunction
3. Patients that the researchers do not think fit into the group,including patients failed in compliance assessment

Primary outcomes:
measure: Relief degree
timeFrame: 1 year
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05096559: Evaluation of Sublingual Microcirculation in Burn During Resuscitation
Official title: The Evaluation of Sublingual Microcirculation To Guide Fluid Resuscitation In Patients With Burn: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burn Shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with burns greater than 20% TBSA admitted to ICU within the 1st 6 hours post-burn

Brief summary: The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation.

Microcirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years old
* Burn \>20% TBSA
* Patients with burn admitted within the 1st 6 hours

Exclusion Criteria:

* Age \< 18 years old.
* Pregnant patients.
* Patients with severe renal insufficiency.
* Patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock
* Patients with airway edema that preclude the measurement of sublingual microcirculation

Primary outcomes:
measure: • Lactate level
timeFrame: 24 hours
Secondary outcomes:
measure: total vessel density
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy hospitals
Study officials:
References:
Clinical trial NCT02280759: Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Official title: Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Gastroenteritis
Keywords: diarrhea, gelatin tannate, acute gastroenteritis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 72
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.


Eligibility criteria: Inclusion Criteria:

* children \< 5 years old
* diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \> 1 day but \< 5 days
* inform consent sign

Exclusion Criteria:

* regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
* underlying gastrointestinal tract disorder presenting with diarrhea
* breastfeeding \>50%
* malnutrition (weight/high \<3pc)

Primary outcomes:
measure: Duration of diarrhea
timeFrame: 7 days
Secondary outcomes:
measure: Need of intravenous rehydration due to diarrhea
timeFrame: 7 days
measure: Need of hospitalization in outpatients
timeFrame: 7 days
measure: Vomiting
timeFrame: How many times for 7days
measure: Weight gain
timeFrame: 7 days
measure: Diarrhea recurrence
timeFrame: 7 days
measure: Frequency of watery stools
timeFrame: 7 days
measure: Adverse effects
timeFrame: 7 days
measure: Severity of diarrhea due to modified Vesikari score
timeFrame: 7 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw, Poland
Study officials:
affiliation: Medical University of Warsaw
name: Hanna Szajewska, Profesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
citation: Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530.
Clinical trial NCT01342159: Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
Official title: Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: bevacizumab, diabetic macular edema, triamcinolone
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects

Detailed description: Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema

Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )

Exclusion Criteria:

* history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
* an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
* systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
* major surgery within the prior 6 months or planned within the next 28 days

Primary outcomes:
measure: Visual acuity
timeFrame: baseline, 1 month, 3 months, 6month, 9 month, 12 month
Secondary outcomes:
measure: Central macular thickness
timeFrame: baseline, 1 month, 3 months, 6 months, 12months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: JiWon Lim
Study officials:
References:
Clinical trial NCT02592759: Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
Official title: Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2015-10-30
Enrollment: 23
Sex: ALL
Minimum age (years): 19
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 evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.

Detailed description: This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
* 72 hours \~ 3 months after stroke
* Upper extremity hemiplegia with Brunnström stage 2-5.
* The patients can sit to receive treatment for at least 1 hour

Exclusion Criteria:

* The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
* Contracture due to severe limitation of motion
* Upper extremity spasticity in the wrist and fingers with modified Ashworth scale \> 2 points
* Fugl-Meyer Assessment-Wrist \& Hand score \>= 21 points
* moderate to severe cognitive dysfunction \< MMSE 18 points
* Severe aphasia
* The patients who has been diagnosed as malignant tumor

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity change
timeFrame: Change from baseline points at 2 weeks and 6 weeks
Secondary outcomes:
measure: Brunnström stage change
timeFrame: Change from baseline stage at 2 weeks and 6 weeks
measure: Modified Barthel Index change
timeFrame: Change from baseline points at 2 weeks and 6 weeks
measure: Care Burden Scale change
timeFrame: Change from baseline points at 2 weeks and 6 weeks
measure: Hand power change
timeFrame: Change from baseline power at 2 weeks and 6 weeks
measure: Jebsen Hand function Test change
timeFrame: Change from baseline points at 2 weeks and 6 weeks
measure: Box and Block Test change
timeFrame: Change from baseline points at 2 weeks and 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Shi-Uk Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang MG, Yun SJ, Lee SY, Oh BM, Lee HH, Lee SU, Seo HG. Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial. Front Neurol. 2020 Nov 9;11:580393. doi: 10.3389/fneur.2020.580393. eCollection 2020.
Clinical trial NCT04434859: Temporomandibular Disorders Among Patients With Tinnitus
Official title: Incidence of Temporomandibular Disorders Among Patients With Tinnitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tinnitus
Temporomandibular Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tinnitus lasting more than 3 months

Brief summary: The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination.

Detailed description: The patients with tinnituswill be asked about symptoms related to temporomandibular disorders, and also will be examined in order to diagnose such disorders.

Eligibility criteria: Inclusion Criteria:

* Tinnitus lasting more than 3 months

Exclusion Criteria:

* Head and Neck Space Occupying Lesion
* Previous degenerative disease of the temporomandibular koint

Primary outcomes:
measure: Description of temporomandibular disorders in the patient's history
timeFrame: 1 year
measure: Positive findings in the physical examination of the temporomandibular joint and muscles
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01352559: Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype
Official title: Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients
biomarkers
phenotype
Antidepressant Response
Adverse Reaction to Drug
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration.

Detailed description: The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.

Eligibility criteria: Inclusion Criteria:

1. eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: Antidepressant Response at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Biological value at 0 and 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01193959: Pemetrexed in Advanced Non-small Cell Lung Cancer
Official title: Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients treated with single agent pemetrexed

Brief summary: Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution
* Patients treated with single agent pemetrexed for metastatic disease
* Availability of full clinical data

Exclusion Criteria:

* Cytological diagnosis of advanced Non-small cell lung cancer
* Lack of tumor tissue at our institution
* Lack of full clinical data

Primary outcomes:
measure: Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.
timeFrame: one year
Secondary outcomes:
measure: Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy.
timeFrame: one year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando SANTORO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580459: CARE Mentalizing-Focused Parenting Group Outcomes Study
Official title: Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relationship
Parenting
Keywords: Attachment
Parenting
Parent-Child Relationship
Caregivers
Parents
Child Mental Health
Child Development
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: The FAR Fund
First posted: 2020-10-08
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a treatment as usual (TAU) group in an outpatient child mental health clinic.


Eligibility criteria: Inclusion Criteria:

* Parents/caregivers of child receiving mental health services at community child outpatient clinic
* English- or Spanish-speaking

Exclusion Criteria:

* Parent has severe mental illness or significant cognitive impairment
* Child has significant developmental delay

Primary outcomes:
measure: Change in parental reflective functioning
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in parenting stress
timeFrame: Baseline to post-intervention (12 weeks)
Secondary outcomes:
measure: Change in parent psychiatric distress
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in child social-emotional impairment
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in family functioning
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in parent emotion regulation
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in parent perceptions of social support
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in parent perceptions of belongingness
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in parent-child relationship
timeFrame: Baseline to post-intervention (12 weeks)
measure: Change in reported exposure to adverse childhood experiences (ACEs)
timeFrame: Baseline and post-intervention (12 weeks)
measure: Change in parent experiences of racism and discrimination
timeFrame: Baseline and post-intervention (12 weeks)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Amanda Zayde, PsyD
role: PRINCIPAL_INVESTIGATOR
References: