louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04214717: Study of DC-CIK Combined With Chemotherapy for Advanced Solid Tumor
Official title: Study of Dendritic Cell-activated Cytokine-induced Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Detailed description: Patients in group A will receive 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of DC-CIK with chemotherapy in patients with treatment-refractory solid tumors.

Eligibility criteria: Inclusion Criteria:

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. Estimate survival \> 3 months;
5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)

Primary outcomes:
measure: Disease Control Rates (DCR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
affiliation: Yantai Yuhuangding Hospital
name: Peiwen Lian, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03390517: A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
Official title: A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Sigmoid Cancer
Keywords: fluorescence angiography
indocyanine green
anastomotic leakage
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-01-04
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.

Detailed description: The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.

Eligibility criteria: Inclusion Criteria:

* Have a planned circular stapled colorectal anastomosis
* Have signed an approved informed consent form for the study

Exclusion Criteria:

* Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.

Primary outcomes:
measure: Anastomotic Leak Rate
timeFrame: 0 to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT02964117: Associations Between Air Pollutants Exposures and Respiratory System Study
Official title: Associations Between Air Pollutants Exposures and Respiratory System Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2016-11-15
Enrollment: 106
Sex: ALL
Minimum age (years): 23
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects including health volunteers and COPD patients,both of them without severe cardiopulmonary diseases and long-term residents in Beijing

Brief summary: Epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. However, the potential mechanisms of adverse effects remains scare. The present study will assess the association between air pollutants and respiratory related parameters to elucidate possible mechanisms.


Eligibility criteria: Inclusion Criteria:

* Long-term residents, aged \>23 and \<82 years

Exclusion Criteria:

* Severe cardiopulmonary diseases, active inflammatory diseases, cancer

Primary outcomes:
measure: Lung Function indices were performed in peking university third hospital
timeFrame: Repeated-measure study was conducted from November,2014 to January,2016,lung function was measured by every four months
Secondary outcomes:
measure: Inflammation related biomarkers were measured by flow cytometry
timeFrame: Repeated-measure study was conducted from November,2014 to January,2016,biomarkers were measured by every four months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Bei He, MD/Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04336917: Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
Official title: Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer Surgery
Postoperative Analgesia
Keywords: Rhomboid intercostal and subserratus plane block
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study
Primary purpose: TREATMENT

Brief summary: Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. We aimed to investigate the efficacy of Rhomboid intercostal and subserratus plane block (RISS) for postoperative analgesia in patients undergoing breast cancer surgery.

Detailed description: This prospective randomized controlled trial will be carried out on female patients who scheduled for breast cancer surgery. Our hypotesis is that this new interfascial plane block technique will able to provide postoperative analgesia in breast cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 18-85 years and ASA physiological score I-III who undergone breast cancer surgery

Exclusion Criteria:

* Patients refused to participate.
* Patients with known or suspected allergy to the used medication.
* Patients with psychiatric-neurological disorders that may affect pain perception,
* Patients regularly taking antipsychotics and antidepressants.
* Patients with potential risk of coagulopathy.
* Uncooperative patients.

Primary outcomes:
measure: Postoperative opiod consumption
timeFrame: The first 24 hours postoperatively
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: The first 24 hours postoperatively
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Education and Training Hospital
Study officials:
affiliation: SBÜ Konya EAH
name: Betul Kozanhan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02620917: Continuos Subcutaneous Insulin Infusion in Italy
Official title: Survey on Continuos Subcutaneous Insulin Infusion in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
CSII
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 6623
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we will evaluate allItalian patients treated with insulin pump

Brief summary: This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.

Detailed description: The aim of the study is to collect clinical and metabolic characteristics of patient treated with CSII in Italy.

Data will be collected through a questionnaire sent by e-mail to CSII experienced Diabetes Centers ( both adult and pediatric patients) . The questionnaire assessed: (1) number of CSII-treated patients; (2) patients and pump characteristics; (3) structure and organization of Diabetes Centers providing CSII therapy; (4) metabolic control.

Eligibility criteria: Inclusion Criteria:

* all patients treated with CSIIin Italy

Exclusion Criteria:

* none

Primary outcomes:
measure: Efficacy Assessed by Median of HbA1c,
timeFrame: 1 year
measure: Patients With Severe Hypoglycemia
timeFrame: 1year
measure: Number of Patients With Glycated Hemoglobin on Target
timeFrame: 1 year
Secondary outcomes:
measure: Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting
timeFrame: 1 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
affiliation: University of Padova
name: Daniela Bruttomesso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepore G, Bonfanti R, Bozzetto L, Di Blasi V, Girelli A, Grassi G, Iafusco D, Laviola L, Rabbone I, Schiaffini R, Bruttomesso D; Italian Study Group on the Diffusion of CSII. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):335-342. doi: 10.1016/j.numecd.2017.12.001. Epub 2017 Dec 9.
Clinical trial NCT01856517: Upregulation of Alpha-1 Receptors Upon Septic Shock?
Official title: Up Regulation of Alpha-1 Receptors Upon Septic Shock ?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Septic Shock
Keywords: pressor response
chronotropic response
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).


Eligibility criteria: Inclusion Criteria:

* patients presenting to the CCU with septic shock : SBP\<90 mm Hg refractory to volume load (\>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for \>1 h (0.1 mcg.kg-1.h-1 i.e. \>0.5 mg.h-1/70 kg) to maintain mean BP\>65 mm Hg.
* criteria for sepsis :temperature\>38.5 or \<36°C ; WBC\>12 000 or \<4000/ml ; tachypnea (\>20 cycles par min) or mechanical ventilation ; tachycardia : \>90 bpmin
* written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"

Exclusion Criteria:

* age\<18 ans
* pregnancy
* mental illness making informed consent impossible
* Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
* individual without social security coverage or participating in another biomedical research
* Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
* HR\<70 bp/min
* pre-exitus

Primary outcomes:
measure: change in pressor response to exogenous noradrenaline
timeFrame: 0 and 24 h
Secondary outcomes:
measure: change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.
timeFrame: 0 and 24 h
Other outcomes:
Locations:
city: Lyon
country: France
facility: Critical Care Unit, Hopital Desgenettes
Study officials:
References:
Clinical trial NCT04450641: Piloting a Mobile Game for Behavioral Therapy
Official title: A Gamified Mobile Platform for Improving Social Communication in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: digital
mobile health
game
autism
technology
therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 186
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
Primary purpose: OTHER

Brief summary: The following study aims to understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. The app will walk participants through a variety of charades style games. The interactive games will be video recorded and all data are transferred securely to the Wall Lab for analysis. This study is enrolling parents of children with ASD who are at least 18 years of age and have a child between 3-12 years old. Parents are asked to complete questionnaires before and after playing the GuessWhat game with their child 3-4 times per week for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Parent who is at least 18 years old of child with autism.
* Child with autism is between 3 and 12 years old at time of baseline data collection.

Exclusion Criteria:

* Parent is not able to read or speak English
* Parent does not have an Android or iOs smartphone compatible with GuessWhat App

Primary outcomes:
measure: Change in parent reported social responsiveness from week 0 to week 4
timeFrame: Baseline (Week 0), Week 4
measure: Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
timeFrame: Baseline (Week 0), Week 4
Secondary outcomes:
measure: GuessWhat App Usage Data
timeFrame: 4 weeks
measure: Parent reported feedback
timeFrame: Week 4
measure: Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
timeFrame: Baseline (Week 0), Week 4
Other outcomes:
measure: Baseline Parent Reported Social Communication
timeFrame: Baseline (Week 0)
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Dennis P Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06167941: Identification of Integrin ab Expression in Lung Cancer Patients
Official title: Identification of Integrin ab Expression in Lung Cancer Patients for Clinical Application of Cancer-Target Fluorescent Contrast Agent for Image-Induced Precise Lung Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Expression of Integrin ανβ3 in Lung Cancer
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC (adenocarcinoma or squamous cell carcinoma) who had undergone surgical treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018

Brief summary: It has been reported that the expression rates of integrin αvβ3 and integrin αvβ5 in NSCLC are 89% and 100%, respectively. Among RGD (Arg-Gly-Asp) peptides, cRGDyK peptide (cRGD) known as integrin ανβ3 and ανβ5 antagonist has been widely used for targeting various cancers including NSCLC, glioblastoma, and colon carcinoma as well as prostate cancer. In this study, the investigators aim to analysis the expression of integrin ανβ3 in lung cancer patients.

Detailed description: Patient samples: From the Human Resource Bank of the Institute of Pathology, Korea University, the investigators collected paraffin-embedded tissue sections from 61 patients with NSCLC (adenocarcinoma =50, squamous cell carcinoma = 11) who had undergone surgical treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018 under the IRB of Guro Hospital 2019GR0460. Samples were excluded when patients had undergone perioperative chemo- or radiotherapy. Among the tissues excised from lung cancer patients, lung cancer and normal tissue were classified as pathologically, defined as normal tissue and cancer tissue, and stained with an integrin ανβ3 primary antibody.

Eligibility criteria: Inclusion Criteria:

* NSCLC (adenocarcinoma or squamous cell carcinoma) who had undergone surgical treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018

Exclusion Criteria:

* patients had undergone perioperative chemo- or radiotherapy

Primary outcomes:
measure: integrin expression level
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Thoracic and Cardiovascular Surgery, Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hyun Koo Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT01212341: Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor
Official title: A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Lymphomas
Solid Tumors
Keywords: Allogenetic NK cells
Lymphomas
Solid tumors
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GC Biopharma Corp
First posted: 2010-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Histologically or cytologically confirmed malignant lymphoma or solid tumor
* After the failure of standard treatment
* KPS \>70 or ECOG PS 0-2
* Adequate bone marrow, renal, and liver functions
* Expected survival at least 3 months
* Informed consent

Exclusion Criteria:

* Pregnancy or lactating woman
* HIV patients
* Prior exposure to cell-based therapy
* Hypersensitivity to interleukin-2
* Patients with autoimmune disease

Primary outcomes:
measure: To determine the MTD of allogenetic NK cells
timeFrame: 4-5 weeks
Secondary outcomes:
measure: To determine the overall response rate
timeFrame: 4-5 weeks
measure: To evaluate the safety
timeFrame: 4 -5 weeks
measure: To evaluate the pharmacokinetics of allogeneic NK cells
timeFrame: 4-5 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: