louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00065884: Valproate Response in Aggressive Autistic Adolescents
Official title: Valproate Response in Aggressive Autistic Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Autism
Keywords: Adolescents
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will examine the effect of valproate, a medication used to treat seizures and bipolar disorder, on aggressive behavior in children and adolescents with autism.

Detailed description: Autism is a complex biological disorder that generally lasts throughout a person's life. It starts before age three and causes delays or problems with many different ways in which a person develops or grows. Some people with autism become very aggressive and can hurt others or themselves. This study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcg/ml than to placebo. The study will also assess the safety of valproate in autistic adolescents. This represents the first double-blind study of valproate in mentally retarded/developmentally delayed populations.

Participants in this study will undergo DSM-IV evaluation, the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule, and baseline blood tests. After baseline screening, all participants will be given a placebo for 1 week. Participants will then be randomized to receive either valproate or placebo for 8 weeks. Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind. The Aberrant Behavior Check-list-Community (ABC-C) irritability subscale will be the primary measure; the Overt Aggression Scale (OAS), ABC-C hyperactivity subscale, Clinical Global Impressions (CGI) problem severity, Self-Injurious Behavior Questionnaire (SIB-Q), and a valproate side effects checklist will be secondary measures.

Eligibility criteria: Inclusion Criteria

* Autism
* Lives in the Kansas City area

Exclusion Criteria

* Psychoactive maintenance medication
* Degenerative central nervous system disorder
* Unstable medical illness
* Seizures in the 6 months prior to study entry
* History of valproate sensitivity or previous liver disease
* History of ovarian cysts
* Low platelet count or raised liver transaminases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Outpatient MR/Autism Clinic, University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Jessica A. Hellings, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884584: Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
Official title: Assessment of Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The surgeon may remove a very small amount of additional tissue compared to what would be removed if you were not enrolled in the study. This tissue may prove to contain tumor or it may contain normal tissue. The surgical cavity will be examined by a special laser pen after the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells where the ICG dye collected are still remaining and the surgeon would then remove those. After the tumor and the tissue around it are removed and sent to the laboratory, the tissue may be examined using that same laser pen to see where the cancer cells are and compare that to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is hoped that what the dye shows and what is seen with the microscope will be alike.

Detailed description: PRIMARY OBJECTIVES:

I. To validate the use of intraoperative indocyanine green (ICG) for better definition of tumor margins therefore, minimizing the necessity of a second surgical procedure to obtain negative margins.

OUTLINE:

Patients receive indocyanine green solution intravenously (IV) between 2-8 hours before surgery. Fluorescence measurements are taken from all specimens removed during surgery.

After completion of study, patients are followed up at 48 hours.

Eligibility criteria: Inclusion Criteria: Patients with a tumor that will be treated surgically.

Exclusion Criteria:

* Patients with a known history of reaction to iodine or iodine-containing compounds.
* Pregnant women. Any patients found to be pregnant will be excluded from the study.

Primary outcomes:
measure: The contrast ratio (CR, defined as the integrated fluorescence intensity measured in a known tumor area divided by the integrated fluorescence intensity of a known "not tumor" area)
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University-Winship Cancer Institute
name: David Kooby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149784: Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
Official title: Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer Metastatic
Keywords: Metastasis colorectal cancer
Chemotherapy
Resection of primary tumor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 480
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: There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years old
* both genders
* ECOG:0-2 score
* Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge
* CT,MRI,or PET-CT confirmed metastasis
* MDT confirmed unresectable metastasis lesion
* No evidence of obstruction, bleeding, perforation
* WBC≥4.0×109/L，Neu ≥2.0×109/L，PLT≥100×109/L
* No contraindication for chemotherapy
* No evidence of other malignant tumor
* Expected survival time \> 6 months

Exclusion Criteria:

* mCRC patients who did not respond to first line chemotherapy
* Require surgical intervention during the primary tumor-related symptoms
* Obvious coagulopathy
* Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia
* Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
* Pregnant or lactating women or women of childbearing age who refuse to accept contraception.
* Nearly three months participated in clinical trials of other persons.
* Mental abnormalities

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants with Adverse Events both in surgery group and chemotherapy group
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Gong Chen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Zhi-zhong Pan, Prof.
role: STUDY_CHAIR
affiliation: Sun Yat-sen University
name: De-Sen Wan, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00130702: Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Official title: A Phase II Study of Iressa (Gefitinib), in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelogenous Leukemia, Acute
Keywords: AML
acute myelogenous leukemia
gefitinib
Iressa
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Boston Children's Hospital
First posted: 2005-08-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

Detailed description: Patients will receive Iressa daily until either disease progression or intolerable toxicity develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once weekly for the first 8 weeks, a physical exam and complete blood count with differential will be performed.

For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year. After the first year a physical exam, bloodwork will be performed every 3 months and bone marrow biopsies every 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients must have pathologically documented acute myelogenous leukemia and either not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease; or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 30 days.
* ECOG performance status 0, 1 or 2
* Age \> 18 years
* Adequate kidney and hepatic function
* Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea.
* Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion.

Exclusion Criteria:

* Uncontrolled active infection
* Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy
* Current chemotherapy or chemotherapy within the last 4 weeks.
* Pregnancy or nursing mothers
* Infection with HIV

Primary outcomes:
measure: To determine the response rate of Iressa in patients with acute myelogenous leukemia
Secondary outcomes:
measure: To determine the safety of Iressa in patients with acute myelogenous leukemia
timeFrame: 2 years
measure: to determine the biologic activity of Iressa in patients with acute myelogenous leukemia
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Daniel J DeAngelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850702: Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine
Official title: Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Lung Neoplasms
Keywords: Double-lumen Endotracheal Intubation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.

The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.

Participants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.

Researchers will compare saline group to see if saline effects


Eligibility criteria: Inclusion Criteria:

1. aged 18-65 years, American Society of Anesthesiologists class I-II
2. participants undergoing double-lumen endotracheal intubation under general anesthesia
3. signed informed consent and volunteered to participate in the experiment

Exclusion Criteria:

1. Poor control of hypertension
2. preoperative arrhythmia
3. severe coronary artery or heart valve disease
4. sequelae of cerebrovascular accident
5. severe lung, liver, kidney and immune system diseases
6. Suspected difficult airway
7. confirmed or suspected allergy to this trial drug
8. As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)

Primary outcomes:
measure: mean arterial pressure after intubation
timeFrame: Immediately after intubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02798302: Bag Valve Mask vs Non-rebreather at Flush Rate
Official title: Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).


Eligibility criteria: Inclusion Criteria:

* Age \>17

Exclusion Criteria:

* Pregnant
* Any facial hair more than stubble that might impede a mask seal

Primary outcomes:
measure: Fraction of expired oxygen
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02271802: Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids
Official title: Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SCFA Metabolism
Keywords: Butyrate
Interorgan metabolism
Short-chain fatty acids
Gut production
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2014-10-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this placebo-controlled randomized parallel study the effects of a butyrate enema on plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera, liver and the splanchnic area are investigated

Detailed description: Patients undergoing upper abdominal surgery are included. During surgery they receive a butyrate enema or placebo enema. Before and after rectal administration, plasma samples are taken from several veins and arteries to analyse SCFA concentrations and fluxes from portal drained viscera, liver and the splanchnic area.

Eligibility criteria: Inclusion Criteria:

* patients undergoing open liver resection or pancreaticoduodenectomy

Exclusion Criteria:

* known parenchymal liver disease
* presence of ileostomy or colostomy
* patients with inflammatory bowel disease
* antibiotics, prebiotics or probiotics 2 months prior to surgery

Primary outcomes:
measure: Plasma SCFAs
timeFrame: 0, 5, 15, 30 min after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University Medical Center
name: CHC Dejong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Beek CM, Bloemen JG, van den Broek MA, Lenaerts K, Venema K, Buurman WA, Dejong CH. Hepatic Uptake of Rectally Administered Butyrate Prevents an Increase in Systemic Butyrate Concentrations in Humans. J Nutr. 2015 Sep;145(9):2019-24. doi: 10.3945/jn.115.211193. Epub 2015 Jul 8.
Clinical trial NCT04888702: Holter of Movement in Patients with SMA Undergoing Treatment.
Official title: Holter of Movement in Patients with Type 2 or 3 Spinal Muscular Atrophy When Initiating Treatment with Spinraza ° or Risdiplam. Acti-SMA Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Muscular Atrophy
Keywords: Actimyo
Accelerometry
Motor neuron disease
Risdiplam
Nusinersen
Home monitoring
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
name: Erasme University Hospital
name: Queen Fabiola Children's University Hospital
name: Centre Hospitalier Régional de la Citadelle
First posted: 2021-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their improvement under treatment.
Primary purpose: OTHER

Brief summary: Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed spinal muscular atrophy.
* Treatment by Spinraza ° or by risdiplam planned.
* Over 6 years old.
* Signed informed consent.

Exclusion Criteria:

- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.

Primary outcomes:
measure: 95th centile of stride velocity
timeFrame: 39 months
measure: 50th centile of stride velocity
timeFrame: 39 months
measure: 95th centile of stride length
timeFrame: 39 months
measure: 50th centile of stride length
timeFrame: 39 months
measure: Upper limb function evolution in patient with SMA undergoing treatment
timeFrame: 39 months
Secondary outcomes:
measure: 6-minute walk test
timeFrame: 39 months
measure: Dynamometric measures
timeFrame: 39 months
measure: 10-metre walk test
timeFrame: 39 months
measure: rise from floor
timeFrame: 39 months
measure: 4-stair climb
timeFrame: 39 months
measure: revised upper limb module (RULM)
timeFrame: 39 months
measure: Hamersmith funcitonnal motor scale (HFMS)
timeFrame: 39 months
measure: motor function measure (MFM)
timeFrame: 39 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme Hospital - Cliniques universitaires de Bruxelles
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Bucharest
country: Romania
facility: National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"
Study officials:
affiliation: CHR Citadelle-CHU liège
name: Margaux Poleur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04579302: Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia
Official title: Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Keywords: Serratus anterior block
Erector spinae block
Postoperative analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

Detailed description: 90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.

Eligibility criteria: Inclusion Criteria:

* Patients with class II physical status (American Society of Anaesthesiologists) ,
* Age between 18-70 years,
* Scheduled for thoracic cancer surgery

Exclusion Criteria:

* Patient refusal.
* Local infection at the site of the block.
* Cardiac dysfunction (ejection fraction \<45%).
* Significant respiratory disorders.
* Preexisting neurological or psychiatric disease.
* Allergy to one of the study drugs.
* Pregnancy.
* Coagulopathy

Primary outcomes:
measure: total morphine consumption in first postoperative 24 hours
timeFrame: first 24 postoperative hours
Secondary outcomes:
measure: intraoperative fentanyl requirement
timeFrame: during anaesthesia
measure: numerical rating scale
timeFrame: the first 24 postoperative hours
measure: pulmonary functions
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute - Vairo University - Egypt
name: Mohamed E Hassan, MS
role: PRINCIPAL_INVESTIGATOR
References: