louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02323022: Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)
Official title: IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed acute myeloid leukemia (AML) patients. The main question it aims to answer is:

•Does IAC regimen higher the complete remission rate in initial diagnosed AML patients? Researchers will compare IAC regimen to IA regimen to see if IAC works to treat AML.

Participants will:

* Receive IAC or IA as induction regimen
* Receive a second cycle of re-induction if partial remission
* Visit the clinic once every 3 to 6 months for assessment


Eligibility criteria: Inclusion Criteria:

* Initially diagnosed as AML (except APL)
* Aged between 18 and 60 year old
* Eastern Cooperative Oncology Group (ECOG) score no more than 3
* Informed consent file (ICF) signed

Exclusion Criteria:

* AML secondary to chronic leukemia and myeloproliferative neoplasms (MPNs)
* With other underlying malignancies
* Severe and uncontrolled infection
* Intolerant to the chemotherapy

Primary outcomes:
measure: Complete Remission Rate
timeFrame: 1-2 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Disease-Free Survival
timeFrame: 2 years
measure: Cumulative Incidence of Relapse (CIR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191722: "Medikidz Explain JIA Comic Book- Hebrew"
Official title: Evaluating the Efficacy of a Comic Book as an Educating Tool for Children With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: We believe, that the results of this study will show that children learn from the comic book about their disease, and are now more aware and less frightened about it, and increase their compliance.

Detailed description: We believe, that the results of this study will show that children learn from the comic book about their disease, and are now more aware and less frightened about it, and increase their compliance. If so, it may promote the use of comic books or other fun educational tool in teaching children various other diseases.

Eligibility criteria: Inclusion Criteria:

Children with JIA aged 10-18 after parents signed ICF

Exclusion Criteria:

Parents that do not wanf their children to participate in the study.

Primary outcomes:
measure: 30% or more improvement in a knowledge questionnaire (before and after reading the comics booklet)
timeFrame: 2 Years
Secondary outcomes:
measure: 10% or higher score in CHQ questionnaire (after reading the comics booklet)
timeFrame: 2 Years
measure: better compliance ( >1 score improvement in 1-5 scale score, as evaluated by the physician after reading the comics booklet).
timeFrame: 2 years
Other outcomes:
Locations:
city: Petah-Tikva, 14 Kaplan s.
country: Israel
facility: SCMCI
Study officials:
affiliation: Schneider Children Medical Center of Israel
name: Gil Amarilyo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hampton T. Media lab uses videos, comics, and more to help people understand health issues. JAMA. 2012 Apr 25;307(16):1679-80. doi: 10.1001/jama.2012.507. No abstract available.
Clinical trial NCT00399022: Treatment With Duloxetine for OCD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: OCD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-11-14
Enrollment: 40
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: TREATMENT

Brief summary: Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI


Eligibility criteria: Inclusion Criteria:

* OCD as main diagnosis according to DSM-IV
* Age 18 to 65
* Men and women
* YBOCS score is 18 or more, or 12 or more in case of only obsessions

Exclusion Criteria:

* Patients treated with Duloxetine, currently or in the past
* Patients having comorbid schizophrenia or psychotic disorder or bipolar disorder Patients with substance abuse disorder in the last 6 months Patients who were suicidal or did serious suicide attempt in the last year Pregnant or lactating women, or woman of childbearing potential, which is not using adequate contraception Patients with neurologic disturbance or disorder Patients with serious or imbalanced medical condition Patients with allergic response to SSRI or duloxetine Patients who started new treatment (CBT or pharmacology) in less than 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05240339: Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)
Official title: Characterization and Progression of Minor Phenomena in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Parkinson Disease Psychosis
Hallucinations
Delusion
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: ACADIA Pharmaceuticals Inc.
First posted: 2022-02-15
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must meet criteria for clinically probable PD according to the MDS clinical diagnostic criteria for PD. Notably, in these new criteria, PD and dementia with Lewy bodies are recognized as most likely existing on a continuous spectrum and dementia is not an exclusion criterion for PD.

Brief summary: Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to:

1) To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease)
* Parkinson's disease minor phenomena
* ≥30 years of age
* Proficient in English
* Willing and able to provide informed consent

Exclusion Criteria:

* Any current or prior history of formed hallucinations or delusions
* Current or prior treatment with an antipsychotic medication (regardless of indication)
* Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder
* Unable or unwilling to complete study activities
* Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation

Primary outcomes:
measure: Cumulative probability of developing hallucinations or delusions over time
timeFrame: baseline to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00375622: Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Hemorrhagic Telangiectasia
Keywords: HHT
Epistaxis
Tamoxifen
Hemoglobin
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of cases. Good response to hormone treatment has been documented, although its use remains controversial. A double-blind placebo-controlled trial with estrogen treatment did not show any benefit over placebo. The aim of this study is to examine the efficacy of an antiestrogenic agent, TAMOXIFEN, in the treatment of HHT-associated epistaxis. The study will include up to 60 patients, over 18 years old.

Detailed description: Patients with HHT-related epistaxis who will attend our center will randomly be assigned to 6 months of treatment with either Tab. tamoxifen 20 mg once daily or placebo. The group will included both men and women over the age of 18 years.

A detailed medical history will be taken at presentation. All patients will be examined by an otolaryngologist before and during the trial to assess the nasal condition and telangiectases and blood clots in the airway, nasal and oral cavity, and body skin. Blood will be collected for blood count and measurement of clotting time and liver function at onset of the trial and once monthly during treatment. Patients will be requested to complete a daily chart describing the course of their epistaxis, and female patients will be referred for gynecologic follow-up, including ultrasound. Evaluations will be conducted once a month throughout the treatment period.

The study was approved by the Ethics Committee of Rabin Medical Center. All patients will sign a consent form.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from HHT with severe epistaxis
* Over 18 years old

Exclusion Criteria:

* Under 18 years old
* Pregnancy
* Treatment with anticoagulance
* Treatment with hormones

Primary outcomes:
measure: Frequency of epistaxis.
measure: Duration of epistaxis.
measure: Hemoglobin level.
Secondary outcomes:
measure: Quality of life.
measure: Nasal airway.
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center, Clalit Health Services
name: Eitan Yaniv, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06281639: RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
Official title: RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with a scheduled PCU the day of recruitment

Brief summary: The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \&lt;1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.


Eligibility criteria: Inclusion Criteria:

* \<1 years old
* Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU

Exclusion Criteria:

* Open Chest
* On ECMO
* Deemed medically unstable by care team
* Cardiology, ICU, hospitalist or bedside nurse concerns

Primary outcomes:
measure: RAPID imaging quality
timeFrame: 30minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Gwenyth Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04927039: Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients
Official title: Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediastinal Mass
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One-lung ventilation (OLV) is essential during mediastinal mass excision. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung. In addition, it is reported that supine positioning of patient during OLV, which is required during mediastinal mass excision, results in worse oxygenation than lateral decubitus positioning.

Iloprost is a prostaglandin analogue and when inhaled during OLV, it acts selectively on the pulmonary vasculature, reducing pulmonary vascular resistance of well-ventilated lung and thereby alleviating ventilation-perfusion mismatch. The purpose of this study is to evaluate the effects of inhaled iloprost on oxygenation during one-lung ventilation in patients undergoing mediastinal mass excision.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for Video-assisted thoracoscopic surgery (VATS) mediastinal mass excision
2. Patient age from 20 to 80
3. American Society of Anaesthesiologists (ASA) physical status classification II\~III

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD) with Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio \< 0.7 and percentage of predicted FEV1 ≤ 80%
2. Diffusing capacity of carbon monoxide (DLCO) \< 80%
3. Aspartate transaminase (AST) level ≥100 IU/mL or alanine transaminase (ALT) ≥ level 50 IU/L
4. Creatinine clearance ≤ 30mL/min
5. Congestive heart failure, arrhythmia
6. Unstable angina, coronary artery occlusive disease (CAOD), history of myocardial infarction within 6 months
7. Pulmonary edema, pulmonary arterial hypertension
8. Allergic to prostaglandin or prostacyclin analogue
9. Patients with peptic ulcer bleeding, trauma, intracranial hemorrhage
10. History of cerebrovascular disease (e.g. transient ischemic attack, stroke) within 3 months
11. Valvular heart disease
12. Pregnant women

Primary outcomes:
measure: PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
timeFrame: Twenty minutes after the completion of drug inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
name: Kyuho Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00365339: Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
Official title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Protease Inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Primary outcomes:
measure: Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
Secondary outcomes:
measure: Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06102239: New Diagnostic Markers In Dignosis Of Complicated Appendix
Official title: New Diagnostic Markers In Dignosis Of Complicated Appendix
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complicated Appendicitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Most common cause of acute abdomen is acute appendicitis delay dignosis of acute appendicitis lead to complications as perforation this study examined efficacy of hyperbilirubinemia\&hyponatremia as indicator of complicated appendicitis


Eligibility criteria: Inclusion Criteria:

* all patient admitted for acute appendicitis underwent surgery and post operativly confirmed histopathology of acute appendicitis

Exclusion Criteria:

* patient with liver disease Liver transplantation Chronic alcoholism Congental biliary disease Pregnancy Appendicular neoplasm Hemolytic disease Hepatocellular carcinoma

Primary outcomes:
measure: Level of bilirubin in acute appendicitis
timeFrame: 6 months
measure: Level of sodium in acute appendicitis
timeFrame: 6 months
measure: Level of c-reactive proteins in acute appendicitis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospital
Study officials:
References:
citation: Virmani S, Prabhu PS, Sundeep PT, Kumar V. Role of laboratory markers in predicting severity of acute appendicitis. Afr J Paediatr Surg. 2018 Jan-Mar;15(1):1-4. doi: 10.4103/ajps.AJPS_47_16.
citation: Kar S, Behera TK, Jena K, Sahoo AK. Hyperbilirubinemia as a Possible Predictor of Appendiceal Perforation in Acute Appendicitis: A Prospective Study. Cureus. 2022 Feb 2;14(2):e21851. doi: 10.7759/cureus.21851. eCollection 2022 Feb.
citation: Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.
citation: Kanumba ES, Mabula JB, Rambau P, Chalya PL. Modified Alvarado Scoring System as a diagnostic tool for acute appendicitis at Bugando Medical Centre, Mwanza, Tanzania. BMC Surg. 2011 Feb 17;11:4. doi: 10.1186/1471-2482-11-4.
Clinical trial NCT00772239: Perioperative Coagulation Management in Cardiac Surgery.
Official title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Surgery
Bleeding
Keywords: Coagulation Management
Cardiac surgery
Bleeding
Rotem
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2008-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cardiac surgery is bleeding requiring transfusion surgery .

The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.

All these changes contribute to increase the need for transfusions during heart surgery.

The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.

100 pateinst (50 in each arm) should be included in this trial.


Eligibility criteria: Inclusion Criteria:

* Adults\> 18 years
* Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
* given informed consent

Exclusion Criteria:

* Patient supported by a pre or postoperative circulatory technical assistance

Primary outcomes:
measure: Quantity of different blood transfusion
timeFrame: during cardiac surgery management
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
city: Bordeaux
country: France
facility: Service d'Anesthésie réanimation Chirurgicale
city: Limoges
country: France
facility: Service Anésthésie
city: Limoges
country: France
facility: Service d'Anesthésie
Study officials:
affiliation: CHU limoges
name: Nathalie NATHAN-DENIZOT, MD
role: STUDY_CHAIR
References: