louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02204644: The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Official title: Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: CML, CML-CP,MMR,TKI
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 400
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: A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Randomized,Open Label,Control


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18-75 year-old
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
4. Adequate organ function

Exclusion Criteria:

1. received TKIs drug treatment before enrollment
2. Central nervous system leukemia
3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
4. Cardiac dysfunction
5. Previous splenectomy
6. History of congenital or acquired bleeding disorders unrelated to CML
7. Previous malignancy except CML
8. Acute or chronic liver or severe kidney disease unrelated to CML
9. Pregnant, breastfeeding, child bearing potential but failed to take effective contraception

Primary outcomes:
measure: SIX-month major molecular response rate
timeFrame: six months
Secondary outcomes:
measure: major molecular response rate
timeFrame: 3 months, 9 months and 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hospital of Blood Diseases, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
citation: Zhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. doi: 10.1158/1078-0432.CCR-20-1600. Epub 2020 Sep 14.
Clinical trial NCT01604044: Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Female Infertility
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 579
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.


Eligibility criteria: Inclusion Criteria:

* women with story of infertility sine causa and mild-moderate male factor
* regular ovulatory menstrual cycles
* BMI ≤27 kg/m2
* normal day 3 hormonal pattern
* bilateral tubal patency

Exclusion Criteria:

* mono/bilateral tubal occlusion,
* severe male factor
* polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
* pelvic inflammatory disease
* endometriosis
* sexual organ malformations
* neoplasms or breast pathology incompatible with gonadotropin stimulation.

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies
timeFrame: 30 days
Other outcomes:
measure: duration of stimulation, total gonadotropin dose, number of midsize follicles, dominant follicles, E2 levels, endometrial thickness on hCG day, Progesterone levels, endometrial thickness on the midluteal phase.
timeFrame: 30 days
Locations:
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli
Study officials:
References:
citation: Moro F, Scarinci E, Palla C, Romani F, Familiari A, Tropea A, Leoncini E, Lanzone A, Apa R. Highly purified hMG versus recombinant FSH plus recombinant LH in intrauterine insemination cycles in women >/=35 years: a RCT. Hum Reprod. 2015 Jan;30(1):179-85. doi: 10.1093/humrep/deu302. Epub 2014 Nov 14.
Clinical trial NCT00635544: Cross-Over Multicentre Study in Adolescents
Official title: Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Hyperlipidemia
Keywords: Adolescence
Overweight
Dietary Fiber
Glycemic Index
Healthy lifestyle
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 European centres.

Secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.


Eligibility criteria: Inclusion Criteria:

* Age 13-16 yrs
* Written informed consent
* Menstrual cycle for at least 6 months
* Overweight

Exclusion Criteria:

* Taking part simultaneously in another research trial
* Involvement in physical training (\>4 h/week of vigorous physical activity)
* Any dietary treatment in the previous two months
* Body weight changes \> 3 kg in the previous two months
* Gastrointestinal diseases, irritable bowel syndrome, or positive history for recurrent gastrointestinal symptoms such as nausea, vomiting, bloating, epigastric pain, abdominal pain, abdominal discomfort, flatulence, severe constipation
* Kidney diseases
* Type 1 or type 2 diabetes
* Thyroid or other hormonal diseases
* Other secondary causes (including illnesses) of hyperlipidemia or altered glucose metabolism
* Severe hyperlipidemia (total cholesterol \> 300 mg/dL or triglycerides \>300 mg/dL)
* Severe hypertension
* Positive history for eating disorders
* Any regular drug treatment
* Any food allergy and intolerance

Primary outcomes:
measure: blood glucose and lipids
timeFrame: after 3 weeks of dietary treatment
Secondary outcomes:
measure: blood hormones and inflammatory status parameters
timeFrame: after 3 weeks of dietary treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition and Dietetics, Harokopio University
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Anyagcseregondozó
city: Napoli
country: Italy
facility: Dipartimento di Pediatria Università di Napoli "Federico II"
city: Madrid
country: Spain
facility: Instituto del Frio. Departamento de Metabolismo y Nutrición
Study officials:
References:
Clinical trial NCT00421044: A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Official title: An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Tumors
Keywords: EPO
Patupilone
Solid Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 14
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: Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.


Eligibility criteria: Inclusion Criteria:

* Completion of the core study is required for participation in the extension.
* 18 years of age or older
* World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
* Life expectancy of 3 months or more
* Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Presence of any other active or suspected acute or chronic uncontrolled infection
* Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
* History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
timeFrame: at completion of the study
measure: To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
timeFrame: at completion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego/Moores Cancer Center
state: California
city: San Antonio
country: United States
facility: Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01002144: C-Reactive Protein as a Predictor for Airway Hyper-Responsiveness
Official title: C-Reactive Protein as a Predictor for Airway Hyper-responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with suspected asthma underwent metacholine chalange test.

Brief summary: Background: Increased serum high sensitivity C-reactive protein (hs-CRP) has been associated with airway inflammation in asthma and may serve as a surrogate marker for the presence of airway hyper-responsiveness (AHR) in this set-up. This study was designed to evaluate the predictive value of hs-CRP for AHR assessed by metacholine challenge test (MCT), in adults with suspected Asthma.


Eligibility criteria: Inclusion Criteria:

* subjects that were referred to Metacholine challenge test

Exclusion Criteria:

* age \< 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Mordechai Yigla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05838144: Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis
Official title: Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program .
2. Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.

Detailed description: 1. Acapella group.Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program.
2. Only routine physical therapy program group( control group). Will only take medications and routine chest physical therapy program Spirometer measures such as forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be measured for every patient before and after the end of 7 days.

Eligibility criteria: Inclusion Criteria:

1. bronchiectasis patients.
2. Age range between 40 to 55 years old of both gender.
3. Cooperative patients.

Exclusion Criteria:

1. Patients with severe cardiac disorders.
2. Un controlled hypertensive patients.
3. Un controlled diabetic patients.

Primary outcomes:
measure: Spirometry measures
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shymaa yussuf abo zaid
Study officials:
affiliation: Lecturer
name: Shymaa Y Abo zaid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06982144: AI-based Prediction Model of Difficult Tracheal Intubation Using Medical Image Parameters
Official title: AI-based Prediction Model of Difficult Tracheal Intubation Using Medical Image Parameters
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Difficult Airway
Keywords: difficult airway
AI-based method
medical imaging
prediction model
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck CT data undergoing surgery under general anesthesia with endotracheal intubation

Brief summary: Difficult airway is a life-threatening event during anesthesia. Prediction model is helpful to detect high-risk patients and decrease the risk of un-anticipated difficult airway. Present models are usually based on Mallampati grade and the width of mouth open. However, the prediction accuracy is only about 0.7-0.8 in different populations. Present study is designed to investigate if AI-based prediction model using medical imaging parameters (such as CT and MRI) can increase the accuracy of prediction model.


Eligibility criteria: Inclusion Criteria:

1. age ≥18 years old;
2. surgical patients undergoing general anesthesia with endotracheal intubation;
3. with head and neck CT examination results
4. Consent to participate in the study.

Exclusion Criteria:

1. The presence of laryngeal edema;
2. The presence of airway stenosis, including internal airway stenosis (such as foreign body or tumor) or stenosis caused by external tracheal mass compression;
3. tracheo-esophageal fistula;
4. severe gastroesophageal reflux;
5. previous upper airway surgery, such as laryngeal cancer radical surgery, snoring surgery, etc.

6）participating in other research projects

Primary outcomes:
measure: The accuracy of prediction model based on AI analysis of medical imaging parameters
timeFrame: day 1 (From enrollment to the end of anesthesia induction)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00850044: Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
Official title: A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Keywords: FIH
SAD
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* overall healthy subjects
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* history of gastrointestinal issues or procedures
* history of seizures, diabetes or cancer (except basal cell carcinoma)
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
* abnormal screening laboratory results that are considered clinically significant by the investigator
* current enrollment in another clinical study
* previous enrollment in this study
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
* pregnant or breastfeeding female
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Primary outcomes:
measure: Pharmacokinetics (blood draws, pre- and post-dose)
timeFrame: 4 days
measure: Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 15981
state: Illinois
Study officials:
affiliation: Abbott
name: Adebayo A Lawal, MD
role: STUDY_DIRECTOR
References:
citation: Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24.
Clinical trial NCT04881344: Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease
Official title: Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease, a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 42
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: Hemorrhoidal disease is a frequent anorectal disorder and the main reason for a visit to a coloproctologist. Hemorrhoids are present in healthy individuals. However, they can become pathologic, manifesting with pain, prolapse, itching, bleeding or soiling. Initially, they can be managed conservatively. When this failed to cure the symptoms, surgical therapy is indicated. For grade II (hemorrhoids prolapsing during straining but reducing spontaneously) or grade III (hemorrhoids prolapsing during straining but requiring manual reduction), laser hemorrhoidoplasty or mucopexy are safe and efficient procedures to treat hemorrhoids. However, the optimal treatment is still under debate. Recently, a randomized controlled trial reported lower recurrence and faster return to work associated with laser therapy. We aimed to compare both therapies, to assess the benefits of laser therapy for the treatment of hemorrhoidal disease symptoms, using a validated score.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Hemorrhoidal disease grade II to III unresponsive to medical therapy
* Age ≥18

Exclusion Criteria:

* Inability to follow the procedures of the study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons,
* Anesthesiology contraindications to surgery,
* Emergency situation,
* Hemorrhoids associated with pregnancy,
* Oher surgical intervention performed at the same time of the hemorrhoids treatment,
* Concomitant anorectal disorders (fissure, fistula), thrombosed hemorrhoid,
* Previous pelvic radiotherapy, previous proctologic intervention during the last three months.

Primary outcomes:
measure: The Symptom Score
timeFrame: 6 postoperative months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01735292: Safety of the Automatic Respiration Transfer System- Timer
Official title: Safety of the Automatic Respiration Transfer System- Timer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care Patients on a Ventilator
Keywords: Ventilation, timer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
First posted: 2012-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to have their ventilator placed on a timer which at a specific time in the future stops the ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes during the use of the timer with the regular ventilator. In addition, we will evaluate whether the timer stops the ventilator and switches to CPAP at the designated time.


Eligibility criteria: Inclusion Criteria:

* Ventilated patients with informed consent

Exclusion Criteria:

* Non- ventilated patients

Primary outcomes:
measure: Safety of the Automatic Respiration Transfer System- Timer
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Charles Sprung, MD
role: PRINCIPAL_INVESTIGATOR
References: