louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963533: The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis
Official title: The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
telomere length
comorbidity
Eastern Cooperation Oncology Group (ECOG)
chemotherapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy in National Taiwan University Hospital will be enrolled for screening. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.

Brief summary: The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Detailed description: Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility criteria: Inclusion Criteria:

1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.

Exclusion criteria:

includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.

Primary outcomes:
measure: The correlation between telomere length shortening and cancer treatment outcome
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Kuan-Yu Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04313933: Plasma Citrulline in Preterm With NEC
Official title: Plasma Citrulline in Preterm With NEC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NEC
Citrulline
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals

Brief summary: Aim of study

Detailed description: Introduction

Eligibility criteria: Inclusion Criteria:

* preterm neonates \< 35 weeks Preterm neonates\< 2kg Preterm neonates diagnosed with necrotizing enterocolitis

Exclusion Criteria:

* renal dysfunction Inborn error of metabolism Congenital malformation

Primary outcomes:
measure: plasma citrulline as a marker of Necrotizing enterocolitis diagnosis
timeFrame: 1 Year
Secondary outcomes:
measure: Citrulline as a marker of intestinal recovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University
Study officials:
affiliation: Ain Shams University
name: Amira Mostafa
role: STUDY_DIRECTOR
References:
Clinical trial NCT03459833: Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
Official title: Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: premature ejaculation
IELT
hyaluronic acid
glans penis augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
Primary purpose: TREATMENT

Brief summary: This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .


Eligibility criteria: Inclusion Criteria:

* occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy

Exclusion Criteria:

* Erectile dysfunction
* Hypo or hyperthyroidism
* Hypogonadism
* Hyperprolactinemia
* Drug abuse
* Psychiatric disorders or related medications

Primary outcomes:
measure: IELT
timeFrame: Change from baseline after one month
measure: AIPE
timeFrame: Change from baseline after one month
Secondary outcomes:
measure: IELT
timeFrame: Change from baseline after three, six and nine months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Andrology, Cairo University
name: Hamed A Hamed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01690533: Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease
Official title: Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-Infective Agents
Keywords: Avelox
Laryngopharyngitis
Tonsillitis
Bronchitis acute
Pneumonia
Secondary infection in chronic respiratory diseases Sinusitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 497
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings)

Brief summary: The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It is a local prospective and observational study of patients who have received Avelox tablets for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and assessed during the period of treatment with Avelox.


Eligibility criteria: Inclusion Criteria:

* Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings) who meet the following criteria:
* 20 years old or older
* with infection of mild or moderate severity
* Patients who meet the following criteria immediately before starting the therapy: ≥37°C of body temperature, expectoration of purulent or mucopurulent sputum, and either white blood cell count ≥8,000/mm3 or CRP ≥0.7 mg/dL

Exclusion Criteria:

* Patients who are contraindicated based on the product label.

Primary outcomes:
measure: Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)
timeFrame: After 7 days
measure: Clinical efficacy rate (Response, Minor Response, No Response and Indeterminable) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Response or Minor Response proportional to number of all cases.
timeFrame: After 7 days
Secondary outcomes:
measure: ADR incidence rates classified by patient's background factors
timeFrame: After 7 days
measure: Efficacy rates classified by patient's background factors
timeFrame: After 7 days
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03069833: Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Official title: Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Polyp
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

the same as colonoscopy

Exclusion Criteria:

the same as colonoscopy

Primary outcomes:
measure: Sensitivity, Specificity, False Positive, False Negative
timeFrame: Duration between endoscopic diagnosis and pathologic diagnosis is about one week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Endoscopy Center, Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center, Taiwan
name: Peng-Jen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729533: The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Official title: The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Keywords: ICSI
IMSI
Pregnancy
Sperm morphology
Unexplained infertility
Lead sponsor: Sapientiae Institute
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 0
Sex: FEMALE
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.

The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Detailed description: When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis.

It has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls.

It has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates.

The motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.

The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Eligibility criteria: Inclusion Criteria:

* Women of good physical and mental health
* Undergoing assisted reproduction as a result of unexplained infertility
* Women with regular menstrual cycles of 25-35 days
* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
* Women with body mass index (BMI) less than 30 kg/m2
* Women with both ovaries and intact uterus

Exclusion Criteria:

* Men with abnormal semen parameters according to the 2010 WHO values
* Women with polycystic ovaries
* Women with endometriosis
* Women with gynaecological/medical disorders
* Women or men with a positive result for sexually transmitted diseases
* Women who had received hormone therapy for at least 60 days preceding the study

Primary outcomes:
measure: Pregnancy rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sapientiae Institute
Study officials:
References:
Clinical trial NCT04696133: Sensory Integration Versus Fine Motor Intervention in Children With Autism
Official title: Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Quality of life
sensory integration
fine motor skills
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.


Eligibility criteria: Inclusion Criteria:

* Age ranges from 8 to 12 years.
* Mild to moderate autistic features

Exclusion Criteria:

• Significant visual or auditory defects.

Primary outcomes:
measure: Gilliam autism rating scale
timeFrame: 3 months
Secondary outcomes:
measure: Bruininks-Oseretsky Test Of Motor Proficiency
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Emam H El-Negamy, professor
role: STUDY_CHAIR
affiliation: Cairo University
name: kamilia saad
role: STUDY_DIRECTOR
affiliation: Cairo university, Egypt
name: dalia galal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02735733: Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
Official title: Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine if a balloon tamponade catheter filled with cold saline is more effective than a catheter filled with room temperature saline in controlling post partum hemorrhage.

Detailed description: When post partum hemorrhage occurs one mode of therapy is to place a balloon tamponade catheter into the uterus to compress the bleeding vessels. When this mode of therapy has been chosen by the attending physician the patient will be randomized to either the room temperature arm (control) or the cold arm (study). The balloon catheter is placed through the vagina into the uterus and inflated using normal saline; room temperature for the control group and approximately 32 degrees F for the study group. Traction is placed on the catheter to tamponade the vessels in the lower uterine segment. Blood from the uterus passes through a central lumen of the balloon and will be collected and measured. Total measured blood loss for each group will be compared.

Eligibility criteria: Inclusion Criteria:

* women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri

Exclusion Criteria:

* anyone outside of the specified age group
* anyone who declines to participate in the study

Primary outcomes:
measure: Total measured blood loss
timeFrame: time frame is approximately 24 hours, until the balloon catheter is removed from the uterus
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
Clinical trial NCT02248987: Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Schizophrenia patients treated with clozapine
2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine
3. Healthy volunteers

Brief summary: The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia
* clinically stable state

Exclusion Criteria:

* history of previous head injury, epileptic disorder, other medical comorbidity
* substance abuse/dependence

Primary outcomes:
measure: Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.
timeFrame: within 2 weeks from enrollment
Secondary outcomes:
measure: resting state functional magnetic resonance imaging
timeFrame: within 2 weeks from enrollment
measure: diffusion tensor imaging
timeFrame: within 2 weeks from enrollment
measure: clinical measure including Positive and Negative Syndrome Scale
timeFrame: within 2 weeks from enrollment
measure: neurocognitive function test
timeFrame: within 2 weeks from enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04434287: Study of Prognostic Factors in Patients Admitted to ICU for Stroke
Official title: Study of Prognostic Factors in Patients Admitted to ICU for Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Critically Ill
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale Blanche) BREST (The Brest REgistry of STroke)

Brief summary: Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS \<10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).

The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.


Eligibility criteria: Inclusion Criteria:

* acute stroke
* ICU admission for acute stroke
* 1 organ dysfunction : coma, shock, respiratory failure

Exclusion Criteria:

* refuse participation

Primary outcomes:
measure: Mortality
timeFrame: through ICU hospitalization, an average of one month
Secondary outcomes:
measure: Mortality
timeFrame: At 90 days
measure: Functional outcome: Modified Rankin Score
timeFrame: at hospitalization discharge, an average of three months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03416387: Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT).
Official title: Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Surgery
Keywords: complex liver surgery
3D printing
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 20
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: Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once 3D printers have become more affordable, the true strength of this technique has been recognized because of its ability to obtain anatomical models based on the unique characteristics of each patient. Liver resections are challenging operations because of the complex nature of the liver and venous anatomy within the liver, so 3D imaging is a promising new tool for surgical planning.


Eligibility criteria: Inclusion Criteria:

* Complex liver tumors (bilobar disease, infiltration of suprahepatic veins or requiring two-time resection or intrahepatic vascular reconstruction).
* Preoperatively was performed, a CT scan and / or MRI of all patients were performed to document the tumor distribution, estimate remaining liver volume, and identify tumor-vessel relationships in order to know the intraoperative vascular anatomy.

Exclusion Criteria:

-

Primary outcomes:
measure: Surgical planing
timeFrame: 2 weeks
Secondary outcomes:
measure: Teaching for students and residents
timeFrame: 1 day
measure: Understanding of surgery by the patient
timeFrame: 1day
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Clinic and University Virgen de la Arrixaca Hospital
Study officials:
References: