louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00717015: Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer
Official title: Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Hormone Receptor Positive Breast Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-07-16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We aim to enroll 200 patients onto our study over a period of 2 years. Patients will be recruited from the oncology outpatient clinic in National University Hospital. Participation in the study will be strictly voluntary and written informed consent will be obtained from all subjects according to institutional and governmental guidelines. Consent will be obtained by attending doctors or co-investigators of the study prior to blood sampling.

Brief summary: We hypothesized that subjects with CYP2D6\*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen.

Primary objectives:

* To determine the steady state pharmacokinetics of tamoxifen and its metabolites
* To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* At least 18 years of age.
* On tamoxifen for at least 3 months for adjuvant therapy.
* On a stable diet for past 1 week before blood sampling.
* Compliant with tamoxifen medication.
* Completed adjuvant chemotherapy and/or adjuvant radiation therapy.

Exclusion Criteria:

• Patients should not be on the list of medications for the last 1 week before accrual to the study

Primary outcomes:
measure: To determine the steady state pharmacokinetics of tamoxifen and its metabolites
measure: To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Chiung Ing Wong, MRCP, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00787215: A Survey on the Rate of Glucose Intolerance in Hong Kong Chinese
Official title: A Survey on the Rate of Glucose Intolerance in Hong Kong Chinese: Validation of the Chinese University Diabetes Screening Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Impaired Glucose Tolerance (IGT)
Impaired Fasting Glucose (IFG)
Glucose Intolerance
Keywords: oral glucose tolerance test
Hong Kong Chinese
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong Chinese without history of diabetes

Brief summary: Hypothesis: There is a high rate of glucose intolerance among Hong Kong Chinese.

The investigators plan to screen Hong Kong Chinese from the community with oral glucose tolerance test (OGTT). The subjects will be referred from GP centers in the community and self-referred with public advertisement on this survey.


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese without history of diabetes

Exclusion Criteria:

* known diabetic patients

Primary outcomes:
measure: Glucose intolerance status by OGTT
timeFrame: 2 months
Secondary outcomes:
measure: Glucose intolerance status predicted by Chinese University Diabetes Risk Score validated by OGTTT
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Gary Ko
Study officials:
affiliation: Hong Kong Institute of Diabetes and Obesity
name: Gary Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687515: Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
Official title: Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis With Polyposis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 91
Sex: ALL
Minimum age (years): 23
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in the preoperative management of chronic rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis (nasal obstruction, rhinorhea, loss of smell, and headache/facial pain) for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography (CT) scan. The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.
* Bilateral nasal polyps were present and endoscopic biopsy demonstrated eosinophilic polyposis. Patients were not recruited who had large polyps (total Kennedy score＝6).

Exclusion Criteria:

* a previous oral corticosteroid treatment.
* recent sinus surgery
* ASA intolerance
* cystic fibrosis
* pregnancy
* serious or unstable concurrent disease or psychological disorder.

Primary outcomes:
measure: Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)
timeFrame: 2 weeks
Secondary outcomes:
measure: Physicians' assessment of nasal polyp size reduction
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03365115: Intrathecal Morphine and Fentanyl for Knee Arthroplasty
Official title: Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Arthroplasty
Keywords: spinal anesthesia
morphine
fentanyl
pain
knee
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 111
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled total knee replacement under spinal anesthesia
* ASA I-III

Exclusion Criteria:

* Coagulopathy
* Heart disease
* Liver disease
* Kidney disease
* Infection
* Psychological disorder
* Allergy to bupivacaine
* Allergy to morphine
* Allergy to fentanyl
* Inability to use patient-controlled analgesic device
* Opioids due to chronic pain

Primary outcomes:
measure: Postoperative pain scores at 6 hour postoperatively
timeFrame: At 6 hour postoperatively
Secondary outcomes:
measure: Postoperative pain scores at 12 and 24 hour postoperatively
timeFrame: At 12 and 24 hour postoperatively
measure: Patient-controlled analgesic device requirements
timeFrame: At 6, 12, and 24 hour postoperatively
measure: Number of participants with nausea
timeFrame: At 6, 12, and 24 hour postoperatively
measure: Number of participants with vomiting
timeFrame: At 6, 12, and 24 hour postoperatively
measure: Number of participants with pruritus
timeFrame: At 6, 12, and 24 hour postoperatively
measure: Number of participants with respiratory depression
timeFrame: At 6, 12, and 24 hour postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04175015: The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste
Official title: The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste. A Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Education
Keywords: Education
Randomised trial
Children
SMARTY
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this trial is to determine if the colour of sweets (candy) effects taste.

Detailed description: The purpose of this trial is to increase children's awareness of randomised controlled trials and gain insights into the best way to conduct a fair comparison. Everyday children are faced with health claims, some reliable and some not so reliable. The purpose of the SMARTY trial is to help children critically assess and develop a critical eye when it comes to information they encounter every day, in particular when it comes to their health. The SMARTY trial is a pragmatic, two group, parallel, randomised trial.

Eligibility criteria: Inclusion Criteria:

* parental/guardian consent obtained

Exclusion Criteria:

* unable or unwilling to ingest intervention.
* medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)

Primary outcomes:
measure: Taste
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: National University of Ireland Galway
state: Co. Galway
Study officials:
affiliation: National University of Ireland, Galway
name: Declan Devane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04710485: Sphenoorbital Meningioma Management.
Official title: Spheno_orbital Meningioma Enplaque With Proptosis; Surgical Techniques and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Meningioma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient candidate for surgery will be included in our study.

Brief summary: Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.


Eligibility criteria: Inclusion Criteria:

* all patients who have spheno_orbital meningioma with proptosis and candidate for surgery.

Exclusion Criteria:

* all patients have proptosis caused by other lesions than spheno_orbital meningioma.

Primary outcomes:
measure: Clinical assessment for vision.
timeFrame: For 6 months
measure: Clinical assessment for proptosis
timeFrame: For 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Assiut Au University
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02045485: P Wave and QT Dispersion in Psoriasis
Official title: Increased Risk of Atrial and Ventricular Arrhythmia in Long-lasting Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhytmia in Psoriasis
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy.

Brief summary: Background:

Several reports have demonstrated an association between psoriasis and cardiovascular diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.

Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area and Severity Index (PASI).

Detailed description: Ninety-four outpatient psoriasis patients and 51 healthy people were included in the study. Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded. Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy. Severity of the psoriasis was evaluated by psoriasis area and severity index (PASI). Patients were evaluated by physical examination, 12-lead electrocardiography and transthoracic echocardiography.

Eligibility criteria: Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded.

Primary outcomes:
measure: duration of p wave and QT interval
timeFrame: 3 -360 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06863285: Asthma Control Through Telemedicine
Official title: The Pharmacist Led Educational Interventions Through Telemedicine to Improve Asthma Control: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthmatic Patients
Keywords: Asthma
Telemedicine
pharmacist
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 140
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence.

Pharmacist's intervention aims to answer:

1. How a pharmacist intervention program impact medication adherence in persistent asthma?
2. To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control?
3. Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.

Detailed description: This is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (Public and private hospitals) and telecommunication (WhatsApp, network calls and messaging). The investigator will use snowball method to approach patients through telecommunication. Recruited patients will be randomly divided into two groups: the Control and the experimental group. The Control Group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. Using Telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. The intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients.

Pre-validated questionnaires will be used for the assessment

1. The adherence to asthma medication questionnaire (AAMQ-13).
2. Asthma Control test TM (ACT).

Eligibility criteria: Inclusion Criteria:

* Age above 11 years.
* Persistent Asthma Patient.
* Patients taking medications and inhaler.
* Patient who will consent for the study.
* Patient with basic telecommunication facility.
* Patient who responded to messages and calls.

Exclusion Criteria:

* Patients who will refuse to participate in study will not be included.
* Irresponsive patients to messages and calls

Primary outcomes:
measure: Asthma Control Score
timeFrame: 1 month
measure: Patients Medication Adherence Score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Hamdard University
state: Punjab
Study officials:
References:
Clinical trial NCT04515485: A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Official title: A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparoscopy
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women going for laparoscopic surgery under the O\&G department.

Brief summary: This is a prospective study to collect a nomogram of intra-abdominal volume correlated with height and weight for O\&G patients undergoing minimally invasive surgery.

Detailed description: This is a prospective study from the date of approval of the study for a period of 24 months.

The potential participants are from O\&G department who will be undergoing laparoscopy

The participant's height, weight, and total volume of carbon dioxide gas infused into the abdomen are collected from CPSS to create a standard operative pneumoperitoneum of 18mmHg for all patients undergoing laparoscopic procedures.

Patients with an abdomino-pelvic mass, or pelvic masses larger than 12 weeks size, or assessed to have an abdominal mass are excluded. Pregnant and/or breast feeding women are also excluded.

Specific patient identifiers will not be collected into the data collection and are not necessary to the study or to achieving to the objective of the study. Therefore data will not contain any identifiers.

Eligibility criteria: Inclusion Criteria:

* O\&G patients that are undergoing laparoscopic surgery.

Exclusion Criteria:

* Patients with an abdomino-pelvic mass
* Patients with pelvic masses larger than 12 weeks size
* Patients assessed to have an abdominal mass
* Pregnant and/or breast feeding women

Primary outcomes:
measure: Creation of a nomogram
timeFrame: 2 years
measure: Recording height
timeFrame: 2 years
measure: Recording weight
timeFrame: 2 years
measure: Recording intra-abdominal volume during surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00417885: A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
Official title: Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Detailed description: The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
* Postmenopausal
* ECOG \[Eastern Cooperative Oncology Group\] \</=1
* Evaluable(e.g bone only disease allowed) and Measurable disease \[RECIST (Response Evaluation Criterion in Solid Tumors)\]

Exclusion Criteria:

* HER2 \[Human Epidermal Growth factor Receptor 2\] positive disease not previously treated with herceptin
* Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
* Radiation therapy within 2 weeks of first study treatment

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From start of treatment until Day 1 of every other cycle (8 weeks) or death
Secondary outcomes:
measure: Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: From start of treatment until Day 1 of every other cycle (8 weeks)
measure: Duration of Response (DR)
timeFrame: From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer
measure: Overall Survival (OS)
timeFrame: From start of study treatment until death
measure: Time to Tumor Progression (TTP)
timeFrame: From start of treatment until Day 1 of every other cycle (8 weeks)
measure: Clinical Benefit Rate (CBR)
timeFrame: From start of treatment until Day 1 of every other cycle (8 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: