louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00264004: Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
Official title: A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumors
Keywords: Advanced Solid Tumours
phase II
Hypertension
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion Criteria:

* Prior treatment with a VEGF inhibitor
* Poorly controlled hypertension

Primary outcomes:
measure: Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
timeFrame: 12 week treatment period
measure: Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
timeFrame: 12 week treatment period
Secondary outcomes:
measure: Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
timeFrame: First 6 weeks of 12 week treatment period
measure: Objective Response Rate
timeFrame: 12 week treatment period
measure: Best Percentage Change in Tumour Size
timeFrame: Randomisation until end of treatment period
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05465304: Effect of Azithromycin in Preventing Premature Labour
Official title: Effect of Azithromycin on Pregnancy Prolongation in Women at Risk for Premature Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant With Complication
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomized Controlled prospective study

Brief summary: This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.

The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin

Detailed description: A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.

The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.

. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with \<34 weeks of gestation,
* Hospitalization for risk of preterm labour,
* Threat of preterm labour, or preterm labour itself.
* Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
* Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes

Exclusion Criteria:

* Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required \<37 weeks.

Primary outcomes:
measure: Effect of Azithromycin in preventing premature labour
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University teaching Hospital
state: Beni-Suef
Study officials:
affiliation: Beni-Suef University
name: Raghda R.S Hussein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806104: Fructo-oligosaccharides and Irritable Bowel Syndrome
Official title: Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Beghin-Meiji
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.


Eligibility criteria: Inclusion Criteria:

* IBS subjects according to Rome III criteria
* Incomfort below or equivalent to 30mmHg during Tensostat test
* between 18 and 60 years
* no antibiotic treatment for the last 2 months
* less than 20g of dietary fibres consummed per day
* no analgesic treatment
* no treatment for intestinal transit

Exclusion Criteria:

* subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
* excessive consumption of alcohol or tobacco
* participating to another clinical study
* pregnant women
* antidepressor or anxiolytic treatment

Primary outcomes:
measure: rectal sensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: taxonomic composition of intestinal microbiota
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Barcelona
country: Spain
facility: Vall Hebron Hospital
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Michel Dapoigny, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017404: A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
Official title: A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
* Karnofsky performance status≥70 and measurable or evaluable;
* Stages Ⅲa-ⅢC;
* Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
* Adequate marrow function (WBC count\> 4.0×10(9)/L, neutrophil\> 2.0×10(9)/L, platelet count \> 100×10(9)/L，hemoglobin \> 90g/L );
* AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
* ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
* Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
* Expected lifetime ≥ 12 months;
* Pregnancy tests of reproductive age women is negative;
* All patients provided written informed consent.

Exclusion Criteria:

* Distant metastasis;
* Severe heart failure (NYHA grade II or higher);
* Active and uncontrolled severe infection;
* Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
* Pregnancy or breast feeding;
* Other situations that investigators consider as contra-indication for this study

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 4 cycles (each cycle is 21 days) of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Shi Jiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT03673904: High Sensitive CRP in Prediabetics and Diabetes
Official title: High Sensitive CRP Level in Prediabetics and Newly Diagnosed Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assess Level of High Sensitive CRP in Diabetics and Prediabetics
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study individuals were recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital

Brief summary: The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c

Detailed description: This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital

Eligibility criteria: Inclusion Criteria:

* Pre-diabetic patients:

  * A fasting blood glucose level (100 to 125 mg/dL). or
  * A 2-hour blood glucose level (140 to 199 mg/dL) .or
  * Hb A1C 5.7% to 6.4%.
* Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)

  * A fasting blood glucose level \>126 mg/dl
  * A 2-hour blood glucose level \> 200 mg/dl
  * Hb A1C \> 6.5%

Exclusion Criteria:

* Pregnant or lactating females.
* Patients who have recent infection.
* Patients with acute inflammatory diseases as autoimmune diseases.
* Patients with malignancy or on chemotherapy.
* Patients with acute or chronic liver or renal diseases

Primary outcomes:
measure: statistical significant elevation of high sensitive CRP in diabetics and prediabetes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00509704: Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
Official title: Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Keywords: Sutent
tumor necrosis
DCE-MRI (Dynamic enhanced magnetic resonance imaging)
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2007-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)

Brief summary: The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

Detailed description: Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2\*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.

Eligibility criteria: Inclusion Criteria:

* patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
* histologically verified stage IV renal cell carcinoma of clear cell type
* measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
* Karnofsky score \> 70%
* age \> 18 year.
* written informed consent

Exclusion Criteria:

* contra-indications for MRI
* contra-indications for treatment with Sunitinib
* previous systemic treatment within the last 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
Study officials:
affiliation: UMC St Radboud
name: C.M.L. van Herpen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848804: Hearing Screener Study
Official title: Linus Health Hearing Screening Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Screener
Lead sponsor: Linus Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Up to three US sites will be used in this study for enrollment. Participants will be recruited from the following clinics: nursing home, memory clinic, primary and/or specialty care in order to recruit subjects with a range of hearing functions.

Brief summary: The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter


Eligibility criteria: Inclusion Criteria:

* All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.

Exclusion Criteria:

* Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.

Primary outcomes:
measure: Hearing Thresholds
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Wake Forest
country: United States
facility: Crossover Mangement
state: North Carolina
Study officials:
affiliation: Linus Health
name: Joyce Gomes-Osman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06632704: Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.
Official title: Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders and Physical Impairments
Keywords: hand movement impairment
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2024-10-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.

Brief summary: User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview

Detailed description: Video recording of tooth brushing technique Picture of toothbrush bristles after study period

Eligibility criteria: Inclusion Criteria:

* Individuals with specific movement disorders and physical impairments, such as, but not limited to, Parkinson disease, Huntington disease, multiple sclerosis, arthritis, cerebral palsy, stroke, and/or tremors that affect their ability to perform daily tasks, such as brushing their teeth.

Exclusion Criteria:

* Individuals with severe oral health issues such as oral cancer, ulcers, or severe periodontal disease.
* Individuals who are unable to open their mouth enough that it would prevent using a brushing device.

Primary outcomes:
measure: user experience
timeFrame: 1 week, 2 weeks and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania school of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: Deputy Director, Center for Clinical and Translational Research Clinical Associate Professor, Department of Oral Medicine
name: Eugene M Ko, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02951104: Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Official title: Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 35
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: Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.


Eligibility criteria: Inclusion criteria:

* Age \> 18 years
* Diagnosis of Group 1 or Group 4 PAH based on PAPm \> 25 mmHg, PAWP \<15 mmHg, PVR \>3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
* Willingness and ability to comply with study procedures.
* No known hypersensitivity to the components of USCOM electrodes

Exclusion criteria:

* Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
* Evidence of postcapillary pulmonary hypertension on right heart catheterization

Primary outcomes:
measure: Cardiac output measurement correlation at baseline
timeFrame: 30 minutes
Secondary outcomes:
measure: Cardiac output measurement correlation after vasodilator testing
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
References: