louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00013858: Environmental Contaminants and Infant Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mercury Poisoning
Lead Poisoning
Keywords: methylmercury
PCBs
lead
fish consumption
breast-feeding
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
Collaborators: name: Indian and Northern Affairs, Canada
name: Health Canada
name: Danish Institute for Public Health
First posted: 2001-04-03
Enrollment: 280
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.

Detailed description: Due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the Arctic region. The Inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. The contaminants assessed in this study include polychlorinated biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.

Eligibility criteria: infant born during recruitment period to a mother who is a resident of Povungnituk, Inukjuak, and Kuujjuarapik, Quebec or Nuuk, Greenland

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beauport
country: Canada
facility: Public Health Centre of Quebec
state: Quebec
Study officials:
References:
citation: Dewailly, E., Bruneau, S., Ayotte, P., Liliberte, C., Gingras, S. Belander, D. and Ferron, L. Health status at birth of Inuit newborn prenatally exposed to organochlorines - Chemosphre, 1993, 27: 359-366.
citation: Dewailly E, Ayotte P, Bruneau S, Laliberte C, Muir DC, Norstrom RJ. Inuit exposure to organochlorines through the aquatic food chain in arctic quebec. Environ Health Perspect. 1993 Dec;101(7):618-20. doi: 10.1289/ehp.93101618.
citation: Jacobson SW, Fein GG, Jacobson JL, Schwartz PM, Dowler JK. The effect of intrauterine PCB exposure on visual recognition memory. Child Dev. 1985 Aug;56(4):853-60.
citation: Jacobson JL, Jacobson SW. Intellectual impairment in children exposed to polychlorinated biphenyls in utero. N Engl J Med. 1996 Sep 12;335(11):783-9. doi: 10.1056/NEJM199609123351104.
Clinical trial NCT01387958: A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients
Official title: Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Hepatitis C virus
Chronically infected
treatment naive
non responders to prior therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 32
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: This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
* No prior therapy or inadequate response to therapy for hepatitis C.
* Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.

Exclusion Criteria:

* Use of other investigational drugs within at least 30 days of enrollment
* Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Measure: Change in hepatitis C viral load as assessed by PCR
timeFrame: 2 weeks
Secondary outcomes:
measure: Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.
timeFrame: 28 days
measure: Measure: LCQ908 concentrations in the blood
timeFrame: over 21 days
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8.
Clinical trial NCT02362958: A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Official title: Sun Yat-sen University Cancer Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HER2 Positive Breast Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Detailed description: Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* HER2-expressing primary or metastatic tumor
* Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
* Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
* Signed and dated an informed consent form
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Pregnant or breast feeding
* left ventricular ejection fraction (LVEF) \< 45% by echocardiogram
* Disease-free interval (DFI) less than 12 months
* Uncontrolled medical problems
* Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
* Patients were unable or unwilling to comply with program requirements

Primary outcomes:
measure: progression-free survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-Yu Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan F, Zhong M, Ma Y, Song C, Zhang L, Lin Y, Wu Z, Zhang Y, Huang J, Xu F, Shi Y, Wang S, Yuan Z, Xia W, Bi X. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: a phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022 Mar 15;22(1):271. doi: 10.1186/s12885-022-09399-2.
Clinical trial NCT00211458: Treatment of Age-Related Macular Degeneration With Anecortave Acetate
Official title: Treatment of Age-Related Macular Degeneration With Open-label Anecortave Acetate Sterile Suspension (15mg) Following Failed Treatment With Photodynamic Therapy With Visudyne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: Age-Related Macular Degeneration
Lead sponsor: Manhattan Eye, Ear & Throat Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization following failure of treatment with photodynamic therapy using Visudyne.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of patients that previously had a failure of treatment with photodynamic therapy using Visudyne.
2. Patients must be at least 50 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eye, Ear & Throat Hospital
state: New York
Study officials:
affiliation: Manhattan Eye, Ear & Throat Hospital
name: Jason S Slakter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04576858: Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
Official title: Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: Circulating Tumor DNA
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 1950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with gastroesophageal cancer in five prospective cohorts. Neither WGS/WES on primary tumor nor serial blood samples for ctDNA are mandatory for inclusion in the study. However, it is highly encouraged to perform WGS/WES of the primary tumor. A retrospective cohort will be open for inclusion to facilitate initial hypothesis testing to be validated in the prospective cohorts

Brief summary: This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

* Surgical resection + perioperative chemotherapy (cohort 1)
* Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)
* Definitive chemoradiotherapy with curative intent (cohort 3)
* Systemic therapy with the intent to prolong survival (cohort 4)
* Palliative treatment without the use of chemotherapy (cohort 5)


Eligibility criteria: Inclusion Criteria:

Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

Exclusion Criteria:

Patients not providing informed consent

Primary outcomes:
measure: Time to recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Time to progression
timeFrame: 1 year
measure: Overall survival
timeFrame: 5 year
measure: Response rate RECIST 1.1
timeFrame: through study completion, an average of 1 year
measure: Response duration RECIST 1.1
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT06944158: Antimicrobial Resistance (AMR) Study
Official title: Antimicrobial Resistance (AMR) Knowledge, Attitudes, and Practices Among Healthcare Workers in Syria: Multicenter Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anti-Microbial Resistance
Keywords: Antibiotics
Resistance
Knowledge
Lead sponsor: University of Aleppo
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The target population of this study is healthcare workers of both sexes (25-65 years old).

Brief summary: This study aims to investigate the knowledge, attitudes and behaviours of the antibiotic resistance and prudent antibiotic use among healthcare workers in Syria

Detailed description: This will be a multicenter cross-sectional study across the country.

The online questionnaire will be conducted in different governorates and published online through social media.

An online link to the web-based questionnaire will be developed using Google forms; it was self-designed based on questions used in previous similar studies\[1\]-\[5\].The questionnaire will take about 5-10 minutes to be completed by each participant.

The questionnaire consists of eight sections.

All participants fulfilling the inclusion criteria will be invited to participate. Snowball sampling will select the study participants with a confidence level of 95% and a margin of error of 5%. The lower limit of participants should be included is 200 healthcare workers.

The questionnaire will be pre-tested on a small sample of participants to confirm the practicability and clarity of questions to check the content. Observations of the pilot study will not be included in the final analysis.

Responses will be downloaded from Google form as an excel sheet, and data will be analyzed using SPSS version 28.

Eligibility criteria: Inclusion Criteria: We include healthcare workers, males or females aged 25 to over 65.

-

Exclusion Criteria: Participants who do not agree to fill the questionnaire, who do not agree to fill all requested questions, and who filled the questionnaire before.

-

Primary outcomes:
measure: Knowledge, attitude and practice of health care workers (KAP)
timeFrame: 06/01/2025
Secondary outcomes:
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Faculty of Medicine, University of Aleppo
Study officials:
References:
Clinical trial NCT05654558: Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
Official title: Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Overbite
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.


Eligibility criteria: Inclusion Criteria:

* Permanent dentition present except for third molars
* No history of previous orthodontic treatment.
* Class I or II malocclusion with minimal or no lower anterior crowding (\<3 mm)
* Excessive overbite (\>3 mm).

Exclusion Criteria:

* Syndromic patients as well as individuals with skeletal asymmetry
* Endodontically treated or periodontally involved loweranterior teeth.
* Need for tooth extraction in the lower arch.
* Agenesis (except for third molars)
* Any kind of tooth/root shape anomaly

Primary outcomes:
measure: Overbite
timeFrame: six months
measure: True incisor intrusion
timeFrame: six months
measure: Proclination of lower incisors
timeFrame: six months
measure: Lower incisor intrusion and proclination
timeFrame: six months
measure: Lower incisor intrusion
timeFrame: six months
measure: Extrusion of lower first molar
timeFrame: six months
measure: Distal tip of lower first molar
timeFrame: six months
Secondary outcomes:
measure: Depth of curve of Spee
timeFrame: six months
measure: Depth of gingival sulcus
timeFrame: six months
measure: Width of keratinized gingiva
timeFrame: six months
measure: Root resorption of lower incisors
timeFrame: six months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mona Elmaghraby, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Hanan Ismail, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Hassan Kassem, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02586558: Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
Official title: Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colic
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2015-10-26
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.


Eligibility criteria: Inclusion Criteria:

* Healthy, term infant from a singleton birth (=\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour

Exclusion Criteria:

* Infants with known genetic syndromes; birth weight (\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy

Primary outcomes:
measure: Infant crying and fussing behaviour
timeFrame: 6 weeks
Secondary outcomes:
measure: Infant crying and fussing behaviour
timeFrame: 6 weeks
measure: Stool Microbiota
timeFrame: 6 weeks
measure: Stool calprotectin
timeFrame: 6 weeks
measure: Parent satisfaction
timeFrame: 6 weeks
measure: Infant behaviour
timeFrame: 6 weeks
measure: Infant feeding patterns
timeFrame: 6 weeks
measure: Infant stool patterns
timeFrame: 6 weeks
measure: Postnatal depression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: David Braley Health Sciences Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: John Cairney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06203158: Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease
Official title: Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
Keywords: durg efficacy
Crohn's Disease
Ustekinumab
Intestinal Epithelial Fucosylation
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).

Brief summary: The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Molecular markers that can accurately predict the efficacy of UST are urgently needed to provide theoretical basis for guiding individualized treatment. Therefore, this study intends to explore the impact of intestinal epithelial fucosylation levels on the efficacy of UST in patients with Crohn's disease(CD), aiming to provide predictable molecular markers for UST to accurately treat CD.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with moderate to severe Crohn's disease
2. Receiving treatment with ustekinumab
3. Received colonoscopy and collected intestinal tissue samples before and after treatment

Exclusion Criteria:

1. Pregnancy
2. Hypersensitivity to any component of ustekinumab
3. Cognitive or developmental disabilities prevent you from completing this study
4. Combined with diseases such as RA, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors

Primary outcomes:
measure: clinical remission rate at 24 week
timeFrame: at 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: