louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01197014: A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Official title: A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Amlodipine, Losartan
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study Design :

- A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Detailed description: Primary Objective:

- To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Eligibility criteria: Inclusion Criteria:

* Age 18-55 years
* Healthy Caucasian volunteers
* Non smokers or mild smokers

Exclusion criteria:

* Pregnancy and/or breast-feeding
* Participation in another clinical trial within 60 days prior to Period 1

Primary outcomes:
measure: AUC, Cmax
timeFrame: 0-144hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Pilsen
country: Czech Republic
facility: CEPHA s.r.o.
Study officials:
References:
Clinical trial NCT00467714: Evaluation Of Cloumella Strut Effect In Tip Rotation
Official title: Evaluation of Cloumella Strut in Maintenance of Tip Rotation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nose Deformities, Acquired
Keywords: RHINOPLASTY ,ESTHETIC SURGERY
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.

Detailed description: In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.

Eligibility criteria: Inclusion Criteria:

* RHINOPLASTIC PATIENTS

Exclusion Criteria:

* REVISION SURGERY,
* INCOMPLETE STRIP,
* FACIAL ANOMALY

Primary outcomes:
measure: TIP ROTATION
timeFrame: 6 month after surgery
Secondary outcomes:
measure: TIP PROJECTION
timeFrame: 6 month after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Hospital
Study officials:
affiliation: deputy of research of tehran university medical science
name: mohmad sadeghi, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05804214: Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
Official title: Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infant Growth
Parent and Infant User Experience
Keywords: Complement
infant formula
dairy and plant based
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 2
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants that are fed with dairy and plant based infant formula ≤ 4 months of age. Infants should be enrolled within three months after start with dairy and plant based infant formula.

Before screening, parents should already autonomously have decided to use dairy and plant based infant formula for their infant according to the label of the product.

Brief summary: A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.

Detailed description: The study collects growth data from 58 participating infants whose parents autonomously decided to use the dairy and plant based infant formula for their infant daily within the first three months of their infant's life, either supplemental to breastfeeding or as sole source of feeding. Parents are asked to complete 2-3 online questionnaires in which data is collected on infant growth (as assessed during regular visits to the Municipal Child Healthcare Clinic), feeding characteristics, parent and infant experience with the product, and whether their infant has been to a doctor or is taking medication.

Eligibility criteria: Inclusion Criteria:

1. Parents autonomously decided to feed their infant with at least one bottle per day of dairy and plant based infant formula in combination with breastfeeding or as sole source of feeding.
2. Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product
3. Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
4. Infant is being fed daily with dairy and plant based infant formula at time of enrolment

Exclusion Criteria:

1. Infant started feeding with dairy and plant based infant formula \>3 months ago at time of enrolment
2. Participation of the infant in any other studies involving infant formula feeding (products) concomitantly

Primary outcomes:
measure: Development of weight, length, and head circumference
timeFrame: 5 Months +2 weeks
Secondary outcomes:
measure: Development of length, BMI, and head circumference
timeFrame: 5 Months + 2 weeks
measure: Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age
timeFrame: 5 Months + 2 weeks
measure: Experience of parent and infant
timeFrame: after using product for 2 and 5 Months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Ncru, Danone Nutricia Research
Study officials:
References:
Clinical trial NCT01449214: Ultrasound-Guided Technique for Thoracic Epidural Insertion
Official title: Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Thoracic epidural
Epidural anesthesia
Ultrasound
Palpation
Thoracic spine
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracic epidural analgesia and anesthesia are effective in improving the quality of intraoperative and postoperative pain relief during thoracic and abdominal surgical procedures. Conventional epidural techniques have significant limitations. Due to the anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the insertion requires a more technically challenging paramedian approach. The safety and feasibility of bedside ultrasonography for the lumbar spine has already been established and it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia

Detailed description: • The feasibility and the reliability of US imaging for the thoracic spine has been proven by comparing the findings of ultrasound scans to MRI measurements, which is the standard imaging technique for the depiction of the spine. Pre-puncture US assessment may contribute to the safety and efficacy of the thoracic epidural technique. The purpose of this study is to compare the ultrasound-guided thoracic epidural insertion technique with the conventional anatomic landmarking technique of contacting bone and walking-off the lamina

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia.
* Consent to participate and signed consent form.

Exclusion Criteria:

* Contraindication to epidural anesthesia.
* Marked spinal deformities or a history of spinal instrumentation
* Emergency surgery.
* Inability to communicate in English.
* BMI\>35 kgm-2

Primary outcomes:
measure: Needle redirections
timeFrame: 30 minutes
Secondary outcomes:
measure: Bony contacts
timeFrame: 30 minutes
measure: New insertion point
timeFrame: 30 minutes
measure: Number of insertions
timeFrame: 30 minutes
measure: duration of ultrasound scanning
timeFrame: 30 minutes
measure: duration of epidural procedure
timeFrame: 30 minutes
measure: complications during epidural insertion
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Cristian Arzola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828814: Different Strategies for Preventing Severe Acute Malnutrition in Niger
Official title: Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: pediatrics
Ready-to-use Supplementary Food
corn soy blend
cash transfer
prevention of malnutrition
Niger
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: United Nations World Food Programme (WFP)
First posted: 2013-04-11
Enrollment: 7836
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 6 to 24 months

Brief summary: Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.


Eligibility criteria: Inclusion Criteria:

* resident in selected villages
* height between 60 and 80 cm.

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Incidence of severe acute malnutrition
timeFrame: 15 months
Secondary outcomes:
measure: Mortality
timeFrame: duration of follow-up (15 months)
Other outcomes:
Locations:
city: Madarounfa
country: Niger
facility: Villages
state: Maradi
Study officials:
affiliation: Epicentre
name: Céline Langendorf, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sayyad-Neerkorn J, Langendorf C, Roederer T, Doyon S, Mamaty AA, Woi-Messe L, Manzo ML, Harouna S, de Pee S, Grais RF. Preventive Effects of Long-Term Supplementation with 2 Nutritious Food Supplements in Young Children in Niger. J Nutr. 2015 Nov;145(11):2596-603. doi: 10.3945/jn.115.213157. Epub 2015 Sep 30.
citation: Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Toure LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.
Clinical trial NCT03143114: Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
Official title: Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Fibroid
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.

Detailed description: All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.

Eligibility criteria: Inclusion Criteria:

* Infertility for at least one year.
* Presence of intramural myoma.
* Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.

Exclusion Criteria:

* Age is \< 20 or \> 33 years.
* Symptomatic fibroid causing pelviabdominal swelling.
* Presence of \> 2 myomas.
* Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).
* Presence of any other cause of infertility.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-8 weeks gestational age
Secondary outcomes:
measure: Miscarriage rate
timeFrame: 12 weeks gestational age
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Port Said
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University
Study officials:
affiliation: Port Said University
name: Waleed El-refaie, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Khaled Samir, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mahmoud M Awad, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01141114: Study of Patient Navigation to Promote Colon Cancer Screening
Official title: Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: community health centers
colorectal cancer screening
urban health
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Harvard Medical School (HMS and HSDM)
First posted: 2010-06-10
Enrollment: 465
Sex: ALL
Minimum age (years): 52
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.


Eligibility criteria: Inclusion Criteria:

* Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.

Exclusion Criteria:

* Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)
* Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF \< 35%)
* Severe COPD (FEV1\< 1liter or on home oxygen)
* CVA with severe functional impairment (aphasia or hemiparesis)
* MS with severe functional impairment
* Renal failure with CrCl\< 30 or on dialysis
* Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months
* Chronic active liver disease or cirrhosis, with albumin \< 3 or elevated INR
* Advanced HIV disease (CD4 count \<200)
* Severe lupus (with cerebritis or renal failure as defined above)
* Severe complications of diabetes (blindness, amputations other than toes)
* Advanced Dementia
* Psychosis
* Paranoia
* Active substance abuse
* Schizophrenia
* Psychiatric hospitalization within the past year

Primary outcomes:
measure: completion of colorectal cancer screening
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of detection of polyps and cancers in intervention vs. control groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance/Harvard Medical School
name: Karen E Lasser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.
citation: Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, Fletcher RH, Ayanian JZ. Colorectal cancer screening among ethnically diverse, low-income patients: a randomized controlled trial. Arch Intern Med. 2011 May 23;171(10):906-12. doi: 10.1001/archinternmed.2011.201.
Clinical trial NCT05789914: The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial
Official title: Peking University School of Stomatology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Guided Tissue Regeneration
Extracellular Matrix Scaffold of Small Intestinal Submucosa
Keywords: guided tissue regeneration
Small Intestinal Submucosa
Randomized Controlled Clinical Trial
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 20
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: The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.


Eligibility criteria: Inclusion Criteria:

* periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.

Exclusion Criteria:

* smokers, pregnant female, other systematic disease

Primary outcomes:
measure: clinical attachment loss
timeFrame: Baseline and 6 months after surgery
measure: clinical attachment loss
timeFrame: baseline and 12 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of stomatology
state: Beijing
Study officials:
References:
Clinical trial NCT00688714: Study to Investigate Safety and Tolerability of a Single Dose of AZD6482
Official title: A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Antiplatelet Effect
Keywords: Antiplatelet
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).


Eligibility criteria: Inclusion Criteria:

* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Provision of written informed consent

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
* Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse
* Known impaired glucose intolerance or known or suspected Gilbert´s syndrome

Primary outcomes:
measure: General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables
timeFrame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
Secondary outcomes:
measure: Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)
timeFrame: Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
measure: Pharmacokinetics and inhibition of platelet aggregation
timeFrame: Prior to dose and repeatedly during 24 hrs after dose.
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, Sweden
name: Marianne Hartford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Wilmington, DE United States
name: Brian Bryzinski, MD
role: STUDY_CHAIR
References: