louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01232725: Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Official title: Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Outcomes of VLBW Infants
Keywords: BSID III
Human Milk
Donor Human Milk
Preterm infant
Breastfeeding
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-11-02
Enrollment: 121
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.


Eligibility criteria: Inclusion Criteria:

* \<1501 g weight at birth

Exclusion Criteria:

* chromosomal anomalies
* congenital heart disease
* congenital disorders known to impair neurodevelopment

Primary outcomes:
measure: Cognitive scale score of the Bayley Scales of Infant Development, III
timeFrame: 18 - 22 months' adjusted age
Secondary outcomes:
measure: Late Onset sepsis
timeFrame: 4 months
measure: length of hospital stay
timeFrame: 4 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Tarah T Colaizy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023425: Clinical Trial of Donepezil Between the Naive Group and the Switching Group
Official title: Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Keywords: naive group
switching group
treatment response
Efficacy
Adverse event
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Eisai Korea Inc.
First posted: 2009-12-02
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical efficacy of donepezil between the naive group and the switching group.

Detailed description: The purposes of this study are:

1. to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
2. to help to clinicians in choosing the best treatment

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Secondary outcomes:
measure: Seoul Activities of Daily Living (S-ADL)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
measure: Seoul-Instrumental Activities of Daily Living (S-IADL)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
measure: Korean Neuropsychiatric Inventory (K-NPI)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06162325: Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients
Official title: The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Myeloid Leukemia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed acute myeloid leukemia (AML) patients of the age 18 to 59 years old.

Brief summary: The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification.
* Age ≥ 18 years and ≤ 59 years
* Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up.
* Be comprehensive of the research, and able to provide informed consent.

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL).
* Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine.
* Unable to understand or participate.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Assess up to 24 months.
Secondary outcomes:
measure: Complete remission (CR) rate
timeFrame: On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.
measure: Rate of minimal residual disease (MRD) negativity
timeFrame: MRD will be tested after every cycle of therapy and during follow-up.
measure: Overall survival (OS)
timeFrame: Assess up to 24 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00491725: Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs
Official title: A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-06-26
Enrollment: 187
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 weeks
* HbA1c: 8.0-10.0%
* Current treatment with OAD on monotheray or OAD on combination therapy
* Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Recurrent major hypoglycaemia as judged by the Investigator
* Uncontrolled hypertension
* Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Primary outcomes:
measure: HbA1c
timeFrame: after 18 weeks of treatment
Secondary outcomes:
measure: Post Prandial Plasma Glucose
measure: Fasting Plasma Glucose (FPG)
measure: Safety profile
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06463925: Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk
Official title: Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne
Keywords: facial and truncal acne
Effaclar Duo+M
acne lesions
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

Detailed description: The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.

Statistical methodology:

Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.

Significance level:

The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.

Eligibility criteria: Inclusion Criteria:

* phototype I to VI
* mild to moderate acne on the face and trunk

Exclusion Criteria:

* cutaneous pathology on the studied zone other than acne
* topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products

Primary outcomes:
measure: efficacy on total acne lesion count on face and trunk
timeFrame: from baseline to Day168
Secondary outcomes:
measure: Evaluation of the degree of severity of acne on the face
timeFrame: from baseline to Day168
measure: Evaluation of the degree of severity of acne on the trunk
timeFrame: from baseline to Day168
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: CIDP Brasil
Study officials:
affiliation: Centre International de Développement Pharmaceutique (CIDP)
name: Renato Moura
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04121325: Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis
Official title: Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Pain
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroparesis patients with abdominal pain.

Brief summary: To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.

Detailed description: Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.

Eligibility criteria: Inclusion Criteria:

* Should be able to give informed consent for the study
* Has Enterra GES device in place for at least 2 months
* Continue to have moderate to severe abdominal pain on at least one pain questionnaire or \>5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
* Abdominal pain should be either persistent; for example, daily for at least \>1 hour, be chronic for \>2 months, and refractory to original Enterra GES settings

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Any other active health problems that would render patient unable to complete the study

Primary outcomes:
measure: Abdominal Pain
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Thomas Abell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03485625: Adjuncts to IVRA, a Comparison Between Ketorolac and Paracetamol
Official title: Adjuncts to Intravenous Regional Anaesthesia, a Comparison Between Ketorolac and Paracetamol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was planned to compare the effect of ketorolac 20 mg to 300 mg of paracetamol when added to lidocaine 3 mg/kg for Intravenous regional anaesthesia.

Detailed description: All patients were premedicated 15 minutes before the surgical procedure with I.V. 0.06mg/kg of midazolam. In the operating room, patients were monitored for non invasive blood pressure (NIBP), oxygen saturation (Spo2) and pulse rate (PR).

Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers. The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist. During surgery if patient reported pain during operation (VAS 4 or greater) inj. fentanyl 1 μg/kg was given and total amount used was recorded. Postoperatively patients were questioned for pain and if VAS \> 4, 75 mg intramuscular diclofenac was given.Total amount used was recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status I or II, who will be scheduled for surgery of the hand or the forearm were included in this study after informed consent

Exclusion Criteria:

* Severe Raynaud's Disease
* Sickle Cell Disease
* Crush injury to the limb
* A history of allergic reaction to lidocaine
* Liver disease or kidney disease
* Significant cardiovascular disease
* Highly nervous and uncooperative patients
* Patient with history of opioid dependence
* Drug or alcohol abuse
* Psychiatric disorder
* Neurological diseases

Primary outcomes:
measure: The time to first analgesic request.
timeFrame: 1 year
Secondary outcomes:
measure: sensory block
timeFrame: 1 year
measure: motor block
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Omar Ali
Study officials:
affiliation: Assiut University
name: Khaled Abdel-Baki Abdel-Rahman, Lecturer of anaesthesia
role: STUDY_CHAIR
References:
Clinical trial NCT05823025: Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales (WIVOP-Scales)
Official title: Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Stiffness
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient have chronic disease (hypertension, sleep apnea, BPCO) likely to have a high PWV.

Brief summary: The aim of this study is to evaluate the diagnostic performance of Withings bathroom scales WBS08 and WBS12 to measure PWV (Pulse Wave Velocity).

Detailed description: Patients likely to have a high PWV (having hypertension, sleep apnea or chronic obstructive pulmonary disease) are included in hospitals. Each patient will have his PWV measured with Withings WBS08 and WBS12 and its reference the SphygmoCor CvMS.

Eligibility criteria: Inclusion Criteria:

* The subject is an adult, man or woman (18 years old or more),
* Subjects affiliated or eligible to a social security system,
* Subjects having expressed their consent to take part in the study.
* Two subsets of patients will be included in the study :

  * Hypertensive patient
  * Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)

Exclusion Criteria:

* Minors under 18 years old,
* Subject is pregnant,
* Subjects having a pacemaker or an ICD (Implantable cardioverter defibrillator),
* Subjects having refused to give their consent,
* Vulnerable subjects according to the French regulation in force:

  * Individuals deprived of liberty by a court, medical or administrative order,
  * Individuals legally protected or unable to express their consent to take part in the study,
  * Individuals unaffiliated to or not beneficiary of a social security system,
  * Individuals who fit in multiple categories above,
* Individuals linguistically or mentally unable to express their consent,
* Individuals having a lower limb amputation bigger than toes,
* Individuals not able to stand still for a few minutes.

Primary outcomes:
measure: PWV measurement bias
timeFrame: 1 year
measure: PWV measurement deviation
timeFrame: 1 year
Secondary outcomes:
measure: Safety use
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges Pompidou European Hospital
state: Ile De France
city: Grenoble
country: France
facility: CHU Grenoble
state: Rhône-Alpes
Study officials:
affiliation: Georges Pompidou european hospital
name: Pierre Boutouyrie, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04619225: Cardiac Output and Recovery Time
Official title: Correlation Between Cardiac Output and Recovery Time After Reversal of Rocuronium-Induced Blockade with Sugammadex
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
Tetragraph
AMG
EMG
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old.
* Patients willing to participate and provide an informed consent.
* Patients undergoing an elective surgical procedure requiring administration of rocuronium, and the use of a pulmonary artery catheter intraoperatively.

Exclusion Criteria:

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field.

Primary outcomes:
measure: Recovery time after administration of sugammadex and its correlation to cardiac output measure
timeFrame: Up to 1 hour postoperative
Secondary outcomes:
measure: Correlation of speed of recovery from neuromuscular blockade and age.
timeFrame: Up to 1 hour postoperative
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J.Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References: