louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01169740: Transcutaneous Measurement of Jaundice in the Newborn
Official title: Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Keywords: Hyperbilirubinemia
Neonatal
Serum bilirubin
Transcutaneous bilirubin
Skin color
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants admitted to normal newborn nursery

Brief summary: Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples.

We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age.

Detailed description: Whenever a blood sample is drawn for measurement of bilirubin in a newborn, a transcutaneous measurement of skin yellow color will be made. Such measurements will also be included in all infants when a CRP-test (blood sample for C-reactive protein) has been ordered, as well as in connection with the routine blood sampling for metabolic screening. Only infants where parents have given written consent for their infant will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Newborn infant admitted to normal newborn nursery

Exclusion Criteria:

* Informed consent not obtained

Primary outcomes:
measure: Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)
timeFrame: 12 months
Secondary outcomes:
measure: Differences in TcB measured at the forehead or at the sternum
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Instititue director
name: Vibeke Videm, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00349440: Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Official title: Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-07
Enrollment: 93
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: The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).


Eligibility criteria: Inclusion Criteria:

* Males or females \> 18 years old
* Mild-moderate symptoms of dry eye prior to surgery
* Scheduled to undergo bilateral LASIK or PRK
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Prior use of topical cyclosporine within the last 1 year
* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Ocular disorders
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies

Primary outcomes:
measure: Dry Eye Symptoms
timeFrame: 1.5 years
Secondary outcomes:
measure: Dry eye signs
timeFrame: 1.5 yrs
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Southeastern Laser and Refractive Surgery
state: North Carolina
Study officials:
affiliation: Southeastern Laser and Refractive Surgery
name: Karl Stonecipher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00302640: Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Official title: Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rotavirus Infection
Adenoviridae Infection
Norovirus Infection
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 50
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.


Eligibility criteria: Inclusion Criteria:

* Age \<12 years.
* Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
* Stool positive for adenovirus, norovirus or rotavirus by ELISA.

Exclusion Criteria:

* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Other identified causes of diarrhea at screening.
* Serious systemic disorders incompatible with the study.

Primary outcomes:
measure: Time from first dose to resolution of symptoms.
timeFrame: P-0.0105
Secondary outcomes:
measure: Virologic response (negative ELISA) at day 7-10.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University Children's Hospital, Cairo, Egypt
name: Mona Abu-Zekry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. doi: 10.1016/S0140-6736(06)68852-1.
Clinical trial NCT02576340: Spasmolytic in Upper Gastrointestinal Endoscopy
Official title: Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroscopy
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.


Eligibility criteria: Inclusion Criteria:

* no hypersensitivity to the agent.

Exclusion Criteria:

* Emergent cases,the cases with low mental compatibility and pregnant women were excluded from the study. Moreover, the procedures under sedation, cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes were excluded.

Primary outcomes:
measure: motility
timeFrame: 3 months
Secondary outcomes:
measure: patient tolerance
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03383640: Early Active Finger Exercises in Replanted Fingers
Official title: Will Early Active Finger Exercises in Replanted Fingers Improve Mobility? A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Total or subtotal amputation injury of 1-4 of the four ulnar digits
* Injury distal to the MCP joint
* Must have injured flexor tendon which requires suture
* Must have a fracture
* Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
* The finger must have had a stable circulation for at least 5 days post-surgery

Exclusion Criteria:

* Arthrodesis/temporary fixation of the MCP joint
* Bilateral amputation injury
* Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
* Patients who cannot follow the planned controls

Primary outcomes:
measure: TAM
timeFrame: 12 months
Secondary outcomes:
measure: Quick-DASH
timeFrame: 12 months
measure: VAS Pain
timeFrame: 12 months
measure: VAS Function
timeFrame: 12 months
measure: Grip strength
timeFrame: 12 months
measure: Key pinch
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06173440: Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital
Official title: Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acinetobacter Baumannii
Keywords: Acinetobacter baumannii
Imipenem-resistant
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI

Brief summary: Colonization with imipenem-resistant Acinetobacter baumannii (IBA) is an unfavorable event for the patient, especially in intensive care. Indeed, it exposes the patient to the risk of developing serious infections, extremely difficult to treat. ABRI is a particularly resistant bacterium in the environment. When an ABRI epidemic occurs in a department as central to the hospital as a surgical resuscitation department, the control of such an event can be extremely complex. There are few clear and detailed descriptions in the literature of how to manage this type of outbreak, let alone an ABRI outbreak of this magnitude.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Patient having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI (according to bacteriological results transmitted to the hygiene service).
* Subject having given his/her agreement, after information, for the reuse of his/her data for the purpose of this research

Exclusion criteria:

* Subject having expressed his opposition to participate in the study
* Subject under guardianship or curatorship
* Subject under legal protection

Primary outcomes:
measure: Retrospective description of the management of an imipenem-resistant Acinetobacter baumannii outbreak that occurred from 2015 to 2019 in a surgical intensive care unit
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Equipe opérationnelle d'hygiène - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02586740: Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Artery Stenosis
Tetralogy of Fallot
Pulmonary Atresia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals.

Brief summary: Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent pulmonary artery angioplasty during the period between October 1st 2010 and October 1st 2015 at NCH.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients who experience hemorrhage
timeFrame: During catheterization procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02703740: Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
Official title: Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aesthetics
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

Detailed description: Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale

Eligibility criteria: Inclusion Criteria:

* Is at least 19 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Has a WSRS score \> or = to 3 for both NLF
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months

Exclusion Criteria:

Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs

* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
* Is pregnant, lactating, or not using acceptable contraception.

Primary outcomes:
measure: Number and description of adverse events that are related to treatment
timeFrame: 1 month
Secondary outcomes:
measure: Number and description of adverse events that are related to treatment
timeFrame: 72h/3 months/6 Months/9 months/12 months
measure: Treatment efficacy assessed by WSRS
timeFrame: 1/3/6/9/12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: CREABIO
Study officials:
References:
Clinical trial NCT03997240: Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults
Official title: A Randomized Wait-list Control Trial Evaluating the Effect of Team-based Applied Clinical Neuroscience Care on Self-reported Symptoms of Depression and Cerebellar Function in Adults With Medication-resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.

Detailed description: Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. This research will provide an initial first step towards answering the following three research questions:

1. Does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression?
2. Does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population?
3. Are changes in dysmetria and balance control correlated with a change in depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* You are over the age of 18.
* You have been diagnosed with depression.
* You are currently taking medication for depression or have previously taken medication.
* You have been or were on your depression medication for at least 3 months.
* You feel/felt that the medication is/was not helping.

Exclusion Criteria:

* Had a lifetime history of severe neurologic or mental illness (e.g. schizophrenia or substance abuse)
* Are pregnant
* Have pending litigation or a recent history of spinal fracture, metastatic cancer, chiropractic care within the past month
* Present with contraindications to chiropractic care

Primary outcomes:
measure: P300 Auditory Evoked Potential task
timeFrame: 20 minutes
Secondary outcomes:
measure: Shift Balance Platform
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Marietta
country: United States
facility: NeuroLife Institute
state: Georgia
Study officials:
affiliation: Life University
name: Stephanie Sullivan, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172340: Diet and Exercise for Underserved Women
Official title: Behavioral/Support Intervention for Diet and Exercise Among Underserved Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: behavioral
diet
exercise
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.

Detailed description: Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.

Eligibility criteria: Inclusion Criteria:

* 25-50 years of age
* live in Census tracts with 25% or more below poverty in Columbia, SC
* waist circumference \>88 cm

Exclusion Criteria:

* insulin-dependent
* pregnant
* moderate exercise contraindicated
* not in control of food choices \[institutional setting or restricted diet\]
* uncontrolled hypertension
* weight \>430 pounds

Primary outcomes:
measure: body weight
timeFrame: one year
measure: waist circumference
timeFrame: one year
Secondary outcomes:
measure: dietary fat intake
timeFrame: one year
measure: saturated dietary fat intake
timeFrame: one year
measure: fruit and vegetable intake
timeFrame: one year
measure: dietary fiber intake
timeFrame: one year
measure: total energy intake
timeFrame: one year
measure: physical activity level
timeFrame: one year
measure: social support
timeFrame: one year
measure: healthy eating behaviors
timeFrame: one year
measure: exercise self-efficacy
timeFrame: one year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prevention Research Center, University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Patricia A Sharpe, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: