louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03496753: Effect of LED Therapy for Treatment Nipple Fissure
Official title: Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nipple Disorder
Keywords: nipple fissure
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain.

Detailed description: Nipple fissures are the second major cause of the discontinuation of breastfeeding, following a sensation of insufficient milk, which leads to bottle feeding. Poor positioning of the child in relation to the breast, an inadequate frequency or duration of breastfeeding and improper suckling are the main causes of nipple fissure. Discontinuing breastfeeding deprives the infant of essential nutrients and also deprives the mother of certain health benefits. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures.

The aim of this study is to evaluate LED therapy in treatment of nipple fissures

Eligibility criteria: Inclusion Criteria:

1. Nursing mothers aged 18 years or older
2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales
3. Having given birth to a healthy, full-term child
4. Performing exclusive breastfeeding
5. Newborn with no oral, palatal or maxillofacial abnormalities
6. Newborn weighing between 2500 and 4000 grams

Exclusion Criteria:

1. History of psychological disorder
2. Presence of mastitis
3. Bacterial or fungal infection in breasts
4. Use of breast pump or plastic nipple

Primary outcomes:
measure: Nipple fissure
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Mandaqui Hospital
state: Sao Paulo
Study officials:
References:
Clinical trial NCT06589453: Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants
Official title: Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cleft Lip and Cleft Palate
Keywords: Cleft lip and palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.

Detailed description: The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.

Eligibility criteria: Inclusion Criteria:

* Non-syndromic Infants with complete BCLP infants
* Infants less than 1 month of age.
* Males and females.
* Infants with displaced premaxilla
* Patients whose parents provided written consent for the study.

Exclusion Criteria:

* Patients above 1 month of age.
* Syndromic and systemically ill infants.
* Patients with unilateral cleft lip and palate.
* Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
* Medically compromised patients
* Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.

Primary outcomes:
measure: Nasolabial esthetics
timeFrame: 4-6 months
Secondary outcomes:
measure: Maxillary arch changes
timeFrame: 4-6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04837053: Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)
Official title: An Individualized Decision Aid for Physicians and Patients for Total Knee Replacement in Osteoarthritis (Value-based TKR): Study Protocol for a Multi-center, Stepped Wedge, Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthroplasty, Replacement, Knee
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany
First posted: 2021-04-08
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty.

Detailed description: The tool will guide the SDM process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. Furthermore, it will present health information about knee replacement to empower the patient. To investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT) design.

Eligibility criteria: Inclusion Criteria:

* patient with knee osteoarthritis who are candidates for knee replacement
* capacity to consent
* understanding of the German language (written and oral)
* age of 18 years or older
* informed consent

Exclusion criteria:

* meeting not all inclusion criteria

Primary outcomes:
measure: Decision quality
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Fulfillment of patient expectations
timeFrame: 12 months
measure: Oxford Knee Score (OKS)
timeFrame: 12 month
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden
state: Saxony
Study officials:
affiliation: TU Dresden
name: Jörg Lützner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lange T, Deckert S, Beyer F, Hahn W, Einhart N, Roessler M, Sedlmayr M, Schmitt J, Lutzner J. An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial. BMC Musculoskelet Disord. 2021 Sep 12;22(1):783. doi: 10.1186/s12891-021-04546-5.
Clinical trial NCT04102553: F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
Official title: Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Cancer Recurrent
Lead sponsor: ABX advanced biochemical compounds GmbH
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


Eligibility criteria: Inclusion Criteria:

* male with original diagnosis of prostate carcinoma with prior definitive therapy
* suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
* life expectancy of 6 months or more as judged by the investigator
* willing and able to undergo all study procedures
* informed consent in writing (dated and signed)

Exclusion Criteria:

* age: less than18 years
* contraindications for F-18-Fluorocholine
* contraindications for any of the ingredients of F-18-PSMA-1007
* close affiliation with the investigational site; e.g. first-degree relative of the investigator
* at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
* having been previously enrolled in this clinical trial
* mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
* being clinically unstable or requiring emergency treatment
* being considered a vulnerable person

Primary outcomes:
measure: To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
timeFrame: Within 6 months after PET/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin Clermont-Ferrand
city: Lyon
country: France
facility: Centre Léon Bérard LUMEN
city: Nancy
country: France
facility: Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04983953: Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
Official title: An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hemorrhages
Lead sponsor: Heuron Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 236
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (1) Adults over 19 years old (2) Brain CT images acquired (3) who confirmed with intracranial haemorrhage(abnormal cohort) or not intracranial haemorrhage or normal(normal cohort)

Brief summary: cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.


Eligibility criteria: Inclusion Criteria:

* Adults over 19 years old
* Brain CT acquired
* Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
* Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan

Exclusion Criteria:

* Patients with brain tumor or cerebral toxoplasmosis
* Patients with brain abscess or brain calcification
* Poor or incomplete brain CT image quality

Primary outcomes:
measure: Sensitivity and specificity of cHS
timeFrame: Within 4 weeks after collecting data
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
References:
Clinical trial NCT04077853: Progesterone in Expectantly Managed Early-onset Preeclampsia
Official title: Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

Detailed description: Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment

Eligibility criteria: Inclusion Criteria:

* Gestational age between 20+0 and 33+6 weeks.
* Singleton pregnancy.
* Willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
* Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
* Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
* Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
* Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
* Severe Oligohydramnios (AFI \< 5cm)
* Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
* Eclampsia;
* Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
* Intrauterine fetal death.
* Patient is unable or unwilling to give consent.
* Patients currently using progesterone for other indications.

Primary outcomes:
measure: The mean difference between blood pressure measurements in both groups
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT01740453: Effect of Interscalene Block on Ventilatory Function
Official title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Depression
Anesthesia Morbidity
Block
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (\< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

Detailed description: Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.

Eligibility criteria: Inclusion Criteria:

* surgery : scheduled for elective shoulder surgery
* available for 1 month of follow up
* physical status : 1, 2, 3

Exclusion Criteria:

* body mass index \> 35
* contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
* vital capacity less than 1.5 liters
* cardiac or renal insufficiency
* physical status \>3, pregnant, weigh less than 50 kg

Primary outcomes:
measure: Reduction of the pulmonary forced vital capacity
timeFrame: Day 2
Secondary outcomes:
measure: Reduction of the pulmonary maximum forced expiratory flow
timeFrame: Day 2
measure: Morphine consumption
timeFrame: Day 2
measure: Pain score at rest and motion
timeFrame: Day 2
Other outcomes:
measure: Duration of sensory interscalene block
timeFrame: Day 2
Locations:
city: Paris
country: France
facility: Centre hospitalier La Pitié Salpetriere
state: Ile de France
Study officials:
affiliation: Caremeau Hospital, Nimes, France
name: Philippe Cuvillon, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333853: Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm)
Official title: Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).


Eligibility criteria: Inclusion Criteria:

* Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%.
* The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs).
* The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment).
* Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own.

Exclusion Criteria:

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Measured hypoglycemia
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Los Angeles
country: United States
facility: Children's Hospital, Los Angeles
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Portland
country: United States
facility: Radiant Research
state: Oregon
Study officials:
affiliation: Joslin Diabetes Center
name: Lori Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laffel LM, Hsu WC, McGill JB, Meneghini L, Volkening LK. Continued use of an integrated meter with electronic logbook maintains improvements in glycemic control beyond a randomized, controlled trial. Diabetes Technol Ther. 2007 Jun;9(3):254-64. doi: 10.1089/dia.2006.0021.
Clinical trial NCT02732353: Absorption and Muscle-stimulating Effect of Hydrolyzed and Minced Beef
Official title: Absorption and Muscle-stimulating Effect of Hydrolyzed and Minced Beef
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meat Protein Supplements
Protein Absorption and Amino Acid Availability
Muscle Protein Synthesis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein synthetic response is measured and compared during the early postprandial period (0-3 hours) after ingestion of the two meat products.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-obese (BMI\<30)

Exclusion Criteria:

* Chronic medical disease
* \>5 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation

Primary outcomes:
measure: Change in skeletal muscle protein fractional synthetic rate
timeFrame: During the postprandial period (0-3 hrs).
Secondary outcomes:
measure: Protein absorption
timeFrame: During the postprandial period (0-3 hrs).
measure: Plasma amino acid concentration
timeFrame: During the postprandial period (0-3 hrs).
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Kasper Dideriksen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Lars Holm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Søren Reitelseder, PhD
role: PRINCIPAL_INVESTIGATOR
References: