louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004797: Pilot Study of Fructose for Sickle Cell Crisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: disease-related problem/condition
genetic diseases and dysmorphic syndromes
hematologic disorders
pain
rare disease
sickle cell anemia
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2000-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis.

II. Obtain tolerability information in selected patients treated with fructose for more than 72 hours.

Detailed description: PROTOCOL OUTLINE: In the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. The dose of fructose is escalated in each successive group after tolerability data are evaluated.

In the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient. Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria.

Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell crisis requiring hospital admission Crisis began at least 12 hours prior to admission Medical records documenting sickle cell disease and previous crisis requiring hospital visit during the last 24 months available at study site No thalassemia No complex hemoglobinopathy involving thalassemia and sickle cell disease

--Patient Characteristics-- Renal: Creatine no greater than 2.2 mg/dL No requirement for regular dialysis Other: Weight above or below 30% of ideal body weight No fructose intolerance No insulin-dependent diabetes No HIV seropositivity No acquired immune deficiency syndrome (AIDS) or AIDS-related illness No general anesthetic for 7 days prior to and 2 days following entry Primary language allows communication with study staff Demonstration of ability to read and understand pain scales required Ability to identify crisis starting time accurately, i.e., to within 6 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shirley Ryan AbilityLab
name: David Green
role: STUDY_CHAIR
References:
Clinical trial NCT02156297: Sorafenib to Treat FLT3-ITD AML
Official title: Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
FLT3-ITD Mutation
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 100
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: Patients who diagnosed as AML with FLT3-ITD mutation and accepting the prescription of sorafenib.

Brief summary: It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is:

1. Definitely diagnosed as AML
2. FLT3-ITD mutation has been confirmed
3. Accepting the prescription of sorafenib


Eligibility criteria: Inclusion Criteria:

* Definitely diagnosed as AML
* FLT3-ITD mutation has been confirmed
* Accepting the prescription of sorafenib

Exclusion Criteria:

* Can not take drugs orally
* Can not follow the doctors' advices
* Other reasons that investigators considered as contra-indications for this study

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to 2 years
measure: Progress-Free Survival
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 2 years
measure: Leukemia-Free Survival
timeFrame: up to 2 years
measure: Median time to the onset of sorafenib resistance
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT03239197: Project SHARE (motherS Have All the Right microbEs)
Official title: An Exploratory Study to Evaluate the Transfer of the Maternal Microbial Consortia to Infants During and Following Birth
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Microbiota
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant mothers and their infants, planning a vaginal birth and breastfeeding as primary source of nutrition

Brief summary: This is an exploratory study designed to collect microbial samples from several body locations from 6 pairs of mothers and their newborn infants at various time points.


Eligibility criteria: Inclusion Criteria:

* Mother- pregnant female, singleton infant
* Infant- vaginal birth, breastfeeding as primary source of nutrition

Exclusion Criteria:

* Mother- antibiotic, steroid or antimicrobial use
* Infant- antibiotic, steroid or antimicrobial use

Primary outcomes:
measure: Maternal staphylococci is transferred to infant during and following birth.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Marshfield Clinic
name: Joseph Welter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
citation: Dowd SE, Sun Y, Wolcott RD, Domingo A, Carroll JA. Bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP) for microbiome studies: bacterial diversity in the ileum of newly weaned Salmonella-infected pigs. Foodborne Pathog Dis. 2008 Aug;5(4):459-72. doi: 10.1089/fpd.2008.0107.
citation: Capone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23.
citation: Mueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development: mom matters. Trends Mol Med. 2015 Feb;21(2):109-17. doi: 10.1016/j.molmed.2014.12.002. Epub 2014 Dec 11.
citation: Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.
citation: Madan JC, Farzan SF, Hibberd PL, Karagas MR. Normal neonatal microbiome variation in relation to environmental factors, infection and allergy. Curr Opin Pediatr. 2012 Dec;24(6):753-9. doi: 10.1097/MOP.0b013e32835a1ac8.
Clinical trial NCT02292797: Assessment of the Rosacea Prevalence in the General Population
Official title: Assessment of the Prevalence of Rosacea in the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Part I:

Subjects will be screened from the general population by questionnaires mainly focusing on detection of signs and symptoms of rosacea.

Subjects' answers will be submitted to a pre-defined algorithm to identify the potential subjects with rosacea (screened positive for rosacea, Screened R+).

Part II:

A subgroup of subjects (100 maximum per country) will be randomly selected among those who screened positive for rosacea and will be referred to the closest investigational site (dermatologist practice).

Brief summary: Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population.

Detailed description: Primary objective:

Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis

Eligibility criteria: Part I

Inclusion Criteria:

The following subjects will be included in the study:

* Subjects aged 18 to 65 years old from the general population
* Subjects who are willing to complete the questionnaires

Part II

Inclusion Criteria:

The following subjects will be included in Part II of the study:

* Subjects who screened positive for rosacea during the first part of the study and selected by random method
* Subjects who gave their informed consent to participate in Part II of the study

Primary outcomes:
measure: percentage of subjects with rosacea diagnosis confirmed
timeFrame: general population will be surveyed over an expected average duration of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Galderma R&D
name: Fabien AUDIBERT, Bsc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05542797: Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Official title: Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Miscarriage Threatening
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.

Detailed description: About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.

Eligibility criteria: Inclusion Criteria:

* pregnant women with threated miscarriage in the first trimester.

Exclusion Criteria:

* - pregnant women with abortus incipiens.

Primary outcomes:
measure: Miscarriage rate
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02056197: Influence of an Exercise for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain.
Official title: Influence of an Exercise Program for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain: Single-blind, Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Motor control exercises have demonstrated a good option for recovery from chronic low back pain. The purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface.

We hypothesized the unstable group will present pain reduction and functional improvement.


Eligibility criteria: Inclusion Criteria:

* Non-specific low back pain
* Sedentary
* Previous low back pain last 6 months

Exclusion Criteria:

* Traumatic, inflammatory, infectious or tumours etiology
* Positive neurological findings (leg pain)
* Pregnancy
* Previous spine or lower limb surgery
* Contraindicated for short-waves aplication

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Paulo RG Lucareli, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05603897: Non-standardized vs. Standardized Screening for Dysphagia
Official title: Utility of Non-standardized Clinical Swallow Evaluation vs. Standardized Swallow Evaluation to Identify the Presence of Dysphagia and Risk for Aspiration in Patients Post-ischemic Stroke in Acute Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Keywords: difficulty swallowing
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years old
* Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month
* Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone
* Able to read and comprehend verbal instruction in English and/or Spanish

Exclusion Criteria:

* Adults \> 80 years old
* Pregnant women
* Prisoners
* Those with a prior history of dysphagia
* Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury

Primary outcomes:
measure: Dysphagia measured by MASA
timeFrame: Up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lynn Rehabilitation Center / University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Gemayaret Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584597: A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
Official title: The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mucositis
Head and Neck Cancer
Keywords: Radiation-Induced Mucositis
Head and neck cancer
TRAUMEEL
Mucositis
Radiation
Oral cancer
Inflammation of the mouth
Homeopathic Medication
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 14
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: The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.

Detailed description: Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
* Patients undergoing planned radiation therapy
* Age 18 to 99
* Nonsmokers

Exclusion Criteria:

* Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
* Patients receiving adjuvant chemotherapy
* Pediatric patients (age \< 18)
* Pregnant women

Primary outcomes:
measure: The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Greg Krempl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01993797: Lung Ultrasound in Diagnosis and Management of Bronchiolitis Bronchiolitis
Official title: Lung Ultrasound: a Useful Tool in Diagnosis and Management of Bronchiolitis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Lead sponsor: S. Giacomo Hospital
Sponsor class: OTHER
Collaborators: name: University of Bari
First posted: 2013-11-25
Enrollment: 80
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children presented with signs suggestive of bronchiolitis

Brief summary: To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* children presented with signs suggestive of bronchiolitis

Exclusion Criteria:

* other major pathology

Primary outcomes:
measure: clinical and ultrasound findings
timeFrame: baseline
Secondary outcomes:
measure: ultrasound score for bronchiolitis and clinical outcome
timeFrame: baseline
Other outcomes:
Locations:
city: Monopoli
country: Italy
facility: S Giacomo Hospital
state: Bari
Study officials:
References:
citation: Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6.
citation: Basile V, Di Mauro A, Scalini E, Comes P, Lofu I, Mostert M, Tafuri S, Manzionna MM. Lung ultrasound: a useful tool in diagnosis and management of bronchiolitis. BMC Pediatr. 2015 May 21;15:63. doi: 10.1186/s12887-015-0380-1.
Clinical trial NCT06972797: Accuracy of 3D Slicer Software for Automatic Segmentation Versus Manual Segmentation Using Commercial Software to Evaluate Impacted and Unerupted Maxillary Canine: An Observational Study
Official title: Accuracy of the DentalSegmentator Tool in 3D Slicer Software Compared to Manual Segmentation in Romixes Software in the Evaluation of Unerupted and Impacted Maxillary Canine: An Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Impacted Canines
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: DICOM data will be collected from the data base anonymously

Brief summary: Our research question will be, can automatic segmentation of maxillary impacted and unerupted canine using DentalSegmentator tool in 3D silcer software be as accurate as manual segmentation?


Eligibility criteria: Inclusion Criteria:

Age ranges from 8-70y (from 8 to less than15y for unerupted group - from 15 to 70y for impacted group). b. Scans clearly showing unerupted and impacted maxillary canines.

Exclusion Criteria:

1. Scans with artifacts obscuring the area of interest.
2. Scans with fractures or pathological lesions obscuring the area of interest.
3. Image blurring due to patient movement during acquisition which could interfere with image interpretation.

Primary outcomes:
measure: 3D volume analysis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university- faculty of dentistry
state: القاهرة
Study officials:
References: