louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03999086: Thromboelastography-Guided Fluid Management in Spinal Surgery
Official title: Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Mayo Clinic receiving a multi-level spinal fusion surgery.

Brief summary: The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.

Detailed description: Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89

Exclusion Criteria:

* patients with tumors, infection, or trauma

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: post operative approximately 1 day
measure: Volume of transfused packed red blood cells
timeFrame: post operative approximately 1 day
measure: Adverse Events
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Jamal McClendon, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720586: Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
Official title: Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eyelid Diseases
Keywords: entropion
blepharoplasty
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 40
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: lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

Detailed description: traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

Eligibility criteria: Inclusion Criteria:

1. Lower eyelid involutional entropion
2. dermatochalasis

Exclusion Criteria:

1. Other eyelid disease,
2. Other causes of entropion
3. Previous eyelid surgery

Primary outcomes:
measure: Global Aesthetic Improvement Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benaha university faculty of medicine
name: Tarek R Elahamky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853086: Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
Official title: United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 139
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from speciality practice settings

Brief summary: This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Detailed description: Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

Eligibility criteria: Inclusion Criteria:

* All haemophilia A or B patients with inhibitors treated with NovoSeven are included

Exclusion Criteria:

* No exclusion criteria beyond the contraindications described in the approved product information text

Primary outcomes:
measure: Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes.
timeFrame: Assessments at 6 month intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01057186: Hypophosphatemic Rickets in Norway
Official title: Hypophosphatemic Rickets in Norway
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypophosphatemia, Familial
Rickets
Hyperphosphatemia
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohorts will be selected from Norwegian patients with hypophosphatemia and hyperphosphatemia.

Brief summary: The purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and hyperphosphatemia.


Eligibility criteria: Inclusion Criteria:

* All patients in the Norwegian population with hereditary hypophosphatemia, with or without rickets
* Patients in the Norwegian population with hereditary hyperphosphatemia

Exclusion Criteria:

-

Primary outcomes:
measure: Growth
timeFrame: Up to 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Childrens departement
Study officials:
affiliation: Haukeland University Hospital, Pediatric department
name: Robert Bjerknes, Professor, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05577286: Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
Official title: Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes mellitus
type 1 1 Diabetes mellitus
plyometric exercises
balance
muscle strength
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.

Detailed description: We still lack the evidence of plyometric exercises in pediatric population with Diabetes mellitus . Therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 Diabetes mellitus

Eligibility criteria: Inclusion Criteria:

* Age will range from six to 10 years
* Both sexes
* Chronicity of the disease ranges from 3 to \<5 years.
* Controlled diabetes with insulin dosage described by physician.

Exclusion Criteria:

* Heriderty sensory or autonomic peripheral neuropathy.
* Unstable cardio-vascular disorders
* History of fractures or surgery in the lower extremities in the past 12 months.
* Diagnosed with other hormonal diseases.
* Children who practice regular sports.

Primary outcomes:
measure: muscle strength
timeFrame: after 3 successive months
measure: balance
timeFrame: after 3 successive months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: Doaa A Mahmoud Sanad, Phd
role: STUDY_CHAIR
affiliation: Cairo university, faculty of physical therapy
name: Samya M Aly Hussein, B.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo university, faculty of physical therapy
name: Aboalnaga A Abdelrahim Hamed
role: STUDY_DIRECTOR
References:
Clinical trial NCT04425486: Parents' Knowledge Toward Pediatric Dentistry
Official title: Parents' Knowledge, Attitudes &Awareness Toward Pediatric Dentistry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parents' Knowledge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children(aged 3-12 years)

Brief summary: The aim of the study is to assess the Parents' Knowledge, Attitudes \&Awareness toward Pediatric Dentistry.

Detailed description: Primary teeth are the valuable assets of a child. In children, milk teeth/primary teeth play a vital role for eating, phonetics and esthetics. Primary teeth are also essential in the development of the mouth. They maintain the arch length within the jaw and provide guides for the eruption pathway of the permanent teeth.

Problems in primary teeth in the form of pain and swelling can cause distress to the child, leading to inability to chew or speak properly and even may affect the appearance of a child. Premature loss of primary teeth can cause an earlier eruption of permanent successors and interfere with the harmony of adult dentition resulting in crowding caused by shifting and or drifting of the teeth toward the extraction space. Moreover, psychological, morphological and functional problems may result from premature loss of primary teeth.

Most parents are unaware of the role a pediatric dentist plays in their child's life, and the importance of dental visits at an early age is underestimated as most believe that the milk teeth are going to exfoliate and it not worth paying much attention to. Even if a parent is recommended to take the child to a pediatric dentist, many may not consider doing the same since awareness of importance of primary teeth is less.

Eligibility criteria: Inclusion Criteria:

* Parents of children aged 3 years- 12 years.
* Children with no previous dental treatment.
* Healthy children without any systemic diseases.

Exclusion Criteria:

* Refusal of participations.

Primary outcomes:
measure: Parents' Knowledge, Attitudes &Awareness toward Pediatric Dentistry
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04145986: Evaluation of Prognostic Monitoring for Young Breast Cancer Patients
Official title: Evaluation of Prognostic Monitoring for Young Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 200
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients with ages equal 35 or below.

Brief summary: The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment for young ladies will be studied.

Detailed description: 200 patients younger than 35 with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female
* invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump
* Breast cancer-related chemotherapy and radiotherapy completed
* Young ladies with ages equal 35 or below

Exclusion Criteria:

* Male
* Aged above 35
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient

Primary outcomes:
measure: immune inflammation-related protein complexes
timeFrame: 2 years
measure: blood markers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shi Na
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03238586: HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
Official title: HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: hiv
aids
alcohol
health
knowledge
motivation
skills
behavior
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-08-03
Enrollment: 232
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: A clinical study for patients with HIV that investigates the best way to reduce HIV transmission risk, and to improve the overall health of people living with HIV/AIDS. Participants will complete four assessments over the course of one year and will be randomly assigned to a five-week treatment program.

Detailed description: The main purpose of this research study is to investigate the best way to reduce HIV transmission risk and to improve the overall health of people living with HIV/AIDS. This study tests an intervention program that aims to improve knowledge, motivation, and skills. The intervention program is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* Recent alcohol use

Exclusion Criteria:

-

Primary outcomes:
measure: Viral load
timeFrame: Change from baseline at 3 months, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: University Medical Center New Orleans Infectious Disease Services
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center
name: Patricia Molina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638386: Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery
Official title: Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee
Complication of Surgical Procedure
Keywords: Robotic-assisted surgery
Bone plug
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent robotic-assisted total knee arthroplasty in the RHOC between December 2020 and October 2022

Brief summary: Introduction: Complications of robotic-assisted total knee arthroplasty (TKA) seem to be rare and consist mainly of infections or fractures. In the Reinier Haga Orthopedisch Centrum (RHOC), postoperative bleeding is experienced to be a complication that often occurs, mainly at the tibial wounds of the registration pins used in robotic-assisted TKA. This often results in longer hospital stay and might interfere with the current fast track knee surgery by a delayed discharge. To overcome this complication, nowadays bone plugs are used in the two drill-holes. Currently, it is unknown whether these bone plugs reduces the incidence of postoperative bleeding.

Objective: To evaluate the incidence of postoperative bleeding in patients that underwent a robotic-assisted TKA and received bone plugs in the two drill-holes in the tibia, compared to patients that underwent the same operation but did not receive bone plugs.

Study design: Retrospective, inventory study

Study population: All patients that underwent a robotic-assisted TKA in the RHOC from December 2020 till October 2022.

Intervention: In the past, some patients that underwent a robotic-assisted TKA received a bone plug in the two tibial drill-holes. This bone is collected from the excess bone that is removed during the operation.

Main study parameters/endpoints: Incidence of postoperative bleeding in both groups.


Eligibility criteria: Inclusion Criteria:

* Underwent robotic-assisted total knee arthroplasty between December 2020 and October 2022 with or without the use of bone plugs
* Does not object against use of medical data

Primary outcomes:
measure: Number of patients with postoperative bleeding
timeFrame: December 2020 - October 2022
Secondary outcomes:
measure: Length of hospital stay
timeFrame: December 2020 - October 2022
measure: Complications
timeFrame: December 2020 - October 2022
measure: Reasons which might lengthen hospital stay
timeFrame: December 2020 - October 2022
Other outcomes:
Locations:
city: Zoetermeer
country: Netherlands
facility: RHOC
state: Zuid- Holland
Study officials:
References:
Clinical trial NCT04460586: Pharmacokinetics of Omadacycline in Cystic Fibrosis
Official title: Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Paratek Pharmaceuticals Inc
First posted: 2020-07-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.

Detailed description: Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential source of lung infection in CF patients. As omadacycline demonstrates antimicrobial activity against a number of pathogens in CF, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with CF in the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with CF.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CF based on positive sweat chloride or known CF mutation
* Age \>=18 years

Exclusion Criteria:

* Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs \& symptoms and an acute decline in relative FEV1 of 10% or greater.
* Pregnancy or breastfeeding
* Serious past allergy to a tetracycline antibiotic
* No alcohol, nicotine, or caffeine-containing products during the study period
* Hemoglobin \< 8 g/dL

Primary outcomes:
measure: Cmax
timeFrame: 3 Days
measure: Tmax
timeFrame: 3 days
measure: AUC
timeFrame: 3 days
measure: Absolute Bioavailability
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: Keck Medicine of USC
name: Adupa P Rao, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00485186: Gene Polymorphisms Influencing Steroid Synthesis and Action
Official title: Investigation of Gene Polymorphisms Influencing Steroid Synthesis and Action in Patients With Deficient Steroid Biosynthesis and Disorders of Sex Development
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorders of Sex Development
Congenital Adrenal Hyperplasia
Congenital Adrenal Hypoplasia
Adrenal Insufficiency
Mineralocorticoid Deficiency
Intersex
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Disorders of Sex Development
* Congenital Adrenal Hyperplasia
* Congenital Adrenal Hypoplasia
* Adrenal Insufficiency
* Mineralocorticoid Deficiency
* Salt-loss

Brief summary: The extend of steroid biosynthesis and action is mainly dependent on underlying genetic polymorphisms and gene mutations. These sequence variations in multiple genes involved in steroid biosynthesis and action cause different diseases (for example congenital adrenal hyperplasia or disorders of sex development). In addition, sequence variations in several other genes may influence the severity of a genetically caused disease of steroid biosynthesis or action. By this, the differences in an observed phenotype may be explained. Within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several genes which are known to influence the action of steroid hormones will be analysed in patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of steroid action and disorders of sex development. The primary aim is to set up a correlation of the disease phenotype with the different genotypes detected.


Eligibility criteria: Inclusion Criteria:

* Disorders of Sex Development
* Congenital Adrenal Hyperplasia
* Congenital Adrenal Hypoplasia
* Adrenal Insufficiency
* Mineralocorticoid Deficiency
* Salt-loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Paul-Martin Holterhus, MD
role: STUDY_CHAIR
affiliation: University Hospital Schleswig-Holstein
name: Felix G Riepe, MD
role: PRINCIPAL_INVESTIGATOR
References: