louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02801201: Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation
Official title: Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breech Presentation
Keywords: sedation
spinal anesthesia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
* covered by a an insurance system
* signed contentment

Exclusion Criteria:

Obstetric contraindications:

* placenta previa
* 3rd trimester bleeding
* suspicion of fetal anoxia
* patient has already received more than one caesarean section
* multi-fetal pregnancy
* HIV +
* anticoagulant therapy

Anesthesiologic contraindications:

* infection at the puncture site, systemic infection or severe sepsis
* intracranial hypertension
* uncompensated heart failure
* constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent
* neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery
* syringomyelia

Primary outcomes:
measure: Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
timeFrame: 24 hours
Secondary outcomes:
measure: occurrence of side events due to the manipulation itself
timeFrame: Day 0
measure: occurrence of side events due to anesthesia
timeFrame: Day 0
measure: The pain experienced by the patient: assessed by the Visual Analogic Scale
timeFrame: Day 0
measure: The final delivery mode (caesarian section or vaginal)
timeFrame: Day 0
measure: The presentation in childbirth
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Julien CHEVREAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711501: Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: post-operative pain
diode laser
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

Detailed description: Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.

Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.

Eligibility criteria: Inclusion Criteria:

* patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR

Exclusion Criteria:

* general contraindication for bone augmentation or implant surgeries,
* existence of swelling or pain at the time of surgery,
* smoking habits, pregnancy, and lactation.

Primary outcomes:
measure: post-operative swelling intensity
timeFrame: Within the first 6 days after surgery
Secondary outcomes:
measure: post-operative pain intensity
timeFrame: Within the first 6 days after surgery
measure: implant success
timeFrame: 3 months later
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
city: Tehran
country: Iran, Islamic Republic of
facility: Neda Moslemi
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT04210401: Reusable Duodenoscope Culture Registry
Official title: Registry of Culture Results From Reusable Duodenoscopes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Endoscopy
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data will be collected from patient who have a endoscopic retrograde cholangiopancreatography procedure at the Center for Interventional Endoscopy.

Brief summary: This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing.

Detailed description: This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing. This information will allow us to elucidate the number of endoscopic procedures that can be performed using a single duodenoscope until microorganisms are cultured from duodenoscopes after standard of care cleaning and reprocessing. This will in turn allow us to improve the delivery of healthcare to patients undergoing endoscopic procedures.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Any patient undergoing endoscopic retrograde cholangiopancreatography procedure using a reusable duodenoscope

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Microorganism Growth
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
state: Florida
Study officials:
affiliation: AdventHealth Orlando
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04595201: Clinical Follow-up of Pregnant Subjects Undergoing NIPT
Official title: Clinical Follow-up of Pregnant Subjects Undergoing NIPT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Integrated Genetics
First posted: 2020-10-20
Enrollment: 25000
Sex: FEMALE
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: The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.

Brief summary: To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

Detailed description: To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.

Eligibility criteria: Inclusion Criteria:

* Subject was pregnant and received NIPT from Sequenom/Integrated Genetics
* Subject was 18 years of age or older at the time of NIPT
* Pregnancy outcome is available

Exclusion Criteria:

* None

Primary outcomes:
measure: NIPT clinical outcome performance
timeFrame: 9 months
measure: NIPT clinical outcome performance
timeFrame: 9 months
measure: NIPT clinical outcome performance
timeFrame: 9 months
measure: NIPT clinical outcome performance
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Westborough
country: United States
facility: Integrated Genetics
state: Massachusetts
Study officials:
affiliation: Integrated Genetics
name: Kimberly Fanelli, MS, CGC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06103201: Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
Official title: Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI.

The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study.

Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).


Eligibility criteria: Inclusion Criteria:

* History of acute head injury with or suspected non-penetrating acute TBI
* Suitable to undergo contrast-enhanced MRI
* Negative serum pregnancy test

Exclusion Criteria:

* Inability to undergo MRI scan
* Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
* Positive pregnancy test

Primary outcomes:
measure: Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)
timeFrame: within two years post enrollment
Secondary outcomes:
measure: Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.
timeFrame: within two years post enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Dirk Mayer, Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939401: A Study Regarding Tissue Response During and After Treatment for Anal Cancer
Official title: ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies from Anal Cancer in Predicting Response and Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer
Keywords: Anal cancer, Tumour micro environment, Chemoradiotherapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2023-07-11
Enrollment: 400
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 referred to Sahlgrenska University Hospital with anal cancer

Brief summary: The aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining:

* The tumour microenvironment
* The localisation of and cellular interactions between the tumour and immune cells
* The gene and protein expression by cells present in the tumour and surrounding tissue.

Detailed description: All adult patients with anal cancer presenting within the Sahlgrenska University Hospital catchment area or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. The patients that are newly diagnosed or that have a suspected recurrence will be offered to enter the study with biopsies as well as blood samples during the diagnostic examination that is performed under anaesthesia. Biopsies will then be taken during follow-up exams if applicable. Biopsies will also be taken during surgery if that is scheduled and in cases where surgery is not necessary biopsies will be taken if the patient undergoes examinations under anaesthesia after treatment cessation.

If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or recurrent anal cancer

Exclusion Criteria:

* No diagnosis of anal cancer, contraindication to biopsies and blood samples

Primary outcomes:
measure: Tumour micro environment
timeFrame: 2024-2029
measure: ctDNA
timeFrame: 2024-2029
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT03689101: The Relationship Between CD138 Count of Endometrium and Reproductive Outcome
Official title: To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 148
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear.

Firstly, This study aims to explore the relationship between endometrial CD138 count and pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the investigators want to find a cut-off value which is related to reproduction outcome.


Eligibility criteria: Inclusion Criteria:

* age between20 and 38 years;
* regular menstrual cycles;
* body mass index (BMI) ranged from 18 to 25

Exclusion Criteria:

* uterine abnormalities;
* intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids \>4.0 cm and/or endometrial pressure)

Primary outcomes:
measure: CD138 counting
timeFrame: 7 days after LH surge (LH+7)
measure: clinical pregnancy rate
timeFrame: about 28 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Fei Gong, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933101: Vascular Inflammation in Adolescents With Type 1 Diabetes
Official title: Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Coronary Artery Disease
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Endocrinology clinic

Brief summary: The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.

Detailed description: Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.

Eligibility criteria: Inclusion Criteria:

* Adolescents ages 12-18 years
* Tanner stage III-V
* T1DM \> 2 years
* HgbA1c \<8 or \>10 for previous 2 years

Exclusion Criteria:

* Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
* Family history of premature cardiovascular disease
* Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
* Anemia defined as Hgb \<11.0 g/dl
* ADHD
* Congenital heart disease
* Pituitary tumor
* Known allergy to ultrasound gel
* Recent head injury
* Chromosomal abnormalities

Primary outcomes:
measure: Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
timeFrame: 1 year
Secondary outcomes:
measure: To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM
timeFrame: 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Ghufran Babar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035901: Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial
Official title: Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elementary Students With Handwriting Difficulties
Keywords: handwriting, legibility, visual perception, occupational therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will focus on (1) developing the Chinese characteristic-based VMI-focused program, namely visual-perception motor-coordination integration program (CCVPMCI) involving the most Chinese-handwriting-related skills training and (2) investigating the effectiveness of the CCVPMCI program on handwriting performance in children with handwriting difficulties in Taiwan.


Eligibility criteria: Inclusion Criteria:

1. poorer handwriting performance than the peers referred from teachers.

Exclusion Criteria:

1. severe neurological or pervasive developmental disorders that might directly impeded writing
2. intellectual disability that might directly impeded writing
3. musculoskeletal, or sensory (hearing, vision) disorders that might directly impeded writing
4. difficulty in reading or expressing

Primary outcomes:
measure: The change from baseline Chinese Legibility Scale (CLS) at one month and six months
timeFrame: baseline, one month, six months
measure: The change from baseline Chinese Handwriting Evaluation Form (CHEF) at one month and six months
timeFrame: baseline, one month, six months
Secondary outcomes:
measure: The change from baseline Developmental Test of Visual Perception - Third Edition (DTVP-3) at one month and six months
timeFrame: baseline, one month, six months
measure: The change from baseline Beery-Buktenica Developmental Test of Visual-Motor Integration at one month and six months
timeFrame: baseline, one month, six months
measure: Pediatric Motivation Questionnaire (PMQ)
timeFrame: through study completion, an average of one month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Department of Occupational Therapy
Study officials:
References: