louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00213863: Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
Official title: Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vocal Cord Paralysis
Keywords: porous titanium implants
thyroplasty
vocal cord paralysis
male or female more than 18 years old
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.


Eligibility criteria: Inclusion Criteria:

* Males or females greater than 18 years old

Exclusion Criteria:

* Age less than 18 years
* Pregnant women
* Local carcinoma excluding radiotherapeutic or surgical control
* Bad general condition
* Contraindication to general anesthesia
* Non-controlled diabetes

Primary outcomes:
measure: Nasofibroscopy
timeFrame: 8 days and 3 months after surgery
measure: Voice control and recording
timeFrame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
measure: All types of complication
timeFrame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Christian Debry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03921463: Changes of Pelvic Floor Functions in Women at Different Postpartum Time
Official title: the Key Laboratory of Female Pelvic Floor Disorders Diseases, Beijing, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Disorders
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy postpartum women

Brief summary: The main purpose of this study was to observe the pelvic floor muscle strength abnormalities of cesarean section and vaginal delivery at different time points within six months after delivery without any intervention. It was a prospective observational study, and the main study population was healthy postpartum women. Regular follow-up was conducted at 6 weeks, 9 weeks, 3 months, 4 months, 5 months and 6 months postpartum. The follow-ups included gynecological examination, pelvic floor electrophysiological indexes (category I and II muscle fiber strength and fatigue), questionnaire (ICI- Q-SF, OABSS, UDI-6), and pelvic floor ultrasound. The incidence of pelvic floor muscle strength abnormality at different postpartum time points was statistically analyzed, the high-risk factors of postpartum pelvic floor function abnormality caused by pregnancy and delivery were analyzed, and the general rules of the natural development of pelvic floor function were observed.


Eligibility criteria: Inclusion Criteria:

* 1)Age: 20 \~35 years old; 2) first parturients registered in the obstetrics department of our hospital; 3) no medical complications before pregnancy, no UI and POP (according to the standard of POP-Q stage); 4) no obstetric complications; 5) the patients agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

* 1) patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity shall be determined by the researcher to affect clinical research compliance; 2) follow up the patients with difficulty.

Primary outcomes:
measure: Incidence of pelvic floor muscle strength abnormality at different postpartum time
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03479463: Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
Official title: A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Larynx Cancer
Pharynx Cancer
Pharyngocutaneous Fistula
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-center, matched case registry. The medical records of approximately 40 patients meeting all documentation and eligibility requirements will comprise the retrospective cohort. A total of 40 subjects will be enrolled prospectively at Mount Sinai Hospital. It is expected that the majority of the subjects will be recruited through the investigators' standard admission practices. All subjects selected for the study will not be excluded because of race or ethnicity and all efforts will be made to adequately represent the patient population in the area in which they are chosen.

Brief summary: This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.

Detailed description: This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.

Eligibility criteria: Inclusion Criteria:

1. Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
2. Subject is age 18 or older
3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

1. Subjects currently enrolled in or planning to enroll in another clinical trial
2. Subjects with a known history of poor compliance with medical treatments
3. Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
4. Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
5. Subject has undergone previous pharyngeal reconstructive surgery
6. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

Primary outcomes:
measure: Incidence of Pharayngocutaneous Fistula Development (PCF)
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Brett Miles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946763: Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?
Official title: Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Procare Riaya Hospital
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications).

In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.

Detailed description: The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.

Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.

Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.

Recovery assessment and data recording is done by a blinded anesthesiologist.

Eligibility criteria: Inclusion Criteria:

* Adults more than 18 years old.
* ASA 2.
* BMI more than 35.
* scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.

Exclusion Criteria:

* Renal impairment.
* Hepatic dysfunction.
* Alcohol or drug abuse.
* Disabling Central nervous or cerebrovascular diseases.
* Treatment with opioids or any psychoactive medication.
* Inappropriate Mini mental state exam.

Primary outcomes:
measure: Quality of anesthesia recovery
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alkhobar
country: Saudi Arabia
facility: Procare Riaya Hospital
state: Eastern Province
Study officials:
affiliation: Procare Riaya Hospital
name: Ahed Zeidane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01517763: Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure
ICON
ThermoSmart
SensAwake
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Sleep Health Centers
First posted: 2012-01-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
* Successful titration Polysomnography (PSG).
* Fluency in both written and spoken English.

Exclusion Criteria:

* Participants prescribed and fitted with any PAP device in the past 2 years.
* Contraindicated for CPAP or AutoCPAP therapy.
* Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
* Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
* Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
* If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
* If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
* If the physician objects to their patient taking part in the study.

Primary outcomes:
measure: Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
timeFrame: On day 90 after randomization
Secondary outcomes:
measure: Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
timeFrame: On day 90 after randomization
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Sleep HealthCenters
state: Massachusetts
Study officials:
References:
Clinical trial NCT03517163: Boston Outcomes of Autism in Toddlers Study
Official title: The Boston Outcomes of Autism in Toddlers Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Autism
Keywords: Asperger's
autism
autism spectrum disorder
ASD
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 225
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.

Brief summary: The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities.

Detailed description: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in domains of social communication and restrictive and repetitive behavior. There is general agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should be diagnosed as early as possible since young toddlers are at a critical stage in early development when intervention is theoretically most effective. The rate of persistence of an ASD diagnosis is heavily debated.Therefore this study attempts:

1. To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and functional outcomes, as defined by cognitive level, adaptive functioning, language skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among children who received a DSM-5 ASD diagnosis at \< 36 months.
2. To evaluate predictors of rate of persistence and functional outcomes among kindergarten grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
* Enrolled in or just finished Kindergarten

Exclusion Criteria:

* Individuals with known genetic disorders including, but not limited to, Fragile X syndrome, Down syndrome, Tuberous Sclerosis Complex and those with 16 p deletions/duplications.

Primary outcomes:
measure: ASD Symptomatology
timeFrame: 3 years (Age of diagnosis to Kindergarten Age)
measure: Cognitive Level
timeFrame: 3 years (Age of diagnosis to Kindergarten Age)
measure: Language Level
timeFrame: 3 years (Age of diagnosis to Kindergarten Age)
measure: Adaptive Functioning
timeFrame: 3 years (Age of diagnosis to Kindergarten Age)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Pediatrician/Researcher
name: Elizabeth Harstad, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06248463: Blood Pressure Assessment in Waiting Room During Pregnancy
Official title: Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertension
Pregnancy Induced Hypertension
Keywords: Hypertension in pregnancy.
Blood Pressure measurement.
Lead sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Sponsor class: OTHER
Collaborators: name: University of Salamanca
First posted: 2024-02-08
Enrollment: 659
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with suspected hypertension

Brief summary: The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are:

Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM).

Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes.

Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.

Detailed description: 659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval \>10 years).

Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.

BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. The SBP and DBP results obtained in the waiting room will be compared with the ABPM results.

Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.

Eligibility criteria: Inclusion Criteria:

Woman during the first 12 weeks of pregnancy Maternal age\>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI\>30. Hyperglycemia Renal disease

Exclusion Criteria:

Any inability to perform 24-h ambulatory BP measurement

Primary outcomes:
measure: Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)
timeFrame: 10 mounths
measure: Maternal
timeFrame: 10 months
measure: Newborn
timeFrame: 10 monts
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00206063: Long Term Open Follow-up With H376/95 vs. Warfarin
Official title: Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke Prevention in Patients With Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion Criteria:

* Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency

Primary outcomes:
measure: Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Research Site
state: California
city: Oostduinkerke
country: Belgium
facility: Research Site
city: Helsingor
country: Czech Republic
facility: Research Site
city: Most
country: Czech Republic
facility: Research Site
city: Plzeo
country: Czech Republic
facility: Research Site
city: Poibram
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Arhus
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Savonlinna
country: Finland
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Siedice
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
Study officials:
References:
Clinical trial NCT00172263: The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Severe Acute Respiratory Syndrome
Keywords: Immunology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%.

After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV).

Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.


Eligibility criteria: Inclusion Criteria:

* Healthy adults, children and cord blood

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: China
facility: Li-Chieh Wang, MD
state: Taiwan
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Chieh Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: