louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04863937: Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance
Official title: Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Control
Keywords: Dynamic Knee Stability
Lead sponsor: Spalding University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)).
Primary purpose: PREVENTION

Brief summary: This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared to the standard knee sleeve and no device groups.

Detailed description: Eighteen healthy college athletes participated in this prospective cohort study with a randomized device order. FPPA was measured during single leg triple hop for distance using two-dimensional biomechanical techniques to estimate dynamic knee valgus loading. A 10-cm visual analog scale survey collected data regarding subject perceived knee control, sports movement capability and overall satisfaction for each condition. Pearson correlations delineated knee valgus, safety and performance relationship perceptions (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Healthy women
* College athletes
* ≥ 18 years

Exclusion Criteria:

* Knee injury history
* Any current lower extremity injury

Primary outcomes:
measure: Frontal Plane Knee Projection Angle
timeFrame: Immediately after the intervention
measure: Subject Confidence in Sports Safety and Performance Perceptions
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Charities College of Health and Natural Sciences
state: Kentucky
Study officials:
affiliation: Spalding University
name: John Nyland
role: STUDY_DIRECTOR
References:
Clinical trial NCT02339337: A Pilot Study To Evaluate the Efficacy of Response Guided Therapy of Peginterferon Alfa Plus Ribavirin in the Treatment of Patients With HCV/HBV Co-Infection
Official title: A Randomized-Controlled, Comparative Study, To Evaluate the Efficacy of Tailored Regimen of Peginterferon Alfa Plus Ribavirin According to Rapid Virological Response and Baseline Viral Loads in the Treatment of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection: A Pilot Study (Pioneer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HBV/HCV Co-infection
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 203
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: This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects were randomized into 2 groups at treatment initiation. Subjects who were randomized into the genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day) for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for 6 months. For subjects who were randomized into the response guided therapy (RGT) group, the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1, a pre-treatment low viral load (LVL, \< 400000 IU/mL) and RVR (defined asHCV RNA \<50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.


Eligibility criteria: Inclusion Criteria:

* seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA.
* negative HBeAg
* serum alanine aminotransferase (ALT) levels between 1-10-fold of the upper limit of normal (ULN)
* treatment naive or had previously failed interferon monotherapy.

Exclusion Criteria:

* decompensated liver disease (Child-Pugh score ≥ 7)
* Pregnant or breast-feeding women
* serum creatinine ≥ 2 mg/dL
* evidence of alcoholism or drug abuse
* any other known disease that was not suitable for Peg-IFN therapy.

Primary outcomes:
measure: Rate of HCV sustained virological response
timeFrame: 6 months after completion of therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01413737: Postoperative Results of Surgical Treatment of Lung Cancer After 30 Days
Official title: Postoperative Results of Surgical Treatment of Lung Cancer After 30 Days
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung cancer patients after surgery at St Olavs University Hospital

Brief summary: This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the same hospital (St Olav University Hospital, Trondheim, Norway).


Eligibility criteria: Inclusion Criteria:

* Lung cancer patients after surgery in 2002-2004 at dept for Heart and Lung Surgery, St.Olavs University Hospital, Trondheim, Norway.

Exclusion Criteria:

* Carcinoid tumor, small-cell lung cancer, lung metastases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU
state: Sør-Trøndelag
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: National Taiwan Normal University
name: Rune Haaverstad, Ph.D
role: STUDY_CHAIR
References:
citation: Hjelde H, Sundstrom S, Odegard A, Hatlinghus S, Abusland AB, Haaverstad R. [Recurrence and survival after surgical treatment of lung cancer]. Tidsskr Nor Laegeforen. 2010 Jan 14;130(1):25-8. doi: 10.4045/tidsskr.09.0689. Norwegian.
citation: Roth K, Nilsen TI, Hatlen E, Sorensen KS, Hole T, Haaverstad R. Predictors of long time survival after lung cancer surgery: a retrospective cohort study. BMC Pulm Med. 2008 Oct 27;8:22. doi: 10.1186/1471-2466-8-22.
Clinical trial NCT01087437: Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Skeletal Deformities
Leg Length Discrepancy
Keywords: Distraction osteogenesis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Amorfical
First posted: 2010-03-16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in order to equalize leg length discrepancy and correct skeletal deformities or to achieve greater height in short stature people. The femur and tibia are the bones most frequently lengthened. The surgery is currently performed at Hadassah Medical Center routinely by the pediatric orthopedic team utilizing a variety of external fixation devices.

The procedure involves application of an external fixation device to the bone, creation of an osteotomy and gradual, controlled distraction of the bone fragments On the last week of the distraction phase and every month thereafter, patients will be provided with a monthly supply of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by Amorphical). Starting on the first day of the last week of the distraction phase, during the entire consolidation phase until the external fixator is removed; adults will orally consume two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given 25 mg calcium per kg body weight up to the daily adult dose of 1000mg .


Eligibility criteria: Inclusion Criteria:

1. Males and females
2. Ages 4-30 years old.

Exclusion Criteria:

1. Product Allergy
2. Refusal to participate the study.
3. Metabolic Disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organizaton
Study officials:
References:
Clinical trial NCT04055337: Flap Sliding to Treat Post-LASIK Striae
Official title: Flap Sliding Technique for Managing Flap Striae Following Laser in Situ Keratomileusis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LASIK Complication Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy and safety of a simple, noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK). Included eyes underwent flap sliding 1-2 days after surgery, which involved using a cellulose sponge to gently slide the flap perpendicular to the striae. The flap was not lifted during the procedure. Thirteen of 14 eyes were successfully managed with flap sliding. Uncorrected distance visual acuity (DVA) improved in all patients 1 day after flap sliding, with 11 eyes having a corrected DVA of 20/25 or better. Complications following flap sliding occurred in 2 eyes. We believe that our study makes a significant contribution to the literature because it demonstrates a simple, noninvasive technique for managing flap striae that develop during early post-LASIK epithelial healing.


Eligibility criteria: Inclusion Criteria:

Significant flap striae in the visual zone within 2 days following microkeratome LASIK.

Exclusion Criteria:

* striae 2 days after surgery
* visually insignificant striae

Primary outcomes:
measure: UDVA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alforsan eye center
Study officials:
References:
citation: Abdelazeem K, Nassr MA, Abdelmotaal H, Wasfi E, El-Sebaity DM. Flap Sliding Technique for Managing Flap Striae following Laser In Situ Keratomileusis. J Ophthalmol. 2020 Feb 24;2020:5614327. doi: 10.1155/2020/5614327. eCollection 2020.
Clinical trial NCT06240637: Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation (HMV)
Official title: Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Invasive Ventilation
Keywords: Telemonitoring
NIV
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Societat Catalana de Pneumologia (SOCAP)
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2024-02-05
Enrollment: 48
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: The goal of this clinical trial is to evaluate whether telemonitoring, added to the usual process of adaptation to home mechanical ventilation (HMV), achieves a more efficient correction of hypoventilation (reduction of hypercapnia).

Detailed description: The study population consist of patients with hypercapnic respiratory failure eligible for Home Mechanical Ventilation (HMV) with a total of 48 subjects (24 per group).

In those patients with hypercapnic respiratory failure who have an indication for home mechanical ventilation (HMV), without criteria for life support, the initial titration will be performed following the protocol of the Pulmonology Service. After their education, patients will be randomized into one of the following groups: the control group and the telemonitoring group with daily review of Home Mechanical Ventilation (HMV) data. The objectives are to evaluate whether hypoventilation is corrected more efficiently, compare treatment adherence between both groups, analyze unforeseen visits, and assess the number of hospital admissions.

Eligibility criteria: Inclusion Criteria:

* Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
* Patients who require ventilation with spontaneous-timed mode.
* Signing of informed consent.

Exclusion Criteria:

* Patient already treated with mechanical ventilation or home CPAP.
* Patient requiring mechanical ventilation as life support.
* Pregnancy.
* Cognitive impairment that makes it impossible to understand the informed consent for the study.
* Psychiatric pathology that makes compliance with therapy or its follow-up difficult.
* Impossibility of complying with the protocol.
* Expected survival less than 12 months.
* Any other condition that, in the opinion of the researcher, could interfere with the objectives of the study

Primary outcomes:
measure: Measurement of pCO2 by arterial blood gas
timeFrame: 6 months
Secondary outcomes:
measure: Adherence
timeFrame: 6 months
measure: Unforeseen visits
timeFrame: 6 months
measure: Hospital admissions
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT05762237: Deep Learning Models for Prediction of Intraoperative Hypotension Using Non-invasive Parameters
Official title: Prediction of Intraoperative Hypotension Using Non-invasive Monitoring Devices: Development of Deep Learning Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Hypotension
General Anesthesia
Keywords: intraoperative hypotension
noninvasive monitor
deep learning algorithm
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 5175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population included patients who underwent inhaled general anesthesia for non-cardiac surgery between June 2016 and August 2017 at Seoul National University Hospital, Seoul, South Korea.

Brief summary: The investigators aimed to investigate the deep learning model to predict intraoperative hypotension using non-invasive monitoring parameters.

Detailed description: Intraoperative hypotension is associated with various postoperative complications such as acute kidney injury. Therefore, precise prediction and prompt treatment of intraoperative hypotension are important. However, it is difficult to accurately predict intraoperative hypotension based on the anesthesiologists' experience and intuition. Recently, deep learning algorithms using invasive arterial pressure monitoring showed the good predictive ability of intraoperative hypotension. It can help the clinician's decisions. However, most patients undergoing general surgery are monitored by non-invasive parameters. Therefore, the investigators investigate the prediction model for intraoperative hypotension using non-invasive monitoring.

Eligibility criteria: Inclusion Criteria:

* The patients who are included in the open database, VtialDB.
* The patients who underwent inhaled general anesthesia for non-cardiac surgery.
* The patients who have non-invasive monitoring data including blood pressure, electrocardiography, pulse oximetry, bispectral index, and capnography.

Exclusion Criteria:

* The patient with missing data.

Primary outcomes:
measure: Deep learning model's prediction ability on intraoperative hypotension event
timeFrame: through study completion, an average of 3 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyun Joo Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Lee HC, Chu YS, Song SW, Ahn GJ, Lee H, Yang S, Koh SB. Deep learning models for the prediction of intraoperative hypotension. Br J Anaesth. 2021 Apr;126(4):808-817. doi: 10.1016/j.bja.2020.12.035. Epub 2021 Feb 6.
citation: Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-resolution time-synchronised physiological data from multiple anaesthesia devices. Sci Rep. 2018 Jan 24;8(1):1527. doi: 10.1038/s41598-018-20062-4.
Clinical trial NCT04347837: Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
Official title: Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Standard Bariatrics
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety is defined by the absence of device related adverse events in the study period. Usability is evaluated based on surgeon evaluation of the device following each use.

This is a open label clinical trial to be conducted at three US sites. Up to 60 participants will be enrolled and will be followed for 6 weeks after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients age 18 to 65 undergoing a procedure requiring longitudinal gastric resection including: laparoscopic sleeve gastrectomy, laparoscopic gastric wedge resection, laparoscopic duodenal switch/loop duodenal switch.

Exclusion Criteria:

1. Age \< 18 years
2. Incarceration
3. Prior gastric or foregut surgery (hiatal hernia repair, lap band +/- removal, Nissen fundoplication, gastrostomy tube, greater curve plication, sleeve gastrectomy etc.)
4. Diagnosed bleeding disorder (hyper or hypocoagulable state)
5. Systemic anticoagulation
6. Significant organ system disease

   1. Stage III CKD or greater
   2. Liver cirrhosis (any)
   3. CHG with EF \< 50%
   4. COPD with O2 dependence
   5. Uncontrolled diabetes mellitus (A1C \> 10%)
7. Intraoperative surgeon evaluation indicates the subject is not a candidate for longitudinal gastric resection with the Titan Stapler due to anatomic factors such as extensive abdominal adhesions or the device will not fit for the particular application.

Primary outcomes:
measure: Safety of the Titan SGS stapler
timeFrame: 6 weeks
measure: Usability
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Kaleida Health Buffalo General Hospital
state: New York
city: Cary
country: United States
facility: WakeMed Bariatric Specialists of North Carolina
state: North Carolina
city: West Chester
country: United States
facility: West Chester Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03019237: Effect of Intranasal Anti-IgE Antibodies on IgE Production
Official title: The Effect of Intranasal Application of Anti-IgE Antibodies on IgE Production in Patients Suffering From Seasonal Allergic Rhinitis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples, specific and total IgE levels will be assessed.

Detailed description: The intranasal challenge study will be performed over 8 weeks outside of the birch pollen season (November to January) as a randomized, double blind and placebo-controlled study. During a screening visit, 15 individuals will be recruited according to eligibility criteria. They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or placebo). Intranasal administration will take place on three consecutive days and serum samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of total and specific IgE levels

Eligibility criteria: Inclusion Criteria:

birch pollen allergy

Exclusion Criteria:

history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation

Primary outcomes:
measure: change of allergen-specific IgE
timeFrame: 8 weeks
Secondary outcomes:
measure: changes in total IgE
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Otorhinolaryngology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Verena Niederberger, MD
role: PRINCIPAL_INVESTIGATOR
References: