louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05331677: Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator
Official title: Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deformities Around the Knee in Pedietrics
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting.

The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis.

The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis


Eligibility criteria: Inclusion Criteria:

* Genu valgus having tibio-femoral angle more than 15 degrees.
* Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees
* More than one plane defirmity
* Age 10 - 16 yrs
* Range of motion:

  1. Full extension
  2. More than 100 in flextion

Exclusion Criteria:

* Genu recurvatum.
* Flexion deformity.
* Pathological conditions (e.g: bone softening diseases
* Dysplasia
* Limb length discrepancy

Primary outcomes:
measure: Thoresen scoring system
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Espandar R, Mortazavi SM, Baghdadi T. Angular deformities of the lower limb in children. Asian J Sports Med. 2010 Mar;1(1):46-53. doi: 10.5812/asjsm.34871.
citation: Edgerton BC, Mariani EM, Morrey BF. Distal femoral varus osteotomy for painful genu valgum. A five-to-11-year follow-up study. Clin Orthop Relat Res. 1993 Mar;(288):263-9.
Clinical trial NCT00404677: The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics
Official title: The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be related to the degree of airway hyperresponsiveness, a hallmark of asthma. In several studies, asthmatic individuals with mild airway hyperresponsiveness (AHR) (methacholine PC20 \> 2 mg/mL) had a difference in methacholine PC20 with and without deep inhalations that averaged 1.8 doubling methacholine concentrations (p=0.0003). Conversely, asthmatic individuals with moderate to severe AHR (methacholine PC20 ≤ 2 mg/mL) had a non-significant difference in methacholine PC20 with and without deep inhalations (p=0.09). This loss of deep inhalation bronchoprotection is also now believed to play an important role in the pathogenesis of asthma. Airway inflammation is another of the key features of asthma and information on airway inflammation is increasingly being used in the diagnosis and treatment of asthma. The level of airway inflammation (as measured by fraction of exhaled nitric oxide and sputum eosinophilia) has also been shown to be correlated to the level of airway hyperresponsiveness (as measured by methacholine PC20). In addition, glucocorticoids have been shown to decrease airway hyperresponsiveness, further suggesting that these two phenomena, airway inflammation and airway hyperresponsiveness, are related. We therefore suggest that the degree of airway inflammation is related to the loss of deep inhalation bronchoprotection and expect there to be a negative correlation between the degree of deep inhalation bronchoprotection and airway inflammation.


Eligibility criteria: Inclusion Criteria:

* diagnosis of asthma

Exclusion Criteria:

* other lung disease(s)
* smoking

Primary outcomes:
measure: fraction of exhaled nitric oxide, sputum eosinophils and methacholine PC20
timeFrame: freaction of exhaled nitric oxide data collected prior to methacholine challenges; sputum collected after the first methacholine challenge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan
name: Donald Cockcroft, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426477: Veritas in Non-Bridging Ventral Hernia Repair
Official title: Veritas in Non-Bridging Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hernia
Keywords: Ventral hernia
Abdominal wall hernia
Incisional hernia
Biologic mesh
Veritas Collagen Matrix
Veritas
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2011-08-31
Enrollment: 20
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: Study surgeons will recruit patients from within their own practice, or through their typical referring sources.

Brief summary: The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Ability to understand and read English
* Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
* Must be of ambulatory status
* Primary closure can be obtained during surgery
* Repair is such that one piece of Veritas can be used to reinforce the repair

Exclusion Criteria:

* Hernia is undetectable on physical exam
* There is evidence of existing cancer
* BMI ≥ 40
* Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
* Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products

Primary outcomes:
measure: Hernia recurrence
timeFrame: 2 Years
Secondary outcomes:
measure: Number of Medical and Surgical Complications
timeFrame: 2 years
measure: Change in Quality of Life
timeFrame: Baseline to 2 Years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Department of Surgery
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Colon & Rectal Surgery, P.A.
state: Georgia
city: Fredericksburg
country: United States
facility: Pratt Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT05214677: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809 and DW1809-1 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Rheumatoid Arthritis
Back Pain
Acute Upper Respiratory Tract Infection
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

* Clinically significant Medical History
* In the case of women, pregnant(Urine-HCG positive) or lactating women

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 8 hour
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 8 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
References:
Clinical trial NCT03658577: Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome
Official title: Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Actue Coronary Syndrome
Keywords: Actue Coronary Syndrome
Beta-Blocker
Percutaneous Coronary Intervention
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was selected from ten major cardiac centres in ShenZhen,CHINA.

Brief summary: Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in Actue Coronary Syndrome(ACS) patients. This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ACS after percutaneous coronary intervention (PCI).

Detailed description: The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend beta-blockers for secondary prevention in patients with ACS without regard to reperfusion therapy. However, evidence supporting this recommendation originated from studies conducted before the introduction of reperfusion therapy or studies in patients treated with fibrinolysis. In the present era of PCI, there are no prospective randomized studies looking at the effects of long-term beta-blocker therapy on clinical outcomes in ACS patients. Moreover, results from registry data and post-hoc analysis on beta-blocker therapy in patients undergoing PCI are inconsistent.

In particular, the beneficial effect of long-term beta-blocker therapy has not been well established in patients with relatively low risk, such as preserved left ventricular systolic function or single-vessel disease. Therefore, we investigated the association of beta-blocker therapy at discharge with clinical outcomes in ACS patients after PCI.

Eligibility criteria: Inclusion Criteria:

1. consecutive patients 18 years of age or older;
2. patients diagnosed as ACS(including STEMI、NSTEMI and UA) by doctor at discharge;
3. patients undergoing primary PCI.

Exclusion Criteria:

missing beta-blocker information.

Primary outcomes:
measure: all-cause death
timeFrame: 3 years
Secondary outcomes:
measure: MACE
timeFrame: 3 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: professor, Chief of cardiovascular department
name: ShaoHong P Dong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06150677: Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Official title: Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Hypoxia
Hypercapnia
Apnea
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria: Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant.
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
measure: Blood pressure
timeFrame: before, during and after intervention (up 10 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT02900677: Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
Official title: Developing and Testing the Effects of Patient-centered Prehabilitation Program on Improving Fatigue, Nutritional Status, and Quality of Life in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Fatigue
Nutrition
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2016-09-14
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this three-year study are to:

1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
2. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Detailed description: Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Eligibility criteria: Inclusion Criteria:

* patients with pancreatic cancer and are going to receive surgery.

Exclusion Criteria:

* poor functional status

Primary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline physical symptom at 12 months
Secondary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline fatigue at 12 months
Other outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline quality of life at 12 months
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Shiow-Ching Shun, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05115877: Evaluation of Outcomes From Treatment of Benign or Malignant Gastrointestinal Diseases
Official title: Evaluation of Outcomes From Treatment of Benign or Malignant Gastrointestinal Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Disease
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with benign or malignant gastrointestinal diseases.

Brief summary: This study will be a retrospective, registry study collecting data of patients who were diagnosed with benign or malignant gastrointestinal diseases. Data will be collected from patient's chart retrospectively once the patients have completed proper treatment follow up with physicians' practice.

Detailed description: It is reported in the literature that the treatment of any gastrointestinal disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with gastrointestinal cancer continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. The goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity.

The main aim of this study is to evaluate and compare the outcomes from our treatment of benign or malignant gastrointestinal diseases through medical chart review.

There is a need to understand and improve the current diagnosis and treatment algorithm for gastrointestinal pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed and treated for gastrointestinal diseases, benign or malignant from 2005 to 2030.
* Age ≥18 years

Exclusion Criteria:

* Patients that are not diagnosed with or treated for gastrointestinal diseases
* Age \<18 years

Primary outcomes:
measure: Overall survival
timeFrame: Jan 2005 - Jan 2030
measure: Overall symptom
timeFrame: Jan 2005 - Jan 2030
measure: Mortality
timeFrame: Jan 2005 - Jan 2030
measure: Morbidity
timeFrame: Jan 2005 - Jan 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Dhiresh R Jeyarajah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518553: Plasma Purification and Chronic Hepatitis B
Official title: Shanghai Pudong Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis b
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of nucleoside analogues （HA） alone and plasma purification +HA in reducing HBV viral load.

Detailed description: Chronic hepatitis B (CHB) is a major disease harmful to human health and an important cause of liver cirrhosis and liver cancer. Hepatitis B virus (HBV) cccDNA exists for a long time in the liver of infected persons and serves as a template for HBV replication, which makes it difficult to eradicate HEPATITIS B virus infection. Antiviral drugs are commonly used clinically, including interferon and nucleoside analogues, but there are problems of recurrence and drug resistance. These drugs are not directly targeted at cccDNA and are therefore inefficient at reducing cccDNA. How to quickly and efficiently reduce the viral load of HBV-DNA, inhibit THE TRANSCRIPTION of HBV-CCCDNA RNA, and promote the negative conversion of HBeAg is an urgent problem to be solved at present, so it is particularly important to find other more effective drugs or methods. Plasma purification is a new treatment method in which the pathogenic factors (hepatitis B virus, etc.) are trapped in the hollow fibers by special membrane materials and removed. Therefore, this study adopts the randomized control method to explore the effect of plasma purification on HBV clearance, aiming to explore the effectiveness and safety of plasma purification in reducing HBV DNA viral load and inhibiting HBV cccDNA RNA transcription, so as to provide new treatment ideas and methods for future treatment of hepatitis B virus infection, which is beneficial to the society and individuals.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Chronic hepatitis B Disease
2. hepatitis B virus HBeAg is positive
3. hepatitis B virus HBV-DNA virus load is more than 100000cps/ml

Exclusion Criteria:

1. Hypotension
2. Cardiopulmonary insufficiency
3. Coagulation disorders
4. Heparin allergy

Primary outcomes:
measure: Concentration of HBV(hepatitis B virus) HBeAg is serologically negative
timeFrame: 2 years
Secondary outcomes:
measure: Concentration of HBV-DNA virus load is undetected
timeFrame: 2 years
measure: Concentration of hepatitis B virus cccDNA RNA transcription becomes undetectedly
timeFrame: 2 years
measure: hepatitis B virus HBsAg serological transformation is negative
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Hui Min Jin, MD
role: PRINCIPAL_INVESTIGATOR
References: