louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00008840: A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Official title: A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 866
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.

Detailed description: Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.

Eligibility criteria: Inclusion Criteria:

You may be eligible for this study if you:

* Are at least 12 years of age.
* Are hospitalized with low white blood cell counts.
* Have received at least 96 hours of IV antibiotics.
* Have an oral temperature (or equivalent) of 38.0 C (100.4 F) or greater within the 24 hours before the study starts.
* Are not pregnant or breast-feeding.
* Agree to use a barrier method of contraception (e.g., a condom) during the study

Exclusion Criteria:

You will not be eligible for this study if you:

* Have a serious fungal infection.
* Have a history of an allergic reaction to antifungal agents.
* Are taking certain medications which may interfere with the study drug.
* Are participating in a clinical trial of any investigational drug.
* Have previously participated in this trial.
* Have any conditions which could affect your safety, make evaluation of response difficult, or make it unlikely that you can complete the course of therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Mary Ellen Bradley
state: Alabama
Study officials:
References:
Clinical trial NCT05315440: The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.
Official title: The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cuff Tear Arthropathy
Keywords: shoulder rehabilitation
range of motion
rotator cuff repair
instrument assisted soft tissue mobilitation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: In shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides with improving the range of passive movement: this process often requires considerable time of both patients and physiotherapists. This study aims to verify whether it is useful to add instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic rehabilitation protocol in order to accelerate recovery times of passive range of motion.

Detailed description: There is conflicting evidence about early versus delayed postoperative rehabilitation after arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could increase the risk of rupture of the tendon in long time, especially for large tears; delayed protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote tendons healing but could determine shoulder stiffness. Our research question is if after the delayed protocol used in our institute (40 -day immobilization period) it migh be useful to add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the classic rehabilitation protocol of the shoulder in order to speed up recovery times of the passive movement range.

Eligibility criteria: Inclusion Criteria:

* arthroscopic rotator cuff repair
* partial lesion due to tendon degeneration (1 or 2 anchors reparation)

Exclusion Criteria:

* traumatic tendon lesions
* associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions
* shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis

Primary outcomes:
measure: Passive Range of Motion Recovery of the Shoulder
timeFrame: after 2 weeks of treatment
Secondary outcomes:
measure: Reduction of pain measured by Visual Analogue Scale (VAS)
timeFrame: after 2 weeks of treatment
measure: Shoulder function improvement measured by Constant Murley and Dash scales
timeFrame: after 2 weeks of treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
Clinical trial NCT03486340: Prevention of Chest Pain in Chemo-treated Cancer Patients
Official title: Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Carcinoma
5-Fluorouracil Toxicity
Cardiotoxicity
Chemotherapeutic Toxicity
Acute Coronary Syndrome
Coronary Artery Calcification
Chest Pain
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2018-04-03
Enrollment: 218
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: This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.


Eligibility criteria: Inclusion Criteria:

* Histologically verified cancer
* First-time treatment with 5-FU/Capecitabine
* Expected remaining lifetime \> 6 months
* Informed consent

Exclusion Criteria:

* Known ischemic heart disease
* Ischemia-suspicious symptoms prior to 5-FU treatment
* Ischemia-suspicious ECG-changes prior to 5-FU treatment

Primary outcomes:
measure: Acute coronary syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Chest pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Departments of Oncology and Medicine, Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Vibeke B Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, Vejle Hospital, Denmark
name: Lars H Jensen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02070640: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Official title: Near Infrared Fluorescence Cholangiography During Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Keywords: cholecystectomy
cholecystitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
name: Society of American Gastrointestinal and Endoscopic Surgeons
First posted: 2014-02-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Detailed description: This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.

Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Planned laparoscopic cholecystectomy

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant
* Allergy to ICG, iodine, and/or shellfish
* Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
* Lactating

Primary outcomes:
measure: Complications Related to ICG
timeFrame: From time of injection to 1st post-op follow-up
Secondary outcomes:
measure: Incidence of Anatomic Identification With NIRF-C
timeFrame: Intraoperative
measure: Time to Complete NIRF-C and IOC
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Vimal K Narula, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974540: USG vs Palpation for Cricothyroid Membrane Determination
Official title: Ultrasound Versus Physical Examination for Cricothyroid Membrane Determination in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Cricothyroid Membrane
Keywords: Cricothyrotomy
Palpation
Ultrasonography
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients between the ages of 1-18, who are in ASA I-II physical status and who will undergo elective surgery under general anesthesia by the Pediatric Surgery at Marmara University Pendik Training and Research Hospital will be included in the study.

Brief summary: Emergency cricothyroidotomy is a very important technique to ensure airway safety in acute situations. Problem in identifying the cricothyroid membrane is a major contributor to high failure, as the most common complication during cricothyrotomy is the misplacement of the cannula. The success rate of emergency airway access performed by anesthesiologists and emergency medicine specialists was found to be low due to the low frequency of the procedure. The aim in this study is to compare the palpation method with the ultrasonugraphy (USG)-based method in determining the cricothyroid membrane. The hypothesis is that USG is more successful than palpation in identifying the cricothyroid membrane. In addition, the relationship between difficult intubation and measurements such as the cricothyroid membrane length, the cricoid cartilage and the skin distance, the distance between the cricoid cartilage and the second tracheal ring will be evaluated.


Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) I and II physical status
* Elective pediatric surgery
* Patients going to be intubated

Exclusion Criteria:

* ASA III or above physical status
* Emergency surgery
* Patients having tracheostomy
* Patients going to have laryngeal mask

Primary outcomes:
measure: Distance between palpation-based and USG-based determination of the cricothyroid membrane
timeFrame: On the 1 day of the surgery. After the anesthesia induction and intubation.
Secondary outcomes:
measure: Cricothyroid membrane length
timeFrame: On the 1 day of the surgery. After the anesthesia induction and intubation.
measure: Skin distance from cricoid cartilage
timeFrame: On the 1 day of the surgery. After the anesthesia induction and intubation.
measure: Distance between cricoid cartilage and 2nd tracheal ring
timeFrame: On the 1 day of the surgery. After the anesthesia induction and intubation.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Department of Anesthesiology and Reanimation
Study officials:
affiliation: Marmara University Department of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007040: Interstitial Lung Disease Associated
Official title: Interstitial Lung Disease Associated
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Keywords: Interstitial lung disease, ANCA, CTD, IPAF, IIP
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial pneumonia based on clinical symptoms and radiologic features, with or without histopathologic results.

Brief summary: This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

Detailed description: We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

1. Baseline data collection:

   1. Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings \[routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies\], pulmonary function tests (PFTs), and chest HRCT scans.
   2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.
   3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.
   4. Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.
2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.
3. Outcome

Eligibility criteria: Inclusion Criteria:

* Males and females
* Aged from 18 to 85 years with informed consent
* Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results

Exclusion Criteria:

* ILD induced by drug, environment, or occupational exposure
* Hypersensitivity pneumonitis and sarcoidosis

Primary outcomes:
measure: All-cause mortality
timeFrame: From baseline until the date of death from all cause, up to 5 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: Juhong Shi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149240: Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
Official title: A Phase II, Multicentre, Randomised, Double-blind, Parallel and Controlled With Placebo Pilot Study to Evaluate the Efficacy and Safety of a Single Dose of Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment, in Patients With Primary Myofascial Syndrome of Cervical and Dorsal Localisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myofascial Pain Syndromes
Keywords: DYSPORT
botulinum toxin A
myofascial pain syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 24
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 main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
* Punctuation of 4cm or more in a 10cm visual analog scale.
* Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.

Exclusion Criteria:

* Patients diagnosed with fibromyalgia or with a spread pain.
* Patients having received previously botulinum toxin.
* Patients having received anesthetic injections at the trigger points within the month before the visit.
* Patients having received corticosteroids injections at the trigger points within three months before the selection visit.

Primary outcomes:
measure: The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
measure: Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
measure: Pain evaluated by the patient through a visual analog scale.
measure: Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient.
measure: Usual analgesic intake modification (on a daily basis by filling out a Patient's diary).
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital "Vall d 'Hebrón". Barcelona
city: Madrid
country: Spain
facility: University Hospital of Alcorcón
city: Santiago de Compostela
country: Spain
facility: Complexo Médico Quirúrgico del Conxo
city: Valencia
country: Spain
facility: University Hospital "La Fe". Valencia
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00106340: Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Official title: Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-03-23
Enrollment: 3118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility criteria: Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Time to HbA1c >8%
timeFrame: 2 year
Secondary outcomes:
measure: Change from baseline in HbA1c at 5 years
timeFrame: 2 years (amended)
measure: Adverse event profile after 5 years of treatment
timeFrame: 2 years (amended)
measure: Coefficient of failure for HbA1c from week 24 to 5 years
timeFrame: 2 years (amended)
measure: Change from baseline in fasting plasma glucose at 5 years
timeFrame: 2 years (amended)
measure: Change from baseline in body weight at 5 years
timeFrame: 2 years (amended)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Nurnberg
country: Germany
facility: Investigative Centers
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: