louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04952883: Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With COPD
Official title: A Cross-sectional Study of Endogenous Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient with stable chronic obstructive pulmonary disease

Brief summary: HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets.

Detailed description: This study aimed to investigate the relationship between endogenous H2S and pulmonary vascular remodeling on HRCT in patients with COPD through the determination of H2S and its synthase mRNA levels in blood and pulmonary vessels by HRCT, to evaluate the role of H2S in pulmonary vascular remodeling in COPD and to provide a basis for seeking new therapeutic targets. This study had predictive value for clinical prognosis of patients. It had important clinical guiding significance and social and economic benefit to comprehensively understand the pathogenesis of COPD.

Eligibility criteria: Inclusion Criteria:

* Patients meet the GOLD 2016 guidelines for diagnostic criteria of COPD: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (FEV1)/forced vital capacity (FVC) \< 70%.

Exclusion Criteria:

- 1. Other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases.

2. Patients who are unable to understand and/or complete questionnaire.

Primary outcomes:
measure: Plasma levels of H2S and its synthase nucleic acid and pulmonary vascular remodeling indexes on HRCT in COPD patients
timeFrame: 1 year
Secondary outcomes:
measure: Relationship between plasma H2S and its synthase nucleic acid levels and pulmonary vascular remodeling indexes on HRCT in patients with COPD
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Yahong Chen, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05609383: Out-patient Discharge Management After General Intravenous Anesthesia
Official title: Out-patient Discharge Management After General Intravenous Anesthesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Evaluation
Outpatient Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing digestive endoscopy

Brief summary: The lower limit of time for postoperative observation and discharge criteria for diagnostic or operational tests program in outpatient under general intervenous anesthesia/sedation

Detailed description: When is it considered safe for an outpatient to leave after a advanced procedure of general anesthesia/sedation

Eligibility criteria: Inclusion Criteria:

* patients aged from 18 years with American Society of Anesthesiologists (ASA) physical status I to II were selected. The adaptation and contraindications of the Chinese expert consensus on sedation/anesthesia in digestive endoscopy will be used

Exclusion Criteria:

* The inclusion criteria were the patient underwent general anesthesia with endotracheal intubation or patients with systemic comorbidities or unable to walk independently or those who suffered from severe adverse events that required in-hospital observation after diagnosis and treatment or the patients with no available assistance after discharge or the emergency endoscopy patients

Primary outcomes:
measure: time of discharge
timeFrame: mo more than 60 mintues
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: LIANGYU FANG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05402683: Ultrasound Versus Clinical Tests as Predictors of Difficult Endotracheal Intubation in Patients With Obstructive Sleep Apnoea Undergoing Elective Surgery Under General Anaesthesia
Official title: Ultrasound Versus Clinical Tests as Predictors of Difficult Endotracheal Intubation in Patients With Obstructive Sleep Apnoea Undergoing Elective Surgery Under General Anaesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Intubation in Obstructive Sleep Apnea
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be carried out on OSA patients prepared for elective surgery under general anaesthesia with tracheal intubation from Tanta University Hospitals

Brief summary: Obstructive sleep apnoea (OSA) is the most serious kind of the sleep-disordered breathing group, characterised by recurrent episodes of partial to complete obstruction of the upper airway resulting in inefficient alveolar gas exchange and desaturation\[1\].

It is a commonly encountered condition with a reported prevalence of 9-25% in the general population \[2\].

However, the majority of OSA patients presenting for surgery remain undiagnosed or untreated\[3\], contributing to a high rate of unexpected adverse airway outcome\[4\].

The various airway abnormalities represented by OSA include a large tongue, collapsible airway and crowding of the oropharyngeal structures, among others\[5\].

Accurate airway assessment should always be performed so as to provide appropriate planning and management of expected difficult intubation, but the common clinical screening tests (Mallampati score, inter-incisor distance, mento-hyoid distance, BMI, etc ) have shown low sensitivity and specificity with a limited predictive value, especially if only a single assessment method is used\[6\].

Ultrasonography could be a highly sensitive and specific tool for prediction of difficult intubation in OSA patients presented for elective surgery by measuring tongue base thickness, distance between lingual arteries, hyo-mental distance and condylar mobility.


Eligibility criteria: Inclusion Criteria:

1. 21-60 years old
2. ASA I, II, or III
3. STOP-BANG scoring \>3

Exclusion Criteria:

* 1) Age \<21 years old 2) patients with cervical spine injury, limited neck mobility, neck swelling 3) patients with lost incisor teeth 4) asymmetric mobility of the temporomandibular joint as in maxillofacial injuries/malignancies prior to surgery on the airway 5) pregnancy

Primary outcomes:
measure: ultrasound parameters
timeFrame: preoperative assessment
Secondary outcomes:
measure: which is better
timeFrame: preoperative assessment
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University hospitals
state: Gharbya
Study officials:
affiliation: Tanta university hospitals
name: Amer AB Soliman, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639883: A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision
Official title: A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in Healing of Incisional Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Scar
Incision
Abdominal
Wound (Morphologic Abnormality)
Keywords: wound healing
Scar
abdominoplasty
Lead sponsor: AiViva BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized, double-blind, vehicle-controlled, dose-escalation
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

Detailed description: This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Eligibility criteria: Inclusion Criteria:

* Eligible for an abdominoplasty
* Nonsmoker
* Fitzpatrick I-IV
* Weight \>45Kg
* BMI \<= 35

Exclusion Criteria:

* Existing scars in study area, active infection
* Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Primary outcomes:
measure: Adverse events
timeFrame: Day 1 through Day 49
Secondary outcomes:
measure: Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
timeFrame: Day 7 through 49
measure: Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
timeFrame: Day 7 through 49
measure: 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
timeFrame: Day 7 through 49
Other outcomes:
Locations:
city: Folsom
country: United States
facility: Kaufman and Davis Plastic Surgery
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
Study officials:
affiliation: Novella Clinical
name: James Milbauer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00470483: A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects With Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Social Phobia
Keywords: PET
Social Anxiety Disorder
fRMI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration


Eligibility criteria: Inclusion criteria:

* Outpatient with Social Anxiety Disorder
* The subject is healthy
* Willing to restrict alcohol intake
* Capable of giving informed consent

Exclusion criteria:

* Subjects with depression or any other psychiatric condition
* Subjects positive for HIV or hepatitis
* Subjects taking drugs or other medication
* Pregnant or becoming pregnant during the study
* Subjects who have donated blood
* Subjects who are left-handed
* Subjects with claustrophobia
* Subjects with an electronic device or ferromagnetic metal foreign body

Primary outcomes:
measure: fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).
timeFrame: baseline and after 8 weeks
Secondary outcomes:
measure: fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).
timeFrame: baseline and after 8 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02640183: EMLA Cream in Hysteroscopy Practice
Official title: Lidocaine-Prilocaine (EMLA®) Cream in Hysteroscopy Practice: A Prospective Randomized Non-blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anesthetics, Local
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
5. Absence of sedative use 24 h before admission

Exclusion Criteria:

1. Hypersensitivity or allergy to anesthetics
2. refusal of the patient
3. Patients under age 18 and pregnant.
4. Patients on anti-arrhythmic drugs due to possibility of drug interaction.
5. Unbearable pain that involves other analgesic measures.
6. Allergic reactions to topical anesthetics

Primary outcomes:
measure: Pain experienced during the procedure scored using a VAS.
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06836583: Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery
Official title: ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK in ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY: RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK in ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY
Keywords: sphenopalatine ganglion block
transphenoidal pituitary gland surgery
ultrasound guided sphenopalatine ganglion block
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).Secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects

Detailed description: Endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. It is a minimally invasive surgical technique to access sellar and parasellar lesions.

The main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (PPFB) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (PPFB)can be done transnasal or percutaneous ultrasound guided

Eligibility criteria: Inclusion Criteria:

* patients belonging to American Society of Anesthesiologists (ASA) class I or II
* patients scheduled for Endoscopic Transphenoidal Pituitary gland Surgery

Exclusion Criteria:

Patients will be excluded if; .History of allergy or contraindication to any of the studied drugs.

* Patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .Obese patients with BMI more than 35 Kg/m2.

Primary outcomes:
measure: Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
timeFrame: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00540683: Measurement of the Distribution of Optical Properties in Adult Human Muscle
Official title: Measurement of the Distribution of Optical Properties in Adult Human Muscle
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Muscle Disorder
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from outpatient clinic at University Of California Irvine, and staffs and students.

Brief summary: The researcher can use Diffuse Optical spectroscopy technique that uses harmless levels of near-infrared light to probe the concentrations and states of important physiological molecules such as hemoglobin water and lipids in human muscle,.

Detailed description: The researcher can monitor muscle physiology, for example during exercise or in response to external factors such as shock by Diffuse Optical spectroscopy technique.

The Diffuse Optical spectroscopy technique can determine significant changes in muscle, muscle structure, muscle tissues metabolism and hemodynamics.

Eligibility criteria: Inclusion Criteria:

* Male or Female age 18 years and older
* Diagnosed of Cachexic condition
* Diagnosed of Cellulite adult female 18 years and older

Exclusion Criteria:

* Pregnant women
* Taking light sensitive drugs for use in photodynamic therapy

Primary outcomes:
measure: Healthy Muscle
timeFrame: upto 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute University of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Bruce Tromberg, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490983: Telemonitoring Study - for Chronic Myeloid Leukemia (CML)
Official title: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic Myeloid Leukemia
Chronic Phase CML
Lead sponsor: Rex Cancer Center, Raleigh, NC
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Leap of Faith Technologies
First posted: 2011-12-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

Detailed description: This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older.
* Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
* Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
* ECOG Performance status 0, 1, or 2
* Adequate end organ function, defined as:

  * Total bilirubin \< 1.5 xULN
  * SGOT and SGPT \<2.5 x ULN
  * Creatinine \< 1.5 x ULN
  * ANC \> 1.5
  * Platelets \> 100,000
* Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.
* Patient is able to read and speak English
* Patient is willing and able to use a cell phone
* Written, voluntary informed consent

Exclusion Criteria:

* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Primary outcomes:
measure: eMedonline will be used to measure non-compliance in taking oral drug regimens.
timeFrame: at 6 months, non-compliance will be measured in each arm of study
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Healthcare
state: North Carolina
city: Raleigh
country: United States
facility: Rex Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Cancer Center - Wakefield
state: North Carolina
Study officials:
affiliation: Rex Cancer Center - Wakefield
name: Robert Wehbie, MD
role: PRINCIPAL_INVESTIGATOR
References: