louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01187589: PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
Official title: Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Respinova LTD
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
* Post-bronchodilator FEV1/FVC \< 0.7
* Post-bronchodilator FEV1 in the range 30% - 70% predicted
* Age: 40 years or older
* Patient signed the informed consent form

Exclusion Criteria:

* Pneumothorax in the past, per anamnesis.
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
* Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
* Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
* Other severe systemic disease
* Non-cooperative or non-compliant patient

Primary outcomes:
measure: Lung deposition
timeFrame: 1 hour
measure: Pulmonary functions
timeFrame: 1 hour
Secondary outcomes:
measure: Dyspnea
timeFrame: 1 hour
Other outcomes:
Locations:
city: Tzrifin
country: Israel
facility: Assaf Harofe Medical Center Nuclear Medicine Institute
Study officials:
affiliation: Assaf Harofe Medical Center
name: Haim Golan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547989: Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
Official title: Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: ASA class I and II
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 46
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: Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

Detailed description: Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m.

Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia.

A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.

Eligibility criteria: Inclusion Criteria:

* Extended mamma surgery one-sided
* ASA class I and II

Exclusion Criteria:

* All contra indications for local anaesthesia
* Coagulation disorders
* Infection
* Allergic reactions

Primary outcomes:
measure: reduction of unplanned admissions and reduction of VAS score.
timeFrame: one week
Secondary outcomes:
measure: to determine the safety and performance (efficacy) of the technique and the investigational product.
timeFrame: one week
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital
Study officials:
affiliation: azM
name: Esther Bouman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02734329: Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Neoplasms
Keywords: Nephron sparing surgery
Zero ischemia
Warm ischemia
Laparoscopic
Radiofrequency ablation
Microwave ablation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Changzheng Hospital
name: Changhai Hospital
name: Shanghai 6th People's Hospital
name: Fudan University
First posted: 2016-04-12
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.


Eligibility criteria: Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
* patients scheduled for laparoscopic nephron sparing surgery
* patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

* patients' aged \>80 years
* patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
* patients not able to tolerate the laparoscopic procedure
* patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney
* patients with the renal tumor involving urinary collecting system

Primary outcomes:
measure: the change in glomerular ﬁltration rate (GFR) of the affected kidney
timeFrame: Baseline and 30 months
measure: changes of estimated GFR (eGFR)
timeFrame: Baseline and 30 months
Secondary outcomes:
measure: estimated blood loss
timeFrame: during surgery
measure: rates of positive surgical margin
timeFrame: postoperative，up to 2 weeks after surgery
measure: postoperative complications
timeFrame: postoperative，up to 30 days
measure: the rate of local recurrence
timeFrame: through study completion, an average of 3 years
measure: operative time
timeFrame: During surgery
measure: Hospital stay time
timeFrame: The time from the surgery day to patient discharge, up to 2 weeks
measure: progression-free survival rate
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
References:
Clinical trial NCT05391529: Patients Decision Making in Choosing Between Colonic Investigation Alternatives
Official title: Patients Decision Making in Choosing Between Colonic Investigation Alternatives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Disease
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Highland
First posted: 2022-05-26
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: This study will involve recruiting patients on the waiting list for colonoscopy or colon capsule endoscopy from one NHS Scotland Health Board.

Brief summary: This is a qualitative interview study to understand patients' priorities for different aspects of tests when considering a colonic investigation. Patients currently waiting for colon capsule endoscopy (CCE), and colonoscopy will be invited to take part. Semi-structured interviews will be carried out over the telephone following an interview guide. Recorded interviews will be transcribed and undergo thematic analysis. We will seek to publish the results of this study to inform future research and developments for colonic investigations.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 who are on the waiting list for a colonoscopy or CCE. Only patients who can provide valid consent will be included.
* English language speaking (translation services are not available for this study).

Exclusion Criteria:

* Patients undergoing colonoscopy due to positive bowel screening test or due to surveillance of known colonic pathology.

Primary outcomes:
measure: Completion of a qualitative interview discussing the patients priorities for different aspects of tests when considering a colonic investigation
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Completion of a qualitative interview discussing what patients' perceptions of the decision-making process are when choosing between colonic investigations
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05687929: Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets
Official title: Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 3500
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: Patients with chronic pain \> 1 month and VAS \> 40 mm Patients who can take the acetylaconitine tablets orally

Brief summary: 1. To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
2. To study and analyze the main influencing factors of the acetylaconitine tablets.

Detailed description: The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic pain \> 1 month and VAS \> 40 mm Patients who can take the acetylaconitine tablets orally

Exclusion Criteria:

* Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally

Primary outcomes:
measure: VAS (0-100mm), IDpain
timeFrame: December 2022 to December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT04312529: Analysis of Shoulder Muscle Activity During Isokinetic Evaluation of Rotators
Official title: Analysis of Shoulder Muscle Activity During Isokinetic Evaluation of Rotators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Activation
Electromyography
Muscle Strength
Shoulder
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to assess the impact of different positions of the glenohumeral joint on the maximum muscle contraction of different shoulder muscles. The muscles do not contract with the same intensity depending on the position of the arm in relation to the trunk. With the determination of this optimal position to activate the shoulder muscles as much as possible, we will be able to strengthen the patients during their revalidation.


Eligibility criteria: Inclusion Criteria:

* Male subjects aged 18-35.
* Playing a sport using the upper limb (handball, volleyball, swimming, tennis) at least 6h/week

Exclusion Criteria:

* Pain in the shoulder
* Shoulder pathologies such as gleno-humeral dislocation, tendinopathy, sub-acromial conflict, etc.
* History of shoulder surgery (prosthesis, stabilizing surgery, etc.)

Primary outcomes:
measure: strength test
timeFrame: Day 1.
measure: Electrical activity of the muscles
timeFrame: Day 1.
Secondary outcomes:
measure: Weight
timeFrame: Day 1
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Université de Liège
Study officials:
References:
Clinical trial NCT00718029: Cerebrospinal Fluid (CSF) Raltegravir Substudy
Official title: MK: Raltegravir Concentrations in Cerebrospinal Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Human Immunodeficiency Virus
Cerebrospinal Fluid
Raltegravir
Drug Concentrations
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-07-18
Enrollment: 4
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: Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.

Brief summary: The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.

The hypotheses are:

* Raltegravir concentrations in CSF will be measurable
* Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
* Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.


Eligibility criteria: Inclusion Criteria:

* Enrollment in a raltegravir parent protocol at UCSD.
* Willing to undergo lumbar puncture.
* Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.

Exclusion Criteria:

* Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets\<50,000/µL), hemophilia, or use of anticoagulant medication.
* Psychiatric disease that would interfere with study participation, in the opinion of the investigator.
* No major opportunistic infections within 30 days.
* Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego AntiViral Research Center
name: Scott L Letendre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850429: BioDulse: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Healthy Adults
Official title: BioDulse: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A three arm, acute randomised, double blind crossover design feeding study will be used to establish the impact and dose response to co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.
Primary purpose: BASIC_SCIENCE

Brief summary: Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a healthy population.


Eligibility criteria: Inclusion Criteria:

* Aged 18-67

Exclusion Criteria:

* Terminal disease
* Past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment;
* Exclusively receiving enteral or parenteral nutrition,
* Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and SOP.

Primary outcomes:
measure: Postprandial blood glucose area under the curve (AUC)
timeFrame: 120 min
Secondary outcomes:
measure: Timecourse of blood glucose concentration
timeFrame: 0, 15, 30, 45, 60, 90, 120 min
measure: Postprandial serum insulin area under the curve (AUC)
timeFrame: 120 min
measure: Postprandial serum insulin concentration
timeFrame: 0, 15, 30, 45, 60, 90, 120 min
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Brian Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708929: Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Official title: Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Polymorphism
Macular Degeneration
Regional Blood Flow
Ocular Physiology
Keywords: Age-related macular degeneration
Complement factor H
Choroidal blood flow
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.

Given that it is known that impaired regulation of choroidal vascular tone is present in patients with AMD, the current study seeks to investigate whether the Tyr402His polymorphism is associated with altered choroidal autoregulation in healthy subjects. For this purpose a total of 100 healthy volunteers will be included in order to test the hypothesis that an impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His variant.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Choroidal blood flow during isometric exercise
timeFrame: 10 minutes
measure: Tyr402His genotyping
timeFrame: screening
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: 20 minutes
measure: Intraocular pressure
timeFrame: before and after blood flow measurements
measure: Systolic/diastolic blood pressure
timeFrame: 20 minutes
measure: Pulse rate
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhöfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02647229: Colonic Irrigation for Colonoscopy Preparation
Official title: Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonoscopy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 0
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 purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.


Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients (\>18 years old) who require screening or surveillance colonoscopy
* Ability to give consent

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnant patients
* Patients under the age of 18
* Active ulcerative colitis or crohn's disease flare
* Prisoners

Primary outcomes:
measure: Comparison of Boston Bowel Prep Score (BBPS)
timeFrame: 1 Day
Secondary outcomes:
measure: Difference in Adenoma Detection Rate (ADR)
timeFrame: 1 Day
measure: Difference in the number of follow ups needed after colonoscopy
timeFrame: 1 Day
measure: Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
timeFrame: 1 Day
measure: preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
timeFrame: 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Basil Lucak
role: PRINCIPAL_INVESTIGATOR
References: