louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05049135: Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.
Official title: Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: sleep monitor
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: VitalThings
First posted: 2021-09-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners

Brief summary: To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.

Detailed description: A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.

Eligibility criteria: Inclusion Criteria:

* referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
* able to sign an informed consent

Exclusion Criteria:

* Pregnancy
* Serious disease which could affect ability to complete the study
* Complicated sleep disorders

Primary outcomes:
measure: Apnea/hypopnea index
timeFrame: 72 hours
Secondary outcomes:
measure: Sleep score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust
Study officials:
affiliation: NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging
name: Øystein Risa, PhD
role: STUDY_DIRECTOR
affiliation: North Trøndelag Hospital Trust
name: Carl Platou, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00171535: Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension
Official title: A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
high blood pressure
valsartan
amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension


Eligibility criteria: Inclusion Criteria:

* Patients with severe hypertension

Exclusion Criteria:

* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Adverse events and serious adverse events at each study visit for 6 weeks
Secondary outcomes:
measure: Sitting and standing blood pressure measurements after 6 weeks
measure: Laboratory test data after 6 weeks
measure: Vital signs at each study visit for 6 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02425735: Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
Official title: γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Keywords: Immunotherapy, γδ T Cell, heptocellular liver cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2015-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, effects of γδT cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed description: Liver tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria: Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>50
3. Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery, gd Tcells/ DC-CIK.
6. Life expectancy: Greater than 3 months
7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease and diabetes

Primary outcomes:
measure: Reduced size of the tumors
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
citation: Alnaggar M, Xu Y, Li J, He J, Chen J, Li M, Wu Q, Lin L, Liang Y, Wang X, Li J, Hu Y, Chen Y, Xu K, Wu Y, Yin Z. Allogenic Vgamma9Vdelta2 T cell as new potential immunotherapy drug for solid tumor: a case study for cholangiocarcinoma. J Immunother Cancer. 2019 Feb 8;7(1):36. doi: 10.1186/s40425-019-0501-8.
Clinical trial NCT02616835: Investigating the Physiology of Targeted Theta-burst Neuromodulation
Official title: Investigating the Physiology of Targeted Theta-burst Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Institute of Mental Health Nottingham
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.


Eligibility criteria: Inclusion Criteria:

* No personal history of neurological or psychiatric disorders

Exclusion Criteria:

* Have had a brain injury or neurological disorder
* Have ever suffered an epileptic fit
* Have any non-removable metal implants
* Drink more than 20 units of alcohol per week on a regular basis
* Currently take any illicit drugs on regular basis
* Likely to be pregnant
* Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder
* Currently take any psychotropic medication

Primary outcomes:
measure: Changes in functional connectivity following TMS administration using functional MRI
timeFrame: One hour
Secondary outcomes:
measure: Changes in brain metabolites following TMS administration using MR spectroscopy
timeFrame: One hour
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Sarina Iwabuchi
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Sarina Iwabuchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03877835: Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
Official title: Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Disease
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Nordlandssykehuset Bodo
First posted: 2019-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single intervention
Primary purpose: TREATMENT

Brief summary: The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.

Detailed description: The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty.

The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.

Eligibility criteria: Inclusion Criteria:

* 18-78 years old,
* BMI 20-35 kg.m-2
* ASA physical status 1-3

Exclusion Criteria:

* unable to consent,
* pregnancy,
* pre-existing severe respiratory disease,
* use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol,
* allergy to local anaesthetics,
* patients on regular opioids,
* atrioventricular block,
* peripheral neuropathy.

Primary outcomes:
measure: NRS
timeFrame: Postoperatively at 1 hour
measure: The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes
timeFrame: 30 minutes after the blocks
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
References:
Clinical trial NCT03296735: A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I
Official title: A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheterization
Posture
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.

In the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.


Eligibility criteria: Inclusion Criteria:

- the patients who receive elective neurosurgical surgery and require central venous catheter

Exclusion Criteria:

* the patients who have puncture site infection
* the patients who have chemoport, pacemaker in right subclavian vein
* the patients who had received right mastectomy or right pneumonectomy
* other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)

Primary outcomes:
measure: The cross-sectional area of right subclavian vein
timeFrame: 1 minutes after position change
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.
citation: Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.
Clinical trial NCT01215435: Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Official title: An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 245
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 trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
* HbA1c at least 7.0 % - maximum 11 % at screening
* Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 OADs
* OADs dosed at least 50% of the maximum recommended dose

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* The receipt of any investigational medicinal product within one month prior to this trial
* Suffer from a life threatening disease (cancer)
* Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
* Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
* Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
* Recurrent hypoglycaemia or hypoglycaemic unawareness
* Anemia (haemoglobin below 10 mg/dl)

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
timeFrame: Week 0, Week 11
Secondary outcomes:
measure: Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Number of Treatment Emergent Hypoglycaemic Episodes
timeFrame: Week 0 to Week 36
Other outcomes:
Locations:
city: Teheran
country: Iran, Islamic Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04328935: Written Exposure Therapy for Post-traumatic Stress Syndrome
Official title: A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
written exposure therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-group design. Repeated measurements
Primary purpose: TREATMENT

Brief summary: To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder

Detailed description: A non-inferiority trial in JAMA Psychiatry showed that written exposure therapy (WET) was non-inferior to a gold standard CBT treatment. In comparison to other trauma-focused CBT protocols, WET generally demands less therapist-time, and specifically, less than half compared to CBT that consists of 12 weekly sessions á 60 minutes. The aim of this study is to translate and replicate these results in a Swedish context. This first step is a small feasibility trial which will guide a subsequent large-scale trial.

Eligibility criteria: Inclusion Criteria:

* Meet criteria for PTSD.
* If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry.
* ≥ 18 years
* Situated in Sweden
* Be able to express themselves in Swedish, both in verbally and written form.
* Informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
* Ongoing CBT for trauma
* Ongoing trauma-related threat (e.g. living with a violent spouse)

Primary outcomes:
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Time Frame: Baseline, week 5 and follow-up at 6 months
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
timeFrame: Time Frame: Baseline, week 5 and follow-up at 6 months
measure: Euroqol, EQ-5D
timeFrame: Time Frame: Baseline, week 5 and follow-up at 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT01091935: Safety of Intravenous Lidocaine Infusions
Official title: Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2010-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult outpatients attending St Joseph's Chronic Pain Clinic in one of two time periods who have been diagnosed with chronic neuropathic pain by clinical history and examination and are scheduled to receive a lidocaine infusion for pain management

Brief summary: The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

Detailed description: Eligibility Criteria:

Adults \> 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009.

Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes.

Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.

Eligibility criteria: Inclusion Criteria:

* Adult outpatients \> 18 years \< 80 years diagnosed with chronic neuropathic pain

Exclusion Criteria:

* Unable to provide informed consent
* Unable to speak and understand English
* Liver, kidney, or cardiac failure
* Allergy to Lidocaine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's Health Care
state: Ontario
Study officials:
affiliation: Associate Professor,Dept of Anesthesia and Perioperative Medicine,University of Western Ontario, Lawson Health Research Institute
name: Patricia K Morley-Forster, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, University of Western Ontario, Lawson Health Research Institute
name: Patricia K Morley-Forster, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attal N, Gaude V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. doi: 10.1212/wnl.54.3.564.