louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01587664: NewBreez Safety and Efficacy Evaluation
Official title: Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Swallowing Disorders
Keywords: Swallowing disorders
Aspiration
Lead sponsor: ProTiP Medical
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
3. Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
4. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
5. Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

1. Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
2. Major swallowing disorder
3. Existing coagulation disorder
4. Previous esophageal stenting
5. Life-expectancy \< 12 months
6. Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment

Primary outcomes:
measure: Aspiration score at 1 month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
city: Bobigny
country: France
facility: Hopital Avicenne
Study officials:
affiliation: UCL Mont-Godinne (Belgium)
name: Marc Remacle, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847664: Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
Official title: A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy of Oral Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in the Treatment of Acute Uncomplicated Diverticulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Diverticulitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated diverticulitis.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent,
2. Patient is eligible for out-patient treatment,
3. Men or women between 18 and 80 years of age,
4. Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
5. Presence of significant left lower quadrant pain during the last 24 hours before baseline,
6. CRP \> ULN and/or leucocytosis (\> ULN) at screening visit

Exclusion Criteria:

1. Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
2. Right-sided diverticulitis,
3. Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
4. Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
6. Hemorrhagic diathesis,
7. Active peptic ulcer disease,
8. Abnormal hepatic function or liver cirrhosis,
9. Abnormal renal function,
10. Colorectal cancer or a history of colorectal cancer,

Primary outcomes:
measure: Rate of patients with treatment success at the day 10 visit
timeFrame: 10 days
Secondary outcomes:
measure: First visit with treatment success
timeFrame: 10 days
measure: Rate of surgical intervention of acute diverticulitis
timeFrame: 10 days
measure: Rate of hospitalisation due to acute diverticulitis
timeFrame: 10 days
measure: Rate of occurrence of complicated diverticulitis
timeFrame: 10 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Evangelisches Krankenhaus Kalk
state: Nordrhein-Westfalen
Study officials:
References:
Clinical trial NCT03971864: Peripheral Vascular Disease and Coronary Artery Disease
Official title: The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACS patients

Brief summary: This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.

Detailed description: Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as ACS underwent coronary angiography and OCT examination
* Agreed to accept peripheral artery ultrasound examination

Exclusion Criteria:

* In-stent restenosis, coronary dissection, coronary spam, thrombus
* left main artery disease
* Age\>85 years old
* Cardiogenic shock or stroke admission
* Severe hepatic or renal dysfunction
* Poor quality of OCT image or massive thrombus

Primary outcomes:
measure: Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
Clinical trial NCT03299764: Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
Official title: Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: COPD
Lead sponsor: Research Center Borstel
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD

Detailed description: Intervention:

Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Age \>40 years
3. COPD diagnosis known for at least 12 months
4. NIV therapy for at least 3 months

4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7. Patient is able to follow the study protocol

Exclusion Criteria:

1. Current COPD exacerbation (is allowed 4 weeks after end of treatment)
2. Radiologically proven pneumonia within the past month
3. Other leading pulmonary illness
4. Tracheostomy
5. Pneumothorax
6. Pregnancy or lactation
7. BMI \>35 kg/m²
8. Steroid therapy with \>15 mg prednisolon daily for \>1 month
9. Condition causing hypercapnia other than COPD
10. 6MWT distance of \>300 meters within the last 7 days
11. Previous therapy with the Vigaro NIV device
12. Weight loss of more than 5 kg / 12 months
13. Further criteria to exclude confounding factors

Primary outcomes:
measure: Walking distance in 6-minutes walking test
timeFrame: 3 months
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: Number of hospital admissions
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
state: Baden-Württemberg
city: Wangen
country: Germany
facility: Waldburg-Zeil Kliniken - Fachkliniken Wangen
state: Baden-Württemberg
city: Borstel
country: Germany
facility: Research Center Borstel
state: Schleswig-Holstein
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf
state: Schleswig-Holstein
city: Hemer
country: Germany
facility: Lungenklinik Hemer
Study officials:
References:
Clinical trial NCT03970564: Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer
Official title: Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Metastatic
Nodes, Lung
Keywords: ultrasound
lymphadenopathy
lung cancer
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
Collaborators: name: European Respiratory Society
First posted: 2019-05-31
Enrollment: 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected and later on confirmed lung cancer with evidence of enlarged mediastinal lymph node(s) measuring \> 10 mm in short diameter on Computerised Tomography

Brief summary: This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer

Detailed description: In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy.

The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging

Eligibility criteria: Inclusion Criteria:

* Suspected and later on confirmed lung cancer
* Presence of at least one mediastinal lymph node measuring \> 10 mm in short diameter on computerised Tomography

Exclusion Criteria:

* Age \<18
* History any malignancy apart from non-melanomatous skin cancer
* Inability to give informed consent

Primary outcomes:
measure: Adequacy of lymph node sampling
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of patients with malignant cervical lymphadenopathy
timeFrame: 7 days
measure: Proportion of patients with nodal status upstaged
timeFrame: 7 days
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
References:
Clinical trial NCT00444964: Growth Hormone Use in Adults With Prader-Willi Syndrome
Official title: Growth Hormone Use in Adults With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prader-Willi Syndrome
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

Detailed description: The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months. Specific outcomes to be evaluated are as follows:

• Increased IGF-1 as a function of human growth hormone dosage compared with baseline.

1. Improvement of indicators or risk factors for co-morbid diseases \[diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function\] in participants.
2. Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
3. Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
4. Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures.

Eligibility criteria: Inclusion Criteria:

* 16 to 60 years old
* Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
* Low IGF-1 level (e.g.,≤25%) at baseline
* Ability to provide informed consent or availability of a suitable legally authorized representative

Exclusion Criteria:

* Pregnancy
* Previous treatment with growth hormone
* Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
* History of severe scoliosis
* Heart disease
* Uncontrolled high blood pressure or history of stroke
* Morbid obesity (using PWS growth charts)
* Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results

Primary outcomes:
measure: Body Composition
timeFrame: 12 and 24 months
measure: Blood Chemistry
timeFrame: 12 and 24 months
measure: Physical Activity
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Merlin G Butler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440164: Superior Silybin Bioavailability in Healthy Volunteers
Official title: Superior Bioavailability of the Silybin-Phosphatidylcholine Complex in Oily-Medium Soft-Gel Capsules Versus Conventional Silymarin Tablets in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Chronic Liver Disease
Keywords: liver fibrosis
Hepatoprotective
Sylimarin
Lead sponsor: Medica Sur Clinic & Foundation
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All healthy volunteers

Brief summary: Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective, blind, single-dose crossover study with a one-week wash-out period. It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis. All subjects were negative for HIV, HBV, and HCV.

Detailed description: In healthy volunteers single-dose crossover study with a one week, It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination

Eligibility criteria: Inclusion Criteria:

* volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases.

The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis

Exclusion Criteria:

* Subject with HIV, HBV, HCV
* Subject with comorbidities
* Subject less 18 years old Subject higher 50 years old

Primary outcomes:
measure: Time of the Bioavailability of the Silibinin vs Sylimarin
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mendez-Sanchez N, Dibildox-Martinez M, Sosa-Noguera J, Sanchez-Medal R, Flores-Murrieta FJ. Superior silybin bioavailability of silybin-phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets in healthy volunteers. BMC Pharmacol Toxicol. 2019 Jan 11;20(1):5. doi: 10.1186/s40360-018-0280-8.
Clinical trial NCT05520164: Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
Official title: Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Infant, Newborn, Disease
Keywords: Pain
Newborn
Non-Drug Pain Management
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Pendik District Health Directorate
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

Detailed description: The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.

Eligibility criteria: Inclusion Criteria:

* Gestational age of 38-41 weeks,
* Chronological age of 2-28 days,
* Without any physical, metabolic or genetic disease,
* Newborns who did not use any analgesic drugs before the procedure

Exclusion Criteria:

* Newborns whose heel blood cannot be taken at once

Primary outcomes:
measure: The Newborn Infant Pain Scale (NIPS)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pendik Mehmet Oguz Family Health Center
Study officials:
affiliation: Pendik District Health Directorate
name: Sümeyye KOSE, Phd Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Besey OREN, Associate Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01726764: Interaction Between St John's Wort and Metformin?
Official title: Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Depression
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.


Eligibility criteria: Inclusion Criteria:

* Men aged 18-64 years
* Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
* Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose

Exclusion Criteria:

* Chronic alcohol abuse
* Hypersensitivity to metformin or St John's Wort
* Daily intake of drugs requiring prescription

Primary outcomes:
measure: Change in Area Under Curve (AUC) 0-24h of metformin
timeFrame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion
Secondary outcomes:
measure: Oral glucose tolerance test (OGTT)
timeFrame: During the first 2 hours of each metformin ingestion
measure: Pharmacokinetics of metformin
timeFrame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below
measure: Change in messenger RiboNucleic Acid (mRNA)
timeFrame: Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day)
Other outcomes:
measure: Hypericin/hyperforin
timeFrame: At t=0 in 2nd period
Locations:
city: Odense
country: Denmark
facility: Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Per Damkier, MD ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Tore B. Stage, M.Sc. Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Kim Brøsen, Professor, MD
role: STUDY_DIRECTOR
References: