louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02559882: How to Test Success of a Renal Denervation
Official title: Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension, Resistant to Conventional Therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 11
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: Patient with therapy resistant hypertension and clinical indication for renal nerve ablation

Brief summary: The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.

Detailed description: We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention

Eligibility criteria: Inclusion Criteria:

Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure \>140/90 mmHg and 24-hour blood pressure \>130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation.

Exclusion Criteria:

* Secondary cause of hypertension
* Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm
* Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).
* Alcohol or drug abuse,
* Malignancy (unless healed or remission \> 5 years)
* Pregnancy
* Know allergy to contrast medium
* Participation in another study within the last month

Primary outcomes:
measure: Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B
timeFrame: chronic
measure: lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation
timeFrame: chronic
Secondary outcomes:
measure: Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based
timeFrame: chronic
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Cardiology University Heart Center Zurich University Hospital
Study officials:
affiliation: University Heart Center Cardiology University Hospital Zurich
name: Isabella Sudano, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822782: Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Official title: Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Lesion
Keywords: Perineal tear
Perineal lesion
Vaginal flora
Birth
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months.

Brief summary: The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with a gestational age \> 34 weeks delivering at the Nîmes University Hospital

Exclusion Criteria:

* Patient under judicial protection
* Adult patient under any kind of guardianship
* Patient refuses participation

Primary outcomes:
measure: Presence/absence of a vaginal lesion due to delivery
timeFrame: Upon delivery (Day 0)
measure: Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file
timeFrame: Upon delivery (Day 0)
Secondary outcomes:
measure: Recorded qualitative and quantitative analysis of vaginal flora in patient's file
timeFrame: Upon delivery (Day 0)
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurie Becerra, Sage Femme
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Philippe Lavigne, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015.
Clinical trial NCT05942482: Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey
Official title: Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Paraganglioma
Keywords: Paraganglioma
glomus
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent head and neck surgeries at Pamukkale University Hospital between 2007 and 2023, resulting in a histopathological diagnosis of paraganglioma

Brief summary: The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.

Detailed description: 39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* Histopathological diagnosis of carotid paraganglioma
* Histopathological diagnosis of vagal paraganglioma
* Histopathological diagnosis of jugular paraganglioma
* Histopathological diagnosis of tympanic paraganglioma

Exclusion Criteria:

-Inadequate information in files

Primary outcomes:
measure: Postoperative recurrence
timeFrame: may 2023-june 2023
measure: Postoperative nerve paralysis
timeFrame: may 2023-june 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03497182: Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
Official title: Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.

Detailed description: Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test.

The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.

Eligibility criteria: Inclusion Criteria:

* admitted to Emergency Department
* suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
* age 18 or older

Exclusion Criteria:

* member of Vulnerable Patient Population
* unable to complete Patient Informed Consent process/document

Primary outcomes:
measure: Volatile Organic Compound (VOC) Pattern
timeFrame: five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura County Medical Center
state: California
Study officials:
affiliation: Director Pediatrics
name: Chris Landon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01427582: YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access
Official title: YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Soft Tissue Sarcoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2011-09-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with YONDELIS (trabectedin), access to this investigational treatment.

Detailed description: The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.

The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. 18 years-of-age or older.
3. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.
4. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.
5. Hematologic variables:

   * Hemoglobin ≥9 g/dL
   * ANC ≥1,500/μL
   * Platelet count ≥100,000/μL
6. Serum creatinine ≤ upper limit of normal (ULN)
7. Hepatic function variables:

   * Total bilirubin ≤ ULN
   * Total alkaline phosphatase ≤ ULN, or if \> ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN.
   * AST (serum aspartate transaminase \[SGOT\]) and ALT (serum alanine transaminase \[SGPT\]) must be ≤ 2.5xULN
   * Albumin ≥2.5 g/dL

Exclusion Criteria:

1. Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.
2. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent
3. Active viral hepatitis or chronic liver disease
4. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
5. Active infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Texas
name: John C. Bagwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04125082: A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
Official title: A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Treated With Insulin
Lead sponsor: Diabetes and Glandular Disease Clinic
Sponsor class: INDUSTRY
Collaborators: name: Mannkind Corporation
name: DexCom, Inc.
First posted: 2019-10-14
Enrollment: 29
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 purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
3. Screening A1c 7.5 % - 11.5% inclusive
4. Willing and able to wear CGM system during the study
5. Willing to use only inhaled insulin (Afrezza®) at meals and for correction
6. Able to understand, speak, read and write English
7. Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy

Exclusion Criteria:

1. Diagnosed with COPD
2. Is an active smoker , or has smoked in the past 6 months
3. Diagnosed with asthma
4. Pregnancy, breast-feeding or planning to become pregnant during study period
5. Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
6. Use of oral or injected corticosteroid within 6 weeks of study enrollment
7. Enrollment in another investigational trial at the time of screening

Primary outcomes:
measure: Time In Range
timeFrame: Week 2 to End of Study
measure: Hypoglycemia
timeFrame: Week 2 to Week 16
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Week 2 to Week 16
measure: Quality of Life Questionnaires
timeFrame: Screening to Week 16
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic, P.A.
state: Texas
Study officials:
affiliation: Diabetes and Glandular Disease Clinic, P.A.
name: Mark Kipnes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02440282: Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lower Extremity Amputation
Keywords: patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 86
Sex: ALL
Minimum age (years): 29
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive 86 diabetic foot patients who underwent minor LEA

Brief summary: Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.


Eligibility criteria: Inclusion Criteria:

* diabetic foot patients who underwent minor LEA

Exclusion Criteria:

* emergency cases
* patients who underwent major upper or lower extremity amputations
* patients who received general anesthesia following fail regional or spinal anesthesia
* patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries

Primary outcomes:
measure: Mean blood pressure
timeFrame: every ten minutes from preinduction to 30minutes after sugery
measure: Mean blood pressure
timeFrame: from arrival at recovery room until 20miutes after surgery at recovery room
measure: Heart rate
timeFrame: every ten minutes from preinduction to 30minutes after sugery
measure: Heart rate
timeFrame: from arrival at recovery room until 20miutes after surgery at recovery room
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01630382: Cerebrospinal Fluid Congestion in Spinal Stenosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study group : spinal stenosis patient control group : matched sex, age

Brief summary: The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.


Eligibility criteria: Inclusion Criteria:

* neurogenic claudication more than 3months
* relief neurogenic claudication by lumbar flexion
* spinal stenosis symptom by physical exam.
* who can walk more than 30 min.

Exclusion Criteria:

* vascular claudication by physical exam.( ABI \<0.9)
* structural change in vertebral ( tumor, congenital deformity)
* operation history at spinal bone
* metallic foreign body
* peripheral polyneuropathy

Primary outcomes:
measure: CSF pressure at spinal canal
timeFrame: on time of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01057082: Dietary Supplements and Aging Muscle
Official title: Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Aging
Muscle
Dietary Supplement
HMB
Arginine
Glutamine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether older adults (ages 65-89) who consume the dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate increases in fat-free mass, muscle volume,and physical function.


Eligibility criteria: Inclusion Criteria:

* Ages 65-89
* Ambulatory

Exclusion Criteria:

* Cognitive impairment
* History of renal or hepatic disease
* History of hypotension
* History of peripheral artery disease
* Uncontrolled hypertension
* Uncontrolled diabetes
* Self-reported claustrophobia
* Current smoker
* Steroid or androgen use with the previous 3 months
* Individuals with pacemakers and defibrillators

Primary outcomes:
measure: Fat-free mass as determined by a four-compartment model of body composition
timeFrame: Baseline, 3-months, 6-months
Secondary outcomes:
measure: Appendicular lean mass as determined by dual energy X-ray absorptiometry
timeFrame: Baseline, 3-months, 6-months
measure: Muscle volume as determined by magnetic resonance imaging
timeFrame: Baseline and 6-months
measure: Physical function as determined by questionnaire and a battery of physical performance tests
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amy C Ellis, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis AC, Hunter GR, Goss AM, Gower BA. Oral Supplementation with Beta-Hydroxy-Beta-Methylbutyrate, Arginine, and Glutamine Improves Lean Body Mass in Healthy Older Adults. J Diet Suppl. 2019;16(3):281-293. doi: 10.1080/19390211.2018.1454568. Epub 2018 Apr 19.
Clinical trial NCT04711382: The Use of Faster Acting Aspart in Type 1 Diabetes Patients
Official title: The Use of Faster Acting Aspart in Type 1 Diabetes Patients: Multi-centre Real-world Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Insulin
Time in Range
Keywords: fast acting insulin
glucometrics
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2021-01-15
Enrollment: 438
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult type 1 diabetes patients, with a duration of diabetes of \> 2 years

Brief summary: Data on switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of switching from traditional mealtime insulin to Fiasp in a "real-world" clinical practice setting in people with type 1 diabetes in Belgium.

Detailed description: The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dl) at 6 and 12 months. Secondary endpoints included change in HbA1c, BMI, insulin doses, time below range (T\<70 and T\<54 mg/dl) and time above range (T\>180 and T\>250 mg/dl).

Retrospective analysis Two-center study

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes patients
* Duration of diabetes \> 2 years
* Using CGM for \> 6 months

Exclusion Criteria:

* Using SMBG
* Pregnancy
* Using glucocorticoids or immunosuppressive agents
* Active oncological problem

Primary outcomes:
measure: Time in Range
timeFrame: 12 months
Secondary outcomes:
measure: Time in Range
timeFrame: 6 months
measure: Change in HbA1c
timeFrame: 6 months & 12 months
measure: Change in weight
timeFrame: 6 months & 12 months
measure: Change in insulin doses
timeFrame: 6 months & 12 months
measure: Time below range
timeFrame: 6 months & 12 months
measure: Time above range
timeFrame: 6 months & 12 months
measure: Coefficient of variation
timeFrame: 6 months & 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References: