louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00529165: The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: injection to meal time
human insulin
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate, that there is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Aged 40 - 80 years
* Therapy with human insulin

Exclusion Criteria:

* Pregnancy
* Nutrition disorders
* Psychological disease
* Body Mass Index (BMI) less than 25 kg/m\^2
* HbA1c greater than 9%

Primary outcomes:
measure: HbA1c
timeFrame: Week 16 and 28
Secondary outcomes:
measure: Hypoglycemia
timeFrame: Week 16 and 28
measure: Treatment satisfaction
timeFrame: week 16 and 28
measure: Quality of Life
timeFrame: week 16 and 28
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University, department of internal medicine III
Study officials:
affiliation: University of Jena, department of internal medicine III
name: Ulrich A Mueller, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
citation: Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
Clinical trial NCT05461365: Intranasal Insulin for COVID-19-related Smell Loss
Official title: Intranasal Insulin for COVID-19-related Smell Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anosmia
Smell Loss
Paraosmia
Hyposmia
COVID-19
Lead sponsor: Universidad Panamericana
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to quantify the improvement in olfaction of 27 post-COVID-19 patients, after three intreventions of intranasal insulin during a four week period, with the help of the Threshold, Discrimination and Identification (TDI) score evaluated with Sniffin Sticks®.


Eligibility criteria: Inclusion Criteria:

* COVID-19 in the last 3 to 18 months and who persisted with anosmia, hyposmia or other olfactory dysfunction chronically and without improvement

Exclusion Criteria:

* nasal tumors, chronic sinusitis, drug-induced sinusitis, nasal polyposis, neurodegenerative disease, smoking, pregnancy Hypoglycemia and a previous diagnosis of diabetes mellitus or anatomical malformations such as septal deviation, rhinosinusitis or choanal atresia

Primary outcomes:
measure: SMELL LOSS IMPROVEMENT
timeFrame: 1 MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Universidad Panamerican
Study officials:
References:
citation: Oleszkiewicz A, Schriever VA, Croy I, Hahner A, Hummel T. Updated Sniffin' Sticks normative data based on an extended sample of 9139 subjects. Eur Arch Otorhinolaryngol. 2019 Mar;276(3):719-728. doi: 10.1007/s00405-018-5248-1. Epub 2018 Dec 15.
citation: Kosugi EM, Lavinsky J, Romano FR, Fornazieri MA, Luz-Matsumoto GR, Lessa MM, Piltcher OB, Sant'Anna GD. Incomplete and late recovery of sudden olfactory dysfunction in COVID-19. Braz J Otorhinolaryngol. 2020 Jul-Aug;86(4):490-496. doi: 10.1016/j.bjorl.2020.05.001. Epub 2020 May 25.
citation: Vaira LA, Salzano G, Fois AG, Piombino P, De Riu G. Potential pathogenesis of ageusia and anosmia in COVID-19 patients. Int Forum Allergy Rhinol. 2020 Sep;10(9):1103-1104. doi: 10.1002/alr.22593. Epub 2020 Jun 15. No abstract available.
citation: Rezaeian A. Effect of Intranasal Insulin on Olfactory Recovery in Patients with Hyposmia: A Randomized Clinical Trial. Otolaryngol Head Neck Surg. 2018 Jun;158(6):1134-1139. doi: 10.1177/0194599818764624. Epub 2018 Mar 20.
citation: Mohamad SA, Badawi AM, Mansour HF. Insulin fast-dissolving film for intranasal delivery via olfactory region, a promising approach for the treatment of anosmia in COVID-19 patients: Design, in-vitro characterization and clinical evaluation. Int J Pharm. 2021 May 15;601:120600. doi: 10.1016/j.ijpharm.2021.120600. Epub 2021 Apr 14.
Clinical trial NCT06862765: Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement
Official title: Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement with LuX-Valve Via the Trans-jugular Vein Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-surgical Risk Patients with Severe Tricuspid Regurgitation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 340 consecutive patients for TTVR screening using LuX-Valve Plus at seven cardiac centers.

Brief summary: The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.


Eligibility criteria: Inclusion Criteria:

* (i) age \> 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE \> 4.

Exclusion Criteria:

* (i) left ventricular ejection fraction \< 40%; (ii) systolic pulmonary arterial pressure \> 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.

Primary outcomes:
measure: screening failure rate
timeFrame: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital
state: Fujian
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xi'an
country: China
facility: Department of Cardiovascular Surgery, Xijing Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02797665: Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Pancreatitis
IgG4-related Sclerosing Cholangitis
Obstructive Jaundice
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 30
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 study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.


Eligibility criteria: Inclusion Criteria:

* adults greater than 18 years-old;
* autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
* obstructive jaundice

Exclusion Criteria:

* malignancies; active infections;
* pregnancy or breast feeding;
* standard contraindications to ERCP;
* unwillingness or inability to consent for the study

Primary outcomes:
measure: Clinical remission rate of obstructive jaundice
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Aiming Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02818465: Role of the Interaction Between Advanced Glycation End Products and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients
Official title: Role of the Interaction Between AGEs and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialyzed Patients
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest, advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while accumulation of AGEs will be measured in the serum and in the skin (non invasive). Additionally factors influencing RAGE activation such as genetic polymorphism and level of soluble forms of RAGE will be measured and analyzed.


Eligibility criteria: Inclusion Criteria:

* Renal impairment
* Hemodialysis for more than 3 months
* Have agreed to participate in research
* Affiliated to a social security scheme
* major

Exclusion Criteria:

* Diabetes , for diabetes induces accelerated formation of advanced glycation end products , which could then be a confounding factor in our study.
* Protected by law .
* minors
* pregnant women
* Matt or pigmented skin because the skin hyperpigmentation interfere with reading the skin fluorescence giving falsely elevated values .
* Having an aneurysm of the abdominal aorta known
* Suffering from a progressive neoplastic disease

Primary outcomes:
measure: Frammingham Score
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT01535365: Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Official title: Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Strain
Neck Strain
Keywords: muscular sprain
acute back pain
acute neck pain
heat treatment
cold treatment
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 60
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: Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended. In the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the Emergency Department.

Detailed description: as above

Eligibility criteria: Inclusion Criteria:

* Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.

Exclusion Criteria:

* Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.

Primary outcomes:
measure: Pain Score After Treatment
timeFrame: 30 minutes
Secondary outcomes:
measure: Request for Rescue Analgesia
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: ADAM SINGER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920465: Treatment Regimens for Mifegyne and Cytotec
Official title: Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Medical Abortion
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2009-06-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test two regimens of mifegyne and cytotec for medical abortion. The investigators hypothesize that administration of both medications during one hospital visit will not compromise effectiveness.


Eligibility criteria: Inclusion Criteria:

* above age 18,
* for whom Mifegyne and cytotec are indicated.

Exclusion Criteria:

* inflammation of oral cavity.

Primary outcomes:
measure: percentage of complete abortion
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital- Nahariya
Study officials:
References:
Clinical trial NCT04751565: Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
Official title: Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Detailed description: Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

Eligibility criteria: Inclusion criteria:

* Male and female aged \> 18 years
* TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
* Implants placed in both arches
* Patients with gingivitis or treated periodontitis (i.e., absence of residual PD \> 5 mm)
* Presence of at least 2 mm of keratinized mucosa at implant sites.

Exclusion criteria:

* presence of medical conditions contraindicating treatment of peri-implant mucositis,
* regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment

  * Presence of systemic diseases
  * Pregnant and lactating females
  * Smokers \> 10 cigarettes/day
  * Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  * Implants with modified (i.e. micro-rough) necks
  * Interproximal open contacts between implant restoration and adjacent teeth
  * Peri-implantitis (Renvert, et al., 2018)

Primary outcomes:
measure: Bleeding on Probing (BOP) changes
timeFrame: Baseline (T0), 3-months (T1) and at 6-months (T2)
Secondary outcomes:
measure: Full mouth plaque score (FMPS) changes
timeFrame: Baseline (T0), 3-months (T1) and at 6-months (T2)
Other outcomes:
measure: Pocket probing depth (PD) mm changes
timeFrame: Baseline (T0), 3-months (T1) and at 6-months (T2)
measure: Presence of plaque at implant sites according to plaque index (PlI)
timeFrame: Baseline (T0), 3-months (T1) and at 6-months (T2)
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: Università degli Studi di Mesina
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05083065: Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Official title: Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Vaccine
Menstrual Irregularity
Menopausal Bleeding
Keywords: Covid-19 vaccine
Menstrual Irregularity
Menopausal Bleeding
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 369
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Brief summary: Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection among the general population, reducing significantly both morbidity and mortality.

Nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual Irregularities or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual Irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.


Eligibility criteria: Inclusion Criteria:

* Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Exclusion Criteria:

* Women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, GnRH-analogues, aromatase inhibitors, hormonal replacement therapy in menopause;
* Surgical menopause (hysterectomy and/or bilateral oophorectomy);
* Breastfeeding.

Primary outcomes:
measure: Frequency of the menstrual cycle
timeFrame: 30 days after the administration of the first and second doses of vaccine
measure: Quantity of the menstrual cycle
timeFrame: 30 days after the administration of the first and second doses of vaccine
measure: Duration of the menstrual cycle
timeFrame: 30 days after the administration of the first and second doses of vaccine
Secondary outcomes:
measure: Post-menopausal bleeding
timeFrame: 30 days after the administration of the first and second doses of vaccine
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770665: Validation of the MiCK Assay
Official title: Mayo Clinic Validation of the MiCK Assay
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mesothelioma, Small Cell Lung Cancer, NSCLC
Lead sponsor: Pierian Biosciences
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.

Brief summary: Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

Detailed description: This study will be conducted in two phases.

During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation.

Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase.

During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.

Eligibility criteria: Inclusion Criteria:

* 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.

Exclusion Criteria:

* patients that a sample cannot obtained for testing.

Primary outcomes:
measure: Complete response and survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Validation Support Services 3050 Superior Drive NW
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mary Karaus
role: STUDY_DIRECTOR
References: