louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05384873: Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
Official title: Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer, Nonsmall Cell
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: San Luigi Gonzaga Hospital
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Humanitas Hospital, Italy
First posted: 2022-05-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling


Eligibility criteria: Inclusion Criteria:

* Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
* First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
* Will to participate by providing written informed consent;
* Availability to administer oral supplements and immunotherapy with or without chemotherapy;
* Eastern Cooperative Oncology Group Performance Status ≤ 2;
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Age \< 18 years;
* Inability to sign an informed consent;
* Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Duration of response
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
timeFrame: 4 months
measure: Skeletal muscle mass
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
measure: Self-perceived quality of life
timeFrame: 12 months
measure: Self-reported physical activity level
timeFrame: 12 months
Other outcomes:
measure: Serum levels of immunologic markers
timeFrame: 12 months
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03224273: Clinical Assessment of Two Inlay -Retained Bridge Designs
Official title: Clinical Assessment of Two Inlay -Retained Bridge Designs (Proximal Box Shaped and Inlay Shaped) in Missing Posterior Teeth Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Fractures
Keywords: proximal box design preparation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.

Detailed description: It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. In comparison With the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

Eligibility criteria: Inclusion Criteria:

* Absence of periapical or periodontal or diseases
* sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
* Maintenance of good oral hygiene
* No tooth mobility or grade 1 can be accepted
* Sufficient occluso-gingival tooth height (5mm)
* Good alignment of abutment teeth
* mesiodistal edentulous space preferred not exceed 12mm

Exclusion Criteria:

* Patients under the age of 18 or being incapable of taking out a contract
* Patients with any medical condition that impaired correct oral hygiene
* Endodontic ally treated abutment teeth
* a conspicuous medical or psychological history
* bruxism, or known allergic reaction to the materials used
* limited vertical space for the required connector height of 4mm
* pregnant female patients

Primary outcomes:
measure: fracture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04129073: QUality Of Life and surviVAl in carDIac arreSt Patients
Official title: QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest
Post-Anoxic Coma
Central Nervous System Diseases
Keywords: Comparative Effectiveness Research
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 1600
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac arrest patients admitted to ICU for specific care

Brief summary: QUO VADIS is a national observational study with the aim to describe clinical intervention and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest

Detailed description: Despite recent improvements in post-resuscitation care, about 50% of patients resuscitated from cardiac arrest die or have poor neurological prognosis. Post-anoxic brain injury is common after cardiac arrest and is a major cause of post-resuscitation mortality. Since there has been a significant investment in improving the emergency response to both in-hospital ad out-of-hospital cardiac arrest (IHCA and OHCA, respectevly) patients and reported improvements in short-term survival outcomes, the long-term neurological state and quality of life of survivors and their caregiver is of growing significance.

QUO VADIS is a national observational study created to describe clinical interventions and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest.

The aims of the study are:

* To create an Italian Registry that describes clinical interventions and neuroprognostication tools used in the management of patients admitted to ICU following cardiac arrest
* To evaluate, after one year from the cardiac arrest, the neurological outcome and the quality of life of the patients;
* To evaluate, after one year from the cardiac arrest, the quality of life of caregivers;
* To identify the most effective clinical intervention in the management of post-cardiac arrest patients admitted to ICU;
* To create a prognostic model for patients admitted to ICU after cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 14 years;
* Cardiac Arrest within 24 hours ICU admission

Exclusion Criteria:

* Absence of Informed consent;
* Age \< 14 years

Primary outcomes:
measure: Disability
timeFrame: 6 months
measure: Neurological Outcome
timeFrame: 6 months
measure: Patients quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Caregiver quality of life
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale San Giovanni Bosco, Turin
name: Sergio Livigni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872273: Blood Cell Response to Exercise
Official title: Blood Cell Response to Exercise
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Obese
Overweight
Hypertension
Hyperlipidemia
Glucose Intolerant
High blood sugar
Exercise in obesity
Platelets
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2013-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese adults with Metabolic Syndrome

Brief summary: Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.


Eligibility criteria: Inclusion Criteria:

* 30-60 years old
* BMI \>/=26 and \<40 kg/m2
* not planning to or currently attempting to gain or lose weight
* low reported omega-3 fatty acid intake per Omega-3 Checklist
* Metabolic Syndrome as define 3/5 of the following:Waist circumference: men \> 102 cm women \> 88 cm, triglycerides \> 150 mg/dL, HDL cholesterol: men \< 40 mg/dL women \< 50 mg/dL,Blood pressure \>130/\>85 mmHg,Fasting glucose \> 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)

Exclusion Criteria:

* smoke or use tobacco or nicotine in any form (including pills and patches)
* take any medication that makes you unable to exercise
* have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
* have uncontrolled hypertension
* have alcohol, anabolic steroid, or other substance abuse issues
* consume more than 3 alcoholic drinks/week
* have joint or muscle injuries that affects your ability to exercise
* have cancer (other than skin cancer or carcinoma in situ of the cervix
* pregnant or lactating
* currently exercise regularly
* taking non-steroidal anti-inflammatory medications (aspirin, Aleve, Advil, ibuprofen, naproxen
* take lipid modifying medications such as statins (Lipitor, Zocor)
* take medications for blood glucose such as insulin or metformin
* take medications that affect platelet functions (Plavix)
* taking omega-3 supplements (fish or flax oil)

Primary outcomes:
measure: Platelet Reactivity
timeFrame: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Matthew Picklo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00793273: Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.
Official title: Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 1074
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Insulin-naive or currently treated with another basal insulin
* Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

Exclusion Criteria:

* Type 1 diabetes mellitus
* Patients treated with short acting or with premix insulin
* Women who are pregnant, breast feeding or have the intention to become pregnant
* Known or suspected allergy to the study product or related product
* Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)

Primary outcomes:
measure: Change in HbA1c of treatment
timeFrame: after 12 to 16 weeks
measure: Change in FPG (fasting plasma glucose) of treatment
timeFrame: after 12 to 16 weeks
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: after 12 to 16 weeks
measure: Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation
timeFrame: after 12 to 16 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
state: Oerlikon
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05587673: High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
Official title: A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Indeterminate Colitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 3
Sex: ALL
Minimum age (years): 4
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patients aged 4-25 years of age will be recruited.

In this study, the Investigator hopes to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have an established diagnosis of IBD and are experiencing an acute flare which is not being controlled with first line therapy
* Patients present with typical IBD symptoms which will include, but are not limited to, abdominal pain, loss of appetite, rectal bleeding, diarrhea, obstruction, or passage of mucus.
* Patients referred by the GI team.
* Patients (or guardians/parents) must be able and willing to give consent (or assent where applicable) and be able to attend all study visits.

Exclusion Criteria:

* Patients with MR unsafe metallic implants that will not be able to undergo the MRI portion of the study.
* Patients with renal function impairment (GFR \&lt; 45 mL/min) preventing contrast administration.
* Patients with contrast allergy.

Primary outcomes:
measure: Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
timeFrame: Baseline through week 6
Secondary outcomes:
measure: Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy
timeFrame: Month 6
measure: Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.
timeFrame: Month 6
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Avnesh Thakor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301573: Long Term Follow-Up Study for rAAV-GAD Treated Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson's Disease
Lead sponsor: Neurologix, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.

Brief summary: The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.


Eligibility criteria: Inclusion Criteria:

* Participated in a clinical trial where they received AAV-GAD
* Able to give informed consent to participate in the study

Exclusion Criteria:

* Received Deep Brain Stimulation after receiving AAV-GAD
* Received any experimental device in the brain after receiving AAV-GAD
* Had any type of brain surgery after receiving AAV-GAD
* Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Southfield
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University Health Science Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT03766373: Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
Official title: Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Otitis Media
Lead sponsor: Novus Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.


Eligibility criteria: Inclusion Criteria includes but is not limited to:

1. AOM diagnosis with moderate to severe bulging of the TM and recent (\< 48 hours \[h\]) onset of ear pain.
2. Moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a scale of 0 10) on the NRS 11 as evaluated by the subject at Screening.
3. Generally good health (other than AOM) as determined by evaluation of medical history and physical examination at Screening.
4. Negative urine pregnancy test at Screening for all female subjects of childbearing potential.
5. Able to read and sign written informed consent prior to study participation.

Exclusion Criteria includes but is not limited to:

1. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
2. Subjects with tympanostomy tubes
3. Acute or chronic otitis externa
4. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
7. Permanent hearing loss irrespective of otitis media
8. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment
9. Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
10. Subjects with erythema of the TM without other evidence of otitis media
11. Seborrheic dermatitis involving the affected external ear canal or pinna
12. Use of medications with known vasoconstrictive properties (eg, decongestants \[Afrin®, Sudafed®\]) currently or within 2 h prior to Screening
13. Use of oral analgesics \< 2 h prior to Screening or Baseline (oral analgesics \> 2 h are permitted as long as ear pain criteria are met per Inclusion Criteria)

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: US Clinical Research Group, LLC.
state: California
city: Miami
country: United States
facility: Vista Health Research
state: Florida
Study officials:
References:
Clinical trial NCT04511273: Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder
Official title: Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with overactive bladder symptoms

Brief summary: 80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Detailed description: 80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Eligibility criteria: Inclusion Criteria:

* any female with overactive bladder symptoms, urgency and urgency incontinence

Exclusion Criteria:

* neurologic abnormalities
* Weak bladder contractility
* Diabetics

Primary outcomes:
measure: Sexual function evaluation after 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: