louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02499887: Repeat Emergency Department Visits Among Patients With Asthma and COPD
Official title: Repeat Emergency Department Visits Among Patients With Asthma and COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
COPD
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.


Eligibility criteria: Inclusion Criteria:

* Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
* Patient age ≥ 18 years
* Resident of the City of Buffalo or Erie County
* Discharged to home
* Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
* Able to provide informed consent
* Able to comprehend English language

Exclusion Criteria:

* Received oral or inhaled corticosteroids in the week before ED presentation
* Presented to the ED primarily for prescription refills
* Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
* Admitted to ECMC or discharged to another facility
* Previously enrolled during a prior visit to the ED during the study period
* For female patients--pregnant or pregnancy status indeterminate
* Antibiotics are prescribed to treat current asthma/COPD exacerbation.

Primary outcomes:
measure: Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
Study officials:
affiliation: University at Buffalo, Department of Emergency Medicine
name: Heather A Lindstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579487: Extended Follow-Up Study for Subjects Who Participated in 2010 Study
Official title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.

Detailed description: The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.

Eligibility criteria: Inclusion Criteria:

1. Subject participated in the ZA10-001 study, and received all study treatments.
2. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
2. Subject is pregnant.
3. Subject is unable or unwilling to comply with the study requirements.
4. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
5. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.

Primary outcomes:
measure: Independent Photo Review
timeFrame: 12+ mos post treatment
Secondary outcomes:
measure: Access reduction
timeFrame: 12+ mos post treatment
measure: Subject Satisfaction
timeFrame: 12+ mos post treatment
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Mayoral Dermatology
state: Florida
Study officials:
affiliation: Mayoral Dermatology
name: Flor Mayoral, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03920787: Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
Official title: Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Keywords: inositol
insulin resistance
overweight
children
Lead sponsor: Azienda Ospedaliera San Paolo
Sponsor class: OTHER
Collaborators: name: Lo.Li.Pharma s.r.l
name: Azienda Ospedaliera San Paolo
First posted: 2019-04-19
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS.

In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml.

So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.


Eligibility criteria: Inclusion Criteria:

* 8-18 years old
* overweight or obesity
* basal insulin ≥ 20 uU/ml

Exclusion Criteria:

* pubertal delay
* hypogonadism
* hypothyroidism or hyperthyroidism
* obesity-related genetic diseases

Primary outcomes:
measure: Basal Insulin
timeFrame: 1 month
Secondary outcomes:
measure: Body weight
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: AO San Paolo
state: Mi
Study officials:
affiliation: AO San Paolo
name: Mario Mancini
role: STUDY_DIRECTOR
References:
citation: Mancini M, Andreassi A, Salvioni M, Pelliccione F, Mantellassi G, Banderali G. Myoinositol and D-Chiro Inositol in Improving Insulin Resistance in Obese Male Children: Preliminary Data. Int J Endocrinol. 2016;2016:8720342. doi: 10.1155/2016/8720342. Epub 2016 Nov 1.
Clinical trial NCT05892887: Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation
Official title: Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

Detailed description: The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

Eligibility criteria: Inclusion Criteria:

1. Aged 18-65 years.
2. Both genders.
3. American Society of Anesthesiologists' (ASA) physical status I or II.
4. Undergoing single level lumbar spine fixation.

Exclusion Criteria:

1. Patient refusal.
2. Pregnant females.
3. Renal, lung, heart, or liver disorders.
4. Communication difficulties which might prevent a reliable postoperative assessment.
5. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
6. BMI more than 30 kg/m2.

Primary outcomes:
measure: Total morphine consumption
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Numerical rating scale
timeFrame: Up to 48 hours postoperatively
measure: Time to the first rescue analgesic
timeFrame: Up to 24 hours postoperatively
measure: Postoperative complications
timeFrame: Up to 24 hours postoperatively
measure: 5-point scale
timeFrame: Up to 24 hours postoperative
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT05089487: Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Sleep
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: Proportion of patients free of severe hypoxemia
timeFrame: 30 hours
Secondary outcomes:
measure: Nocturnal oxygenation
timeFrame: 30 hours
measure: Oxygen desaturation index
timeFrame: 30 hours
measure: Periodic breathing
timeFrame: 30 hours
measure: Nocturnal transcutaneous carbon dioxide tension
timeFrame: 30 hours
measure: Visual Analogue Scale
timeFrame: 30 hours
measure: Time spent awake during the night
timeFrame: 30 hours
measure: Cerebral tissue deoxygenation
timeFrame: 30 hours
measure: Cerebral tissue oxygen saturation awake
timeFrame: 30 hours
measure: Cerebral tissue oxygen saturation during sleep without oxygen
timeFrame: 30 hours
measure: Cerebral tissue oxygen saturation during sleep with oxygen
timeFrame: 30 hours
measure: Cerebral oxygen desaturation index without oxygen
timeFrame: 30 hours
measure: Cerebral oxygen desaturation index with oxygen
timeFrame: 30 hours
measure: Cerebral tissue oxygen saturation between different sleep stages
timeFrame: 30 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References:
Clinical trial NCT02397187: Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients
Official title: The Assessment of the Efficacy of a Structured, Dimension-based, STI (Short Term Intervention) in De-compensated Personality-disorder, Hospitalized, Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Personality Disorders
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients

Detailed description: The current study attempts to design a short-term intervention aimed at stabilizing decompensate personality disorder patients in hospitalization. The study is structured as a pilot study, thus will enroll 20 patients only. Patients, upon being hospitalized and after signing the consent to participate in the study, will be randomized to two groups: The first will be treated by the novel, LOOP, concept' the other will be TAU, as routinely done with PersDis patients in the investigators facility. The outcome parameters will be changes in series of questionnaires filled upon being enrolled and at the end of the intervention. Another outcome parameter will be readmission rates in the post-intervention period (3 months).

The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where the investigators experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.

Eligibility criteria: Inclusion Criteria:

* Cluster 2 diagnosis
* No suicide attemts 1 month prior to admission
* Regularly treated
* An active support system
* No urgent need for Rx changes

Exclusion Criteria:

* Drug abuse
* An active Axis 1 diagnosis that requires change in Rx
* Unable to read/write fluently

Primary outcomes:
measure: Questionnaires
timeFrame: up to 28 days
measure: Readmission rates
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02976987: A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.
Official title: A Prolongation of Phase II Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High Grade Cervical Epithelial Neoplasia (CIN2+)
Keywords: Colvir
high grade squamous intraepithelial lesions
cervix
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The infections of high grade induced by the human papilloma viruses cause precancerous lesions of the cervical epithelium. The progression of these lesions can lead to the onset of cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3' (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to complications such as infertility or a risk of preterm birth, hence the need to move towards a non-surgical alternative therapy.

The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).

This clinical trial is a prolongation of the colvir trial, in order to

* assess the long term histological and virological evolution (24 months) of 3 g of 2% (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade intraepithelial neoplasia after complete response, partial response or response failure at the end of the Colvir study.
* assess the long term (24 months) rate of recurrence of histological lesions of the Colvir patients after conisation, in both placebo and treatment groups.


Eligibility criteria: Inclusion Criteria:

* Women who participated in the COLVIR study and received complete treatment

Exclusion Criteria:

* Women from the Colvir study who received incomplete treatment

Primary outcomes:
measure: change in biopsy conclusions (treatment success or not)
timeFrame: 24 months after initial treatment
Secondary outcomes:
measure: HPV viral load
timeFrame: 24 months after initial treatment
measure: HPV genotype
timeFrame: 24 months after initial treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann Hospital
Study officials:
affiliation: CHU Brugmann
name: Catherine Vanpachterbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306187: The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis
Official title: The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoporosis
Keywords: The changes of bone mineral density and bone turnover markers
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

Detailed description: Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Osteoporosis
* Must be able to swallow tablets

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of Participants with bone turnover markers as a Measure of bone quality
timeFrame: At 4 months after the initial treatment
measure: Number of Participants with bone turnover markers as a Measure of bone quality
timeFrame: At 1 year after the initial treatment
Secondary outcomes:
measure: Number of Participants with bone mineral density as a Measure of bone quality
timeFrame: At 4 months after the initial treatment
measure: Number of Participants with bone mineral density as a Measure of bone quality
timeFrame: At 1 year after the initial treatment
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
affiliation: Shinshu University School of Medicine
name: Yukio Nakamura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06687187: Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients
Official title: Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients Under Enteral Feeding; a Comparative Controlled Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Reflux
Lead sponsor: Zulekha Hospitals
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included 124 patients aged between 20 and 60 years requiring enteral feeding via nasogastric (NG) or orogastric (OG) tubes

Brief summary: A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding.

Detailed description: Participants were categorized into three groups: Group I and Group II received neostigmine 1 mg and 2 mg, respectively, and a control group received 10 ml of normal saline. All participants received an intravenous administration of 10 mg of metoclopramide. GRV was measured every 3 hours before enteral feeding. aspiration through nasogastric (NG) or orogastric (OG) tubes was done before the next due bolus of feeding.

Eligibility criteria: Inclusion Criteria:

* patients with a GRV \>120ml
* a normal heart rateExclusion Criteria
* absence of comorbidities such as diabetes and renal failure. exclusion Criteria:
* Patients exhibiting new-onset arrhythmias or heart block
* hypotension (systolic blood pressure less than 60 mmHg)
* experiencing active gastrointestinal bleeding or receiving prokinetic medications 8-12 hours before the intervention
* patients with a history of surgery in the gastrointestinal system in the past two weeks history of extrapyramidal manifestations
* patients with electrolyte imbalance
* pregnant patients,

Primary outcomes:
measure: The risk of aspiration
timeFrame: december 2022 to may 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar faculty of medicine
Study officials:
affiliation: lecturer
name: abdalla e hassan, lecturer
role: PRINCIPAL_INVESTIGATOR
References: