louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02822651: Hypovitaminosis D Prediction Score
Official title: SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Status
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 2592
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (\<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (\<20ng/ml) and 5% with severe deficiency (\<10ng/ml).

Because of the possible consequences of hypovitaminosis D (osteomalacia in adults...), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.

We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.


Eligibility criteria: Inclusion Criteria:

- Men and women aged 18 to 70 years old

Exclusion Criteria:

* Participation in a study related to vitamin D
* Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
* Pregnancy or breast-feeding
* Renal failure : severe renal impairment, dialysis, having kidney transplant
* Known hepatic impairment
* Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
* Known primary hypo/hyperparathyroidism
* Bone cancer/metastases current or in the last 2 years
* Treatment with antiepileptics
* Long-term treatment with glucocorticoids (\> 3 months)
* Treatment with antiretroviral
* Legal incapacity or limited legal capacity
* Non-recipient of French Social Security

Primary outcomes:
measure: 25 (OH) vitamin D blood concentration
timeFrame: The day of inclusion
Secondary outcomes:
measure: Vitamin D concentration level
timeFrame: The day of inclusion
Other outcomes:
Locations:
city: Lyon Cedex 03
country: France
facility: Hospices Civils de Lyon - Pôle IMER
Study officials:
affiliation: Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
name: Anne-Marie SCHOTT-PETHELAZ, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062151: Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Official title: Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Keywords: Acupuncture
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.

Detailed description: Objectives:

Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.

Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:

1. Determine parent and staff acceptability of auricular acupuncture
2. Determine infant tolerance to auricular acupuncture
3. Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
4. Evaluate the effect of auricular acupuncture on time to return to birth weight

Eligibility criteria: Inclusion Criteria:

1. Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
2. Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
3. Parents give written consent within 72 hours of infant receiving first dose of methadone

Exclusion Criteria:

1. Helix or antihelix of ear is deformed and needle is unable to be placed
2. A suspected or confirmed genetic or metabolic syndrome
3. Custody retained by the Department of Children and Families
4. Any skin condition involving the ear(s)
5. Suspected or documented infection at the time of enrollment

Primary outcomes:
measure: Number of Participants With Skin Breakdown and / or Cellulitis
timeFrame: up to 57 days
measure: Percentage of Dislodged Needles
timeFrame: Within three days of placement
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Laura Weathers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04135651: Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope
Official title: Effect of Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Intubation; Difficult or Failed
Cricoid Pressure
Pulmonary Aspiration During Anesthetic Induction
Keywords: Paratracheal pressure
Glottic view
Cricoid pressure
Pentax
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded clinical trial
Primary purpose: OTHER

Brief summary: Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.

Detailed description: Primary outcome

- Duration of intubation

Secondary outcomes

* POGO (percentage of glottic opening) score before and after application of each intervention
* Glottic grade by Cormack Lehane
* The success rate in first attempt
* Intubation difficulty scale
* Hemodynamics during intubation
* Postoperative airway complications

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing surgery under general anesthesia
* American Society of Anesthesiologists Classification 1-2

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
* Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),

Primary outcomes:
measure: Time to intubation
timeFrame: During anesthesia induction procedure
Secondary outcomes:
measure: The percentage of glottic opening (POGO) score
timeFrame: During anesthesia induction procedure
measure: Cormack-Lehane grade
timeFrame: During anesthesia induction procedure
measure: Intubation difficulty scale (IDS)
timeFrame: During anesthesia induction procedure
measure: Intubation difficulty by NRS score
timeFrame: During anesthesia induction procedure
measure: Success rate in first attempt
timeFrame: During anesthesia induction procedure
measure: Hemodynamic changes
timeFrame: During anesthesia induction procedure
measure: Hemodynamic changes
timeFrame: During anesthesia induction procedure
measure: Postoperative complications
timeFrame: An average of 1 hours after extubation
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00162851: Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
Official title: A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-CLL
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Schering Nordiska AB
First posted: 2005-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).


Eligibility criteria: Inclusion Criteria:

* B-CLL that has failed fludarabine

Exclusion Criteria:

* Performance status grade 3

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept. of Hematology, Karolinska University Hospital
Study officials:
affiliation: Dept. of Hematology, Karolinska University Hospital
name: Anders C Osterborg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767351: Variation in Serum Levels of Metformin in Patients With Reduced Renal Function
Official title: Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Metformin
Pharmacokinetics
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 DM followed at the out-patient department at the hospital will be asked to join the study

Brief summary: Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.

In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.

The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.

The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.


Eligibility criteria: Inclusion Criteria:

* Patients above the age of 18 years with type 2 diabetes mellitus.
* Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).
* Treatment with metformin on going.

Exclusion Criteria:

* Severely reduced GFR (\< 30 ml(min/1.73)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Frid A, Sterner GN, Londahl M, Wiklander C, Cato A, Vinge E, Andersson A. Novel assay of metformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010 Jun;33(6):1291-3. doi: 10.2337/dc09-1284. Epub 2010 Mar 9.
Clinical trial NCT06950151: Early Detection of Chronic Kidney Disease
Official title: Cross-sectional Study on the Early Detection of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease who are referred to nephrology teleconsultation from primary care

Brief summary: This retrospective observational study aims to assess the proportion of patients who were appropriately referred from primary care to the nephrology teleconsultation service. The appropriateness of the referral will be determined by the time elapsed between the referral criteria being met and the date of the teleconsultation, as well as by the patient's treatment at the time of referral.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years of age
* Teleconsultation to nephrology from Primary Care in the Garraf region during the period from January to December 2024
* Patients with at least one referral criterion for the nephrology service

Exclusion Criteria:

Participants diagnosed with any of the following conditions:

* Patients with Chronic Kidney Disease previously evaluated by the nephrology service.
* History of requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation).
* Patients hospitalized within the last 3 months with a diagnosis of kidney failure.
* Patients with a known prior diagnosis of Autosomal Dominant Polycystic Kidney Disease or glomerular diseases.

Primary outcomes:
measure: Appropriate referral to teleconsultation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere de Ribes
country: Spain
facility: Consorci Sanitari Alt Penedés-Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Ignacio Manzur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03230877: The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Detailed description: This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Eligibility criteria: Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing F\&P full face mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Trial Mask Seal Comfort
timeFrame: 7 ± 4 days in-home
measure: Trial Mask Seal Acceptability
timeFrame: 14 ± 4 days in-home
Secondary outcomes:
measure: Trial Mask Seal Treatment Performance - Objective
timeFrame: 7 ± 4 days in-home
measure: Trial Mask Seal Usability
timeFrame: 1 hour day-time appointment
measure: Trial Mask Seal Treatment Performance- Subjective
timeFrame: 7 ± 4 days in-home
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Trials of Florida
state: Florida
Study officials:
References:
Clinical trial NCT02033577: Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study
Official title: Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Obesity
Lead sponsor: Aleris Obesity
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2014-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.

Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

Detailed description: Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.

Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

Eligibility criteria: Inclusion Criteria:

* BMI \> 50

Exclusion Criteria:

* Psychiatric disease
* Inflammatory bowel disease
* inability to understand Swedish

Primary outcomes:
measure: Body weight reduction
timeFrame: 2 years from end of inclusion
Secondary outcomes:
measure: Patient assessed quality of life
timeFrame: 2 years from end of inclusion
Other outcomes:
measure: Short-term complications
timeFrame: 0-30 days postoperatively
Locations:
city: Lund
country: Sweden
facility: Aleris Obesity
Study officials:
References:
Clinical trial NCT03528577: A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Official title: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma


Eligibility criteria: Inclusion Criteria:

1. Men or non-pregnant women 18 to 65 years of age.
2. Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
3. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
4. Ability to use inhalation aerosol correctly.

Exclusion Criteria:

1. Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
2. Employees of the Investigator or research center or their immediate family members.
3. Previous participation in this study.
4. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Primary outcomes:
measure: Pharmacodynamic Endpoint Post-dose PC20
timeFrame: Approximately 15 minutes after last inhalation of study product
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: SPARC Site 02
state: Florida
city: Bethesda
country: United States
facility: SPARC site 01
state: Maryland
city: Saint Louis
country: United States
facility: SPARC Site 04
state: Missouri
city: Gastonia
country: United States
facility: SPARC Site 06
state: North Carolina
city: Edmond
country: United States
facility: SPARC Site 05
state: Oklahoma
city: Warwick
country: United States
facility: SPARC Site 07
state: Rhode Island
city: Boerne
country: United States
facility: SPARC Site 08
state: Texas
city: Waco
country: United States
facility: SPARC Site 03
state: Texas
Study officials:
References: