louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01157247: Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Spinal Puncture
Keywords: Anesthetic techniques
regional, spinal
Pain
lumbar puncture
Analgesia, local
Analgesia, intravenous
Lead sponsor: Croatian Society of Regional Anesthesia and Analgesia
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 88
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Background and Objectives: Spinal puncture is painful procedure which may cause patient refusal of spinal anesthesia in future surgery. It could be minimized with topical and infiltration local anesthetic or intravenous opioid application before procedure. Objective was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.

Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled for lower leg surgery. Patients were divided in four equal study groups: spinal needle (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic infiltration (2 ml of 2% lidocaine, 25Gx11/4" needle) or intravenous fentanyl application (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.


Eligibility criteria: Inclusion Criteria:

* Adults
* ASA I or II status
* Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia

Exclusion Criteria:

* Patients with scoliosis
* Degenerative spine deformity
* A history of back surgery or back pain
* Pregnancy
* Perence of coagulopathy
* Systemic or local infection
* Allergy to amide-local anesthetics
* Neurologic damages and mental disability
* More than one spinal puncture attempt
* Patient who was unable to estimate pain score
* High Ramsay sedation score

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital of Traumatology
Study officials:
References:
citation: Almeida GP, Boos GL, Alencar TG, Oliveira Filho GR. [Onset of 1% lidocaine for skin infiltrative anesthesia]. Rev Bras Anestesiol. 2005 Jun;55(3):284-8. doi: 10.1590/s0034-70942005000300005. Portuguese.
citation: Kaur G, Gupta P, Kumar A. A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1065-70. doi: 10.1001/archpedi.157.11.1065.
citation: Calderon E, Pernia A, Roman MD, Perez AC, Torres LM. [Analgesia and sedation in the subarachnoid anesthesia technique: comparative study between remifentanil and fentanyl/midazolam]. Rev Esp Anestesiol Reanim. 2003 Mar;50(3):121-5. Spanish.
Clinical trial NCT05871047: Prevalence of Nerd Neck Between Different Students at Taibah University, Saudi Arabia
Official title: Prevalence of Nerd Neck Between Different Students at Taibah University, Saudi Arabia; Cross Section Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CERVICAL
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practical group was recruited from college of Medical Rehabilitation Sciences and Applied Medical Sciences while non-practical group was recruited from Business Administration. Posters, word of mouth, and WhatsApp groups were used to recruit both groups.

Brief summary: A convenient sample of 82 female students aged 18-24 years participated in analytic observational experiment cross section design. Students were recruited into two groups, practical and non-practical. to answer the following

1. Is there a difference in the prevalence of nerd neck between students of practical and non-practical studying groups at Taibah University from the sitting position?
2. Is there a difference in the prevalence of nerd neck between students of practical and non-practical studying groups at Taibah University from the standing position?


Eligibility criteria: Inclusion Criteria:

* A convenient sample of 82 female students
* the age was between 18-24 years
* Students were recruited from practical and non-practical faculties at taibah university.

Exclusion Criteria:

* we excluded Any student with previous neck or back surgery or history of previous accident
* Also, any student with history of cervical column fracture injury, scoliosis, severe thoracic kyphosis, torticollis, persistent respiratory problems, rheumatic disease.
* also we excluded any student with loss of standing balance and user of hearing aid

Primary outcomes:
measure: the prevalence of nerd neck
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Taibah University
Study officials:
affiliation: Taibah University
name: walaa M ragab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452647: Comparison of Blood Pressure Throughout Pregnancy
Official title: Comparison of Blood Pressure Throughout Pregnancy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: Condition: No specific disease is being studied, few procedures are excluded.
Focus: To obtain blood pressure data and detect any trends to a statistically significant degree.
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2007-03-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population defined as parturients who present for delivery. See Eligibility Criteria.

Brief summary: The purpose of this study is to observe and analyze variation of diastolic blood pressure measurements at third trimester of pregnancy and when they present for delivery in comparison to healthy volunteers.

When patients present for delivery, we expect blood pressure to be lower than normal. However this is not the case. We aim to determine where this trend occurs throughout to duration of pregnancy, and propose possible explanation as to the source of this event.

After discharge, the information recorded includes each patient's blood pressure upon admission to the labor floor, and several blood pressure measurements from prior clinical visits.


Eligibility criteria: Inclusion Criteria:

* Females age 18-40
* Parturients who present for delivery who are not yet in labor

Exclusion Criteria:

* Patients with hypertension, cardiac disease, diabetes, or thyroid disorders
* Parturients who are already in labor upon presentation to the labor floor

Primary outcomes:
measure: Measurment of blood pressure throught pregnancy
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Jay Horrow, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03836547: Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Official title: Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Emphysema
Lung Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with lung disease and a BMI of 35 or greater with significant shortness of breath will be randomized to a multicomponent intervention vs a wait-list control group.
Primary purpose: TREATMENT

Brief summary: Researchers are trying to test the effectiveness and feasibility of a multicomponent lifestyle intervention to support weight loss decreases dyspnea in obese people with chronic lung disease and clinically significant breathlessness.

Detailed description: Patient will be randomized to a 12-week intervention that uses the Weight watchers lifestyle program online, a Garmin Fitness Tracker, blue tooth scale and receive health coaching vs a wait-list control group.

Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years.
* BMI \>=35
* Dyspnea MRC class II or greater
* Diagnosis of lung disease
* Signed informed consent

Exclusion Criteria

* BMI \<35
* Pregnancy
* Recent respiratory illness (within the last 6 weeks)
* Recent exacerbation of chronic lung disease (within the last 6 weeks)
* Already participating in a structured diet and/or exercise program
* Medical contraindication to weight loss (cancer)
* Medical contraindication to unsupervised exercise (unstable angina)

Primary outcomes:
measure: Breathlessness
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Lean Body Mass (lbs.)using InBody 770 Scale
timeFrame: baseline to 12 weeks
measure: Skeletal Muscle Mass (lbs.) using InBody 770 Scale
timeFrame: baseline to 12 weeks
measure: Percent Body Fat using InBody 770 Scale
timeFrame: baseline to 12 weeks
measure: Weight using InBody 770 Scale
timeFrame: baseline to 12 weeks
measure: Body Mass Index using InBody 770 Scale
timeFrame: baseline to 12 weeks
measure: Mindful Eating
timeFrame: baseline to 12 weeks
measure: Daily Steps
timeFrame: baseline to 12 weeks
measure: Daily Sedentary Time
timeFrame: baseline to 12 weeks
measure: Daily Physical Activity
timeFrame: baseline to 12 weeks
measure: Exercise Capacity
timeFrame: baseline to 12 weeks
measure: Sleep Time Measures
timeFrame: baseline to 12 weeks
measure: Sleep Efficiency
timeFrame: baseline to 12 weeks
measure: Disease specific quality of life
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00617045: Duloxetine for the Treatment of Postpartum Depression
Official title: Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postpartum Depression
Major Depressive Disorder
Keywords: Post Partum Depression
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 0
Sex: FEMALE
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 assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.

Detailed description: Study was terminated because of poor enrollment

Eligibility criteria: Inclusion Criteria:

* adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy
* must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale
* speak English or Spanish
* have access to a telephone
* provide written and verbal consent

Exclusion Criteria:

* have current or lifetime psychosis
* an unstable medical condition
* hypertension
* narrow-angle glaucoma
* liver disease
* seizure disorders
* bulimia
* anorexia
* mania
* substance abuse disorders
* have a known hypersensitivity to duloxetine or any of the active ingredients
* are in need of inpatient hospital treatment with an excluded medication
* adolescents under the age of 18

Medication Exclusion

* other antidepressants
* antipsychotic agents
* quinolone antibiotics
* Type 1C antiarrhythmics
* daily benzodiazepines
* Treatment with a monoamine oxidase inhibitor

Primary outcomes:
measure: Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Perinatal & Postpartum Research Program 142 Temple ST Suite 301
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly A Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204945: Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
Official title: Acute Responses in Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: arterial stiffness
echocardiography
nesiritide
high heart pressures
cardiac catheterization
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2005-09-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Research question: What is the response of the heart's pumping function to changes in heart chamber pressures?
2. Experimental design: Patients undergoing routine cardiac catheterization will be studied. A thermodilution pulmonary artery catheter will be inserted through a venous sheath and threaded into the pulmonary artery. After several minutes of quiet rest, baseline hemodynamics will be obtained, including a determination of cardiac output using thermodilution techniques and 30 seconds of pressure recordings from the left ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to determine ejection fraction and indices of diastolic filling. Finally, arterial tonometry will be obtained in quick succession from the brachial, radial, femoral, and carotid arteries. Following the collection of baseline data, a bolus and infusion of nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still infusing, a full set of invasive hemodynamics will again be obtained, as well as brief echocardiographic and arterial tonometry examinations.


Eligibility criteria: Inclusion Criteria:

* Cardiac catheterization

Exclusion Criteria:

* Unstable coronary syndrome,
* Critical coronary stenoses (\>90%),
* Severe peripheral vascular disease,
* Symptomatic hypotension at completion of routine diagnostic cath,
* Significant valvular disease, resting heart rate \>120 beats/min,
* Ejection fraction \<45%,
* Presence of contraindications to nesiritide administration,
* Any evidence of clinical instability.

Primary outcomes:
measure: arterial tonometry
timeFrame: following catheterization, then following 10 minutes of nesiritide infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nancy K Sweitzer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777945: XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer
Official title: Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 46
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: Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel

Brief summary: This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* HER2-negative metastatic breast cancer
* Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Exclusion Criteria:

* Contraindications to Xeloda treatment according to the Summary of Product Characteristics

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: approximately 2 years
Secondary outcomes:
measure: Time to Treatment Failure
timeFrame: approximately 2 years
measure: Overall Response Rate
timeFrame: approximately 2 years
measure: Clinical Benefit Rate
timeFrame: approximately 2 years
measure: Duration of Treatment With Xeloda
timeFrame: approximately 2 years
measure: Percentage of Capecitabine Dose Modifications
timeFrame: approximately 2 years
measure: Number of Participants With Adverse Events
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvár
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Szeged
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01584245: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants
Official title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cow's Milk Allergy
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.


Eligibility criteria: Inclusion Criteria:

* Weight loss within the past 4 weeks
* Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
* Birth weight greater than or equal to 1500 grams
* Solely enteral fed
* Infants with at least one persistent allergy symptom
* No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
* Signed informed consent

Exclusion Criteria:

* History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
* Metabolic disease requiring special attention

Primary outcomes:
measure: Weight gain
timeFrame: 12 weeks
Secondary outcomes:
measure: Allergic manifestations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Centre médical
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Vandoeuvre Lés Nancy
country: France
facility: Médecine Infantile 1
Study officials:
affiliation: Centre médical
name: Delphine de Boissieu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533. doi: 10.1097/MPG.0000000000001374.
Clinical trial NCT02825745: Use of Betashot in Children and Adults With Epilepsy
Official title: A Feasibility Study of the Use of Betashot, a Medium Chain Triglyceride- Based (MCT) Food for Special Medical Purposes (FSMP) in Children and Adults With Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nervous System Disorder
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 77
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy.

MCT is a type of dietary fat used in the ketogenic diet.

Detailed description: This study aims to explore the use of Betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars.

The participants will be required to drink Betashot to enable the following assessment:

1. Tolerance (side effects such as bloating or cramps)
2. Acceptability (flavour, texture, taste)
3. Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)

Eligibility criteria: Inclusion Criteria:

1. Children aged 3-18 years with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication, either with a diagnosis of Dravet syndrome or another early onset epilepsy, the result of a genetic mutation.

   Adults (aged over 18) with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication.
2. Participant/Parent/guardian to comply with the study protocol and participate in active monitoring of tolerance, acceptability and compliance of Betashot via a written record, and to complete questionnaires.

Exclusion Criteria:

1. Children \< 3 years of age
2. Children and adults free from epilepsy for \> 4 weeks
3. Medical conditions that contra-indicate the use of MCT
4. Inability to comply with the study protocol.
5. Currently on a ketogenic diet
6. Children and adults who are totally enterally fed.
7. Females who are pregnant or planning to become pregnant during the study.

Primary outcomes:
measure: Palatability
timeFrame: 12 weeks
measure: Gastrointestinal tolerance
timeFrame: 12 weeks
measure: Compliance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
Study officials:
affiliation: UCL
name: Matthew Walker
role: PRINCIPAL_INVESTIGATOR
References: