louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02986711: Penn State TXT2STAYQUIT Study- a Texting Study to Help Hospitalized Smokers Stay Quit
Official title: Pilot Randomized Trial of Brief Automated Smoking Cessation Intervention and Evaluation for Smokers Discharged From Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. It also aims to assess whether specially designed relapse prevention text messages designed to encourage abstinence from smoking, can increase the proportion of smokers who remain abstinent during the first month after discharge from hospital.

Detailed description: Participants will be those who are hospitalized at Hershey Medical Center and are interested in help to stay quit when they leave the hospital.

Eligibility criteria: Inclusion Criteria:

* Total length of hospital stay at least 24 hours
* Free of cognitive impairment
* Read and speak English
* Smoked at least 20 cigarettes in 30 days prior to entering the hospital
* Willing to give up all forms of tobacco
* Has a cell phone capable of receiving text messages (cell phone is powered on and charged)

Exclusion Criteria:

* Patient has been admitted for a transplant
* Patient has Intensive Care status

Primary outcomes:
measure: Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).
timeFrame: 28 days
Secondary outcomes:
measure: Proportion of Participants Providing Smoking Cessation Status Via Text Message
timeFrame: 28 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Jonathan Foulds, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235911: Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
Official title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 100
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 primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).


Eligibility criteria: Inclusion Criteria:

* diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months

Exclusion Criteria:

* Regular need of \>4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years

Primary outcomes:
measure: Change in PD20 histamine
Secondary outcomes:
measure: number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS
Other outcomes:
Locations:
city: Appingedam
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Riemersma RA, Postma D, van der Molen T. Budesonide/formoterol maintenance and reliever therapy in primary care asthma management: effects on bronchial hyperresponsiveness and asthma control. Prim Care Respir J. 2012 Mar;21(1):50-6. doi: 10.4104/pcrj.2011.00090.
Clinical trial NCT04845711: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy
Official title: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Postoperative Analgesia
Erector Spinae Plane Block
Quadratus Lumborum Block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* aged 21-65 years
* both genders
* American Society of Anesthesiology (ASA) class I-II
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal.
* Coagulopathy.
* History of allergy to local anaesthetic.
* History of liver or renal pathology affecting drug elimination
* Mental dysfunction or cognitive disorders.
* Use of medication such as gabapentin-pregabalin that could affect pain perception.
* Body Mass Index \> 40 kg/m2.

Primary outcomes:
measure: The degree of postoperative pain in the first 24 hours post-operative
timeFrame: first 24 hours post-operative
Secondary outcomes:
measure: Time to first analgesic requirement
timeFrame: first 24 hours post-operative
measure: Total dose of intraoperative consumption of fentanyl
timeFrame: intraoperative
measure: Total dose of rescue analgesia in the first 24hr postoperative
timeFrame: first 24 hours post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine
name: Mai E Hamada, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244411: Exercise and QUality Diet After Leukemia: The EQUAL Study
Official title: Exercise and QUality Diet After Leukemia: The EQUAL Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adult Survivors of Childhood Leukemia
Keywords: EQUAL
Exercise
Diet
Physical activity
14-164
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: St. Jude Children's Research Hospital
First posted: 2014-09-19
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and exercise can help people lose weight and improve other health problems. This two year study will compare two methods of informing participants about ways to lose weight.


Eligibility criteria: Inclusion Criteria:

Eligibility will be confirmed via the CCSS-based medical record and by a series of questions on the EQUAL website, prior to consent.

* Participation in the CCSS cohort
* Diagnosed with acute lymphoblastic leukemia \< 18 years of age
* Cancer free at time of study enrollment
* Current age ≥ 18 years
* A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by self-reported height and weight on the most recent CCSS questionnaire
* Internet access and a personal email account
* Able to read and comprehend informed consent

Exclusion Criteria:

* Prior history of congestive heart failure, coronary artery disease, myocardial infarction, stroke, or unstable angina;
* Medical condition for which weight loss might be contraindicated or which would cause weight loss, such as pregnancy, anorexia or bulimia;
* Use of prescription weight loss medication within the previous 6 months
* History of total body irradiation (TBI)

Primary outcomes:
measure: Weight loss
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chaya Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632111: Pulmonary Involvement in Patients With Fabry Disease
Official title: Impact of the Treatment With Agalsidase Alpha on Lung Function and on Pulmonary Involvement in Patients With Fabry Disease. A Multicenter, Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory patients at University Hospital of Zurich with Fabry disease

Brief summary: The objective of this study is to investigate whether Agalsidase alpha, a drug commonly prescribed in patients with Fabry disease, is associated with improvement of the pulmonary involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the surrogate markers for obstructive lung diseases are a decrease in both forced expiratory volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity. However, the measurement of these lung function parameters is indicated as yearly follow-up examinations with or without the treatment of Agalsidase alpha in patients with Fabry disease.

Detailed description: Pulmonary function tests und DLCO measurements are performed yearly in relation with yearly follow up examinations in the Department of Internal Medicine from the University Hospital of Zurich. We will retrospectively collect the results of the pulmonary functions test (spirometry).

Eligibility criteria: Inclusion criteria:

* All patients with established diagnosis of Fabry disease

Exclusion criteria:

* Missing informed consent

Primary outcomes:
measure: Lung function measurements
timeFrame: From first consultation until present
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Internal Medicine
Study officials:
affiliation: University Hospital Zurich, Division of Internal Medicine
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592111: A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)
Official title: A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediatric
Hodgkin's Disease
Keywords: Pediatric
Hodgkin's Disease
96-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Children's Cancer Group
First posted: 2008-01-11
Enrollment: 21
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.


Eligibility criteria: * Age less than 21 years at diagnosis
* Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease.
* Informed patient/parental consent as required by individual institution and in accordance with the Dept of Health and Human Services
* Approval of this protocol by the individual institutional Human Subjects Review Committee.
* Indicate Hodgkin's disease clinical stage.
* Indicate presence or absence of "B" symptoms.
* For Stage I and II disease indicate the following:
* presence or absence of bulk disease
* number of involved nodal regions
* presence or absence of hilar adenopathy

Primary outcomes:
measure: Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy
timeFrame: Conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tanya Trippett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086511: PANDA: PKU Amino Acid Evaluation
Official title: PANDA: A Cross-sectional Study to Measure Blood Amino Acid Levels in PKU Children on a Protein Substitute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonuria (PKU)
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with PKU and age- and sex-matched non-PKU comparison subjects.

Brief summary: Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine (Tyr). PKU patients have specific dietary needs and must follow a restrictive diet in the aim of preventing toxic levels of the amino acid phenylalanine (Phe) accumulation.

Detailed description: The exploratory study's main objective is to measure blood amino acid levels and to gain quantitative insights in children with PKU on a protein substitute with respect to evaluation of nutritional intake.

Eligibility criteria: Inclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. Age ≥ 2 and ≤ 12 years
2. Willing and able to provide informed consent by parents or legal representatives (and assent if required by local law/regulations)
3. One subject per family

   PKU subjects specific inclusion criteria:
4. PKU subjects identified by newborn screening and started low Phe diet before 1 month age
5. Usage of at least two Phe-free protein substitutes on a daily basis for at least 26 consecutive weeks up to Visit 1
6. Average Phe-level ≤360 µmol/L based on at least two blood Phe values from the past 12 months up to Visit 1

   Non-PKU comparison subjects specific inclusion criteria:
7. Same age (±3 years) and sex as an included PKU subject

Exclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. Current psychiatric disorders
2. Severe hepatic, thyroid or renal dysfunction
3. Acute illnesses like fever, flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to V1)
4. Serious conditions (e.g. cancer, hydrocephalus, fatal heart disease)
5. Participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study

   PKU specific exclusion criteria:
6. Use of BH4, or drugs that may interfere with main outcomes

   Non-PKU comparison subjects specific exclusion criteria:
7. PKU diagnosis or any other diagnosed disorder of amino or organic acid metabolism

Primary outcomes:
measure: Amino acid levels in blood
timeFrame: day 1
measure: Nutrient Intake
timeFrame: day 1 - day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Dr. P. Verloo
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
Study officials:
affiliation: UZ Gent, Belgium
name: Dr. P. Verloo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815111: Evaluation of Ketamine and Multi-modal Analgesics
Official title: Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing planned surgery for cardiac problems

Brief summary: The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.

Detailed description: The investigators plan to study an analgesic regimen of Ketamine and Lidocaine as infusions with Neurontin and acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. The investigators expect that pain scores will be either unchanged or better than historic controls. In addition, the investigators expect that ventilator days and ICU stay will be improved due to reduced incidence of delirium and bowel dysfunction.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) status 1-4
* Undergoing planned surgery for cardiac problems
* 18 years of age and not older than 85 years of age

Exclusion Criteria:

* Severe liver disease (alanine aminotransferase (ALT) , aspartate aminotransferase (AST), or bilirubin \> 2.5 times Upper Limit of Normal)
* Pregnancy or currently breastfeeding
* History of schizophrenia or other hallucinatory psychiatric disorder
* History of chronic or pre-existing pain disorder
* History of heart block
* Severe renal impairment Creatinine Clearance (CrCl)\<30 milliliter(mL)/min

Primary outcomes:
measure: Changes between the two groups assessed by overall ventilator days
timeFrame: Through study completion, an average of one week
Secondary outcomes:
measure: Changes between the two groups assessed by ICU length of stay
timeFrame: Through study completion, an average of one week
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Sean Kiley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00295711: Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Official title: A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 Mg BID, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: bicifadine
chronic low back pain
Lead sponsor: DOV Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain.

The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.


Eligibility criteria: Main Inclusion Criteria:

* Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
* Patients must have required on average daily analgesics for the treatment of low back pain for at least 3 months prior to dosing.

Main Exclusion Criteria:

* Patients may not have moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
* Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
* Patients may not have an unstable medical condition.

Primary outcomes:
measure: - Pain Severity Rating (100 mm visual analog scale)
Secondary outcomes:
measure: Short-Form McGill Pain Questionnaire (SF-MPQ)
measure: Roland-Morris Disability Questionnaire (RDQ)
measure: Short-Form 36 (SF-36) Health Survey
measure: Patient's Global Impression of Change (7-point categorical scale)Physician's Global Impression of Change (7-point categorical scale)
measure: Patient's Global Evaluation of Study Medication (5-point categorical scale)
measure: Physician's Global Evaluation of Study Medication (5-point categorical scale)
measure: Incidence of study discontinuation due to lack of efficacy
measure: Plasma PK of bicifadine
Other outcomes:
Locations:
Study officials:
References: