louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01493908: The Effect of Marketing Variable on Effect of Active Drugs
Official title: The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Placebo effect;
Pain; Analgesic;
Electrical shock
control in healthy volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches.

A Meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance.

In recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. All patients were treated with the exact same medication.

In the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. For the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's wrist.

The investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer participants will be between the ages of 18 and 65

Exclusion Criteria:

* Candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded.
* Taking no pain medication at the time of the experiment.

Primary outcomes:
measure: pain thresholds
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Department of Family Medicine, Hebrew University, JerusaelmIsrael
Study officials:
affiliation: Hebrew University, Jerusalem Israel
name: Amnon - Lahad, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802308: Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
Official title: A Randomized, Partially Blind, Four-way Crossover Study to Determine the Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Male and Female Moderate Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.

Detailed description: Outcome: Pharmacokinetic parameters

Eligibility criteria: Main Inclusion Criteria:

* Body mass index (BMI) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg.
* Current alcohol users who are classified as moderate drinkers
* Able to abstain from alcohol during the 48 hour period preceding each study visit
* Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-Lead ECG, and laboratory evaluation

Main Exclusion Criteria:

* Intolerance towards alcohol
* History of allergy or hypersensitivity to opioids or related drugs or any excipients
* Any history of drug or alcohol dependence
* Clinically significant abnormalities on physical examination, medical history, 12-Lead ECG, vital signs, or laboratory values
* Gastrointestinal disease or constipation or other clinically significant gastrointestinal problems

Primary outcomes:
measure: To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel.
timeFrame: Single-dose evaluation
Secondary outcomes:
measure: To evaluate the safety and tolerability of the co-administration of alcohol and Egalet® morphine. Hematology, biochemistry, urinalysis, ECG, vital signs, physical examination, and adverse events monitoring
timeFrame: Single-dose evaluation
Other outcomes:
Locations:
Study officials:
affiliation: Egalet A/S
name: Christine Andersen, M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00682708: Sentinel Surveillance of Malnutrition, Niger
Official title: Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: malnutrition
ready to use food
Niger
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Niger
name: Medecins Sans Frontieres, Netherlands
First posted: 2008-05-22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006.

This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.


Eligibility criteria: Inclusion Criteria:

* All children resident in randomized villages 6-59 months

Exclusion Criteria:

* N/A

Primary outcomes:
measure: weight-for-height in children 6 to 60 mo of age
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Epicentre
name: Rebecca F Grais
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isanaka S, Nombela N, Djibo A, Poupard M, Van Beckhoven D, Gaboulaud V, Guerin PJ, Grais RF. Effect of preventive supplementation with ready-to-use therapeutic food on the nutritional status, mortality, and morbidity of children aged 6 to 60 months in Niger: a cluster randomized trial. JAMA. 2009 Jan 21;301(3):277-85. doi: 10.1001/jama.2008.1018.
Clinical trial NCT04080908: Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Official title: Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.


Eligibility criteria: Inclusion Criteria:

* Status post placement of durable ventricular assist device with stable clinical status for \>30days
* Hemoglobin \>6 g/dL AND \<13 g/dL (men) or \<12 g/dL (women) within last 90 days
* Serum ferritin \<100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation \<20% within last 90 days
* Able and willing to provide written informed consent

Exclusion Criteria:

* Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
* History of anaphylaxis
* Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months
* Renal failure on hemodialysis
* Respiratory failure on mechanical ventilation
* Disabling Stroke
* Ventricular assist device thrombosis
* Evidence of active gastrointestinal bleeding or other active blood loss
* Hospitalization \<30 days
* Pregnant or breastfeeding women

Primary outcomes:
measure: Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06761508: Comparing of Different Visual Aids Like Video,info-graphics and Pamphlets in Enhancing Community Awareness and Promoting Behavioral Change Towards the Prevention of Hypertension in Basilica of the Most Holy Trinity Onitsha Anambra State,Nigeria
Official title: Comparison of Different Visual Aids in Enhancing Community Awareness and Promoting Behavioral Change in the Prevention of Hypertension in Anambra State,Nigeria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Behavioural change in hypertension prevention
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 81
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is 3-arm, prospective, parallel (1:1:1), randomized controlled trial. A convenience sampling of registered persons who visit Basilica of the Most Holy Trinity in Onitsha, Anambra State, southeastern Nigeria for regular mass and forums on Sunday. Based on G Power, the total estimated sample size is 81. With proportionate stratification, the number of members required for each stratum of 90 catholic men, 450 catholic women, and 100 catholic youth is 12, 57, and 12, respectively. The participants will be randomly assigned from each stratum to the 3-arms (video, cartoon, pamphlet) based on balloting (draw lots).
Primary purpose: PREVENTION

Brief summary: The goal of this observational study is to assess different level of enhanced awareness and behavioral change of adults over the age of 35 who will be educated using video,infographic and pamphlet for the interval of one month


Eligibility criteria: Inclusion Criteria:

* Adults age over 35 years old
* Who does not know his/her blood pressure status within the last 6 months (The person who does not know he or she has a hypertension or not.)
* Who agree to participate

Exclusion Criteria:

* Who cannot come to the church 4 weeks later after the intervention.
* Known hypertensive patients

Primary outcomes:
measure: Behavioural change in hypertension prevetion
timeFrame: One month
Secondary outcomes:
measure: Change in the awareness level of participants from baseline after 4 week
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kasumi 1-2-3 Minami-ku
country: Nigeria
facility: Graduate School of Biomedical and Health Sciences Hiroshima University
state: Japan
Study officials:
References:
Clinical trial NCT04480008: Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
Official title: Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to find out if the Resilient Living Program will improve quality of life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and their caregivers.


Eligibility criteria: Inclusion Criteria for patients:

* Age ≥18 years
* English fluency
* No diagnosed severe cognitive impairment
* Diagnosis of stage IV solid tumor cancer
* Expected prognosis \>6 \<18 months
* Provide written informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Patient baseline distress score ≥4/10 OR identified as having distress that would benefit from program by care team or provider
* Ability to do first Resilient Living session in person

Inclusion Criteria for caregivers:

* Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study
* Provide written informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Age ≥18 years
* English fluency
* No diagnosed severe cognitive impairment
* Ability to do first Resilient Living session in person

Exclusion Criteria:

* As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
* Other psychological co-morbidities such as untreated schizophrenia, bipolar disease

Primary outcomes:
measure: Change in Perceived Stress
timeFrame: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
measure: Change in Anxiety
timeFrame: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Deirdre R. Pachman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833508: Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Official title: Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Exercise capacity
Chemoradiotherapy
Colorectal cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.

Detailed description: Chemoradiotherapy is associated with adverse effects. Patients with certain colorectal cancers undergo chemoradiotherapy prior to surgical resection. We intend to assess patient exercise capacity before and after chemoradiotherapy to assess whether this deteriorates. If there is a deleterious effect, this may affect operative outcome.

Eligibility criteria: Inclusion Criteria:

* Age greater than 65
* Colorectal cancer requiring preoperative chemoradiotherapy

Exclusion Criteria:

* Inability to walk, or exercise on a bicycle or treadmill
* Inability to understand instructions for CPET testing
* ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery)
* Contraindications to Exercise Testing
* Myocardial infarction occurring 10 days or less before CPX testing
* Symptomatic arrythmias
* Left Main Stem coronary disease of \>50%
* Severe hypertension (SBP\>180mmHg)
* Resting SpO2 \<85%
* Acute cardiac inflammatory conditions (myocarditis, pericarditis)
* Unstable angina with symptoms within 4 days
* Dissecting aneurysm of aorta
* Acute pyrexial illness
* Thyrotoxicosis
* Syncopal episodes
* Lower limb thrombosis (arterial or venous)

Primary outcomes:
measure: Change of Anaerobic threshold of 1.5ml/min/kg or more
timeFrame: 6 weeks
Secondary outcomes:
measure: Operative outcome
timeFrame: 6-10 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial NHS Trust, St Mary's Hospital, Praed Street
Study officials:
affiliation: Imperial NHS Trust at St Mary's Hospital
name: Christopher Stonell, FRCA MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
Clinical trial NCT04197908: EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
Official title: Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Cholecystitis
Keywords: Acute cholecystitis
EUS-guided gallbladder drainage
Laparoscopic cholecystectomy
gallbladder polyp
gallstone
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.

Detailed description: The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.

The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.

Eligibility criteria: Inclusion Criteria:

Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.

Exclusion Criteria:

* Pregnancy
* Patients unwilling to undergo follow-up assessments
* Patients with suspected gangrene or perforation of the gallbladder
* Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
* Patients with duodenal obstruction
* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
* Patients with liver cirrhosis, portal hypertension and/or gastric varices
* Abnormal coagulation: international normalised ratio (INR) \> 1.5 and/or platelets \< 50.000/mm3
* Previous drainage of the gallbladder

Primary outcomes:
measure: Clinical success rate
timeFrame: 30 days
Secondary outcomes:
measure: Technical success rate
timeFrame: 30 days
measure: 30-day adverse events rate
timeFrame: 30 days
measure: Stone or polyp recurrences
timeFrame: 3 years
measure: Quality of life scores: Gastrointestinal quality of life index
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
measure: Reintervention rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: CUHK
name: Anthony Teoh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465008: Analgesic Effect of Levobupivacaine in Breast Augmentation
Official title: Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Pain
Keywords: postoperative
Patient-reported
Lead sponsor: ValenciaUGH
Sponsor class: UNKNOWN
First posted: 2015-06-08
Enrollment: 66
Sex: FEMALE
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 purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation

Detailed description: One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.

Eligibility criteria: Inclusion Criteria:

* Women\> 18 and \<= 65 years
* Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
* ASA I and II
* Informed consent signed

Exclusion Criteria:

* Rejection of the patient
* ASA III or higher
* Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness).
* Allergy to NSAIDs, local anesthetics and / or morphine
* Patients treated for chronic pain
* Placement of drains for surgical needs

Primary outcomes:
measure: Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).
timeFrame: at 6 hours the early postoperative period (after the end of anesthesia)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: