louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00895804: Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Official title: Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mood Disorder
Substance-Related Disorders
Amphetamine-Related Disorders
Keywords: MDMA
beta adrenergic
Ecstasy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Heffter Research Institute
First posted: 2009-05-08
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.

Detailed description: We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Sufficient understanding of the German language
* Subjects understand the procedures and the risks associated with the study
* Participants must be willing to adhere to the protocol and sign the consent form
* Participants must be willing to refrain from taking illicit psychoactive substances during the study.
* Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight of the evening before the study session.
* Participants must be willing not to drive a traffic vehicle in the evening of the study day.
* Body mass index: 18-25 kg/m2

Exclusion Criteria:

* Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
* Current or previous psychotic or affective disorder
* Psychotic or affective disorder in first-degree relatives
* Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
* Participation in another clinical trial (currently or within the last 30 days)
* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications.

Primary outcomes:
measure: Effect of pindolol on subjective response to MDMA
timeFrame: 24h
Secondary outcomes:
measure: Effect of pindolol on physiological response to MDMA
timeFrame: 24h
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Heffter Research Center, University Hospital of Psychiatry
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias E Liechti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199004: Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
Official title: German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Acute Lymphocytic Leukemia
Keywords: ALL
Treatment
De novo
Minimal residual disease
Rituximab
Adult
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation


Eligibility criteria: Inclusion Criteria:

* B-precursor ALL (common / pre B-ALL)
* Standard risk
* CD20 expression \>20%
* Ph/BCR-ABL negative
* Age 15-65 years (55-65 if biologically younger)
* Written informed consent

Exclusion Criteria:

* Severe complications due to leukemia or secondary illnesses
* Late relapse of childhood ALL
* Cytostatic pretreatment
* Pregnancy
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
* Known severe allergy to foreign proteins

Primary outcomes:
measure: Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
Secondary outcomes:
measure: Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital of Frankfurt, Medical Dept. II
Study officials:
affiliation: University Hospital, Medical Dept. II
name: Dieter Hoelzer, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03751904: Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
Official title: Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure，Congestive
Lead sponsor: Signature Medical, Inc.
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between the ages of 18 - 80 years
2. Willing and able to sign informed consent form
3. Normal subjects without a history of heart disease who are recruited from the surrounding community
4. Subjects with heart failure undergoing treatment in a hospital setting

Exclusion Criteria:

1. Hemodynamic instability (Systolic BP\>180 or \<90 and Diastolic BP\>90 and \<60)
2. Acute coronary syndrome
3. Prior heart transplant recipients
4. Subjects who are pacemaker dependent
5. Severe obesity (body mass index \> 40 kg/m2)
6. Subjects who are pregnant

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Subjects will be assessed for adverse events through study completion, an average of 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06546904: Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training
Official title: Evaluation of the Effectiveness of Artificial Intelligence Empowered Ultrasound in Regional Anesthesia Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ultrasound-guided Regional Anesthesia
Keywords: artificial intelligence
ultrasound-guided regional anesthesia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.

Detailed description: The AI powered anesthesia ultrasound system integrates ScanNav and NeedleTrainer modules, providing real-time training for medical staff to simulate punctures. Combined with ScanNav's real-time anatomical structure recognition function, it is expected to significantly enhance the training effectiveness of ultrasound-guided regional anesthesia technology.

Eligibility criteria: Inclusion Criteria:

* Voluntary participants;
* Sign the informed consent form.

Exclusion Criteria:

* allergic to ultrasound coupling agents

Primary outcomes:
measure: Success rate of ultrasound-guided puncture
timeFrame: 1day
Secondary outcomes:
measure: Location time
timeFrame: 1day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: mujun Chang, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00748904: Rifaximin Versus Lactulose in Renal Failure
Official title: A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Renal Failure
Keywords: cirrhosis of liver and progressive renal failure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.


Eligibility criteria: Inclusion Criteria:

* cirrhosis of liver of any etiology
* progressive renal failure
* stage 0-2 hepatic encephalopathy

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: slower progression to severe hepatic encephalopathy, stage 3 or 4
timeFrame: during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00782704: Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery
Official title: Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: A self-administered questionnaire to collect data from patients, physicians and nurses about the severity of postoperative surgical complications.
Based on this questionnaire we will develop the morbidity index
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients: all patients of the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich Nurses: Staff nurses of the University Hospital of Zurich Physicians: from different units of the University Hospital of Zurich (Visceral-, Thoracic, Cardiovascular Surgery, Anesthesiology, Intensiv Care Unit, Urology)

Brief summary: The aim is to develop and validate a morbidity index for postoperative complications in patients undergoing visceral surgery.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years
* Capacity to act and no legal guardian
* Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
* German language as daily language.

Exclusion Criteria:

* Patients with cognitive difficulties and diseases, which may yield unreliable answers
* Patients unable to read and write

Primary outcomes:
measure: to develop and validate a morbidity index
timeFrame: preoeprativ and one day before discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Study officials:
affiliation: Department of Visceral and Transplantation Surgery
name: Ksenija Slankamenac, med. pract
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536704: Nicotine Lozenge Bioequivalence Study
Official title: A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: nicotine lozenge
nicotine
nicotine replacement therapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.


Eligibility criteria: Inclusion Criteria:

* Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
* Body Mass Index within the range 19-27 kilograms/meters\^2

Exclusion Criteria:

* Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
measure: Maximum Observed Plasma Concentration [Cmaximum (Max)]
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Secondary outcomes:
measure: AUC [0-infinity (Inf)]
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
measure: Time to Reach Maximum Plasma Nicotine Concentration (Tmax)
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
measure: Apparent Elimination Half-life of Nicotine T(1/2)
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
measure: Elimination Rate Constant for Plasma Nicotine: K (el)
timeFrame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003704: Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation
Official title: Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phantom Limb Pain
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2009-10-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive lower extremity amputation

Brief summary: Phantom limb pain (pain originating from where an amputated limb once was) is a common occurrence after lower extremity amputations, with some sources noting incidence to be as high as 60-80% six months after surgery. This pain can eventually subside, however, cases have been reported of incidence 10 years after surgery. This pain is not only physically detrimental, but can also be psychologically detrimental after a difficult to accept change in the body. Prior studies have been performed using regional anesthetic techniques (including spinals and epidurals) and different medications to attempt to reduce the incidence of phantom limb pain, however, the data have been mostly inconclusive. Of interest, prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia more commonly employed for amputations recently. The purpose of our retrospective study is to look at the incidence of phantom limb pain at our institution over a two year period to determine if peripheral nerve blocks result in a significantly reduced incidence compared to other techniques (spinal, epidural, general anesthesia only). In addition, there is little data on relation of reason for amputation and presence of preoperative neuropathy and incidence of phantom pain. As secondary endpoints, the investigators wish to investigate if certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others) and/or neuropathy lead to a higher incidence of phantom limb pain. The results of this study could impact future management of patients who are to receive amputations and may lead to further prospective studies on the topics involved.


Eligibility criteria: Inclusion Criteria:

* Patients who receive lower extremity amputation

Exclusion Criteria:

* Death or incapacitating medical condition since surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Veterans Affairs North Texas Health Care System
state: Texas
Study officials:
References:
Clinical trial NCT04580004: The Optimization of Medications in Chronic Heart Failure Using a Website
Official title: The Optimization of Medications in Chronic Heart Failure Using a Website
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Heart failure (HF) is the most common hospital discharge diagnosis among older adults in the United States. Strikingly, 2 in 5 patients are readmitted within 1-year following their first HF admission. This results in significant potentially avoidable costs to our already strained healthcare system since hospitalizations result in 70% of yearly HF management costs. One of the most common causes of readmission is lack of medication optimization. This study will determine the effectiveness of a medication optimization website.

Detailed description: In a prospective design, 100 patients will be randomized to the intervention or usual care in a 1:1 fashion. Patients randomized to the intervention will receive an evidence-based medication recommendation intervention. Outcome measures will be collected at baseline and at 2 weeks post-intervention.

Eligibility criteria: Inclusion Criteria:

* left ventricular ejection fraction (LVEF) \</= 40%

Exclusion Criteria:

* pregnancy
* active cancer with a life expectancy less than 12 months
* hospice
* chronic inotropic therapy

Primary outcomes:
measure: The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS).
timeFrame: Change over 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael P Dorsch, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448104: Virtual Reality in Invasive Techniques in Physiotherapy
Official title: Effect of Immersive Virtual Reality as a Distraction Tool to Reduce Pain and Discomfort Associated With Dry Needling Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
dry needling
virtual reality
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry needling is a common physical therapy technique that uses solid acupuncture needles that are repeatedly inserted and removed into the human body. These techniques, despite their benefits, can cause pain. The objective of this study is to analyze the use of virtual reality as a distractor in invasive techniques in physiotherapy. The hypothesis is that the use of immersive virtual reality, evoking relaxation situations, will reduce the sensation of pain during and/or after the technique. To do this, healthy participants will be recruited and the participants will be divided into two groups (experimental and control). Participants in the experimental group will undergo the dry needling technique on latent myofascial trigger points along with the use of immersive virtual reality. The same technique will be performed on participants in the control group but without the use of virtual reality. Pain during and after puncture and strength after puncture will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Have at least one identifiable latent myofascial trigger point in the muscles studied

Exclusion Criteria:

* Suffer any musculoskeletal or neural alteration that could alter the results obtained
* Suffer from belonephobia or extreme and uncontrollable fear of sharp objects

Primary outcomes:
measure: Pain during dry needling
timeFrame: Immediately after technique application in each session (two sessions separated by two weeks)
Secondary outcomes:
measure: Pain after dry needling
timeFrame: Immediately after technique application; 30 minutes after technique application; 1 hour after technique application; 6 hours after technique application; 24 hours after technique application in each session (two sessions separated by two weeks)
measure: Pain pressure threshold
timeFrame: Before technique; Immediately after technique; 30 minutes after technique; 60 minutes after technique in each session (two sessions separated by two weeks)
measure: Strength
timeFrame: Before technique; Immediately after technique in each session (two sessions separated by two weeks)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy, University of Valencia
Study officials:
affiliation: University of Valencia
name: Rodrigo Martín-San Agustín, PhD
role: PRINCIPAL_INVESTIGATOR
References: