louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01165502: Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Official title: Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: MAD study CM3.1-AC100
Healthy men, age 18 - 50
Lead sponsor: CellMed AG, a subsidiary of BTG plc.
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent prior to any study specific procedures;
* Male volunteer aged 18 to 50 years at Screening, both inclusive;
* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)

Exclusion Criteria:

* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
* Blood donation within 3 month before administration of the IP;
* Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician

Primary outcomes:
measure: Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies)
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary outcomes:
measure: Pharmacokinetic samples for CM3.1-AC100
timeFrame: Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: CellMed AG, a subsidiary of BTG plc.
name: Peter Geigle, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT01758302: A Pilot Laboratory Study Investigating How Physical Tasks and Hunger Affect Taste Perception
Official title: A Pilot Laboratory Study Investigating How Physical Tasks and Hunger Affect Taste Perception
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Consumption
Perseverance
Keywords: taste test
food consumption
hunger
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.


Eligibility criteria: Inclusion Criteria:

* Willing to travel to laboratory around lunchtime for the study
* Willing to abstain from eating and drinking caloric beverages for at least 4 hours prior to completing the study
* Typically eats lunch

Exclusion Criteria:

* Diabetes, eating disorder, or any other condition that makes it unadvisable for participant to refrain from eating or drinking caloric beverages for 4 hours.
* Food allergies that would prevent participants from eating chocolate chip cookies or vegetables
* Pregnant or lactating
* Typically goes for longer than 5 hours (not counting sleep time) between meals and snacks
* Physical disabilities that would make it difficult for the participant to walk or to use their hands to grasp objects

Primary outcomes:
measure: physical perseverance
timeFrame: 1 hour
Secondary outcomes:
measure: food preference
timeFrame: 1 hour
measure: Amount of food eaten
timeFrame: 1 hour
measure: Mood
timeFrame: 1 hour
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Xiaomeng Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151879: Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures
Official title: A Multicenter, Open-label Trial to Investigate the Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Epilepsies, Partial
Keywords: partial seizures with or without secondary generalization
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations.

Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s).

Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. Subjects will remain on the same stable dose as received in the OLE trial.

Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.

Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.


Eligibility criteria: Inclusion Criteria:

* Partial seizures with or without secondary generalization.

Exclusion Criteria:

* Subject has previously received iv lacosamide.
* Subject meets the withdrawal criteria for the open-label extension trial.

Primary outcomes:
measure: Evaluate the safety and tolerability of lacosamide when given as iv infusions in subjects who are receiving oral lacosamide in addition to up to 3 concomitant AEDs for partial seizures. The primary variables are adverse events
Secondary outcomes:
measure: Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite.
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Krauss G, Ben-Menachem E, Mameniskiene R, Vaiciene-Magistris N, Brock M, Whitesides JG, Johnson ME; SP757 Study Group. Intravenous lacosamide as short-term replacement for oral lacosamide in partial-onset seizures. Epilepsia. 2010 Jun;51(6):951-7. doi: 10.1111/j.1528-1167.2009.02463.x. Epub 2009 Dec 22.
Clinical trial NCT03963479: Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients
Official title: Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine whether Vitamin B6 and Magnesium improve neurobehavioral status in terms of General observation, Cognitive working, Socialization, Communication and Sensory Dysfunction in patient with Autism Spectrum Disorder.


Eligibility criteria: Inclusion Criteria:

1. Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool
2. Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial
3. Newly diagnosed patient
4. Co-morbid neurological disorder like hyperactivity

Exclusion Criteria:

1. Patients with chronic diseases or any known metabolic or hormonal diseases
2. Patients with any known chromosomal or genetic syndromes
3. Patients unable to give informed consent
4. Patients unable to travel to clinical visits or non co-operative

Primary outcomes:
measure: Autism Spectrum Disorder
timeFrame: 3 months
Secondary outcomes:
measure: Autism Spectrum Disorder
timeFrame: 0 month
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Farhana Khan
Study officials:
References:
Clinical trial NCT04257279: Prospective Robotic Global Research Study (PROGRESS)
Official title: Prospective Robotic Global Research Study (PROGRESS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Disease
Keywords: spine
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and a maximum age of 85 years
* Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
* Able to sign Informed Consent

Exclusion Criteria:

* Previous fusion or fusion attempt at index level(s)
* DEXA score of -2.5 or below (only if clinically indicated - optional)
* Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
* History of substance abuse (drugs or alcohol)
* Mentally incompetent or prisoner
* Worker's compensation
* Pregnant or intention to become pregnant

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Baseline
measure: Numeric Rating Scale
timeFrame: 2 weeks
measure: Numeric Rating Scale
timeFrame: 3 months
measure: Numeric Rating Scale
timeFrame: 6 months
measure: Numeric Rating Scale
timeFrame: 12 months
measure: Numeric Rating Scale
timeFrame: 24 months
measure: Oswestry Disability Index
timeFrame: Baseline
measure: Oswestry Disability Index
timeFrame: 2 weeks
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: 6 months
measure: Oswestry Disability Index
timeFrame: 12 months
measure: Oswestry Disability Index
timeFrame: 24 months
measure: SF-12
timeFrame: Baseline
measure: SF-12
timeFrame: 2 weeks
measure: SF-12
timeFrame: 3 months
measure: SF-12
timeFrame: 6 months
measure: SF-12
timeFrame: 12 months
measure: SF-12
timeFrame: 24 months
measure: Screw Placement Accuracy
timeFrame: 2 weeks
measure: Complications
timeFrame: through study completion, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
Study officials:
References:
Clinical trial NCT02617979: Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
Official title: Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatectomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.


Eligibility criteria: Inclusion Criteria:

* Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy).
* At least 18 years of age.
* Able to read and understand English (the SAFECARE at Home program is only implemented in English)
* Has internet access.
* Knowledge of the internet and how to use web-based programs.
* Not pregnant or breastfeeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Primary outcomes:
measure: Efficacy of the SAFECARE at Home program as measured by readmission rate
timeFrame: 30 days
Secondary outcomes:
measure: Effect of the SAFECARE at Home program as measured by the number of follow-up visits
timeFrame: Through 30 day post-discharge
measure: Comparison of quality of life between SAFECARE at Home patients and patients who received standard post-operative care and education as measured by SF-36
timeFrame: Up to 6 months post-discharge
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan C Fields, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05015179: Mixed Reality Technology in Laparoscopic Partial Nephrectomy
Official title: Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Tumor
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
Collaborators: name: Saint Petersburg State University, Russia
First posted: 2021-08-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study was: a) to evaluate the usefulness of the MR model for renal pedicle exposure and identification of the tumor's exact location during LPN, and b) to evaluate the subjective utility of the MR model as an intraoperative reference tool.

Investigators prospectively enrolled 47 patients with LPN between June 2020 and February 2021. Patients were randomly assigned into two groups: the control group (24 patients), who underwent operation with an intraoperative ultrasound (US) control and the experimental group (23 patients), who underwent operation with the aid of the MR model. Randomization was performed using a computerized randomization program and sealed envelopes. Patients were included in the study if they were 18 years of age or older, were able to sign informed consent, and had T1a renal tumors amenable to LPN. Patients were excluded if they were unwilling to participate or did not meet the inclusion criteria. For each patient, investigators prospectively collected demographic data including age, body mass index, clinical tumor size, side, location, and complexity score according to the PADUA scoring system; perioperative data (including time for renal pedicle exposure and time for renal tumor detection and duration of ischemia); pathological data; data on postoperative functional outcome and complications, classified according to the Clavien-Dindo system.


Eligibility criteria: Inclusion Criteria:

* able to sign informed consent
* had T1a renal tumors amenable to LPN

Exclusion Criteria:

* were unwilling to participate
* did not meet the inclusion criteria

Primary outcomes:
measure: time required to expose renal pedicle during laparoscopic partial nephrectomy
timeFrame: during operation completion, min
measure: time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy
timeFrame: during operation completion, min
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State University Hospital
Study officials:
References:
Clinical trial NCT01190579: Dual Source CT Angiography for Detection of Coronary Artery Stenoses
Official title: Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Chest Pain
Computed Tomography
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
name: Bayer
First posted: 2010-08-27
Enrollment: 398
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses

Brief summary: The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.


Eligibility criteria: Inclusion Criteria:

* suspected coronary artery disease
* chest Pain
* intermediate likelihood of coronary stenoses
* planned invasive coronary angiography
* age 30 to 80 years

Exclusion Criteria:

* non sinus rhythm
* contrast allergy
* renal failure
* unstable clinical condition
* previous coronary revascularization
* calcium score exceeding 800
* inability to perform 10 second breathhold
* possible pregnancy
* metformin medication that cannot be interrupted
* inability to establish antecubital iv access

Primary outcomes:
measure: Accuracy for the detection of coronary artery stenoses
timeFrame: 72 hours
Secondary outcomes:
measure: Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography
timeFrame: 1 hour
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Medical Center
city: Erlangen
country: Germany
facility: University of Erlangen
city: Hamburg
country: Germany
facility: Roentgenpraxis Hamburg
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Klinikum Grosshadern
city: Hyderabad
country: India
facility: Ravi Bathina
city: Monterrey
country: Mexico
facility: Cardiovascular Institute
city: Singapore
country: Singapore
facility: Tan Tok Seng Hospital
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Stephan Achenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776879: Speech Intelligibility of Patients With P D Compared to First Degree Relatives of P D Patients
Official title: Speech Intelligibility of Patients With Parkinsons Disease at Different Stages of the Disease Compared to First Degree Relatives of Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced PD patients Early PD patients First degree relatives

Brief summary: This study will examine speech intelligibility of early parkinson's disease (PD) patients, early PD patients and first degree relatives. The investigators hypothesis that advanced PD patients will present decreased speech intelligibility more than early PD patients. Speech intelligibility of first degree relatives will be normal.

Detailed description: in order to achieve the study's goals objective and subjective research tools will be used.

Objective tools include measuring phonation time, diadokokinetic movements of the oral structures and acoustic analysis .

Subjective tools include self reported questionnaires.

Eligibility criteria: Inclusion Criteria:A

* Advanced PD patients
* Early PD patients
* First degree relatives

Exclusion Criteria:

* Patients with decreased cognitive abilities
* Patients who participate in speech therapy

Primary outcomes:
measure: Maximum phonation time
timeFrame: DAY 1
Secondary outcomes:
measure: Diadokokinetik (DDK): production time of 10x PATAKA, 7x /P/ and 7x /t/
timeFrame: DAY 1
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Tanya Gurevich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amir O, Ashkenazi O, Leibovitzh T, Michael O, Tavor Y, Wolf M. Applying the Voice Handicap Index (VHI) to dysphonic and nondysphonic Hebrew speakers. J Voice. 2006 Jun;20(2):318-24. doi: 10.1016/j.jvoice.2005.08.006. Epub 2005 Dec 1.