louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06874010: A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia
Official title: A Phase 1/2, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Patients With Friedreich's Ataxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Friedreich Ataxia
Lead sponsor: Design Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability, and pharmacokinetics of DT-216P2 administered multiple ascending doses in patients with FA.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18-65 years of age inclusive, at the time of signing the informed consent.
* Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene.
* Stage 5.5 or less on the FSA at screening.
* BMI between 16 and 32 kg/m2 at screening; weight should be \<= 100 kg at screening.
* Male and/or female using protocol defined and regulatory approved contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
* Received an investigational agent within the last 30 days or 5 half-lives, whichever longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment. Exception: Potential participants who are currently on Omaveloxolone must be on stable doses for at least 3 months.
* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.

Primary outcomes:
measure: Frequency of treatment-emergent adverse events (TEAE)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Area under the curve (AUClast, AUCinf)
timeFrame: Up to Week 12
measure: Maximum concentration (Cmax)
timeFrame: Up to Week 12
measure: Time to Cmax (Tmax)
timeFrame: Up to Week 12
measure: Half-life (t1/2)
timeFrame: Up to Week 12
measure: Frataxin expression at baseline and after treatment will be measured
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Scientia Clinical Research Ltd
state: New South Wales
city: East Melbourne
country: Australia
facility: Doherty Clinical Trials
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References:
Clinical trial NCT06601010: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Pancreatic Cancer.
Official title: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Pancreatic Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Keywords: 68Ga-grazytracer PET/CT
Pancreatic cancer
Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for pancreatic cancer.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of pancreatic cancer requiring combination immunotherapy after evaluation according to clinical guidelines
2. Signed and dated informed consent form
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process 4 .aged 18-75 years old 5 .The patient is in good general condition with an expected survival of \&gt; 6 months

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person

Primary outcomes:
measure: Evaluation the responses to immunotherapy of pancreatic cancer
timeFrame: up to about 10 weeks
measure: Standardized uptake value(SUV)
timeFrame: up to about 10 weeks
measure: Target-to-background ratio(TBR)
timeFrame: up to about 10 weeks
Secondary outcomes:
measure: Progress free survival
timeFrame: 1 years
measure: Overall survival
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00424112: Motivation in Alcohol Treatment Facilities
Official title: Stages an Processes of Change in Help-Seeking and Drinking Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Alcohol Abuse
Keywords: motivation to change
treatment motivation
alcohol use disorders
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2007-01-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine if and to what extend a composite measure of treatment motivation and behavior change motivation predicts alcohol treatment success. It is expected that the composite measure based on the stages of the Transtheoretical Model of Behavior Change is a better predictor for treatment outcome than treatment motivation or behavior change motivation alone. Participants will be recruited from alcohol treatment centers. A baseline interview regarding their motivation, drinking behavior and personal treatment goals will be conducted. At the end of treatment, treatment staff will be asked about treatment involvement of each participant. Two follow-up interviews will be conducted after 6 and 12 months. To identify the impact of behavior change and treatment motivation on change in drinking behavior, data will be pooled with a non-treatment seeking sample. Conclusions can be drawn on what motivation pattern best predicts behavior change for those utilizing formal help and for those remitting without formal help (self-changers).


Eligibility criteria: Inclusion Criteria:

* Alcohol dependence
* Alcohol abuse

Exclusion Criteria:

* Persons physically and mentally not capable of participating in study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Johnanna-Odebrecht-Stiftung
state: Mecklenburg-Vorpommern
city: Stralsund
country: Germany
facility: Krankenhaus West
state: Mecklenburg-Vorpommern
Study officials:
affiliation: University Medicine Greifswald
name: Jennis Freyer-Adam, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Applied Sciences Muenster
name: Ulfert Hapke, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Ulrich John, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06950112: Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery
Official title: Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obese Patients With Bariatric Surgery
Lung Ultrasound Score
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score


Eligibility criteria: Inclusion Criteria:

1. patients who have a BMI 30-40 kg/m2
2. American Society of Anesthesiologists (ASA) physical status II or III
3. patients aged between 18 and 60 years,
4. patients scheduled to undergo laparoscopic bariatric surgeries.

Exclusion Criteria:

1. patients' refusal to participate in the study,
2. previous history of thoracic surgery,
3. Patients with a history of chest disease (COPD, emphysema, or pneumothorax),
4. Patients with abnormal pre-operative chest radiographs, such as pneumonia and pleural effusion,
5. Patients with right-side heart failure or impending failure,
6. Patients with known hypovolemia, and Patients with increased intracranial pressure.

Primary outcomes:
measure: The change in lung ultrasound score
timeFrame: Periprocedural
Secondary outcomes:
measure: Lung compliance
timeFrame: Periprocedural
measure: Hemodynamic parameter as oxygen saturation
timeFrame: Periprocedural
measure: Hemodynamic parameter as Heart rate
timeFrame: Periprocedural
measure: Hemodynamic parameter as Mean arterial blood pressure
timeFrame: Periprocedural
measure: End-tidal carbon dioxide (ETCO2)
timeFrame: Periprocedural
measure: Plateau Pressure (Pplat)
timeFrame: Periprocedural
measure: Peak airway pressure (Ppeak)
timeFrame: Periprocedural
measure: Incidence of early postoperative pulmonary complications
timeFrame: At the end of the surgery up to 24 hours after surgery
measure: Length of post anesthesia care unit "PACU" stay.
timeFrame: At the end of the surgery up to 2 hours after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: El gharbia
Study officials:
References:
Clinical trial NCT00168012: Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Official title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Keywords: Immunoglobulin intravenous
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.


Eligibility criteria: Key Inclusion Criteria:

* Patients with primary immunodeficiency
* Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Key Exclusion Criteria:

* Allergic reactions to immunoglobulins or other blood products
* Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
* History of cardiac insufficiency
* Epilepsia

Primary outcomes:
measure: Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
Secondary outcomes:
measure: Rate of acute serious bacterial infections
measure: Number of days out of work/school due to underlying PID
measure: Number of infections
measure: Rate, severity and relationship of all adverse events
Other outcomes:
Locations:
Study officials:
References:
citation: Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.
Clinical trial NCT06144112: Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Liver Transplantation Surgery
Official title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Liver Transplantation Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Liver Diseases
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for liver transplantation surgery.


Eligibility criteria: Inclusion Criteria:

* Liver disease undergoing Liver transplantation

Exclusion Criteria:

-

Primary outcomes:
measure: duration from the time diagnosing r-time prolongation to the time achieving bleeding control
timeFrame: 1 min
Secondary outcomes:
measure: Red Blood Cell amount
timeFrame: 1 hour
measure: FFP amount
timeFrame: 1 hour
measure: Platelet amount
timeFrame: 1 hour
measure: r-time
timeFrame: 10 min
measure: CRT-MA
timeFrame: 10 min
measure: CFF-MA
timeFrame: 10 min
measure: Bleeding
timeFrame: 6 hour
measure: oxygenation profile
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00181012: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics
Official title: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Pain
Keywords: Cancer Related Visceral Pain Resistant to Morphinics
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
* Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
* Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
* Pain resistant to morphinic treatment

Exclusion Criteria:

* Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
* Neurological: non-controlled epilepsy, encephalopathy, or dementia
* Severe hepatic insufficiency
* Severe renal insufficiency
* Respiratory insufficiency
* Patients having surgery or in postoperative period
* Known deficit in G6PD, alanine exposure, or sulphamide treatment
* Porphyria
* Weight \> 80 kg

Primary outcomes:
measure: To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)
timeFrame: continuous intravenous perfusion for 6 days
Secondary outcomes:
measure: To confirm the tolerance of the lidocaine
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Philippe Poulain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06929312: Simulation Based Training In Medical Students
Official title: Effectiveness Of Simulation Based Training Versus Traditional Lecturing For Outbreak Investigation Among Medical Students: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholera
Keywords: Cholera Outbreak Investigation
Cholera
Medical students
Lead sponsor: CMH Lahore Medical College and Institute of Dentistry
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 82
Sex: ALL
Minimum age (years): 22
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transferring classroom learning to real-life situations is a challenge. Tabletop simulation exercises offer a low-cost and context-specific approach for educating students on appropriate responses during health emergencies.

This randomized controlled trial will evaluate the effectiveness of simulation-based training versus traditional lecture methods in enhancing outbreak investigation skills among medical students.

Detailed description: This randomized controlled trial will assess the efficacy of simulation-based training compared to conventional lecture methods in improving medical students' outbreak investigation skills. it will be Conducted at CMH Lahore Medical College over nine months, the trial will include 4th year MBBS students with no prior outbreak investigation training. Participants will be randomized into two groups: an intervention group undergoing simulation-based exercises and a control group receiving traditional lectures.

Eligibility criteria: Inclusion Criteria:

* 4th year MBBS students at CMH Lahore Medical College without prior outbreak investigation training,
* willing to participate and providing informed consent.

Exclusion Criteria:

* students with supplementary exams
* unwillingness to participate, or
* scheduling constraints.

Primary outcomes:
measure: Outcome will be measured via knowledge, expertise in outbreak investigation, and attitude toward community medicine.
timeFrame: at baseline and after two week of teaching methodology applied
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: CMH Lahore Medical College and Institute of Dentistry
Study officials:
affiliation: Department of Community Medicine, CMH Lahore Medical College & IOD (NUMS Rawalpindi)
name: Tahira Raza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106612: Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain
Official title: A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Unstable Angina
Acute Coronary Syndrome
Keywords: randomized controlled trial
controlled clinical trial
comparative effectiveness research
chest pain
angina pectoris
non-invasive cardiac imaging
nuclear stress testing
coronary CT angiography
coronary catheterization
coronary revascularization
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2010-04-20
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.


Eligibility criteria: Inclusion Criteria:

* patient admitted for chest pain / pressure or other suggestive symptoms
* patient has known coronary artery disease (with or without prior revascularization)
* patient has clinical need for non-invasive cardiac evaluation

Exclusion Criteria:

* evidence of ongoing myocardial infarction or hemodynamic instability
* ischemia on EKG (greater than 1mm ST segment deviation)
* contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
* heart rhythm precluding EKG gating
* pregnancy

Primary outcomes:
measure: Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass
timeFrame: 3 months
Secondary outcomes:
measure: Length of hospital stay (time to discharge)
timeFrame: 1 month
measure: Number of participants that have a subsequent non-fatal myocardial infarction
timeFrame: 1 year
measure: Number of participants that die due to any cause
timeFrame: 1 year
measure: Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization
timeFrame: 3 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Linda B Haramati, MD, MS
role: STUDY_DIRECTOR
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Jeffrey M Levsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: