louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01481155: Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Official title: Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Actinic Keratosis
Keywords: actinic keratosis
field cancerisation
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 21
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: The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.

Detailed description: Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.

Eligibility criteria: Inclusion Criteria:

* men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
* at least 2 actinic keratoses, on each of both treatment areas at least one
* Patients must be 18 years or older.

Exclusion Criteria:

* Age 17 years or younger
* lack of patient's informed consent for any of the two treatments
* contraindication for Co2 therapy or for photodynamic therapy
* skin infection in the treatment area

Primary outcomes:
measure: Number of actinic keratoses 3 months after treatment
timeFrame: 3 months
Secondary outcomes:
measure: Histologic features
timeFrame: 1 month after therapy
measure: Epidermal thickness in optical coherence tomography
timeFrame: 1 month after therapy
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Ruhr University
Study officials:
References:
Clinical trial NCT06109155: The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery
Official title: The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgery, Cardiac
Tranxemic Acid
Activated Clotting Time
Heparin
Cardiopulmonary Bypass
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During cardiac surgery with cardiopulmonary bypass support, participants will be divided into 4 groups. During procedure, they will recieve different doses of tranexamic acid and different level of activated clotting time. Then, we will monitor the amount of blood loss and blood transfusion.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.

The main questions it aims to answer are:

1. Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
2. Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?

Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.

Detailed description: This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026.

The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT \> 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB.

The primary outcome will be the volume of postoperative bleeding within 24 hours for each group.

The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* adult, cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* pregnant
* emergency procedure
* immune compromised
* aortic surgery
* end-stage renal disease
* liver disease
* critical status
* incomplete clinical data

Primary outcomes:
measure: Blood loss
timeFrame: 24 hours
measure: blood transfusion
timeFrame: procedure time, an average of 6 hours
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General hospital
Study officials:
References:
Clinical trial NCT05412355: Effects of Incomplete ERAS on Clinical Outcomes in Patients With Colorectal Cancer
Official title: Effects of Incomplete Enhanced Recovery After Surgery Program on Long-term Survival of Patients Undergoing Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Enhanced Recovery After Surgery
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, we are going to collect clinical data of patients undergoing laparoscopic radical surgery from four large hospitals between August 2008 and December 2016.

Brief summary: Enhanced recovery after surgery (ERAS) has been reported to be associated with improved outcomes in many studies, most of which involve short-term effects. Only a few studies have reported the long-term effects of highly compliant ERAS. However, to the best of our knowledge, there are no large-scale comparisons between incomplete ERAS (compliance \< 70%) and non-ERAS. The aim of this comparative study is to analyze and evaluate the long-term outcomes of incomplete ERAS in laparoscopic colorectal cancer surgery.


Eligibility criteria: Inclusion Criteria:

* 1. age older than 18 years;2. pathological diagnosis of colorectal cancer;3. radical surgery was performed; and 4. laparoscopic surgery was performed.

Exclusion Criteria:

* 1. ERAS compliance ≥70%; 2. open surgery; 3. switch to laparotomy after laparoscopic surgery; 4. pregnancy or lactation; 5. severe mental illness; 6. Simultaneous malignant tumors of multiple organs; 7. History of other malignant tumors; and 8. Emergency radical colorectal resection due to obstruction, perforation or bleeding.

Primary outcomes:
measure: long-term survival
timeFrame: Each patient will be followed for 5 years or until death
Secondary outcomes:
measure: Postoperative complications
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
state: Hubei
city: Wuhan
country: China
facility: Union Hospital，Tongji Medical College, Huazhong University of Science and Technology.
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaogang Shu, MD.，PHD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05200455: Microelectrodes in Epilepsy
Official title: Microelectrodes in Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-01-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.

Detailed description: The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.

Eligibility criteria: Inclusion Criteria:

* 18-65 year old
* male or female
* right or left handed
* IQ\>70
* medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
* no contraindications to intracranial electrode study
* able and willing to participate in research

Exclusion Criteria:

* does not meet the inclusion criteria

Primary outcomes:
measure: Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons.
timeFrame: Evaluated for each patient during monitoring period of approximately 2 weeks
Secondary outcomes:
measure: How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage).
timeFrame: Evaluated for each patient during monitoring period of approximately 2 weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Section Chief of Adult Neurology
name: Barbara C Jobst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867255: Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
Official title: Pharmacokinetic Study Comparing Area Under the Curve for a Single Dose of Venlafaxine ER Pre- and Post-gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bariatric Surgery
Gastric Bypass
Roux-en-Y Gastric Bypass
Keywords: venlafaxine
Effexor
antidepressive agent
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.


Eligibility criteria: Inclusion criteria:

- Approved to undergo Roux-en-Y gastric bypass surgery (cost of surgery is NOT included in the study)

Exclusion criteria:

* Pregnant
* Allergy to venlafaxine or desvenlafaxine
* Psychiatric hospitalization within the prior 12 months
* Active professional treatment for recent substance abuse within 12 months of abstinence
* Ongoing psychologic issues, such as personality disorders, difficulties as a trauma survivor, or difficulties with depression unless a stable, documented course of treatment by a licensed mental health professional is available
* Current use of any of the following medications/supplements: 5-hydroxytryptophan, almotriptan, amitriptyline, amoxapine, amoxicillin-clavulanate, amphetamine-dextroamphetamine, atazanavir, bupropion, cinacalcet, citalopram, clarithromycin, clomipramine, desipramine, desvenlafaxine, dextroamphetamine, dextromethorphan, doxepin, duloxetine, eletriptan, entacapone, escitalopram, fluoxetine, fluvoxamine, frovatriptan, haloperidol, imipramine, isocarboxazid, itraconazole, jujube seed extract, linezolid, maprotiline, methylene blue, metoclopramide, metoprolol, milnacipran, mirtazapine, naratriptan, nefazodone, nelfinavir, nortriptyline, paroxetine, phenelzine, procarbazine, protriptyline, quinidine, rasagiline, ritonavir, rizatriptan, saquinavir, selegiline, sertraline, St. John's wort, sumatriptan, tapentadol, terbinafine, toremifene, tramadol, tranylcypromine, trazodone, trifluoperazine, trimipramine, tryptophan, L-tryptophan, venlafaxine, vilazodone, zolmitriptan

Primary outcomes:
measure: Venlafaxine levels pre- and post-gastric bypass
timeFrame: 3 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carrie Krieger, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05756855: Young Adults with Violent Behavior During Early Psychosis
Official title: Young Adults with Violent Behavior During Early Psychosis: an Open Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Schizophreniform Disorders
Delusional Disorder
Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords: psychosis
schizophrenia
violence
aggression
intervention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open pilot clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

Detailed description: The investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the OnTrackNY network. The focus of this open pilot is to explore the acceptability and feasibility of the intervention. The study will enroll early intervention service (EIS) clinician - EIS participant dyads. The planned sample size is 3-4 EIS clinicians and 10-16 EIS participants (up to n=16 dyads). This real-world open pilot will provide feedback to help tailor the intervention to the OnTrackNY setting.

Eligibility criteria: Inclusion Criteria for EIS participants:

* Ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (International Classification of Disease Clinical Modification (ICD-10-CM) Diagnosis Code F20.x)
* Receive First Episode Psychosis (FEP) treatment in one of OnTrackNY clinics/sites with an eligible EIS clinicians
* Willing to participate in research interviews after each study visit during the study period

Exclusion Criteria:

* Unable to provide informed consent
* Not fluent (speaking, reading, writing) in English

Primary outcomes:
measure: Mean Acceptability of Intervention Measure (AIM)
timeFrame: 12 weeks
measure: Mean Feasibility of Intervention Measure (FIM)
timeFrame: 12 weeks
measure: Number of EIS Participants in Attendance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Stephanie Rolin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496455: The Impact of the SCN9A Gene Polymorphism on Postoperative Pain
Official title: The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Pregnancy
Keywords: NAV1.7 Voltage-Gated Sodium Channel
pain, postoperative
cesarean section
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included

Brief summary: The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.

Detailed description: SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.

Eligibility criteria: Inclusion Criteria:

* The women aged 18 to 45,
* in 36 to 40 weeks of pregnancy
* undergoing cesarean section

Exclusion Criteria:

* History of chronic pain or pain disorders
* Psychiatric diseases
* Diabetes mellitus
* Severe cardiovascular, kidney or liver diseases
* Alcohol or drug abuse
* Heavy smoker
* Unable to use the Patient controlled analgesia (PCA) pump

Primary outcomes:
measure: Pain
timeFrame: up to postoperative 24 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: Up to postoperative 24 hours
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School Hospital
Study officials:
affiliation: Gaziosmanpasa University Medical School
name: Tugba Karaman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06033755: Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Official title: A Multidimensional Strategy to Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Induced Laryngeal Obstruction (EILO)
Keywords: EILO
Physiotherapy intervention
Dysfunctional breathing
Adolescent athletes
Diaphragmatic breathing
Postural alignment
Lead sponsor: VID Specialized University
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2023-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.
Primary purpose: TREATMENT

Brief summary: This study aimed to assess if a multidimensional individually tailored intervention, including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional breathing in adolescent athletes with EILO. A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from NPMP body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention involving 18 participants.


Eligibility criteria: Inclusion Criteria:

* Adolescent athletes with symptoms of EILO
* Referred to Norwegian Psychomotor Physiotherapy

Exclusion Criteria:

* Other respiratory symptoms
* Additional diagnosis

Primary outcomes:
measure: Subjective experiences of respiratory distress associated with exercise reported descriptively in an interview pre and post treatment
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Liv-Jorunn Kolnes
Study officials:
affiliation: VID Specialized University
name: Liv-Jorunn Kolnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216655: Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Official title: Comparison of Individual and Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: congenital cataract
anxiety
guardian
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.

Detailed description: Congenital cataract (CC) is the leading cause of reversible blindness during childhood, which appears at birth or during the first decade of life. Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.

Eligibility criteria: Inclusion Criteria: the guardians of kids who had a surgery for congenital cataract recently

Exclusion Criteria:

have other major life hit was diagnosed of anxiety and depression before

Primary outcomes:
measure: similar effect
timeFrame: baseline
measure: efficient effect
timeFrame: baseline
measure: invalid effect
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: