louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00248313: Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
Official title: A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Disease
Keywords: Kidney Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-03
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.


Eligibility criteria: Inclusion Criteria:

* Age: = to ≥ 18 years.
* End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
* Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).

Exclusion Criteria:

* Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.

Primary outcomes:
measure: Kidney Function at 12 months after transplantation.
Secondary outcomes:
measure: Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06390813: Otago Exercises, Square Stepping Exercises, Elderly, Fear of Falling
Official title: Comparison of Square Stepping Exercise Training and Otago Exercise Training in Geriatric Individuals in Terms of Balance and Fear of Falling:Randomized Controlled Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Balance Disorders
Keywords: Square Stepping Exercise
Otago Exercises
Elderly
Fear of Fall
Balance Disorders
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. The volunteer individuals participating in the study were randomly divided into 3 groups as otago exercise group, square stepping exercise group and control group with equal number of men and women.

The individuals who participated in study had a homogeneous distribution in terms of age, gender, BMI, height, weight and occupational status in all three groups. However, the number of female individuals was higher in all three groups. In the study, individuals in the exercise training groups received square stepping and otago exercise training 3 days a week for 6 weeks, while individuals in the control group did not receive any training. All three groups were evaluated before and six weeks after the training.


Eligibility criteria: Inclusion Criteria:

* 65-75 years old
* Education level at least literate
* Able to walk independently
* Standardized Mini Mental Test Score ≥ 24
* No neurological or lower extremity disease
* Healthy geriatric individuals who agreed to participate in the study

Exclusion Criteria:

* Taking 3 or more medications that may affect cognitive status
* Individuals continuing any exercise/rehabilitation program
* Underwent any surgery for the lower extremities
* Having any neurological-orthopedic problem that may affect gait and balance

Primary outcomes:
measure: Tinetti's International Fall Efficacy Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT06903013: Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis
Official title: Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis a Parallel Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy


Eligibility criteria: Inclusion Criteria:

* Healthy individual
* Has primary tooth with irreversible pulpitis
* Cooperative child

Exclusion Criteria:

* Mentally, physically or medically compromised children
* Uncooperative children

Primary outcomes:
measure: Post operative pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02505113: Cavernous Transformation of Portal Vein： Etiology, Diagnosis, Management and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Vein, Cavernous Transformation Of
Keywords: Portal Vein, Cavernous Transformation Of
Hypertension, Portal
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CTPV

Brief summary: To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

Detailed description: To observe the etiology, diagnosis, management and prognosis of cavernous transformation of portal vein.

We perform Montelukast (10mg, q.d., p.o.) fot the treatment of symptomatic cavernous transformation of portal vein and to observe the efficacy such as the decrease of the volume of ascites and hydrothorax.

Eligibility criteria: Inclusion Criteria:

* All patients with CTPV.

Exclusion Criteria:

* Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.

Primary outcomes:
measure: Ascites Volume (mL)
timeFrame: 6 month
measure: Hydrothorax Volume (mL)
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiology
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zaibo Jiang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01248013: Irritable Bowel Syndrome Hypnotherapy
Official title: Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Mind-Body Digestive Center
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of the study was whether gut focused hypnotherapy, in a group format, was successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary goal was to see if any outcome predictors could be determined.

Detailed description: Patients with Irritable Bowel Syndrome entering a group hypnotherapy program are asked to complete a series of questionnaires at the outset, and repeat a symptom severity scale at intervals over the one year period after termination of treatment. Eligibility was limited to patients with age greater than 20.

Outcome measures were improvement in symptom score. Outcome predictors studied included quality of relationships, measured with a Quality of Relationship Inventory and attribution of IBS to physical or emotional cause, measured with a Mind-Body IBS Questionnaire, both administered before onset of hypnotherapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older

Exclusion Criteria:

* Age below 20

Primary outcomes:
measure: Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome
timeFrame: one year
measure: Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.
timeFrame: One year after termination of treatment
Secondary outcomes:
measure: Outcome Predictors
timeFrame: one year
Other outcomes:
Locations:
city: New York
country: United States
facility: Mind Body Digestive Center
state: New York
Study officials:
References:
Clinical trial NCT06905613: Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1
Official title: Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Technical Feasibility
Ambulances
Keywords: MARIE Capnograph
MARIE Nasal Adapter Set O2 - Adult
Mainstream Respiratory Infrared Equipment
capnograph
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Oxlantic Medical AB
First posted: 2025-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In the first step we will include 20 Healthy volunters and if no AE we plan to include 30 patients
Primary purpose: DEVICE_FEASIBILITY

Brief summary: You have been assessed by paramedics as needing to go to the emergency department. During transport, the paramedics will monitor you by, for example, measuring your blood pressure and checking your pulse.

In healthcare, we are constantly working to improve and optimize the degree of monitoring during ambulance transports and through this also be able to start adequate treatment earlier. In this case, we are working to understand whether exhaled carbon dioxide levels can be used to monitor important processes in the body during ambulance transport. Therefore, we offer you to participate in a project that deals with whether we can use a new equipment to measure and monitor exhaled carbon dioxide during the journey to hospital.

This clinical trial is being conducted in Region Uppsala in collaboration with Oxlantic Medical AB. The main responsible and Sponsor for the trial is Oxlantic Medical AB. The research lead for the trial is Region Uppsala and Uppsala University.

This clinical trial has been subject to ethical review and approved by the Ethics Review Authority.


Eligibility criteria: Inclusion Criteria:

* 20 healthy volunteers 18-84 years
* 30 patients between 18-84 years being transported by ambulance

Exclusion Criteria:

* Priority 1 ambulance transports
* Patients needing oxygen supply
* Known pregnancy
* Patients unable to provide informed consent

Primary outcomes:
measure: Adequate values of ETCO2 and respiratory rate
timeFrame: During ambulance transport from the start of the transport to the arrival at the emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Ambulansstationen Uppsala Region
Study officials:
affiliation: Department of Surgical Sciences
name: David Smekal, MD, PhD, docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825513: Safety and Effectiveness of the Akreos Toric Intraocular Lens.
Official title: Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
* Subjects must require a lens power from 15 to 30 diopters.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with corneal pathology potentially affecting topography.

Primary outcomes:
measure: Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
timeFrame: 32 months
Secondary outcomes:
measure: Lens misalignment as determined by postoperative manifest refraction and vector analysis.
timeFrame: 32 months
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gabriele Brenger
role: STUDY_DIRECTOR
References:
Clinical trial NCT05681013: The Effect of Laughter Therapy on Nursing Students
Official title: The Effect of Laughter Therapy on the General Health Status, Sleep Quality, and Stress Level of Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Stress
Insomnia
Sleep Disorder
Mental Health Disorder
Keywords: Sleep Quality
Psychological Stress
General Health
Nursing Students
Laughter Therapy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.

Detailed description: H1.1: Students who receive laughter therapy will have lower mean scores in the general health questionnaire than students who do not receive laughter therapy.

H1.2: Students who receive laughter therapy will have a lower Pittsburgh sleep quality index score than students who do not receive laughter therapy.

H1.3: Students who receive laughter therapy will have a lower mean stress level than students who do not receive laughter therapy.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in research
* Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing
* Not have any health problems that may create a communication barrier
* Being in a quiet environment to participate in the online study due to the pandemic period
* Have an internet connection to attend online sessions

Exclusion Criteria:

* Having undergone abdominal surgery in the past three months
* Having a disability to attend regular sessions

Primary outcomes:
measure: Introductory Information Form
timeFrame: 2 minutes
measure: General Health Questionnaire-28 (GHQ-28)
timeFrame: 5 minutes
measure: Pittsburgh Sleep Quality Index (PUKI)
timeFrame: 5 minutes
measure: Perceived Stress Scale (PSS)
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Muğla Sıtkı Koçman University
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Elif Uner, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05968313: Altered Neural Pain Empathic Reactivity in NSSI Adolescents
Official title: Abnormal Neural Pain Empathic Processing in Adolescents With Non-suicidal Self-Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonsuicidal Self Injury
Pain Empathy
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community

Brief summary: Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. In recent years, growing evidence suggests that NSSI has become a worldwide public health issue. People with NSSI behaviors, especially adolescents, commonly exhibit emotion-related and interpersonal problems. Pain empathy represents an essential basal domain of socio-emotional processing and refers to the ability to empathize, connect and share with others' pain. However, altered empathic processing has not been systematically examined in adolescents with NSSI. To this end, the current functional magnetic resonance imaging (fMRI) study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group (n=40), to compare their neural activity regarding pain empathy processing, which is measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators included conditions of physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli. The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic reactivity to physical pain stimuli in salience and arousal related brain regions but decreased empathic reactivity to affective pain empathic stimuli.


Eligibility criteria: Inclusion Criteria:

* 15-18 years
* right-handed
* normal or corrected normal visual acuity
* meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)

Exclusion Criteria:

* diagnosis of borderline personality disorder, major depressive disorder, other
* psychiatric disorders, etc.
* high suicidal risk
* recent use of medications that can affect neural activity
* have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
* have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)

Primary outcomes:
measure: Neural activity as indexed by BOLD fMRI
timeFrame: About 8 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
References:
Clinical trial NCT05726513: Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
Official title: Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Mechanical Ventilation Complication
Ventilator-Induced Lung Injury
Weaning Failure
Keywords: Electrical Impedance tomography
Weaning trial
Acute respiratory failure
Lung monitoring
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure.

The main question\[s\] it aims to answer are:

* to evaluate which weaning trial is associated to a better regional ventilation distribution
* to evaluate which weaning trial can be comparable to ventilation distribution after extubation

Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 70 years
* Ready to be weaned from mechanical ventilation according to clinical criteria

Exclusion Criteria:

* Age \< 18 years or \> 70 years
* Presence of chest drains
* Presence of pacemaker/impantable cardiac device;
* diagnosis of Pneumothorax, or pneumomediastinum
* Diagnois of neuromuscular diseases
* Use of neuromuscular blockers in the 48 hours before screening;
* Body mass index \> 35 kg/m2
* Refusal to participate of the patient/next of kin

Primary outcomes:
measure: Regional Ventilation distribution using Electrical Impedance Tomography
timeFrame: 2 hours
Secondary outcomes:
measure: Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase
timeFrame: 48 hours
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
References: