louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04610151: The Effects of Guided Imagery on Postoperative Pain Management
Official title: The Effects of Guided Imagery on Postoperative Pain Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Nursing Caries
Keywords: Patient
Postoperative
Pain
Visual Analogue Scale
Guided Imagery
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the effects of guided imagery on postoperative pain management.

Detailed description: The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital. The study was conducted between April and September 2018.

Eligibility criteria: Inclusion Criteria:

* Adult patients at and over the age of 18
* Patients who were able to speak Turkish
* Patients who received spinal anesthesia

Exclusion Criteria:

* Patients who had not previously used guided imagery
* Patients any disease that could cause pain outside the surgery

Primary outcomes:
measure: A mean total score on the Visual Analogue Scale (VAS)
timeFrame: first week
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Leyla ZENGİN AYDIN
state: Sur
Study officials:
References:
Clinical trial NCT05017051: Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
Official title: Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dysexecutive Syndrome
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of 2 groups:

* a group of patients with dysexecutive syndrome
* a group of healthy subjects

Brief summary: Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.

The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.

Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.

Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.

For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.


Eligibility criteria: Inclusion Criteria:

* Patients with a dysexecutive syndrome OR healthy subjects
* Over 18 years-old

Exclusion Criteria:

* Patients

  * Psychiatric pathology (except for Post-Traumatic Stress Disorder)
  * Pregnant or breastfeeding woman
* Healthy subjects

  * Neurologic or psychiatric pathology
  * Pregnant or breastfeeding woman

Primary outcomes:
measure: Lowest number of errors on the executive tasks over the 4 visits
timeFrame: Until the end of the study (3 years)
Secondary outcomes:
measure: Lowest number of errors on the Lego model task over the 4 visits
timeFrame: Until the end of the study (3 years)
measure: Lowest number of errors on the chocolate cake task over the 4 visits
timeFrame: Until the end of the study (3 years)
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
Study officials:
References:
Clinical trial NCT02861651: Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 40
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: Patients with AML-6 treated at Institut Paoli-Calmettes

Brief summary: Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.


Eligibility criteria: Inclusion Criteria:

* Age\>18 year
* Diagnosis of AML6
* Written consent obtained

Exclusion Criteria:

* No written consent
* No frozen samples

Primary outcomes:
measure: Molecular characterization of AML-6 by NGS and CGH array
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
affiliation: Institut Paoli-Calmettes
name: Véronique Gelsi-Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914651: CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
Official title: Comparison of Cumulative Live Birth Rate Per Initial Cycle Between 300 IU and 150IU Starting Dose of rFSH Among Aged Patients With Poor Ovarian Reservation: a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 260
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（AFC）≤ 5 or anti-mullerian hormone（AMH）≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone（GnRH）antagonist protocol. This study is a prospective randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Age Limits≥35 and≤42；
2. AFC≤5 or AMH≤1.2ng/ml；
3. BMI≤30kg/m2；
4. The first IVF/intracytoplasmic sperm injection （ICSI） cycle；

Exclusion Criteria:

1. Any other underlying disease or condition considered IVF is contraindicated.
2. Ovarian hyperstimulation syndrome（PCOS）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm.
3. Autoimmune antibody positive, untreated.
4. History of recurrent miscarriages.
5. Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
6. Simultaneous participation in another clinical study.
7. According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 22 months
Secondary outcomes:
measure: Time to live birth
timeFrame: 22 months
measure: Cycle cancellation rate
timeFrame: 1 month
measure: Number of MII eggs
timeFrame: 1 month
measure: Cumulative Clinic pregnancy rate
timeFrame: 14 months
measure: cumulative pregnancy loss rate
timeFrame: 19 months
measure: Implantation rate
timeFrame: 14 months
measure: Multiple pregnancy rate
timeFrame: 22 months
measure: Neonatal malformation rate
timeFrame: 22 months
measure: Good quality embryo rate
timeFrame: 1 month
measure: Birth weight
timeFrame: 22 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References:
Clinical trial NCT04075851: The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
Official title: The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Thyroid Disease
Keywords: Autoimmune thyroid disease
Thyroid hormone autoantibodies
Hashimoto's thyroiditis
Grave's disease
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022

Brief summary: Thyroid hormone autoantibodies(THAA) in serum can Interfere radioimmunoassay for the determination of free thyroid hormones. Thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (AITD), and abnormal examination results in misdiagnosis and mistreatment. At present, the epidemiological results of THAA in AITD are inconsistent, and the pathogenesis has not been clarified. However, there is no relevant research on THAA in China. This project intends to collect AITD patients and healthy people, detecting THAA, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of THAA in AITD patients, observing the effect of common therapeutic drugs for AITD on THAA, investigating the rule of THAA influencing thyroid function test results .This project will provide the basis and method for how to effectively avoid THAA interfering with thyroid function test.


Eligibility criteria: Inclusion Criteria:

* male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old

Exclusion Criteria:

* Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system

Primary outcomes:
measure: prevalence of thyroid hormone autoantibodies in AITD
timeFrame: measured after 1 year of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Province Hospital
state: Shandong
Study officials:
affiliation: shandong province hospital
name: Haiqing Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT02381951: Spinal Cord Stimulation in the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-03-06
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking.

Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients.

This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease since more than 5 years
* Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy

Exclusion Criteria:

* Atypical Parkinson-like syndrome (e.g. progressive supranuclear palsy)
* Cognitive impairment (MMSE\<24)
* Psychiatric disease
* Contraindication of surgery
* Neuropathic pain in the lower limb or lumbar region

Primary outcomes:
measure: improvement in walking capacity
timeFrame: 2 months
Secondary outcomes:
measure: freezing episodes : reduction of frequency
timeFrame: 2 months
measure: freezing episodes : reduction of cumulated time
timeFrame: 2 months
measure: improvement in motor score of MultiDimentionalScaling-UPDRS scale
timeFrame: 2 months
measure: improvement in "freezing of gait" score
timeFrame: 2 months
measure: improvement in quality of life score
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT05656651: Acute Immunological Effects of Exercise in Cancer Patients
Official title: ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.


Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults \>14 years of age
* undergoing acute cancer treatment (chemotherapy)
* signed informed consent

Exclusion Criteria:

* Inability to follow and implement test instructions
* medical contraindication to HIIT on cycle ergometer
* chemotherapeutic treatment 48 h prior
* Hb \<8g/dl; platelets \< 20,000/ul.

Primary outcomes:
measure: Number of Natural Killer Cells
timeFrame: Change from pre Intervention to immediately after intervention and 1 hour post intervention
Secondary outcomes:
measure: Subjective Quality of Life
timeFrame: Once after intervention
measure: Fatigue
timeFrame: Once after intervention
measure: Nutritional status
timeFrame: Once after intervention
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Miriam Götte, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682951: Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
Official title: Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decompressive Craniectomy
Brain Injuries
Treatment Outcome
Keywords: Decompressive craniectomy
Outcome
Brain injuries
Aneurysmal subarachnoid hemorrhage
Cerebral venous thrombosis
Intracerebral hemorrhage
Ischemic stroke
Traumatic brain injury
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 544
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: All patients undergoing a decompressive craniectomy on a 10 year period in CHRU Nancy, France.

Brief summary: Decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage, cerebral venous thrombosis.

Initially considered as a lifesaving therapy, benefits in terms of survival were shown compared to medical treatment alone.

However, despite a better survival, morbidity and poor neurological outcome are frequent among survivors.

The objective of the study is to identify initial good neurological outcome factors after decompressive craniectomy in a large series of patients, in order to argue surgical and intensive care decisions, considering expected benefit and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in CHRU Nancy, France.

Exclusion Criteria:

* Infectious ou malignant disease leading to decompressive craniectomy.

Primary outcomes:
measure: Good neurological outcome
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Hospital of Nancy
Study officials:
References:
Clinical trial NCT05461651: Infection Prevention After TKA With or Without Vancomycin
Official title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection
Keywords: TKA, Vancomycin
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.

Detailed description: Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.

Eligibility criteria: Inclusion Criteria:

* Gosnartrosis

Exclusion Criteria:

* no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score \> II

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: up to 24 months
Secondary outcomes:
measure: Blood test - CRP
timeFrame: 12 weeks,
measure: Blood test - IL 6
timeFrame: 12 weeks,
measure: Functional tests
timeFrame: 12 weeks,
measure: Functional tests
timeFrame: 6 months,
measure: Functional tests
timeFrame: 12 months
measure: Functional tests
timeFrame: 24 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 weeks
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 24 months
measure: 36-Item Short Form Survey
timeFrame: 6 weeks
measure: 36-Item Short Form Survey
timeFrame: 6 months
measure: 36-Item Short Form Survey
timeFrame: 12 months
measure: 36-Item Short Form Survey
timeFrame: 24 months
measure: Visual analog Scale
timeFrame: 6 weeks
measure: Visual analog Scale
timeFrame: 6 months
measure: Visual analog Scale
timeFrame: 12 months
measure: Visual analog Scale
timeFrame: 24 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 weeks
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 12 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 24 months
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: CMKP
name: Rafal KAminski
role: STUDY_CHAIR
References:
Clinical trial NCT06954051: ERFs Game-based Assessment in AYAs: Validation of Game-based Assessment of Emotion Regulation Abilities
Official title: Validation of Game-based Assessment of Emotion Regulation Abilities Using the REThink Life Online Game in a Population of Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2025-05-01
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This activity will have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults.

Detailed description: Each level of the REThink LIFE online game dedicated to training a specific ER skill has an assessment task for emotion recognition, stress reactivity, mindfulness and positive attention abilities. The aim of this study will be to investigate the validity of in-game performance measurements or scores as indicators of adolescents and young adults' emotion regulation abilities.

Eligibility criteria: Inclusion Criteria:

* adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable

Exclusion Criteria:

* intellectual disability or physical limitations precluded the use of the computer program

Primary outcomes:
measure: Emotion regulation
timeFrame: Baseline
measure: Behavioral difficulties
timeFrame: Baseline
measure: Stress
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
affiliation: Babes-Bolyai University
name: Oana A. David, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: