louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02047370: Manual Therapy in Patients With Asthma
Official title: Effects of Manual Therapy in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Asthma
Keywords: stretching, diaphragm, asthma, manual therapy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and spirometric values in patients diagnosed with asthma.

Detailed description: Asthma is a chronic lung disease involving an inflammation and a narrowing of the airways. Asthma causes wheezing, chest tightness, shortness of breath, and coughing.

A variety of manual therapies are commonly used to treat patients with asthma. There is a need to conduct studies in order to examine the effects of manual therapies on clinically relevant outcomes. Techniques aim to increase movement in the rib cage and the spine to try and improve the working of the lungs and circulation.

Eligibility criteria: Inclusion Criteria:

* Age ranging between 18 and 45 years.
* Diagnosis of asthma.
* No exacerbations during last month.

Exclusion Criteria:

* History of spine surgery.
* Diabetes, neurological or a cardiovascular disease.
* Spine deformities and use of orthopedic devices.

Primary outcomes:
measure: Forced vital capacity
timeFrame: Baseline, 7 days
Secondary outcomes:
measure: Abdominal Kinematics
timeFrame: baseline, 7 days
measure: Airway diffusing capacity
timeFrame: baseline, 7 days
measure: Forced expiratory volume in the first second
timeFrame: baseline, 7 days
measure: Rib cage excursion
timeFrame: baseline, 7 days
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of health Sciences. University of Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05535270: Validation of the Chinese Version of Oxford Depression Questionnaire
Official title: Psychometric Properties of the Oxford Depression Questionnaire in Chinese Patients With Mood Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Emotional Blunting
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 272
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with mood disorders are recruited as outpatients or inpatients with the First Affiliated Hospital of Zhejiang University, School of Medicine.

Brief summary: Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for detecting emotional blunting. The ODQ has high construct validity and internal reliability. However, no scientific validity studies have been conducted on ODQ in Chinese population. Therefore, this study is intended to investigate the reliability and validity of the ODQ in Chinese patients with mood disorders.


Eligibility criteria: Inclusion Criteria:

1) both biological parents were Han Chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the Mini International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires.

Exclusion Criteria:

1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;

Primary outcomes:
measure: Oxford Depression Questionnaire (ODQ)
timeFrame: baseline
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: baseline
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline
measure: Oxford Depression Questionnaire (ODQ)
timeFrame: 2 weeks after baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04428970: Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)
Official title: Intracranial Pressure Monitoring Following Traumatic Brain Injury - Evaluation of Indications, Complications, and Significance of Follow-up Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Intracranial pressure monitoring
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 214
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 transferred to our department after severe TBI who had received invasive ICP monitoring will be included in this study.

Brief summary: The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.


Eligibility criteria: Inclusion Criteria:

* Severe Traumatic Brain Injury (GCS\<9 on arrival)
* Implantation of invasive intracranial parenchymal ICP monitoring

Exclusion Criteria:

* incomplete data records

Primary outcomes:
measure: Complications
timeFrame: up to 30 days
Secondary outcomes:
measure: Clinical outcome
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical Universtiy of Vienna
Study officials:
References:
Clinical trial NCT00163670: The Impact of Sleep Disorders on Motor Vehicle Accidents
Official title: The Impact of Sleep Disorders on Motor Vehicle Accidents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Patients who have sleep disorders may be involved in accidents more frequently than those without. In addition patients who have sleep disorders may have more serious accidents and have increased length of stay.We aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.


Eligibility criteria: Inclusion Criteria:Drivers admitted as result of motor vehicle accidents -

Exclusion Criteria:Drivers aged \< 18 years

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Alfred
name: M Naughton, MD,FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448070: Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
Official title: A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.


Eligibility criteria: Inclusion Criteria:

* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Fasting blood glucose below or equal to 6 mmol/L
* Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Participated in another clinical study with an investigational drug within the last 4 weeks
* Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
* Known or suspected allergy to the trial product or related products
* Family history of type 1 diabetes

Primary outcomes:
measure: AUC (area under the curve) 0-8h (human insulin)
measure: Cmax (maximum plasma concentration)
measure: Area under the curve (glucose infusion rate (GIR)), 0-8h
Secondary outcomes:
measure: tmax (time to reach maximum)
measure: t½ (terminal half-life)
measure: GIR (glucose infusion rate) max
measure: tGIR (glucose infusion rate) max
measure: Area under the curve (C-peptide, 0-8h)
measure: Physical examinations and vital signs
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02828670: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
Official title: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Hemolytic Anemia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of warm AIHA Patients with non-auto-immune hemolytic anemia

Brief summary: T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of warm AIHA defined by

  * Hemoglobin \<11 g/dl
  * Low haptoglobin level
  * Positive direct antiglobulin test (IgG or IgG + complement)
  * Reticulocyte count \>120 G/L
* Patients

  * naive to treatment for hemolytic anemia or a in relapse
  * Older than 18 years
  * Able to understand written and spoken French
* Persons who have provided written consent

Control population

* Patients who have given consent
* Patients over 18 years
* Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls
* Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,...) can be included as a sub-group of controls

Exclusion Criteria:

* Patients without national health insurance
* Pregnancy or breast-feeding women
* Adults under guardianship
* Patients with cancer or malignant hemopathy
* Patients with an on-going infection
* Patients treated with corticoids or immunosuppressants

Primary outcomes:
measure: the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.
timeFrame: baseline
measure: the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05967975: Elastography and Treatment of Lymphoma
Official title: The Role of Sonoelastography in Evaluation of Therapeutic Response in Patients With Lymphoma.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elastography
Lymphoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed as lymphoma , have superficial lymph nodes and not received any treatment

Brief summary: To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.

Detailed description: Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated to be 72%. (1)

Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma (NHL) (90%).

HL is further classified into classical and non-classical types and NHL into B-cell, T-cell and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy and radiotherapy.

The modalities used for staging and follow up of lymphoma are:

* Computed Tomography (CT) chest, abdomen and pelvis.
* Positron Emission Tomography (PET/CT).
* Whole body Magnetic Resonance Imaging (MRI).(3)

Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.(4)

Eligibility criteria: Inclusion Criteria:

* patients who are histopathologically proven as lymphoma, not receive treatment and have superficial lymphadenopathy.

Exclusion Criteria:

* 1-Lymphoma without superficial lymph nodes. 2-patients under treatment.

Primary outcomes:
measure: To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
timeFrame: Average three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Kerols Refaat, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Nagham Nabil, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Abdel-Monem Sayed, Lecture
role: STUDY_DIRECTOR
References:
Clinical trial NCT01467375: Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.


Eligibility criteria: Inclusion Criteria:

* Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

* Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
* Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
* Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
* Known or suspected allergy to trial product or related products
* Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease

Primary outcomes:
measure: Occurrence of adverse events
measure: Frequency of hypoglycaemic episodes
Secondary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Ashford
country: Australia
facility: Novo Nordisk Investigational Site
city: Auchenflower
country: Australia
facility: Novo Nordisk Investigational Site
city: Launceston
country: Australia
facility: Novo Nordisk Investigational Site
city: Nowra
country: Australia
facility: Novo Nordisk Investigational Site
city: Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
city: Rooty Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: Hull
country: Canada
facility: Novo Nordisk Investigational Site
city: London
country: Canada
facility: Novo Nordisk Investigational Site
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Saskatoon
country: Canada
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03367975: NIRS Monitoring During Intracranial Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Intracranial Arteriovenous Malformation
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cerebral aneurysm clipping or av-malformation removal

Brief summary: Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. However, it yields artificial results when the dye indocyanine green (ICG) is applied, which is routinely done for intraoperative angiography.

The investigators examine, to what extent and which duration NIRS is disturbed following ICG application.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for aneurysm clipping or av-malformation removal

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: amount of rSO2 - change [%] induced by ICG-application
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
Study officials:
References:
Clinical trial NCT02680275: Efficacy of Dead Sea Peloid Gel in Chronic Endometritis
Official title: Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Endometritis
Keywords: Chronic endometritis
Miscarriage
Infertility
Lead sponsor: Scientific Center for Family Health and Human Reproduction Problems, Russia
Sponsor class: OTHER_GOV
First posted: 2016-02-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.

Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

Detailed description: Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Eligibility criteria: Inclusion Criteria:

* Women with miscarriage associated with chronic endometritis
* Women without mental disorders able to swallow tablets

Exclusion Criteria: Clinical diagnosis of:

* sexually transmitted diseases
* endometrium hyperplasia and/or polyps
* uterina fibroids
* endocrine disorders
* trombophilia

Primary outcomes:
measure: The prevalence of spontaneous pregnancy the first year after treatment
timeFrame: during first year
Secondary outcomes:
measure: The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.
timeFrame: during 3 months
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Scientific Center for Family Health and Human Reproduction Problems
Study officials:
affiliation: Scientific Center for Family Health and Human Reproduction Problems
name: Marina A Darenskaya, MD
role: STUDY_CHAIR
References: