louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01167491: Study of One Protein Implicated in Wegener Disease
Official title: Activating Receptors and DAP12 Protein in Wegener's Granulomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wegener's Granulomatosis
Keywords: Wegener
CD4+ T cells
DAP12
NKG2D
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an assortment of activating NK cell receptors and their signaling partners, in particular DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the missing link between the different cell components involved in WG (neutrophils, macrophages, CD4 T cells).

Detailed description: The investigators will test our hypothesis of "DAP-12 gain-of-function" by quantitative (mRNA and protein) and qualitative (DNA, signaling and cellular activation) analysis of the DAP12 signaling pathway in WG patients with localized (group 1; n=30) or diffuse WG (group 2; n=30) by comparison with patients with micro polyangitis (group 3; n=30), or with sarcoidosis ( group 4; n=30), and healthy blood donors (group 5; n=30). Blood samples will be collected during a routine medical visit. These results may help to design future therapeutic strategies based on modulation of specific intra-cellular pathways involved in the disease.

Eligibility criteria: Inclusion Criteria:

* Group 1: WG, with granulomatous lesions limited to upper airway or lungs and no evidence of generalized vasculitis ,± biopsy, ± anti-PR3 ANCA
* Group 2: WG with granulomatous lesions plus vasculitis expression (renal, neurological, skin, gut or heart involvement), ± biopsy, ± anti-PR3 ANCA
* Group 3: Necrotizing vasculitis with no granulomatous lesions, ± PAUCI immune glomerulonephritis, ± anti-MPO ANCA
* Group 4: clinical presentation compatible with sarcoidosis, ± biopsy, ± ECA elevated ± tuberculin anergy

Exclusion Criteria:

* \<18 years
* Pregnancy or breastfeeding
* Absence of signed informed consent
* No affiliation to insurance

Primary outcomes:
measure: level of mRNA expression of DAP12
timeFrame: less than 24 hours
Secondary outcomes:
measure: level of expression of DAP 12 downstream signalling proteins
timeFrame: Less than 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Medecine Interne Hôpital Saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Mathilde De Menthon,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03944291: Pudendal Nerve Block for Post-Episiotomy Pain Relief
Official title: Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bupivacaine
Primary purpose: PREVENTION

Brief summary: Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial


Eligibility criteria: Inclusion Criteria:

* Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus

Exclusion Criteria:

* Women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. Also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of the study

Primary outcomes:
measure: Visual Analogue Scale for pain scoring
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT03402594: High Flow Oxygen Therapy and Acute Ischemic Stroke
Official title: Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: High flow oxygen therapy
Oxygen desaturation index
Acute ischemic stroke
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 30
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: Hypoxemia is common in acute ischemic stroke and associated with neurological deterioration and mortality. However, the benefit of oxygen therapy is controversial. Severity of stroke may affect the benefit of oxygen supplementation. Abnormal breathing patterns are commonly found among stroke patients and may increase the risk of hypoxemia. High flow nasal cannula (HFNC) has several advantages from controllable fraction of inspired oxygen (FiO2), reduction of nasopharyngeal resistance and positive end expiratory pressure effect. In this study, we aimed to assess the therapeutic effect of HFNC on oxygen desaturation index (ODI) and neurological outcomes in stroke patients with moderate and severe severities, compared with no and low flow oxygen supplementation.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 or more
2. Clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke
3. Presentation within 72 hours after the stroke onset
4. National of Health Stroke Scale (NIHSS) of 5 or more,
5. Limb weakness defined as motor power grade of 4 or less,
6. Able to give informed consent, or the next of kin was willing to give assent

Exclusion Criteria:

1. Recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation
2. Recognized contraindications for oxygen treatment including chronic hypercapnia and type II respiratory failure
3. Subjects with previous diagnosis of obstructive sleep apnea (OSA) or highly suspicious of OSA, screened by STOPBANG score of 5 or more

Primary outcomes:
measure: Oxygen desaturation index
timeFrame: In the first 24 hours of study period
Secondary outcomes:
measure: Mean oxygen saturation
timeFrame: In the first 24 hours of study period
measure: Lowest oxygen saturation
timeFrame: In the first 24 hours of study period
measure: The number of subjects with oxygen desaturation
timeFrame: In the first 24 hours of study period
measure: Percentages of cumulative time of oxygen desaturation
timeFrame: In the first 24 hours of study period
measure: NIHSS changes
timeFrame: at the 7th day of admission or at discharge date
measure: The number of subjects with NIHSS improvement by 4 or more
timeFrame: at the 7th day of admission or at discharge date
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03368794: Naloxone to TReatment Entry in the Emergency Setting
Official title: Naloxone to TReatment Entry in the Emergency Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Dependence
Opioid Intoxication
Substance Use Disorders
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 0
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 study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.

Detailed description: Randomized controlled trial. Subjects are included if they are being treated by an ambulance in the Malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. Subjects are randomized by ambulance staff to either an active intervention, or a control condition:

Intervention: A telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study.

Control: No telephone alert signal is sent, and the active outreach procedure is not carried out. Ambulance staff hand over written information to the individual about how she/he can apply actively for treatment.

Primary outcome is entry into formal assessment and treatment of the substance use disorder.

Eligibility criteria: Inclusion Criteria:

* survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent

Exclusion Criteria:

* patients unable to understand study information and to provide informed consent

Primary outcomes:
measure: Treatment entry
timeFrame: Two weeks
Secondary outcomes:
measure: Treatment retention
timeFrame: 3, 6, 12, 24 and 36 months
measure: Treatment outcome (urinalysis)
timeFrame: 3, 6, 12, 24 and 36 months
measure: Treatment outcome (hair analysis)
timeFrame: 3 months
measure: Treatment outcome (self-report)
timeFrame: 3, 6, 12, 24 and 36 months
measure: Treatment outcome (quality of life)
timeFrame: 3, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Center
Study officials:
affiliation: Lund University. Region Skåne.
name: Anders Håkansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504994: Stress & Social Cognition in Borderline Personality Disorder
Official title: "Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.

Detailed description: The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight" pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing

Eligibility criteria: Inclusion Criteria:

female patients with BPD and healthy control women, matched for age, body mass index, and education

Exclusion Criteria:

physical illness

Primary outcomes:
measure: empathy
timeFrame: 30 minutes after cyberball
Secondary outcomes:
measure: sharing behavior: amount of monetary units (max 30) shared with co-player
timeFrame: directly after cyberball
Other outcomes:
measure: punishment behavior: number of accepted offers from co-player
timeFrame: 15 minutes after cyberball
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT01820494: Nutritional Management of Infants With Chronic Diarrhea
Official title: Nutritional Management of Infants With Chronic Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Tolerance Infant Study
Keywords: growth
infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 27
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 12 months of age at enrollment
* Candidates for elemental feeding
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion Criteria:

* Any non-approved concomitant study

Primary outcomes:
measure: Weight
timeFrame: Study Day (SD) 1, 28 and 84
Secondary outcomes:
measure: Stool Characteristics
timeFrame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Other outcomes:
measure: Dietary Assessment
timeFrame: Study day (SD) 2-4, 5-7, 25-27 and 81-83
measure: Blood Chemistry
timeFrame: Study Day (SD) 1 and 84
measure: Physician Assessment of Abdominal Complaints
timeFrame: Study Day (SD) 1, 28 and 84
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Detroit
country: United States
facility: Children's Hospital of Detroit
state: Michigan
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD, RD
role: STUDY_CHAIR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
citation: Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136.
Clinical trial NCT01010594: Two Pieces of Fruit to Type 2 Diabetics?
Official title: Two Pieces of Fruit to Type 2 Diabetics?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hospitalsenheden Vest
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 64
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: It has been questioned whether patients with type 2 diabetes who are advised to restrict their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c, body weight, fruit intake and serum lipids) after three months compared to patients with type 2 diabetes who are advised to eat at least two pieces of fruits.

To the investigators' knowledge, no randomized controlled trial has evaluated this.

The investigators therefore perform a randomized controlled trial including 76 patients with type 2 diabetes to investigate this.

The investigators' hypothesis is that:

Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c three months after an initially dietary treatment as type 2 diabetics who are advised not to restrict their fruit consumption.


Eligibility criteria: Inclusion Criteria:

* patients refered from a general practitioner

Exclusion Criteria:

* no Hba1c when refered
* Hba1c lower than 5% or higher than 12%
* patients that require a translator
* patients with severe cardiovascular, renal or endocrine disease
* psychiatric patients
* pregnant patients

Primary outcomes:
measure: Change in Hba1c
timeFrame: three months
Secondary outcomes:
measure: change in bodyweight
timeFrame: three months
measure: change in serum lipids
timeFrame: three months
measure: change in fruit intake
timeFrame: three months
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of nutrition, Regional Hospital West Jutland
Study officials:
affiliation: The Department of Endocrinology and Metabolism, Aarhus University Hospital
name: Allan S Christensen, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen AS, Viggers L, Hasselstrom K, Gregersen S. Effect of fruit restriction on glycemic control in patients with type 2 diabetes--a randomized trial. Nutr J. 2013 Mar 5;12:29. doi: 10.1186/1475-2891-12-29.
Clinical trial NCT00166894: Use of the Triggering Receptor Expressed on Myeloid Cells-1 (TREM-1) in the Diagnosis of Pleural Effusion
Official title: Evaluation of the Triggering Receptor Expressed on Myeloid Cells-1 (TREM-1) as a Diagnostic Tool for Patients With Pleural Effusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Effusion
Keywords: pleural effusion
TREM-1
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The aim of this trial is to evaluate the level of TREM-1 in different kinds of pleural effusion.

Detailed description: The triggering receptor expressed on myeloid cells-1 (TREM-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi. Several experiments by Bouchon and colleagues showed that TREM-1 mediates the acute inflammatory response to microbial products. Human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of TREM-1. Conversely, TREM-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. The presence of a soluble form of TREM-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pleural effusion
* Pleural effusion proved by chest sonography

Exclusion Criteria:

* Conditions for which thoracentesis are contraindicated
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of International Medicine, National Taiwan University Hospital
name: Pan-Chyr Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417294: Effects of a 3D-Printed Port-A Catheter Model Training Course
Official title: Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Cancer
Keywords: 3D printed model
port-a catheter
discharge education
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.

Detailed description: Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.

Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.

Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.

Eligibility criteria: Inclusion Criteria:

* Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
* Have Chinese communication skills

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Patient education effectiveness questionnaire
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: