louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00577928: Value of Fecal Calprotectin
Official title: Correlation of Fecal Calprotectin Level With the Clinical, Endoscopic, Histologic and Radiologic Activity in Inflammatory Bowel diseaseThe Value of Fecal Calprotectin for the Diagnosis and Assessment of Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calprotectin
Inflammatory Bowel Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who had calprotectin assays as part of their evaluations for lower gastrointestinal symptoms in the Division of Gastroenterology at IU within the last 12 months will be considered eligible for the study.

Brief summary: For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin levels will be compared between patients with and without a diagnosis of IBD and the sensitivity, specificity and accuracy will be determined. For the secondary aim - the correlation between calprotectin levels and disease activity - in patients with IBD selected from this cohort, we will determine the association between calprotectin levels and clinical IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease score, pathological activity) and radiological features (bowel wall thickening, enhancement, edema, mesenteric inflammation).


Eligibility criteria: Inclusion Criteria:

* Calprotectin assay at IU in last 12 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael Chiorean, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926493: Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
Official title: Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biofilm Formation
Structural and Microbiological Characterization of Endotracheal Tube Biofilm
Ventilator-associated Pneumonia (VAP)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient \> 18 years of age with mechanical ventilation for \>2 calendar days

Brief summary: Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* patient \> 18 years of age with mechanical ventilation for \>2 calendar days

Exclusion Criteria:

* inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation

Primary outcomes:
measure: Development of Ventilator-associated pneumonia (VAP)
timeFrame: Immediately after extubation of the patient
Secondary outcomes:
measure: Development of other VAP, healthcare-associated infection (HAI) or mortality
timeFrame: Immediately after extubation of the patient
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05784493: Pain After Laparoscopic Hysterectomy
Official title: The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
Collaborators: name: Fırat Can Sogut
name: Ozlem Sevinc Ergul
name: Mehmet Veysel Arın
First posted: 2023-03-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.

Detailed description: The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.

This study is double blind randomized controlled study.

inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition

exclusion criteria: maling cases and conversion to laparotomy

after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .

Eligibility criteria: Inclusion Criteria:

* all of cases that had laparoscopic hysterectomy for bening conditions

Exclusion Criteria:

* maling cases
* conversion to laparotomy

Primary outcomes:
measure: Pain assessed by visual analog scale
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Namik Kemal University
Study officials:
References:
Clinical trial NCT03525093: Hypnotherapy to Improve Coping With Stress
Official title: A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.


Eligibility criteria: Inclusion Criteria:

* Healthy or health-stable participants between 18 and 65 years with increased perceived stress for at least 3 months
* Perceived stress in the last week on the visual analog scale\> 40 mm (VAS 0 - 100 mm)
* Ability to consent and sign declaration of consent

Exclusion Criteria:

* Current or planned participation in a stress management exercise within the next 17 weeks
* Current use of psychotherapeutic treatment
* Presence of moderate or severe acute or chronic disease
* Presence of an acute or chronic mental disorder
* Participation in a study within the last 2 months prior to enrollment
* Lack of understanding of the German language

Primary outcomes:
measure: Perceived Stress on Visual Analogue Scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Perceived Stress on Visual Analogue Scale
timeFrame: 12 weeks
measure: Cohens Perceived Stress Scale 10 Items
timeFrame: 5 weeks, 12 weeks
measure: Stress reduction on Likert Scale
timeFrame: 5 weeks, 12 weeks
measure: Allgemeine Depressionsskala (ADS-K)
timeFrame: 5 weeks, 12 weeks
measure: General Self Efficacy Scale (Schwarzer)
timeFrame: 5 weeks, 12 weeks
measure: SF 36 Quality of Life
timeFrame: 5 weeks, 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Berlin
Study officials:
References:
citation: Fisch S, Trivakovic-Thiel S, Roll S, Keller T, Binting S, Cree M, Brinkhaus B, Teut M. Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial. BMC Complement Med Ther. 2020 Nov 13;20(1):344. doi: 10.1186/s12906-020-03129-6.
Clinical trial NCT03549793: Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
Official title: Can Dance Therapy Improve Motor Learning in Parkinson's Disease?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to experimental group or control group. Both of the groups undergo a rehabilitation treatment. The experimental group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + dance therapy. The control group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + exercises
Primary purpose: TREATMENT

Brief summary: In order to find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.


Eligibility criteria: Inclusion Criteria:

* Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;

Exclusion Criteria:

* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
* Drug-induced dyskinesias;
* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
* cognitive decline (MMSE correct score \< 24)

Primary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: 4 weeks
Secondary outcomes:
measure: 6 Minutes Walking Test (6MWT)
timeFrame: 4 weeks
measure: Balance Berg Scale (BBS)
timeFrame: 4 weeks
Other outcomes:
measure: delayed recall of items
timeFrame: 4 weeks
Locations:
city: Gravedona Ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
affiliation: Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06621693: Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries
Official title: Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-cardiac Surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery

Detailed description: Phrenic nerve injury post cardiac surgery is a serious problem closely related to frequent respiratory complications. It has been associated with diaphragm dysfunction, pneumonia and difficulty weaning from mechanical ventilation in critical ill patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy.

There is increased flow of patients after heart surgery in kasr Aini hospital who suffers from respiratory complication due to phrenic nerve injury so the hospitalization period of them increased which make economic burden in health insurance services with decreased level of quality of life that is the most concern as to improve patient status and relief this burden. So this study aims to decrease respiratory complication and improve phrenic nerve regeneration by using neuromuscular electrical stimulation as a safe, noninvasive , inexpensive and virtually risk free method.

Eligibility criteria: Inclusion Criteria:

* Patients post cardiac surgery (coronary artery bypass graft, valve repair or replacement ).
* Patients referred by physician.
* Medically stable patients.
* Both genders
* Ages from 25 to 45
* BMI 25-29.9 kg/m2
* Able to understand the requirements of the study.
* Conscious patient and respond to verbal commands.

Exclusion Criteria:

Participants will be excluded if they meet one of the following criteria:

* Patients with rib fracture.
* Patients developing lung cancer.
* Patients have dementia.
* Patients on mechanical ventilator after 24 hours
* Metabolically unstable chronic illness

Primary outcomes:
measure: Phrenic nerve conduction study: motor latency
timeFrame: 4 weeks
measure: Phrenic nerve conduction study: Amplitude
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hala Atef Abdel Fattah
Study officials:
affiliation: Cairo University
name: Hala R. Mahmoud, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nagwa M. Badr, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06516393: Kinesio Tape Application in the Treatment of Plantar Fasciitis
Official title: Can Kinesio Tape Negatively Affect the Treatment by Creating a Hard Floor in Plantar Fasciitis Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: Plantar Fasciitis
Radial Extracorporeal Shock Wave Therapy
Kinesio Taping
Pain
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the patients were divided into subgroups by the sports physician according to age, height, body weight and body mass index. Patients with similar characteristics were randomized to one of two groups.
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.

Detailed description: The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of unilateral plantar fasciitis,
* The presence of a heel spur on a lateral radiograph

Exclusion Criteria:

* Lower extremity surgeries or traumas,
* Systemic inflammatory disease,
* Steroid injections administered within the past six months,
* Pacemaker usage,
* Coagulation disorders,
* Use of anticoagulants.

Primary outcomes:
measure: Change from baseline in pain on the Visual Analog Scale (VAS) at week 5
timeFrame: Baseline and week 5
measure: Change from baseline Foot function via the Foot Function Index (FFI) at week 5
timeFrame: Baseline and week 5
measure: Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5
timeFrame: Baseline and week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Bihter Akınoğlu
Study officials:
References:
Clinical trial NCT04194593: Biomarker-based Algorithm for Diagnosis of Glioma
Official title: Development of a New Algorithm-based Classification for Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 samples of gliomas (FFPE and/or frozen tissues)

Brief summary: ATRX (X-linked mental retardation and alpha-thalassaemia syndrome protein) loss and pTERT (Telomerase reverse transcriptase) mutation are diagnostic markers of gliomas. However, 4 to 28% of gliomas shows none of these alterations. The aim of this project is to propose a new test able to detect the telomeric status for every glioma. Based on this test and other markers (such as mutation of IDH1 (isocitrate dehydrogenase 1) and IDH2 (isocitrate dehydrogenase 2)), investigators propose an algorithm, able to classify the main subtypes of gliomas (astrocytoma, oligodendroglioma and glioblastoma).


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of glioma (retrospective),
* Patient with available biological material : extracted DNA and/or FFPE tissue and/or frozen sample.
* Samples are not required any more for diagnosis purpose
* Patient with informed consent

Exclusion Criteria:

* Patient with no informed consent
* Patients with no available biological sample

Primary outcomes:
measure: Determination of the prognosis and diagnosis values of a new qPCR (quantitative polymerase chain reaction) -based biological testing in glioma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL
Study officials:
References:
Clinical trial NCT06260293: The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study
Official title: The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery.


Eligibility criteria: Inclusion Criteria:

1. Adult men and women 19 years of age or older
2. Pathologically diagnosed gastric cancer
3. Able to undergo radical resection (R0)
4. Scheduled for minimally invasive surgery (MIS)

Exclusion Criteria:

1. Pregnant or lactating women
2. Have received chemotherapy and radiation before surgery
3. Scheduled for open surgery
4. Subjects who do not understand or have not given informed consent
5. If healthcare provider (primary care physician) deems it difficult for you to exercise

Primary outcomes:
measure: Shorts Physical Performance Battery(SPPB)
timeFrame: "1 day before surgery", "POD3", "POD 1month"
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
Study officials:
affiliation: Department of Surgery, Yonsei University College of Medicine
name: Hyoung-Il Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03666793: Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care
Official title: Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care, From Hospital to Home: Impact on Readmission at 30 Days After Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Medication Reconciliation
Patient Readmission
Keywords: Elderly
Medication Reconciliation
Patient Readmission
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days after hospital discharge. It compares a group of patients receiving comprehensive care (medication reconciliation at hospital entry, multidisciplinary medication review, and medication reconciliation at discharge), versus another group that does not benefit from the program.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the department of short geriatric stay

Exclusion Criteria:

* Patients already included in the study, and readmitted in the same service.

Primary outcomes:
measure: Rate of readmission at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Time between discharge and first readmission
timeFrame: 30 days
measure: Rate of changes in the prescription after hospital discharge by the general practitioner
timeFrame: 30 days
measure: Identification of Seniors at Risk (ISAR) score
timeFrame: 30 days
Other outcomes:
Locations:
city: Lomme
country: France
facility: GHICL
Study officials:
affiliation: GHICL
name: Fabien Visade, MD
role: PRINCIPAL_INVESTIGATOR
References: