louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03275714: Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Official title: Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Affective Disorder
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.

The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.

Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.

Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.

Study design: Clinical evaluation of a medical device without CE mark; Parallel study design


Eligibility criteria: Inclusion Criteria:

* Written consent of the participant after clarification
* Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
* Age between 18 and 70 years
* Knowledge about using a smartphone

Exclusion Criteria:

* Rejection of participation
* Lack of knowledge about how to deal with a smartphone
* Congenital / early-childhood intelligence reduction
* Moderate / severe dementia

Primary outcomes:
measure: Sleep duration
timeFrame: 6 months
measure: Movement behaviour
timeFrame: 6 months
measure: Mood
timeFrame: 6 months
measure: Communication behaviour
timeFrame: 6 months
Secondary outcomes:
measure: Patient acceptance
timeFrame: 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Study officials:
References:
Clinical trial NCT01589614: A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804
Official title: A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05788614: Retroversion in Reverse Shoulder Arthroplasty
Official title: In a Reverse Shoulder Arthroplasty, Does Function Depend on the Humeral Version? A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Osteoarthritis
Lead sponsor: Hospital Universitario Reina Sofia de Cordoba
Sponsor class: OTHER_GOV
First posted: 2023-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare function in reverse shoulder arthroplasty (RSA) using two different degrees of humeral retroversion (RV). The main question it aims to answer is:

• Does external rotation improves when using a higher retroversion?

Participants will randomly receive a 0 degree or 30 degree RV for their RSA.

They will be followed for two years and clinical outcomes will be recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* patients \> 60 years
* primary rotator cuff arthropathy
* implantation of reverse shoulder arthroplasty

Exclusion Criteria:

* previous surgeries in the shoulder
* post-traumatic arthropathy

Primary outcomes:
measure: External rotation of the shoulder
timeFrame: 2 years
measure: Constant-Murley Score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
state: Cordoba
Study officials:
affiliation: Hospital Universitario Reina Sofía de Córdoba
name: Jose Carlos Minarro, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05528614: Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors.
Official title: Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor of Pancreas
Keywords: Tumor of Pancreas
Metastatic neuroendocrine tumors
Hepatic resection
Pancreatic resection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects (≥18 years old) having had a first pancreatic resection for NET with resections of synchronous metastases

Brief summary: The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature.

The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.


Eligibility criteria: Inclusion criteria:

* Major subjects (≥18 years old)
* Subject having had a first pancreatic resection for NET with resections of synchronous metastases
* Subject having had a first pancreatic resection for NET followed by a delayed resection of synchronous metastases
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Pregnant women
* Subject under safeguard of justice
* Subjects under guardianship or curatorship

Primary outcomes:
measure: Postoperative morbidity and mortality of simultaneous pancreatic and hepatic resectio
timeFrame: Morbidity and mortality at 90 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France
Study officials:
affiliation: Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France
name: Pietro ADDEO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06390514: The Benefits of Vibrating Floors for Deaf Children
Official title: The Benefits of Vibrating Floors for Deaf Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deaf Children
Keywords: vibrating floor benefits
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via vibrations. One such tactile tool used by speech therapists is the vibrating floor, which enables the child to feel sounds through the vibrations perceived by his or her body. Although used in many institutions, there is very little scientific evidence to date of the effectiveness of using the vibrating floor with deaf children.


Eligibility criteria: Inclusion Criteria:

* Deaf children whose project is to develop oral French language skills
* Deaf children with cochlear implants or hearing aids
* Children with previous experience of the vibrating floor

Exclusion Criteria:

* intellectual disability
* impairment

Primary outcomes:
measure: Language assessment
timeFrame: Throughout the entire study, approximately during 24 months
Secondary outcomes:
measure: Questionnaire on feelings and well-being
timeFrame: Throughout the entire study, approximately during 24 months
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Bragard Anne
state: Brabant
Study officials:
affiliation: Université Catholique de Louvain
name: Anne Bragard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03767114: Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
Official title: Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls.

Skin biopsy from patients (psoriasis lesional and non lesional) \& control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis \& PCR.


Eligibility criteria: Inclusion Criteria:

* patients with psoriasis vulgaris
* patients over 18 years of age
* both sexes

Exclusion Criteria:

* patients on treatment for psoriasis within the last two months
* assoiciated autoimmune diseases eg SLE
* pregnancy

Primary outcomes:
measure: Estimation of lesional ERAP1 in psoriatic skin
timeFrame: Maximum 2 years
Secondary outcomes:
measure: Estimation of non lesional ERAP1 in psoriatic skin
timeFrame: Maximum 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01568814: Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation
Official title: Efficacy and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Colonoscopy
Keywords: colonoscopy
bowel preparation
polyethylene glycol
low residue meal
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

Detailed description: We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

Eligibility criteria: Inclusion Criteria:

* Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Breast feeding
* Prior history of surgical large bowel resection
* Severe medical condition such as severe cardiac
* Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
* Drug addiction or major psychiatric illness
* Suspected bowel obstruction or ileus
* Allergy to PEG
* Refusal of consent to participate in the study.

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: 2 months
Secondary outcomes:
measure: Tolerability
timeFrame: 2 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital, Inje University School of Medicine
Study officials:
References:
Clinical trial NCT00982514: Thromboembolic Complications Related to Asparaginase in Children With Acute Lymphoblastic Leukemia (ALL) Treated According to NOPHO ALL 2008
Official title: Thromboembolic Complications Related to Asparaginase in Children With ALL Treated According to NOPHO ALL 2008
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolism
Acute Lymphoblastic Leukemia
Keywords: Asparaginase
thrombosis
ALL
central line
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oslo University Hospital, Department of Pediatrics

Brief summary: The study will examine the prevalence of venous thromboembolism in children with acute lymphoblastic leukaemia treated in accordance with NOPHO ALL-2008. The investigators will prospectively study clinical symptomatic thromboses, asymptomatic central line-associated thromboses, and infections.


Eligibility criteria: Inclusion Criteria:

* Acute lymphoblastic leukaemia,
* Age 1 year to 16 years old,
* Central line,
* Protocol NOPHO ALL 2008.

Exclusion Criteria:

* Refusal of participation,
* Treated according to protocol other than NOPHO ALL 2008.

Primary outcomes:
measure: Clinical evident thrombosis
timeFrame: 33 weeks
measure: Asymptomatic central line-associated thrombosis
timeFrame: 33 weeks
Secondary outcomes:
measure: Positive blood culture
timeFrame: 33 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Dep of Pediatrics
Study officials:
affiliation: Oslo University Hospital
name: Ellen Ruud, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02134795: A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.


Eligibility criteria: Inclusion Criteria:

* Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
* Patient should have a Hoehn \& Yahr staging of 1 to 3 (mild to moderate)
* Patient must be an adult (18 years of age or older)

Exclusion Criteria:

* Women who are pregnant or nursing
* have a history of significant cardiovascular disease (no pacemakers)
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use a hearing aid
* have a cochlear implant
* have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial

Primary outcomes:
measure: Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)
timeFrame: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
References:
Clinical trial NCT05214495: Omega-3 Hydrogel and Prevention of Oral Mucositis
Official title: Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mucositis Oral
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 36
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: PREVENTION

Brief summary: Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.


Eligibility criteria: Inclusion Criteria:

1. Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
2. Patients whose radiotherapy treatment planned dose is 50 Gy or above
3. Males and females with an age not less than 18 years
4. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.

Exclusion Criteria:

1. Patients under Anticoagulants such as warfarin, heparin, or aspirin.
2. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Primary outcomes:
measure: Oral Mucositis Severity
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry Alexandria University
Study officials:
References:
Clinical trial NCT05445895: A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
Official title: A Prospective, Randomized, Active-controlled, Double-blind, Parallel, Multi-center, Phase IV, Exploratory Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Stroke
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke


Eligibility criteria: Inclusion Criteria:

1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.

Exclusion Criteria:

1. Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
2. With a modified Rankin Score (mRS) of 3 or higher before onset.
3. Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
4. History of hypersensitivity to IP or components
5. Not suitable for aspirin administration at the discretion of the investigator

Primary outcomes:
measure: - The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: