louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01837446: Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
Official title: Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stomatitis
Keywords: mucositis
topical morphine
pain
head and neck carcinoma
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-23
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: Oral mucositis is a debilitating side effects of cancer treatment for which there is not much successful treatments at yet. The investigators are going to evaluate the effectiveness of topical morphine compared with a routine mouthwash in managing cancer treatment-induced mucositis. The investigators hypothesize that topical morphine is more effective and more satisfied by patients than the magic mouthwash in reducing severity of cancer treatment-induced oral mucositis.


Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients
* Severe oral mucositis; grade III or IV of the World Health Organization (WHO) rating of global mucositis
* Willingness to participate

Exclusion Criteria:

* History of severe renal or hepatic insufficiency
* Collagen-vascular disease
* Allergic reaction to morphine
* Current smokers or alcohol users
* Pregnant women

Primary outcomes:
measure: Mucositis severity
timeFrame: Up to six days
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: After six days
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Radiation Oncology Department, Seyed Al-Shohada Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Simin Hemati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cerchietti LC, Navigante AH, Bonomi MR, Zaderajko MA, Menendez PR, Pogany CE, Roth BM. Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma. Cancer. 2002 Nov 15;95(10):2230-6. doi: 10.1002/cncr.10938.
citation: Cerchietti L. Morphine mouthwashes for painful mucositis. Support Care Cancer. 2007 Jan;15(1):115-6; author reply 117. doi: 10.1007/s00520-006-0124-8. Epub 2006 Aug 15. No abstract available.
Clinical trial NCT04952246: Clinical Isolation Syndrome of Spinal Cord and Multiple Sclerosis
Official title: Clinical Isolated Spinal Cord Syndrome Was Identified as Multiple Sclerosis Associated Risk Factor Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical Isolation Syndrome of Spinal Cord
Multiple Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinically isolated spinal cord syndrome

Brief summary: The purpose of this study was to investigate the factors that influence the progression of patients with clinically isolated spinal cord syndrome to multiple sclerosis.

Detailed description: This study included patients who were first diagnosed with clinically isolated spinal cord syndrome admitted to the Department of Neurology, Peking University Third Hospital between January 2010 and November 2020. According to the result of the outcome is divided into multiple sclerosis and outcome group, analyzing the characteristics of the age, sex, clinical manifestations, imaging features, evoked potential, blood immune antibody results, rate of cerebrospinal fluid routine biochemical synthesis oligoclonal band IgG, extension, nerve dysfunction score spinal cord clinically isolated syndrome and the influence factors, such as the relationship between the outcome of multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

Diagnosis time and place: Department of Neurology, Peking University Third Hospital from January 2010 to November 2020 Diagnosed as a patient with clinically isolated spinal cord syndrome for the first time

Exclusion Criteria:

none

Primary outcomes:
measure: Progressed to multiple sclerosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijin
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06517446: Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction
Official title: Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Hypofunction
Keywords: Unilateral Vestibular Hypofunction
Virtual Reality
Optokinetic stimulation
Motion Sickness
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted on patients diagnosed with UVH who apply to Prof. Dr. Mete İşeri Ear, Nose and Throat Diseases Polyclinic and Güneşli Erdem Hospital Ear, Nose and Throat and Vestibular Rehabilitation Unit. Participants will be divided into 3 groups by simple randomization (closed envelope) method. To the vestibular rehabilitation group; A conventional rehabilitation program based on structured Cawthorne Cooksey exercises will be applied for 45 minutes once a week with the support of a physiotherapist for 8 weeks. To the optokinetic stimulation group; optokinetic stimulation will be given with virtual reality glasses, and to the combined group; Participants in the vestibular exercise group will receive additional optokinetic stimulation. The application will be done once a week for 8 weeks. Inclusion criteria for the study are; diagnosed with unilateral vestibular hypofunction with VNG test, between the ages of 18-65, class A+ in the System Usability Scale (SUS) and the percentage range being between 96-100%; Exclusion criteria for the study are; Bilateral vestibular hypofunction, visual impairment, neurological disorder and inability to communicate.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with unilateral vestibular hypofunction with VNG test,
* Being between the ages of 18-65,
* Being in the A+ class on the System Usability Scale (SCS) and having a value between 96-100 percentile

Exclusion Criteria:

* Having bilateral vestibular hypofunction
* Having a visual impairment,
* Having a neurological disorder
* Inability to communicate

Primary outcomes:
measure: Headache Impact Scale (HIT-6):
timeFrame: 8 Weeks
measure: Motion Sickness Severity Scale (MSSS)
timeFrame: 8 Weeks
measure: Simulator Sickness Survey (SHA)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: 8 Weeks
measure: Dizziness Handicap Inventory (DHI)
timeFrame: 8 Weeks
Other outcomes:
measure: Sociodemographic data form
timeFrame: 8 Weeks
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Health and Technology University
Study officials:
References:
Clinical trial NCT05905146: Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain.
Official title: Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pathology of the Locomotor System
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
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 evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in the rheumatology department
* Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
* Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion

Exclusion Criteria:

* Patient with cancer or fibromyalgia already diagnosed at inclusion
* Patient with poor French language skills
* Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
* Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
* Patient already included in the study

Primary outcomes:
measure: total duration of treatment in days with strong opioids from day of inclusion
timeFrame: 6 months
Secondary outcomes:
measure: number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)
timeFrame: 3 months
measure: pain assessment (numerical scale) at first patient call after stopping strong opioids
timeFrame: 6 months
measure: number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)
timeFrame: 28 days
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
city: Nîmes
country: France
facility: CHU de Nimes
city: Rouen
country: France
facility: CHU de ROUEN
Study officials:
affiliation: University Hospital, Rouen
name: Catherine CHENAILLER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689710: The Effects of Inositol on Glucose Metabolism in Patients with Metabolic Syndrome At Risk of Cardiac Fibrosis
Official title: The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients with Metabolic Syndrome At Risk of Cardiac Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Cardiac Fibrosis
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis


Eligibility criteria: At least 3 of the following inclusion criteria:

* triglycerides levels ≥ 150 mg/dL
* HDL ≤ 40 mg/dL
* Fasting glycemia \> 100 mg/dL \<126 mg/dl
* Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg
* Hip circumference \> 102 cm in men or 88 cm in women

Primary outcomes:
measure: Body weight
timeFrame: Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days
Secondary outcomes:
measure: Tryglicerides
timeFrame: Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
measure: Hypertension
timeFrame: Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: UOC Medicina Interna e Nefrologia P.O. AQ
Study officials:
affiliation: UOC Medicina Interna e Nefrologia P.O. AQ
name: Davide Grassi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UOC Medicina Interna e Nefrologia P.O. AQ
name: Claudio Ferri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146510: HealtheTech Lifestyle Program
Official title: HealtheLifestyle Behavioral Intervention Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: weight control
compliance
physical activity
nutrition
Health Behavior
Patient Compliance
Lead sponsor: The Cooper Institute
Sponsor class: OTHER
Collaborators: name: HealtheTech
First posted: 2005-09-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.

Detailed description: The study plans are to develop and test the efficacy of a practical, structured, and time-limited behavioral intervention (HealtheLifestyle Program) as a supplement to standard HealtheTech products. Approximately 130 participants will be recruited and randomized to either the HealtheTech Program (focusing on calorie and exercise goals using the BalanceLog for tracking), the HealtheLifestyle Program (using step counters, monthly email letters and calls providing information on activity, nutrition, and weight loss), or a delayed treatment program (after 3 months undergo the intervention above).

Eligibility criteria: Inclusion Criteria: healthy adult men and women, 18-60 years -

Exclusion Criteria: not currently participating in a structured diet or exercise program

-

Primary outcomes:
measure: HealtheLifestyle participants will have greater weight loss
Secondary outcomes:
measure: HealtheLifestyle Program will increase efficacy of products
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Cooper Institute
state: Texas
Study officials:
affiliation: The Cooper Institute
name: Heather Kitzman, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03317210: Intravenous Treatment of Anemia in Pregnancy
Official title: Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
Primary purpose: TREATMENT

Brief summary: The investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.

Detailed description: Fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the Anemia clinic at the Department of Obstetrics, University Hospital Zurich. All patients had singleton pregnancies. All pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (Hb) between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l. In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted. According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly. Patients with an Hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (VENOFER®, Vifor Int., St. Gallen, Switzerland) intravenously twice weekly (group A). If response to therapy was poor (i.e. Hb increase \<0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhEPO (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland) (group B). This cut-off for adequate primary response the investigators choose on the basis of previous experience. Patients with an Hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (Venofer) and rhEPO (Eprex) twice weekly from the start of therapy (group C).

Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase \>1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb \> 10.5 g/dL was achieved.

Eligibility criteria: Inclusion Criteria:

* pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l

Exclusion Criteria:

* vitamin B12 deficiency anemia
* folic acid deficiency anemia
* hemoglobinopathy
* multiples
* liver disease
* kidney disease

Primary outcomes:
measure: Efficacy of Treatment: hemoglobin increase after therapy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Roland Zimmermann, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04448210: Web-based Resource for Children and Adolescents About Clinical Research
Official title: Web-based Resource for Children and Adolescents About Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Chronic Illnesses, Multiple
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.

Detailed description: Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and youth assent will be sought. Participants will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News: Teen for one week. Approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for youth in the intervention group will also include Consumer Satisfaction Questions). Youth in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will complete a Consumer Satisfaction Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Participants must be between the ages of 12 and 17 years.
* Participants must have access to a computer or tablet with Internet connection.
* Participants must be able to read and write in English fluently.

Exclusion Criteria:

* Participants must NOT have previously participated in a clinical trial.

Primary outcomes:
measure: Knowledge Scores at 1 Week
timeFrame: 1 week
measure: Attitudes Scores at 1 Week
timeFrame: 1 week
measure: Beliefs Scores at 1 Week
timeFrame: 1 week
measure: Self-Efficacy to Communicate Scores at 1 Week
timeFrame: 1 week
measure: Self-Efficacy to Gather Information Scores at 1 Week
timeFrame: 1 week
measure: Confidence Scores at 1 Week
timeFrame: 1 week
measure: Procedural Fears Scores at 1 Week
timeFrame: 1 week
measure: Likelihood of Participation Scores at 1 Week
timeFrame: 1 week
measure: Fear Preventing Participation Scores at 1 Week
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Alison Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05647512: Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
Official title: A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma
Other Plasma Cell Diseases
Lead sponsor: LaNova Medicines Limited
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Detailed description: A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility criteria: Inclusion Criteria:

Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:

1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Aged ≥18 years old when sign the ICF, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
4. Life expectancy ≥ 6 months.
5. Subjects must show appropriate organ and marrow function in laboratory examinations

Exclusion Criteria:

Subjects will be excluded from the study, if they meet any of the following criteria:

1. A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
2. Subjects who have severe cardiovascular disease。
3. Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
4. Child-bearing potential female who have positive results in pregnancy test or are lactating.
5. Subject who is judged as not eligible to participate in this study by the investigator.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: Cycle 1 of each cohort. Duration of one cycle is 21 days
measure: Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy
Secondary outcomes:
measure: Area under plasma concentration vs time curve (AUC) for LM-305
timeFrame: Up to finished cycle 5 (each cycle is 21 days)
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu
role: PRINCIPAL_INVESTIGATOR
References: