louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05404308: Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy
Official title: Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paramedical Consultation
Radiotherapy
Proton Therapy
Brain Tumor
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: OTHER

Brief summary: To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).

This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.

This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years;
* Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
* WHO score \< 2
* Mastery of the French language;
* Patient affiliated with a social security system;
* Signature of informed consent prior to any specific procedure related to the study.

Exclusion Criteria:

* Patient with another cancer previously treated with radiation therapy;
* Simultaneous participation in a therapeutic clinical trial;
* Patient deprived of liberty or under guardianship;
* Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
* Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.

Primary outcomes:
measure: Proportion of patients with at least one toxicity requiring intervention
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of toxicities detected
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT04526808: Effects of Low FODMAP Diet on Leaky Gut
Official title: Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2020-08-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.

Detailed description: we aim to evaluate the following in patients with IBS-D. The effect of LFD on colonic permeability. 2.The effect of LFD on abundance of colonic mucosal immune cells specifically T-cell and mast cell abundance 3.The effect of LFD on colonic mucosal microbiome

Eligibility criteria: Inclusion Criteria:

* aged 18-65 years at the time of screening
* normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
* normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
* IBS-SSS score of ≥175 at the end of 7-day screening period

Exclusion criteria:

* individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
* individuals with any known food allergy or insulin-dependent diabetes
* known history of celiac disease, inflammatory bowel disease or microscopic colitis
* prior small bowel or colonic surgery or cholecystectomy
* pregnant patients
* antibiotics in the past 3 months
* those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.

Primary outcomes:
measure: colonic permeability
timeFrame: 4 weeks
Secondary outcomes:
measure: colonic immune cells
timeFrame: 4 weeks
measure: colonic microbiome
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Judy Nee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417508: Nutritional Intervention in Malnourished Elderly Patients
Official title: Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Malnutrition
Keywords: function
elderly
ADL
nutritional supplementation
Quality of life
handgrip strength
Body Composition
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Centre for Research in the Elderly, Tromsoe, Norway
First posted: 2007-01-01
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.

Detailed description: Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index \< 20 kg/m2 are asked to participate.

Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.

Primary and secondary outcome parameters are measured at inclusion and week 12

Eligibility criteria: Inclusion Criteria:

* Body Mass Index \< 20 kg/m2
* Medical In/Outpatient or District Nurse-patient
* Able to take nutritional supplement (sip feeding)
* Able to walk
* Written patient informed consent

Exclusion Criteria:

* Actual malignancy
* Dementia with a Mini Mental Status score \< 24
* Severe depression
* Need for Total Parenteral Nutrition or Tube Feeding
* Prescribed nutritional supplements during more than the last week
* Life expectancy of less than 6 months

Primary outcomes:
measure: Functional Health (Short form 36)
timeFrame: Start and 12 weeks
Secondary outcomes:
measure: Nutritional Measures (at inclusion and week 12)
timeFrame: Start and 12 weeks
measure: Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
timeFrame: at 6 and 12 weeks
measure: Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
timeFrame: Start and 12 weeks
measure: Observed ADL
timeFrame: Start and at 12 weeks
measure: Timed Up and Go test
timeFrame: Start and12 weeks
measure: Hand grip strength
timeFrame: Start and 12 weeks
Other outcomes:
Locations:
city: Tromsoe
country: Norway
facility: University Hospital of Northern Norway, Dep of Medical Gastroenterology
Study officials:
affiliation: University Hospital of Northern Norway, Dep of Medical Gastroenterology
name: Jon R Florholmen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05826808: Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).
Official title: The Different Diagnostic Values of Polysomnographies at Low and at Moderate Altitude - A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kantonsspital Graubünden
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the effect of moderate altitude (\>1000 m.a.s.l.) on sleep examinations (polysomnography).

Detailed description: Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 600 m.a.s.l.) as well as for 2 consecutive nights at the participants home elevations (CH; \>1000 m.a.s.l.). Between the measurements at those two different altitudes there will be a two-week washout period at \>1000 m.a.s.l.. The sequence of altitude exposure will be randomized.

Eligibility criteria: Inclusion Criteria:

* Healthy (no current medical condition or intake of regular medication, except negligible medical issues or accidents not interfering with the current health status or physical performance.)
* Living above 1000 m.a.s.l. since at least 1 year
* No overnight stay at altitudes \<1000 m.a.s.l. in the previous 4 weeks
* 18-70 years old
* Body mass index 18,5-30 kg/m2
* informed consent

Exclusion Criteria:

* Active diseases or health related conditions that require treatment (sleep disorders (mainly sleep apnea), chronic rhinitis, cardiovascular and lung diseases)
* Use of drugs that affect the respiratory center drive (sedatives, sleep inducing drugs, opioids), stimulants or illegal drugs
* Regular consumption of recreational drugs (alcohol and nicotine included)

Primary outcomes:
measure: T90 (time spent in SpO2 below 90%)
timeFrame: 4 nights
Secondary outcomes:
measure: SpO2 (oxygen saturation)
timeFrame: 4 nights
measure: AHI (apnea-hypopnea index)
timeFrame: 4 nights
measure: SWS (slow-wave sleep)
timeFrame: 4 nights
measure: AI (arousal index)
timeFrame: 4 nights
measure: TcCO2 (partial pressure of carbon dioxide)
timeFrame: 4 nights
measure: WASO (wakefulness after sleep onset)
timeFrame: 4 nights
measure: ODI (oxygen desaturation index)
timeFrame: 4 nights
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
Study officials:
affiliation: Kantonsspital Graubünden
name: Tsogyal Latshang, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080608: Nerve Injury in the Hand, an Interview Study
Official title: Patients´ Experiences of Changed Physical Activity Level Following Nerve Injury in the Upper Limb- a Qualitative Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nerve Injury
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Department of Hand surgery Södersjukhuset
First posted: 2021-10-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated surgically due to Injury to the median, ulnar or digital nerve or injury to the brachial plexus. 1-5 years post injury.

Brief summary: This qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand.

Detailed description: Aim:

Has the physical activity level changed in connection with the nerve injury. Experiences of factors influensing this change.

Population: Patients surgically treated for digital,median,ulnar-or plexus nerveinjuries at Södersjukhuset or Universitets sjukhuset in Linköping. 1-3 years ago. Age 18-75.

Method: Interviews are carried out over the phone, digitally recorded and trascribed. The analysis is inductive approach.

Eligibility criteria: Inclusion Criteria:

* Injury to the median, ulnar or digital nerve or injury to the brachial plexus.
* 1-5 years post injury.

Exclusion Criteria:

* Severe psychiatric disease.
* Drug or alcohol abuse.
* Insufficient language understanding.
* Severe diabetes mellitus with nerve complications.

Primary outcomes:
measure: Interview
timeFrame: 1-5 years post injury
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Marianne Arner, Professor
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Cecilia Mellstrand Navarro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04747808: Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
Official title: A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Prostaglandin
Intraocular pressure
Lead sponsor: MediPrint Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-comparative
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age at the Screening Visit
* Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes
* At least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.
* Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50 letters or better

Exclusion Criteria:

* Glaucoma or optic neuropathy due to anything other than above noted reasons Cup-to-disc ratio of \>0.8 in either eye
* Corneal thickness \<480 or \>620 μm

Primary outcomes:
measure: Adverse Event Rate
timeFrame: Day 7
Secondary outcomes:
measure: Intraocular Pressure Elevation
timeFrame: Day 7
measure: IOP Changes
timeFrame: Days 1
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundatoin
state: California
Study officials:
References:
Clinical trial NCT00533208: MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergies
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of MK0524 on seasonal allergies.


Eligibility criteria: Inclusion Criteria:

* Person has had at least 2 years of seasonal allergies
* Person has had a positive skin test to at least 1 of the allergens of the season
* Person is a non-smoker

Exclusion Criteria:

* Person has been hospitalized within the last 4 weeks
* Person is a female who has had a baby within the last 8 weeks or is still breast-feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12.
Clinical trial NCT04360408: The Energy Conservation Education Intervention
Official title: The Energy Conservation Education Intervention For People With End-stage Kidney Disease Receiving Haemodialysis (EVEREST)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
End Stage Kidney Disease
Quality of Life
Keywords: End-stage kidney disease, fatigue, haemodialysis, quality of life
Lead sponsor: Queensland University of Technology
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 126
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: Fatigue is the most common symptom reported by 70 - 85 % of people with end-stage kidney disease (ESKD) receiving haemodialysis (HD). Educational interventions involving energy conservation strategies are helpful in reducing fatigue. However, the effectiveness of energy conservation has not been previously studied in people with ESKD receiving HD. This study aims to develop and evaluate the effectiveness of energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST) in Nepal.

Symptom Management Theory (SMT) will guide this study. A pragmatic cluster randomised controlled trial (pCRT) will be conducted in one dialysis centre in Nepal. People on HD who meet the eligibility criteria will be invited to participate. The primary outcome is fatigue severity and the secondary outcome are other renal symptoms, occupational performance and health-related quality of life. Intention to treat analysis will occur and will include a change in the primary and secondary outcome. The study will provide evidence about the feasibility and effectiveness of EVEREST for symptom management.


Eligibility criteria: Inclusion Criteria:

Participants diagnosed with ESKD and undergoing haemodialysis for ≥ 3 months, aged 18 years and above, able to speak and understand Nepali language and willing to participate will be included in this study.

Exclusion Criteria:

Participants who are in the early stage of CKD or not dependent on HD, those acutely ill, diagnosed with cognitive impairment and those who are not willing to participate will be excluded.

Primary outcomes:
measure: Changes in Fatigue Symptom Inventory (FSI)
timeFrame: Baseline and week 4
measure: Changes in Fatigue Symptom Inventory (FSI)
timeFrame: Baseline and week 8
measure: Changes in Fatigue Symptom Inventory (FSI)
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Other renal symptoms
timeFrame: Baseline and Week 12
measure: Occupational Performance
timeFrame: Baseline and week 12
measure: Health-related quality of life (HRQoL)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
References:
citation: Sharma S, Alexander KE, Green T, Wu MW, Bonner A. Energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST): protocol for a cluster randomised control trial. BMJ Open. 2022 Feb 21;12(2):e056544. doi: 10.1136/bmjopen-2021-056544.
Clinical trial NCT01755208: Light-Scattering Spectroscopy for Detection of Breast Cancer
Official title: Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy, no Evidence of Disease
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-24
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

Detailed description: PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.

OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Eligibility criteria: Inclusion Criteria:

* Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
* Provision of informed consent prior to any study-related procedures

Exclusion Criteria:

* Females with tattoos on either or both breasts
* Females with nipple piercings on either or both breasts
* Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
* Females unable to provide informed consent
* Females s/p treatment for breast cancer

Primary outcomes:
measure: Accurate classifications of women with or without breast cancer
timeFrame: Up to 1 year
measure: Utility of optical markers in distinguishing cancer involved breasts from normal breasts
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jacques Van Dam
role: PRINCIPAL_INVESTIGATOR
References: