louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05239663: GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Official title: The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chemotherapy-Related Cognitive Impairment
Breast Cancer
Keywords: Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 76
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: PREVENTION

Brief summary: The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.

Detailed description: This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.

Eligibility criteria: Inclusion Criteria:

1. Have provided written and signed informed consent;
2. Histologically confirmed invasive ductal carcinoma;
3. Planned to received (neo)/adjuvant chemotherapy;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
5. Can cope with HVLT-RDR and ADAS-Cog evaluation;
6. No prior therapy could induce neurological damage,within 4 weeks
7. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
8. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
9. Compliance with the study protocol.

Exclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
2. Hypersensitivity to experiment agents or components;
3. Women with pregnancy or breast feeding;
4. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
5. Abnormal baseline impairment of cognitive impairment;
6. Poor compliance, unwillingness or inability to follow protocol to continue the study;
7. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Primary outcomes:
measure: HVLT R-DR
timeFrame: 4 weeks after the completion of adjuvant chemotherapy
Secondary outcomes:
measure: HVLT R-DR
timeFrame: 36 weeks after the completion of adjuvant chemotherapy
measure: ADAS-Cog
timeFrame: 36 weeks after the completion of adjuvant chemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00238563: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
Official title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.

Detailed description: Postoperative sub-Tenon Triamcinolone Acetonide in glaucoma filtering surgery

Objectives: Trabeculectomy is a surgical procedure designed to reduce internal eye pressure by draining fluid from within the eye to the sub-conjunctival (superficial eye lining) space. Scar formation from conjunctival and Tenon's capsule fibroblast proliferation represents the most common cause of failure of trabeculectomies. A number of drugs have been use to prevent failure of trabeculectomies from the scarring process including intraoperative mitomycin C (MMC) and preoperative Triamcinalone Acetonide (TA). Over the past several years, intraoperative MMC has become a preferred method of preventing scar formation. This study looks to determine in a prospective, double-blind, randomized method the long-term efficacy and safety of MMC with postoperative TA compared to the standard practice of intraoperative MMC with postoperative prednisolone acetate drops in preventing scar related failures of trabeculectomies.

Eligibility criteria: Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied

Primary outcomes:
measure: Intraocular pressure
Secondary outcomes:
measure: visual field progression, need for further surgery or medications
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT02894463: Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
Official title: Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Keywords: dental care
emeno
abuse
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 76
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients seen in consultation EMENO and being younger than 15 years will be offered this study.

This is a population of non-cooperative patients to dental care or with a disability limiting their cooperation.

A quick questionnaire will be submitted in the consultations EMENO the SSC, the children after their parents' permission.

Brief summary: The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

Detailed description: The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 15 years
* Requiring dental care under MEOPA
* Not opposing, as well as his parents, his participation in the study
* Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)

Exclusion Criteria:

Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.

Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.

Primary outcomes:
measure: presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire )
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Tony Prud'homme, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02443363: Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault?
Official title: Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockroft-Gault?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Function Disorder
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 consecutive patients after kidney transplantation admitted to routine visit in Transplant Centre

Brief summary: The study included 300 patients who are post-kidney transplantation (\> 3 months and \<10 years). An analysis of body composition using bioelectrical impedance, calculated BMI and serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* functioning graft longer than 3 months to 10 years
* no clinical cardiovascular disease during the 6 months preceding entry
* stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy

Primary outcomes:
measure: Differences in estimating GFR using formula MDRD, CKD-EPI and Cockroft-Gault in short and long-term postoperative period.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazovian
Study officials:
References:
Clinical trial NCT03007563: Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Official title: Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Keywords: Diagnosis
Cell Phones
Infant, Newborn
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University Hospital, Akershus
First posted: 2017-01-02
Enrollment: 342
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.

Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.


Eligibility criteria: Inclusion Criteria:

* born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
* born at term
* normal birth weight

Exclusion Criteria:

* in need of advanced medical treatment

Primary outcomes:
measure: Correlation between bilirubin estimates by smartphone pictures and by blood samples
timeFrame: 5 minutes
measure: Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, md prof
role: STUDY_DIRECTOR
References:
citation: Aune A, Vartdal G, Bergseng H, Randeberg LL, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Dec;109(12):2532-2538. doi: 10.1111/apa.15287. Epub 2020 Apr 19.
Clinical trial NCT04471363: Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity
Official title: Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity Intervention: A Needs Assessment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Diagnosis
Couples
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are interested in hearing from cancer survivors and romantic partners from diverse backgrounds. This study is open to both active and inactive individuals. Cancer survivors can have had any type of cancer, cancer treatment, or recurrence(s). Further, we are not limiting participation based on time since diagnosis. Romantic partners do not need to be married, co-habituating, or in a relationship for a specific time-period in order to be eligible. Additionally, this study will not exclude couples in which both individuals are cancer survivors. Lastly, while we prefer both partners within a couple participate, we will not exclude individual participation.

Brief summary: The goal of this research is to explore cancer survivors' and their romantic partners' interest in a couples-based physical activity intervention and whether cancer-specific exercise education influences exercise beliefs and intentions.

Detailed description: This study will assess multiple predictors of couples-based physical activity interest among both survivors and partners including gender, age, current exercise, relationship satisfaction and partner support for exercise. Additionally, this study will include an experimental manipulation in which half of the sample will be randomized to receive cancer-specific exercise education.

Eligibility criteria: In order to be eligible, individuals must answer "Yes" to all of the following statements:

* I am a cancer survivor OR I am the romantic partner of a cancer survivor
* I am not currently undergoing chemotherapy, radiation or surgery nor do I have plans to undergo chemotherapy, radiation or a cancer-related surgery in the next 6 months
* I am in a committed, romantic relationship
* I have access to a computer or tablet with internet
* I have an email address that I am willing to share with the study team
* I am at least 18 years of age and less than 90 years of age

Primary outcomes:
measure: Questionnaire to determine predictors
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT06377163: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children
Official title: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Chest Infection
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 10
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A representative sample of 100 participants was taking by simple random sampling technique from children diagnosed to have community acquired pneumonia from Al Mansoura university hospital and Mansura International Hospital.

Brief summary: Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.

This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate.


Eligibility criteria: - Inclusion criteria:

* Infants and children aged 28 days to ten years (male and female sexes).
* Patients diagnosed with community-acquired pneumonia.
* Pneumonia was diagnosed if the patient fulfilled has fever (temperature ≥38.3° C), Fast breathing (40 breaths per minute if the child is 1 year up to 10 years old), respiratory distress (tachypnea, retractions) and chest indrawing and cyanosis with compatible chest x-ray findings.

Exclusion criteria:

* Neonates
* Children more than 10 years
* Hospital acquired pneumonia
* Chronic lung disease, immunodeficiency and other congenital anomalies

Primary outcomes:
measure: Complete blood count
timeFrame: At the baseline evaluation
measure: C-reactive protein (CRP)
timeFrame: At the baseline evaluation
measure: Blood culture and sensitivity on admission
timeFrame: At the baseline evaluation
measure: Gastric lavage culture or sputum culture on admission
timeFrame: At the baseline evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT03825263: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
Official title: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoedema
Lead sponsor: University of South Wales
Sponsor class: OTHER
Collaborators: name: Cwm Taf University Health Board (NHS)
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational control trial
Primary purpose: TREATMENT

Brief summary: The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.

Detailed description: This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over,
* Able to provide written consent,
* Confirmed diagnosis of lower limb ISL stage II or III.

Exclusion Criteria:

Any of these conditions

* Severe congestive heart failure
* Severe skin problems, lower limb ulcers or wounds.
* Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol.
* Non-pitting chronic lymphoedema.
* Known or suspected deep vein thrombosis.
* Pulmonary embolism.
* Thrombophlebitis.
* Acute inflammation of the skin (erysipelas, cellulitis).
* Uncontrolled/severe cardiac failure.
* Pulmonary oedema.
* Ischaemic vascular disease.
* Active cancer diagnosis.
* Active metastatic diseases affecting the oedematous region.
* Oedema at the root of the extremity or truncal oedema.
* Severe peripheral neuropathy.

Primary outcomes:
measure: Lower Limb Volume
timeFrame: 3 and 6 months of treatment
Secondary outcomes:
measure: Assessment of IPC use on the Quality of Life: QOL Scores
timeFrame: 3 and 6 months
measure: Use of Perometer
timeFrame: 6 months
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: Dewi Sant Hospital
state: RCT
Study officials:
affiliation: University of South Wales
name: Mark Williams, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunn N, Williams EM, Fishbourne M, Dolan G, Davies JH. Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study. Pilot Feasibility Stud. 2019 Sep 30;5:113. doi: 10.1186/s40814-019-0496-4. eCollection 2019.
Clinical trial NCT00226863: Meditation and Hypnosis for Chronic Depressed Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Long Term Depressed Mood
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.


Eligibility criteria: Inclusion Criteria:

* Currently meeting DSM-IV criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more.
* Being 18 years of age or older.
* Being sufficiently proficient in English to be able to participate in group therapy.
* Being able to attend weekly meetings at Stanford.

Exclusion Criteria:

* Concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the SCID interviews).
* Presence or history of psychosis.
* A current primary diagnosis of panic disorder, generalized anxiety disorder, or PTSD.
* A current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months).
* Serious suicidal risk, as defined by:
* Current suicidality, i.e., beyond simple ideation (e.g., making threats or attempts; gathering means; has a plan); OR
* Serious prior attempts (bodily harm; gathered means; hospitalization).
* Has a significant medical condition that could interfere with participation in meditation/yoga.
* Current participation in psychotherapy or a meditation group.
* Has started (or changed level or type of) prescribed antidepressant medication or St. John's Wort in the previous 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Lisa D. Butler, Ph.D.
role: STUDY_DIRECTOR
affiliation: Stanford University
name: David Spiegel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: