louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01765374: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Official title: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rituximab
sonography
clinical response
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 30
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: To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.


Eligibility criteria: Inclusion Criteria:

* failure to at least one TNF-blocking agent

Exclusion Criteria:

* pregnant or childbearing woman
* Rituximab contraindication
* woman unable to use contraceptive means

Primary outcomes:
measure: global score of power-doppler activity measured by ultrasonography on 12 joints
timeFrame: at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Caen, Le Havre, Rouen, Elbeuf
country: France
facility: Normandy
city: Caen
country: France
facility: Department of Rheumatology, CHU de Caen
city: Le Havre
country: France
facility: Department of Rheumatology
city: Rouen
country: France
facility: Department of rheumatology
city: Saint Aubin Les Elbeuf
country: France
facility: Department of Rheumatology CHG Elbeuf
Study officials:
affiliation: University Hospital, Rouen
name: Olivier Vittecoq, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06217874: Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer
Official title: Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with invasive cancer, suspected or known recurrent or metastatic lesions, as well as males with biopsy proven breast cancer

Brief summary: This study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, tumor biopsy and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Female participants must have histologically or cytologically confirmed invasive breast cancer.
* Male participants must have biopsy proven breast cancer.
* Age must be \>= 18 years, and all must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a history of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
* Any other condition, which in the opinion of the patient's treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.

Primary outcomes:
measure: Response to targeted therapies
timeFrame: Baseline
measure: Change in tumor cells
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Fergus J. Couch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04156074: Innovative Food Structures to Enhance Nutrient Bioavailability
Official title: Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Aging Well
Keywords: Vitamin D
Bioavailability
Aging
Fortified foods
Vitamin D status
25-hydroxyvitamin D
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Department of Agriculture Food and the Marine
First posted: 2019-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:

1. Vitamin D enriched (20ug) olive oil emulsion drink
2. Vitamin D enriched (20ug) coconut oil emulsion drink
3. Placebo emulsion drink
4. Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.

Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.

Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.


Eligibility criteria: Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

* Pregnant/lactating
* Smokers
* Individuals who are not free-living
* An inability to read, write or understand English
* Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
* Disease that requires chronic therapeutic nutritional or medical treatment
* Those with conditions that may affect kidney function
* Those with osteoporosis
* Those taking supplemental vitamin D
* Those who have been on a sun holiday in the last 2 months
* Those with a milk protein allergy or lactose intolerance

Primary outcomes:
measure: Vitamin D status
timeFrame: Baseline to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Aifric O'Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688674: Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia
Official title: Dextrose Boluses Versus Dextrose Infusions by Burettes in Prevention of Hypoglycemia Among Preterms Admitted at Mulago Hospital: An Open Label Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 140
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital.

ALTERNATE HYPOTHESIS

• Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.


Eligibility criteria: Inclusion Criteria:

- SELECTION CRITERIA Inclusion criteria

* Preterms whose care givers/ mothers gave informed consent
* Preterms whose age was \< 24 hours of life
* Preterms with birth weight ≥1kg
* Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.

Exclusion Criteria

* Absence of a biological mother or abandoned baby
* Presence of gross congenital abnormalities.
* Very sick (Apgar score ≤ 5 at 5 minutes

Primary outcomes:
measure: Incidence proportion of hypoglycemia
timeFrame: 3months
Secondary outcomes:
measure: survival measured as a proportion
timeFrame: 3months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
state: Mulago
Study officials:
References:
citation: Kutamba E, Lubega S, Mugalu J, Ouma J, Mupere E. Dextrose boluses versus burette dextrose infusions in prevention of hypoglycemia among preterms admitted at Mulago Hospital: an open label randomized clinical trial. Afr Health Sci. 2014 Sep;14(3):502-9. doi: 10.4314/ahs.v14i3.2.
Clinical trial NCT03898674: Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study
Official title: Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study - single arm
Primary purpose: TREATMENT

Brief summary: Prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. The investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. This, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. The feasibility of this technique will be determined prior to embarking on a pilot RCT.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years Within 6 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation Requirement for advanced haemodynamic monitoring (PiCCO system) in the opinion of the attending clinician

Exclusion Criteria:

Patients not expected to survive 24 h in whom the intent of treatment is palliative Patients in whom the primary cause of the shock state is cardiogenic

-

Primary outcomes:
measure: Time to acquire POEM score
timeFrame: 6 hours
measure: Effect of POEM score on clinical decision making
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03780374: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.


Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Speech Intelligibility in Noise
timeFrame: 4 weeks
Secondary outcomes:
measure: Sound Quality - Overall
timeFrame: 16 weeks
measure: Loudness - Laboratory
timeFrame: 8 weeks
measure: Loudness - Daily Life
timeFrame: 16 weeks
measure: Clarity - Daily Life
timeFrame: 16 weeks
measure: Preferred Sound Processing Principle
timeFrame: 16 weeks
measure: Naturalness - Daily Life
timeFrame: 16 weeks
measure: Localization - Daily Life
timeFrame: 16 weeks
measure: Reverberation - Daily Life
timeFrame: 16 weeks
measure: Satisfaction - Overall in Daily Life
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zurich
Study officials:
References:
Clinical trial NCT01578174: The Effect of Dexmedetomidine in the Management of Pain After Uterine Artery Embolization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Control
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.

Detailed description: Leiomyoma are the most common female reproductive tract tumors. Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy. However, post-procedural pain control after UAE remains a major problem. Therefore, the aim of study is to evaluate the efficacy of dexmedetomidine in pain control after UAE.

Eligibility criteria: Inclusion Criteria:

* age ≥ 20,
* ASA class I and II

Exclusion Criteria:

* bradycardia (\< 45 bpm)
* heart block
* liver failure
* renal failure
* uncontrolled hypertension
* body mass index ≥ 30 kg/m2

Primary outcomes:
measure: Fentanyl consumption by patient-controlled analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06887374: Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Children
Official title: Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Term of Mean Duration of Diarrhea in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Watery Diarrhea
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 184
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

Detailed description: Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Aged 6 to 59 months
* Suffering from acute watery diarrhea for ≤ 7 days

Exclusion Criteria:

* Children with blood in stool
* With prior antibiotics use
* Children under study with duration of stay more than 5 days
* clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
* Immunocompromised children
* Hypersensitivity to probiotics
* With prior probiotic administration

Primary outcomes:
measure: Stool frequency
timeFrame: 5 days
measure: Consistency of stools
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital
state: Punjab
Study officials:
affiliation: Children Hospital, Lahore, Pakistan
name: Talha Hassan
role: PRINCIPAL_INVESTIGATOR
affiliation: Children Hospital, Lahore, Pakistan
name: Muhammad Zeeshan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04729374: COVID-19 Vaccine Induced Adaptive Immune Responses
Official title: Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Vaccine
COVID-19
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals to be injected with COVID-19 vaccine

Brief summary: The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.


Eligibility criteria: Inclusion Criteria:

* Healthy and aged between 18 to 59 years

Exclusion Criteria:

* High-risk epidemiology history within 14 days before enrollment
* SARS-CoV-2 specific IgG or IgM positive in serum
* Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples
* Axillary temperature of more than 37·0°C
* Known allergy to any vaccine component
* Thyroid disease

Primary outcomes:
measure: Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
timeFrame: 2 years
measure: Concentration of serum anti-SARS-CoV-2 binding antibody
timeFrame: 2 years
measure: Rate of anti-SARS-CoV-2 T cell response
timeFrame: 2 years
measure: The rate of SARS-CoV-2 infection
timeFrame: 2 years
Secondary outcomes:
measure: Rate of anti-SARS-CoV-2 B cell response
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital, Nanjing University Medical School
name: Yuxin Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Drum Tower Hospital, Nanjing University Medical School
name: Han Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Drum Tower Hospital, Nanjing University Medical School
name: Rui Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760574: Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism
Official title: Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypogonadism; Ovarian
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 1200
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected group will be used as comparison group

Brief summary: Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

Detailed description: In this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected MSM group will be used as comparison group. We will also determine the risk factors associated with male hypogonadism (age, duration of HIV infection, comorbidities, BMI, ART use). Correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.

Eligibility criteria: Inclusion Criteria:

* HIV-infected men who have sex with men
* HIV non-infected men

Exclusion Criteria:

* Use of testosterone supplement, anabolic steroid in the past one year.
* History of pituitary , adrenal or gonad diseases
* History of pituitary surgery or radiation therapy
* History of systemic chemotherapy
* Active opportunistic infection under treatment
* Cancer
* Severe hepatic, renal or cardiac impairment

Primary outcomes:
measure: Symptoms of androgen deficiency
timeFrame: 2021-2030
measure: Serum free testosterone
timeFrame: 2021-2030
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: