louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01317394: Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation
Official title: Retrospective Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-albicans Candidemia
Keywords: non-albicans candidemia
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-albicans candidemia patients

Brief summary: This study is a retrospective research in order to compare and analysis the risk factor, clinical manifestation and efficacy of albicans candidemia by pulling medical records. We hope that this retrospective research will let us understand the method of treatment and prevention of albicans candidemia in order to improve the quality of healthcare.


Eligibility criteria: Inclusion Criteria:

* above 20 years old
* hospital patients
* albicans candidemia patients

Exclusion Criteria:

* pregnant patients or patients under 16 years old
* liver cirrhosis and Child C

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Wen-Sen Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04073394: Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes
Official title: "Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.


Eligibility criteria: Inclusion Criteria:

* Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
* Age: 18-65 years.
* Gender: Men or women.

Exclusion Criteria:

* Weight change greater than 3% in the previous 3 months (weight stable).
* History of bariatric surgery including lap band and bariatric endoscopy.
* Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
* Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
* A positive score on the AUDIT-C questionnaire as judged by an investigator.
* Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence

Primary outcomes:
measure: 12-week total body weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Responder Rate
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Fat Loss
timeFrame: 12 weeks
measure: Calorie Intake
timeFrame: 12 weeks
measure: Calories to Fullness
timeFrame: 12 weeks
measure: Gastric Emptying
timeFrame: 12 weeks
measure: Gastric Emptying 2 Hours
timeFrame: 12 weeks
measure: Anxiety Level
timeFrame: 12 weeks
measure: Emotional Eating
timeFrame: 12 weeks
measure: Resting Metabolic Rate
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andres Acosta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06545994: A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
Official title: A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Pregnancy Complications
Keywords: Polycystic Ovary Syndrome
Pregnancy Complications
Kisspeptin
gestational diabetes mellitus
insulin resistance
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.

Brief summary: The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.

Detailed description: The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40 years old
* Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .

Exclusion Criteria:

* All other diseases with ovulation disorders or hyperandrogenism

Primary outcomes:
measure: Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients
timeFrame: 40 weeks
Secondary outcomes:
measure: The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients
timeFrame: 40 weeks
measure: The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: OB & GYN Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: The Obstetrics & Gynecology Hospital of Fudan University
name: Hexia Xia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364294: Molecular Diagnosis of Systemic Autoinflammatory Diseases
Official title: Molecular Diagnosis of Systemic Autoinflammatory Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Disease
Genetic Disease
Somatic Mutation
Molecular Sequence Variation
Molecular Pathway Deregulation
Keywords: Biomarkers
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2022-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in this research will be recruited during a follow-up consultation for their condition.

Brief summary: Systemic autoinflammatory diseases (SAIDs) are a set of rare clinically and genetically heterogeneous conditions. The project proposes to identify novel genes and specific signatures in subgroups of patients with SAIDs.

Detailed description: SAIDs are characterized by long dormant periods with no or only minor clinical symptoms interrupted by febrile crises accompanied by serous and synovial membrane inflammation that spontaneously resolves. Over the last decades, more than 50 genes encoding key components of the innate immune system have been identified to be involved in the pathophysiology of SAIDs, with both germline and somatic mosaic variations. When disease-causing variations are identified, specific biotherapies are proposed depending on the involved gene and pathway. However, despite these scientific advances, most SAIDs (70%) are of unknown etiology, the diagnosis is made with significant delay, and no targeted therapy can be suggested. This project aims to generate specific understanding and develop strategies for SAID patients with unknown etiology. The investigators aim to advance our understanding of SAIDs pathophysiology, find the disease-causing gene variations and identify the involved cellular pathways that should accelerate correct diagnosis and personalize treatment.

Eligibility criteria: Inclusion Criteria:

* A patient presenting with a clinical and biological aseptic inflammatory syndrome associating one or more of the following signs: spontaneously resolving fever, abdominal (pain, diarrhea), locomotor (arthralgia, myalgia), thoracic (pain, pericarditis), cutaneous, sensory (uveitis, deafness), or renal (amyloidosis) involvement.

Exclusion Criteria:

* Adult subject to legal protection measures (guardianship, curatorship, safeguard of justice).

Primary outcomes:
measure: To identify SAIDs disease-causing mutations and genes and to explore specific biological signatures.
timeFrame: Anytime in the period of 10 years
measure: To identify novel and better assess the disease pathways
timeFrame: Anytime in the period of 10 years
Secondary outcomes:
measure: To propose personalized treatment options
timeFrame: Anytime in the period of 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Trousseau Hospital
Study officials:
References:
Clinical trial NCT03370094: Tele-Stroke: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine - Feasibility
Official title: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: propatient Basel
First posted: 2017-12-12
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The current phase of the project ("Feasibility") will include patients with suspected acute stroke already admitted to the ER of the University Hospital Basel, and patients with suspected acute stroke and who are referred to the Stroke Center of USB by the paramedics.

Brief summary: Observational Study to investigate the technical feasibility, implementation into current diagnostic and treatment pathways and the diagnostic accuracy of the remote patient assessment by using mobile telecommunication ahead of hospitalization.

Detailed description: On-site, pre-hospital clinical assessment of patients with suspected acute stroke can accelerate further diagnostic and treatment pathways after patient arrival at the emergency room or the dedicated stroke center. Interactive video and audio streaming connecting on-site paramedics to a stroke center based stroke physicians can help to overcome these hurdles. Patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire may enable a pre-hospital decision on the need of expedited diagnostic and treatment procedures after arrival at the dedicated stroke center.

Eligibility criteria: Inclusion Criteria:

* Any patient older or equal than 18 years with suspected acute stroke as per the first judgement of the paramedics on-site.
* written informed consent by the patient, or legal representative (next-of kin) or informed consent by an independent physician not involved in the study

Exclusion Criteria:

-patients with symptoms not attributable to stroke in the emergency onsite ( observation of epileptic seizure, recent cerebral trauma, prior syncope or comatose state)

Primary outcomes:
measure: Diagnostic accuracy of the patient evaluation by remote Audio/video session
timeFrame: 1 hour
Secondary outcomes:
measure: Diagnostic accuracy of an automated biometric software
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Philippe Lyrer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02965794: Care Pathways for Colorectal Cancer Surgery
Official title: Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: surgery
bowel
rectum
cancer
nutrition
Lead sponsor: European Pathway Association
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-11-17
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing surgery for colorectal cancer

Brief summary: EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY

Detailed description: This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.

Eligibility criteria: Inclusion Criteria:

1. All consecutive scheduled admissions starting September 2, 2013;
2. Minimum age of 18 years;
3. Elective admission for colorectal cancer surgery

Exclusion Criteria:

1. Emergency (not planned) admission for colorectal cancer surgery;
2. Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Primary outcomes:
measure: Length of stay
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: Time to return to normal diet
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
Study officials:
affiliation: KU Leuven
name: Kris Vanhaecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.
Clinical trial NCT02606994: Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
Official title: Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mucositis
Neoplasms
Keywords: oral mucositis
chemotherapy
toothpaste
Lead sponsor: Oral Defense, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 1
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: The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.

Detailed description: A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste.

In this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 receiving chemotherapy
* Mucositis lesions not exceeding grade 2

Exclusion Criteria:

* Patients receiving high load chemotherapy
* Patients receiving radiation therapy
* Patients receiving oral antivirals, oral antifungals or oral antibacterials
* Patients experiencing oral candidiasis

Primary outcomes:
measure: Oral mucositis changes
timeFrame: Day 1 and 8 of the study
Secondary outcomes:
measure: Quality of life changes
timeFrame: 8 days
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Summit Cancer Centers
state: Washington
Study officials:
affiliation: Summit Cancer Centers, Seattle Cancer Care Alliance
name: Arvind Chaudhry, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05152394: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease

Detailed description: This patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
* Anticoagulation medicine use

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638494: Calcium and Vitamin D Intakes in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypocalcemia
Hypovitaminosis D
Keywords: 25-Hydroxyvitamin D
dietary counseling
pediatrics
allergy
bone metabolism
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 184
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 + and VitD intake \< 70% of dietary reference intakes (DRIs) were invited to participate in prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan, Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1) serum VitD levels were assessed.


Eligibility criteria: Inclusion Criteria:

* Ambulatory healthy subjects (male and female, age range 3-17 years) consecutively observed at our Department for routine clinical examination because vaccination program were considered eligible for the study.

Exclusion criteria

* malnutrition (defined as a weight/height ratio \<5° centile);
* presence of chronic systemic diseases (celiac disease, inflammatory bowel disease, food allergy, cystic fibrosis, malignancy, immunodeficiency, tuberculosis, genetic-metabolic disease, primitive bone disease, diabetes and endocrine disorder);
* and use of systemic steroids in the previous 3 months.

Primary outcomes:
measure: Assessed VitD intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize VitD intake.
timeFrame: about 1 year
Secondary outcomes:
measure: Assessed Ca2 intake in a population of healthy pediatric subjects and evaluate the efficacy and applicability of a nutritional intervention to optimize Ca2 intake.
timeFrame: about 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Federico II University
name: Roberto Berni Canani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cosenza L, Pezzella V, Nocerino R, Di Costanzo M, Coruzzo A, Passariello A, Leone L, Savoia M, Del Puente A, Esposito A, Terrin G, Berni Canani R. Calcium and vitamin D intakes in children: a randomized controlled trial. BMC Pediatr. 2013 May 23;13:86. doi: 10.1186/1471-2431-13-86.