louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03955237: Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level
Official title: Perioperative Fluid Management According to the Preoperative and Perioperative Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Complication
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 different type of fluid
Primary purpose: TREATMENT

Brief summary: Background:Hyperglycemia and hypoglycemia both cause detrimental side effects for pediatric patients. Prolonged fasting time, age dependent physiological diffences and individual differences of patients make complicated the perioperative fluid therapy. Isotonic electrolyte solutions without glucose or with lower glucose concentrations recommended for intraoperative period in pediatric patients.

Objective: The aim of this prospective study is to evaluate the different glucose concentrations(without dextrose, 1 % dextrose+LR, 2 % dextrose+LR) in perioperative infusion solutions according to preoperative blood glucose level to maintain normoglycemia in pediatric patients.

Method: The consecutive 250 eligible pediatric patients aged between 6 months- 12 years with ASA risk score of I-II undergoing surgery lasting less than four hours were enrolled the study in six months period. Patient demographics, procedure, preoperative fasting time, preoperative and postoperative glucose levels were documented. Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL.

Detailed description: Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL

Eligibility criteria: İnclusion criteria;

* 6 months- 12 years old, ASA I-II children
* Undergoing surgery lasting less than four hours were enrolled the study

Exclusion Criteria:

* Diabetes mellitus
* Parenteral nutrition or enteral nutrition
* Patient with metabolic disorders,
* ASA III-IV patients

Primary outcomes:
measure: glucose level
timeFrame: perioperative period
Secondary outcomes:
measure: hyperglysemia or hypoglysemia ratio
timeFrame: perioperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03784937: Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment
Official title: R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Thromboses, Venous
Keywords: Wells Clinical score
Thromboprophylaxis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient adressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification throught the modified Wells score by the referent doctor.

Brief summary: This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.


Eligibility criteria: Inclusion Criteria:

* Any patient addressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification through the modified Wells score by the referent doctor.

Exclusion Criteria:

* Patient addressed to our Vascular Medicine unit for any other reason.
* Patient addressed to our Vascular Medicine unit for DVT detection to help in a pulmonary embolism suspicion.
* Age under 18 yo
* Patients unable to express their informed consent.

Primary outcomes:
measure: Performance of the Wells Clinical prediction score
timeFrame: For enrollment to end of enrollment at 12 months
Secondary outcomes:
measure: Impact of thromboprophylaxis treatment
timeFrame: For enrollment to end of enrollment at 12 months
measure: Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor.
timeFrame: For enrollment to end of enrollment at 12 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalo-Universitaire de Nîmes
Study officials:
References:
citation: Trihan JE, Adam M, Jidal S, Aichoun I, Coudray S, Laurent J, Chaussavoine L, Chausserie S, Guillaumat J, Laneelle D, Perez-Martin A. Performance of the Wells score in predicting deep vein thrombosis in medical and surgical hospitalized patients with or without thromboprophylaxis: The R-WITT study. Vasc Med. 2021 Jun;26(3):288-296. doi: 10.1177/1358863X21994672. Epub 2021 Mar 22.
Clinical trial NCT02501837: The Influence of Oxytocin on Pair-bonding and Emotion Regulation
Official title: The Influence of Oxytocin on Pair-bonding and Emotion Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Healthy women
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers
* In a heterosexual relationship

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Pregnant or lactating

Primary outcomes:
measure: Neural response to photographs of the partner
timeFrame: About one hour after the intranasal administration of oxytocin
measure: Neural response during the regulation of food craving
timeFrame: About one hour after the intranasal administration of oxytocin
Secondary outcomes:
measure: Attractiveness ratings of all stimuli
timeFrame: About one hour after the intranasal administration of oxytocin
measure: Arousal ratings of all stimuli
timeFrame: About one hour after the intranasal administration of oxytocin
measure: Food craving ratings
timeFrame: About one hour after the intranasal administration of oxytocin
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
References:
Clinical trial NCT06416137: Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care
Official title: Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dementia
Alzheimer Disease
Keywords: dementia
migrants
cross-cultural
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All migrants consecutively referred to CCDDs due to cognitive disturbances in one year will be considered.

The following definition of migrants will be consistently adopted in the project: any person living in Italy but born abroad, regardless of the legal status, the reason for migration, and the length of the stay (source: International Organization for Migration).

Brief summary: The number of older migrants with cognitive impairment and dementia living in Italy and attending national healthcare services is rapidly increasing. There is a need to develop diversity-sensitive policies and practices to include migrants and people with different cultural values in the public health response to dementia.

Detailed description: Based on the gaps and barriers identified by the ImmiDem study (GR-2016-02364975), the present project aims to:

i) Describe the clinical and sociodemographic characteristics of migrants with cognitive disorders living in Italy, their health outcomes, and their access to healthcare resources; ii) develop and disseminate screening and assessment tools allowing the cross-cultural cognitive examination of individuals with a migration background; iii) raise awareness about dementia among culturally diverse people and train healthcare professionals in how to provide culturally competent care and support for migrants with cognitive disorders.

Eligibility criteria: Inclusion Criteria:

* Migrant (person who was not born in Italy) attending an Italian CCDD;
* Presence of a cognitive impairment.

Exclusion Criteria:

* A person without any cognitive impairment.

Primary outcomes:
measure: Global cognitive functioning
timeFrame: Baseline
Secondary outcomes:
measure: Frailty
timeFrame: Baseline
measure: Risk factors
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05430737: A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
Official title: A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Stereotactic Body Radiotherapy
High-risk
Efficacy
Safety
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA \> 20 ng/ml) prostate cancer
* a WHO performance status 0-1
* history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment
* Patients with pelvic positive lymph node were also included in our study

Exclusion Criteria:

* distant metastasis
* history of neoadjuvant ADT over 6 months before enrollment
* history of definitive treatment for prostate cancer such as radical prostatectomy
* history of pelvic irradiation; prostate volume≥100 cm3

Primary outcomes:
measure: biochemical relapse-free survival
timeFrame: three months
Secondary outcomes:
measure: the incidence rate of acute toxicity
timeFrame: every week
measure: the incidence rate of late toxicity
timeFrame: three months
measure: patient-reported quality of life
timeFrame: three months
measure: symptom score
timeFrame: three months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: China, SiChuan
state: Sichuan
Study officials:
affiliation: China, SiChuan West China Hospital
name: xin wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04007237: The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial
Official title: The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pityriasis Versicolor
Keywords: mycological efficacy
ketoconazole
selenium disulfide 1,8%
Pityriasis versicolor
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).


Eligibility criteria: Inclusion Criteria:

* Having PV characteristic skin lesions,proven by 20% KOH scraping test and Parker Blue-Black® ink, with the founding of short hyphae and group spores or short hyphae only
* willing to participate in the study by signing the written informed consent
* Subjects under the age of 18 with permission from parents or guardians.

Exclusion Criteria:

* A history of hypersensitivity to the ingredients of the shampoo tested.
* Having skin abnormalities with impaired skin integrity
* In the treatment of topical anti-fungal therapy for less than two weeks or systemic anti-fungal for less than one month.
* Pregnancy and breastfeeding.
* Patients with PV lesions on the face.

Primary outcomes:
measure: mycology efficacy
timeFrame: 7 days
measure: mycology efficacy
timeFrame: 14 days
measure: compliance
timeFrame: 7 days
measure: compliance
timeFrame: 14 days
measure: side effect
timeFrame: 7 days
measure: side effect
timeFrame: 14 days
measure: cost-effectiveness
timeFrame: two weeks
measure: recurrence
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Kecamatan Pulo Gadung
Study officials:
References:
Clinical trial NCT00898937: Gene Expression in Tumor Tissue From Women Undergoing Surgery for Breast Cancer or Core Biopsy of the Breast
Official title: Pilot Study for Analysis of Tumor Gene Expression by DNA Microarray Analysis in Patients Undergoing Breast Cancer Surgery or Core Biopsy Sampling
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 55
Sex: FEMALE
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: Any woman undergoing a breast biopsy or breast surgery

Brief summary: RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more about the genes and proteins found in breast tissue.

PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women undergoing surgery for breast cancer or core biopsy of the breast.

Detailed description: OBJECTIVES:

* Assess tumor gene expression information from women undergoing surgery for breast cancer or core biopsy sampling of the breast.

OUTLINE: This is a pilot study.

Tumor tissue is collected and analyzed for tumor gene expression by DNA microarray analysis for research studies.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Undergoing surgery for breast cancer OR core biopsy sampling of the breast

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Tumor Gene Expression as Assessed by RNA Microarray Analysis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Claudine Isaacs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04026737: Cardiovascular Effects of CART Cell Therapy
Official title: Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lymphoma
Cardiotoxicity
Risk Factor, Cardiovascular
Immunotherapy
Keywords: Cardiotoxicity of Cancer Therapy
Cardio-Oncology
CART Cell Therapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with CD19+ malignancy (including but not limited to acute lymphoblastic leukemia, chronic lymphocytic leukemia, and difuse large B cell lymphoma) and scheduled for treatment with CART cells will be enrolled prior to infusion of CART cells.

Brief summary: This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.

Detailed description: Patients have echo, blood draw, and QoL survey prior to CART infusion, then 2 days, 1 week, 1 month and 6 months following CART infusion. If patients experiences CRS, study team acquires echo within 72 hours of onset. As part of an optional substudy, patients wear an event monitor for 10 days, starting day of CART infusion.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosed with CD19+ malignancy undergoing treatment with CART cells

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Incidence of Left Ventricular (LV) Dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Cardiovascular Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marielle Scherrer-Crosbie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066337: Effect of Ozone Gel on Treatment of Chronic Periodontitis
Official title: Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Diseases
Keywords: Ozone gel
Antioxidants
Chronic periodontitis
Superoxide dismutase
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.

Detailed description: In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.

Eligibility criteria: Inclusion Criteria:

1. The participant's age ranged between 30 and 60 years.
2. All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
3. Willingness to participate and sign the informed consent.

Exclusion Criteria:

1. Any systemic disease that affect the periodontium.
2. Pregnancy, lactation, postmenopausal women
3. People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
4. People who use mouth washes regularly
5. Heavy smoking (\> 10 cigarettes/day)
6. History of alcohol abuse.
7. Participation in other clinical trials.

Primary outcomes:
measure: Superoxide dismutase activity
timeFrame: 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 6 months
measure: Gingival index
timeFrame: 6 months
measure: Probing pocket depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Bone density
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
Study officials:
affiliation: October 6 University
name: Enas Elgendy, ph.D
role: PRINCIPAL_INVESTIGATOR
References: