louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01140529: Dexmedetomidine for the Treatment of Delirium After Heart Surgery
Official title: A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative
Delirium
Psychomotor
Confusion
Keywords: Dexmedetomidine
Lead sponsor: Thorax-Kärlkliniken
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery.

Study design:

Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.


Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3)
* Heart surgery and extracorporeal circulation (ECC) within 7 days
* Written informed consent obtained before surgery
* Mentally competent at the time of written informed consent

Exclusion Criteria:

* Ongoing neuroleptic, propofol and α2 agonist medication
* Intubated patient
* Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure \< 55 mmHg despite volume, vasopressors and IABP)
* Severe bradycardia without pacemaker backup (heart rate \< 50 beats/min)
* AV-conduction block II-III (without pacemaker backup)
* Severe hepatic impairment (Serum bilirubin \> 101 µmol/l)
* Lithium therapy

Primary outcomes:
measure: Need for rescue medication
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: ThoraxKärlkliniken, Universitetssjukhuset
Study officials:
affiliation: ThoraxKärlkliniken, University Hospital, Linköping, Sweden
name: Sten M Walther, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668629: Dermacyd Tina Gel Sweet Flower - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Tina Gel Sweet Flower.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT06210529: Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
Official title: A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.


Eligibility criteria: Inclusion Criteria:

ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.

Primary outcomes:
measure: Pathological complete response (pCR)
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Disease control rate
timeFrame: In the first month, the second month, the third month
measure: Objective response rate
timeFrame: In the first month, the second month, the third month
measure: Adverse events
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02421029: Prolonged Gadolinium Retention After MRI Imaging
Official title: Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heavy Metal Toxicity
Keywords: gadolinium
calcium disodium ethylenediaminetetraacetic acid (EDTA)
heavy metal toxicity
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The researchers propose to investigate the prevalence of gadolinium in the urine of patients with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge. Moreover, will investigate if there is any correlation of gadolinium urine levels with levels of endogenous (e.g zinc) and xenobiotic metals.

Detailed description: The investigators propose to enroll 20 volunteers in this pilot study, including males older than 20 years and postmenopausal women in two groups: Group 1: Individuals who had a gadolinium-enhanced MRI study within 1-4 weeks before participation and Group 2: Individuals who had gadolinium-enhanced MRI study within 3-6 months before enrollment. The results will inform future analyses of gadolinium retention, excretion, and potential symptoms associated with same.

Thus, the specific aims of this cross sectional study are to:

1. Evaluate levels of gadolinium in the urine of adults with normal kidney function and a prior MRI performed within 6 months at baseline, and after a single dose of edetate calcium disodium .
2. Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels.
3. Evaluate for symptoms of gadolinium toxicity.

Eligibility criteria: Inclusion Criteria:

• Subjects who had a contrast enhanced MRI for any indication within 1-4 weeks or 3-6 months, and normal renal function assessed by normal glomerular filtration rate (GFR) \>60 mL/min/1.73 m2 at the time of the gadolinium-enhanced MRI study.

Exclusion Criteria:

* Allergy to edetate calcium disodium
* Prior chelation therapy with edetate disodium since the administration of gadolinium
* Blood pressure \>160/100
* No venous access
* Platelet count \<100,000/mm3
* Liver disease or alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 times the upper limit of normal
* Diseases of copper, iron, or calcium metabolism
* Women of child-bearing potential
* History of lead intoxication; lead encephalopathy; cerebral edema.

Primary outcomes:
measure: gadolinium levels in urine before and after an edetate calcium disodium challenge
timeFrame: within 6 months of a gadolinium-enhanced MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
Study officials:
References:
Clinical trial NCT00732329: Effectiveness of Home Based Occupational Therapy for Dementia.
Official title: Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2008-08-12
Enrollment: 160
Sex: ALL
Minimum age (years): 55
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 if a home based occupational therapy is effective in the treatment of dementia.


Eligibility criteria: Inclusion Criteria:

1. Dementia (according to DSM-IV TR)
2. A score 26 to 12 on the MMSE
3. Must be 55 or older
4. Patient is living at home or therapeutical flat sharing
5. Primary care giver at least 2 days / week available at home
6. Written informed consent from patient and care giver
7. German as dominant language

Exclusion Criteria:

1. Other dementia (p.e. frontotemporal dementia, dementia with Lewy Bodies, Creutzfeldt-Jakob disease, Parkinson's disease or atypical Parkinson's syndromes
2. Dementia with relevant displaying behavioural problems (neuropsychiatric Inventory; NPI, Subscore ≥ 8)
3. Depressive episodes (Geriatric Depression Scale, GDS (short version) ≥ 6)
4. Mental disability
5. Home Based Occupational Therapy for Dementia within the last 6 months
6. Impairment of visual and/or acoustic cognition which does not allow Occupational Therapy
7. Apoplexy with movement disorders which does not allow Occupational Therapy
8. Severe physical/systemic illnesses (cardio-pulmonal, Hematological or metabolic) which do not allow participating
9. Recent history of addictive disorder
10. Intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial
11. Participation in another clinical trial

Primary outcomes:
measure: Alzheimer's Disease Cooperative Study/Activities of Daily Living
timeFrame: 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group)
Secondary outcomes:
measure: - for patients: cognitive performance, displaying behavioural problems, satisfaction with occupational therapy, costs of occupational therapy - for family care givers: burden, medical condition, life-satisfaction
timeFrame: 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Psychiatry and Psychotherapy
city: Günzburg
country: Germany
facility: Department of Psychiatry, Psychotherapy and Psychosomatic
city: Leipzig
country: Germany
facility: Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")
Study officials:
affiliation: Department of Psychiatry and Psychotherapy of University Hospital Dresden
name: Vjera Holthoff, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05208229: The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)
Official title: The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lu-PSMA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
Keywords: WB-MRI (Whole Body- Magnetic Resonance Imaging)
177Lu-PSMA 617
metastatic Castration Resistant Prostate Cancer (mCRPC)
Radio Metabolic Therapy (RMT)
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 2
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mCRPC enrolled in the IRST185.03 Lu-PSMA study

Brief summary: The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA

Detailed description: Multicentric, observational, single arm, prospective, study.

All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows:

* Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed
* At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed
* In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed.

Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.

Eligibility criteria: Inclusion Criteria:

- Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation.

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: disease progression
timeFrame: up to 42 months
Secondary outcomes:
measure: Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI
timeFrame: up to 42 months
measure: response with WB-MRI compared to other assessment
timeFrame: up to 42 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
state: Forlì-Cesena
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: IRST IRCCS
name: Giovanni Paganelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02726529: Brighter Bites - Access, Continuity and Education With Fruits and Vegetables
Official title: Brighter Bites - Access, Continuity and Education With Fruits and Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 710
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the research is to find out how well a new nutrition program works for elementary school students and their families. This program is called Brighter Bites. Brighter Bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy ways. This project is being carried out at six elementary schools in Houston, Texas. Up to 600 first grade students and their parents/guardians are expected to join this project.


Eligibility criteria: Inclusion Criteria:

* Child is in enrolled in the 1st grade in the participating school

Exclusion Criteria:

* None

Primary outcomes:
measure: change intake of servings of fruits and vegetables for the child as assessed using the parent-reported food frequency questionnaire
timeFrame: baseline to 16 weeks
Secondary outcomes:
measure: change in intake of grams of sugar for the child as assessed using the parent-reported food frequency questionnaire
timeFrame: baseline to 16 weeks
measure: change in intake of grams of fat for the child as assessed using the parent-reported food frequency questionnaire
timeFrame: baseline to 16 weeks
measure: change in intake of servings of fruits and vegetables for the parent as assessed using the parent-reported food frequency questionnaire
timeFrame: baseline to 16 weeks
measure: change in availability of fruits and vegetables in the home as assessed using parent-reported surveys
timeFrame: baseline to 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela Sharma, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538729: Use of Alternative Therapy in Acne Vulgaris Patients
Official title: Use of Alternative Therapy in Acne Vulgaris Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 1571
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acne vulgaris Patients between age 12-60

Brief summary: Acne Vulgaris is a chronic skin disease. However, chronic and repetitive due to the quality of life and psychological status of patients can affect. Today, although the treatment is repetitive, chronic and requires follow-up due to the disease patients can turn to alternative and complementary medicine techniques. In recent years, studies on alternative medicine and complementary therapies have been noted in the medical literature. These studies also include Case Reports related to acne vulgaris. However, in our country, there is no study that tells us whether patients with acne vulgaris apply these treatments or not and what the practitioners think about the success of the treatment. The aim of the study will be to clarify issues such as whether patients with Acne Vulgaris apply alternative medicine and complementary therapies for their disease.


Eligibility criteria: Inclusion Criteria:

* Acne vulgaris Patients between age 12-60

Exclusion Criteria:

* the ones who don't want to answer the questions

Primary outcomes:
measure: acne vulgaris questionnaire
timeFrame: september 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Melek Aslan Kayıran
Study officials:
References:
Clinical trial NCT01414829: Efficacy of Gastric Biopsy for Culture and Antibiotic Sensitivity Assessment
Official title: Efficacy of Gastric Biopsy for Culture and Antibiotic Sensitivity Assessment and Comparing of Different Methods for Helicobacter Pylori Disclosure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Other Diseases or Conditions | Patient
Keywords: Peptic disease
Helicobacter pylori
Different methods
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2011-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient referred for gastroscopy because of clinical reasons

Brief summary: Gastric biopsies will be taken to compare different methods of H.pylori disclosure.Standard methods will be compared to culture.


Eligibility criteria: Inclusion Criteria:

* all referred for gastroscopy with clinical or endoscopic signs of peptic disease

Exclusion Criteria:

* coagulation disorders
* pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baruch Padeh MC, Israel
name: Maya PAritsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935829: Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety
Official title: Short-term Effects of a Low Glycemic Index Snack Including Carob on Postprandial Glycemic Responses, Energy Intake and Satiety in Normal-weight, Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetite; Lack or Loss, Nonorganic Origin
Keywords: energy intake
blood glucose
carob flour
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective and objective appetite and energy intake in healthy, normal-weight adults.

Detailed description: This study aimed at 1. firstly determine the glycemic index (GI) of a carob snack compared with an isoenergetic, equal weight chocolate cookie and 2. test the hypothesis that a carob preload consumed as snack before a meal, compared to chocolate cookie would: (a) have greater short-term effect on satiety measured by subsequent ad libitum meal intake, (b) induce greater satiety as assessed by visual analogue scales (VAS), and (c) reduce postprandial glycemic response.

Eligibility criteria: Inclusion Criteria:

- Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions)
* Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)
* Lactose intolerance
* Pregnancy
* Competitive sports
* Lactation
* Alcohol
* Drug dependency

Primary outcomes:
measure: Capillary blood glucose and subjective appetite ratings
timeFrame: 7 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 6 hours
measure: Energy intake after preload
timeFrame: 2 hours
measure: Energy intake next 24hours
timeFrame: 2 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References: