louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03876938: Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy
Official title: Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Antiemetic for Highly Emetogenic Chemotherapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 147
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: Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.

Detailed description: Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.

Eligibility criteria: Inclusion Criteria:

* pathologically proved of solid malignancy
* receive first cycle of cisplatin \>= 50 mg/m2 or cyclophosphamide/doxorubicin

Exclusion Criteria:

* pregnancy
* patients with episode of vomiting within 24 hours before starting chemotherapy
* uncontrolled brain/ CNS metastasis
* gut obstruction
* receive combination of moderate or high emetogenic chemotherapy during Day 2-5
* Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
* currently receive olanzapine with other indication and plan to continue the drug

Primary outcomes:
measure: no nausea rate
timeFrame: Days 1-5 of chemotherapy
Secondary outcomes:
measure: complete remission
timeFrame: Days 1-5 of chemotherapy
measure: >= grade 3 vomiting
timeFrame: Days 1-5 of chemotherapy
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Suthinee Ithimakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02072538: Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result
Official title: Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Major Adverse Cardiovascular Events
Troponin T
GRACE Score
Keywords: Stress testing
Troponin T
GRACE score
Outcome
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 0
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 presenting to our emergency department ("chest pain unit") with typical angina pectoris are being screened for participation. Those meeting the inclusion criteria (typical angina pectoris, absence of symptoms since presentation, low GRACE risk score) are included.

Brief summary: New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score \>140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.


Eligibility criteria: Inclusion Criteria:

* patients presenting to the emergency department ("chest pain unit")
* typical angina pectoris
* absence of symptoms since presentation
* at least 18 years
* low GRACE risk score (\<140 points)
* informed consent, signed agreement

Exclusion Criteria:

* conditions with need for immediate workup
* mental disorders
* dementia
* pregnancy, breast feeding

Primary outcomes:
measure: Major adverse cardiovascular event
timeFrame: 30 days
Secondary outcomes:
measure: Major adverse cardiovascular event
timeFrame: 90 days
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Evangelos Giannitsis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Hugo A Katus, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05932238: Systane® Hydration PF and Systane® Hydration Preserved
Official title: Systane® Hydration PF and Systane® Hydration Preserved
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.

Detailed description: Subjects will participate in the study for approximately 30 days, with a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\] or Contact Lens Dry Eye Questionnaire \[CLDEQ-8\] and Comfortable Wear Time questions).

Eligibility criteria: Inclusion Criteria:

* Subject must be able to understand and sign an informed consent form
* Subject with mild to moderate dry eye
* Subject with CL-related dry eye symptoms
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 3 months prior to screening.
* Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean overall IDEEL-Symptom Bother(SB) score - Group 1
timeFrame: Visit 3 (Day 30)
measure: Resultant overall CLDEQ-8 score - Group 2 and Group 3
timeFrame: Visit 3 (Day 30)
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Integra Eye Care
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05101538: Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction
Official title: Anorexia Nervosa and it's Effects on Brain Function, Body Metabolism and Their Interaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
metabolism
functional imaging
PET
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Totallly 30 female subjects with anorexia nervosa are recuited from the Eating Disorder Unit at the Turku University Hospital who meet the following criteria: i) modified DSM-IV diagnosis of AN with or without amenorrhea; ii) AN onset before the age of 25 years; iii) age between 18 and 32 3 years; iv) no lifetime history of binge eating. Their data are compared with 30 age and sex-matched healthy controls

Brief summary: The neuromolecular and metabolic underpinnings of Anorexia Nervosa (AN) are studied using multi-modal molecular (positron emission tomography with two different radioligands) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Subjects with AN and normal weight adolescents will be studied with PET and MRI and followed for five years.

Detailed description: A total of sixty females (30 with AN, 30 healthy controls) are recruited into this prospective study. The subjects will undergo physical examination, body tissue composition measurement, functional and structural MRI of the brain and body, and positron emission tomography (PET) with ligands \[18F\]-FDG, and \[11C\]carfentanil. Subjects' weight and physical condition will be followed up for 5 years. The study will start in August 2020 and end in the fall of 2028.

Eligibility criteria: Inclusion Criteria for AN:

1. Female sex
2. Age 18-32 3 years
3. BMI \< 17.5 kg/m2
4. Currently fulfilling modified DSM-IV diagnosis of AN with or without amenorrhea, onset age before 25 years
5. Diagnosed less than 2 years ago

For controls:

1. Female sex
2. Age 18-32 3 years
3. BMI 19 20-25 kg/m2
4. No lifetime history of obesity (BMI ≥\> 30) or eating disorders

Exclusion Criteria:

1. Any chronic disease or medication that could affect glucose metabolism or neurotransmission
2. History of psychiatric disorders (excl. AN for the corresponding study group)
3. Smoking of tobacco, taking of snuffs, or use of narcotics
4. Abusive use of alcohol

Primary outcomes:
measure: Changes in brain reward system and metabolism in AN patients
timeFrame: 10 years
measure: Predictive value of baseline body mass index (BMI), functional brain activation and metabolism in AN
timeFrame: 10 y
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
Study officials:
affiliation: Turku PET Centre, Turku University hospital
name: Pirjo Nuutila, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066438: The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
Official title: The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastfeeding
Breastfeeding, Exclusive
Breast Milk Collection
Keywords: antenatal
colostrum
hand expression
prenatal
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in Saskatoon, Saskatchewan who intend to breastfeed. Prospective participants will be invited to enrol in this study if they meet inclusion criteria.

Brief summary: Despite recommendations by several health authorities, the rate of sustained exclusive breastfeeding for two months is less than fifty-five percent in Canada. The two most common reasons for early discontinuation are problems with milk supply and difficulty with technique. Antenatal hand expression (AHE) is a method used to assist with colostrum collection in low-risk pregnancies near term. This method has been shown to have several benefits, including increased milk supply at birth. This study aims to determine if the employment of antenatal hand expression in low-risk pregnancies near term affects the rate of sustained breastfeeding exclusively to two months.


Eligibility criteria: Inclusion Criteria:

* inclusion to breastfeed
* no contraindications to vaginal delivery
* multiple gestation only if cleared for vaginal delivery

Exclusion Criteria:

* intention to formula feed
* antenatal hand expression training provided by staff outside of study protocol
* practiced antenatal hand expression prior to 36 weeks gestation
* breech presentation
* history of preterm labour, preterm birth or threatened preterm labour
* history of (or current) cervical insufficiency
* any contraindication to vaginal delivery (ie. placenta or vasa previa, classical uterine scar, etc.)
* intrauterine growth restriction
* antepartum hemorrhage
* any contraindication to breastfeeding (eg. HIV)
* multiple gestation requiring Cesarean delivery

Primary outcomes:
measure: Exclusive breastfeeding to two months
timeFrame: This metric measured by questionnaire at two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Saskatchewan
name: Almereau Prollius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07004738: Assessment of Rectus Abdominis Muscle Thickness and Residual Bladder Volume Before and After Pelvic Floor Exercises
Official title: Ultrasound Assessment of Rectus Abdominis Muscle Thickness and Residual Bladder Volume Before and After Pelvic Floor Exercises
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: pelvic floor exercises
rectus abdominis muscle thickness
residual bladder
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. All participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. Pelvic floor dysfunction will be diagnosed by an Obstetrics and Gynecology Specialist. Participants will be divided into two groups as the Pelvic floor exercise group and the control group.

Detailed description: The study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. All participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. Pelvic floor dysfunction will be diagnosed by an Obstetrics and Gynecology Specialist. Participants will be divided into two groups as the Pelvic floor exercise group and the control group. Group distributions will be made by randomization.org website. Participants in the pelvic floor exercise group will be instructed to do daily pelvic floor exercises under the guidance of a physiotherapist specialized in pelvic health. No exercises will be given to women diagnosed with pelvic floor dysfunction in this group. Women will continue their routine lives and their evaluations will be made.

Eligibility criteria: Inclusion Criteria:

* were being between 20-40 years of age,
* having pelvic floor dysfunction,
* not having any problems that would prevent performing pelvic floor exercises

Exclusion Criteria:

* previous pelvic surgery
* active urinary tract infections
* neurological conditions affecting bladder control

Primary outcomes:
measure: Ultrasound Measurements
timeFrame: 20 minutes
measure: The residual bladder volume measurement
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang X, Li H, Luan B, Han R, Lun W. Dynamic Evaluation of the Rectus Abdominis Muscle before and after Delivery by Ultrasonography. Evid Based Complement Alternat Med. 2022 Aug 26;2022:9751136. doi: 10.1155/2022/9751136. eCollection 2022.
Clinical trial NCT01347138: Health Care Management for the Elderly in Community Through Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorders
Senile; Depression
Keywords: Screening
depression
case management
Lead sponsor: National Clinical Research Coordination Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2011-05-04
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Depression in late life has been associated with losses in functioning and quality of life, mortality, and increased health care costs. Although late life depression can be successfully treated with antidepressant medication or psychotherapy, few older adults receive adequate trials of such treatment in community in Korea. Barriers, such as loss of loved ones, medical illnesses, and social stigma associated with depression, lack of social and financial support, to effective treatment of depression can be especially problematic for older adult. Screening has been valuable in overcoming barriers to diagnosis. Over 60 year old community dwelling people will be screened for symptoms of four geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder). Those who will be screened positive for each condition will be refer to clinic for diagnosis. Among them only those cases confirmed as depression by psychiatrists will be enrolled in this study. Enrolled patients will be randomly assigned to either case management or usual care conditions.

The objective of the study is to test whether a system of screening, assessment, and follow-up provided by case manager improves in recognizing the target geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.


Eligibility criteria: Inclusion Criteria:

* over 60 year old
* having medicare insurance

Exclusion Criteria:

* dementia and other psychiatric disorders

Primary outcomes:
measure: Geriatric Depression Score
timeFrame: 6 months after baseline
Secondary outcomes:
measure: quality of life
timeFrame: 6 months after baseline
measure: treatment compliance
timeFrame: 6 months after baseline
measure: suicide ideation
timeFrame: 6 months after baseline
Other outcomes:
Locations:
city: Choongju
country: Korea, Republic of
facility: City of Choongju public health center
state: Choongchungbuk-Do
Study officials:
affiliation: The Catholic University of Korea
name: Hyeon Woo Yim, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05144438: Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
Official title: Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metallic Trace Elements
Metal-type Environmental Pollutants
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-03
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, over 18 years old, pregnant (first trimester) or desires conception

Brief summary: A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* Patient with desire to conceive
* 1st trimester of pregnancy
* Patient having been informed of the study and not opposing the use of the data collected
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Women under 18 years old
* 2nd and 3rd trimester of pregnancy
* Patient objecting to the use of the data collected
* Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Rémy-de-Provence
country: France
facility: Pôle médical Saint Bernard
Study officials:
References: