louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01851746: A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
Official title: A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Ovarian Cancer
Keywords: recurrent ovarian cancer
lobaplatin
docetaxel
carboplatin
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: residents of a certain town

Brief summary: The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 70 years old
2. singed the information consent form
3. Expected survival time \>3 months
4. Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.

Exclusion Criteria:

1. Recurrence within 6 months after receiving initial platinum-based chemotherapy
2. without radiographic evidence for tumor recurrence
3. receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy

Primary outcomes:
measure: Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
timeFrame: from pre-chemotherapy to 4-6 weeks post-chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: Hong-bing Cai, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01560546: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
Official title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Hypogonadism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2012-03-22
Enrollment: 43
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.

Detailed description: Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.

Eligibility criteria: Inclusion Criteria:

* Male gender age 50-70
* Bioavailable testosterone \< 7,3 nmol/L
* Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

* HbA1c \> 9,0 %, BMI \> 40 kg/m2, Haematocrit \> 50%,
* Known malignant disease, PSA \> 3 ug/L, Nycturia \> 3 times,
* Abnormal routine blood samples,
* Severe hypertension,
* Significant EKG-changes,
* Wish of parenthood,
* Active mental illness,
* former or present abuse,
* Severe illness of heart-, lung- or kidney,
* Primary or secondary hypogonadism.

Primary outcomes:
measure: Lean body mass
timeFrame: approximately three years
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: three years
measure: Regional body composition and liver fat
timeFrame: three years
measure: Glucose and lipid oxidation
timeFrame: three years
measure: Myostatin and satellite cells
timeFrame: 8 years
measure: Inflammation
timeFrame: 8 years
measure: Physical activity
timeFrame: three years
measure: Quality of life
timeFrame: three years
measure: Sexual function
timeFrame: Three years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
name: Marianne Andersen, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.
Clinical trial NCT01234246: Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
Official title: Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Patients and Their Partners
Keywords: Colorectal cancer
Sexual function
Sexual dysfunction
Quality of (sexual) life
Partners
Body image
Anxiety (state and trait)
Depressive symptoms
Personality
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2010-11-04
Enrollment: 1371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer and their partners

Brief summary: In this project the main focus is on assessing sexual functioning and the quality of sexual life after the treatment of colorectal cancer in patients and their partners.

Patients and their partners complete questionnaires concerning sexual functioning, quality of life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months, and 12 months after diagnosis.

The results of this prospective study will give insight in 1) the incidence of sexual problems and the extent patients with colorectal cancer and their partners are bothered by these problems across time, 2) the effect of different treatment modalities on sexual functioning, 3) the relation between sexual problems and quality of life, 4) the determinants of sexual problems and the quality of sexual life adopting the biopsychosocial approach of patients with colorectal cancer who have been treated with surgery, radiation and/or chemotherapy, and more specifically to the role of personality and patient factors and sexual functioning/the quality of sexual life.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with colorectal cancer in one of the participating centra, and their partners are asked to participate in this study prior to treatment.
* Patients have to be between 18 and 75 years old.

Exclusion Criteria:

* Disease recurrence at baseline or metastases.
* Poor expression of the Dutch language.
* Dementia.
* History of psychiatric illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Tilburg
country: Netherlands
facility: TweeSteden Hospital
Study officials:
affiliation: Tilburg University
name: B.L. den Oudsten, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tilburg University
name: J.A. Roukema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tilburg University
name: J. de Vries, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547246: Transcranial Magnetic Stimulation and Bulimic Craving
Official title: Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia
Keywords: bulimia
repetitive transcranial magnetic stimulation (rTMS)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may be considered appropriately by using paradigms developed in the framework of embodied cognition theories.

In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for food in these patients, as measured by reaction time.

Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms have not yet been explored.

Detailed description: The exams / treatments of the study include:

* a 20 minute session of rTMS at a frequency of 10 Hz.
* cognitive testing and attention, which will be made on the computer before and 24 hours after the session of rTMS.

Cognitive test consist in , on a computer screen:

* Is first displayed, food and non-food words. The patient must pull a lever to it if the letter A is present in the word and push the lever if the letter A is missing the word.
* Then presents a series of food and non-food words. The patient must pull a lever to it if it deems that the word has a positive meaning and push the lever if it determines that the word has a negative meaning

Eligibility criteria: Inclusion Criteria:

* right-handed patient
* Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
* Normal BMI

Exclusion Criteria:

* Previous history of seizures or epilepsy.
* Participants with a somatic problem restricted movement or an uncorrected visual acuity problem.
* History of head trauma, neurological disease or unstabilized serious physical illness.
* Major Depressive Episode at the time of the study

Primary outcomes:
measure: Motor response time
timeFrame: 24h after rTMS session
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Torrance SIGAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520646: A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
Official title: A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acromegaly
Cardiomyopathies
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acromegaly is a disease characterized by excess growth hormone(GH) and insulin like growth factor(IGF)-1. Pituitary GH secreting adenoma is the major cause of acromegaly. Acromegalic cardiomyopathy is one of the leading causes of death in acromegalic patients. No efficient medicine is available for acromegalic cardiomyopathy until now and there were limited studies. Empagliflozin is proved to decrease the risk of heart failure in diabetic patients and independent of blood glucose control. We planed to evaluate the structure of heart by MRI before and after 6 months treatment with empagliflozin in acromegalic patients to investigate the effect of empagliflozin on acromegalic cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

* patients with pituitary GH adenomas confirmed by surgery

active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs

Exclusion Criteria:

* patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP\>150mmHg or DBP\>95mmHg patients with contraindications to MRI

Primary outcomes:
measure: Left ventricular mass index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00750646: Observational Study of How Patients Take Eye Drops
Official title: The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: compliance
eye drop administration
MEMS
adherence
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
Collaborators: name: Alcon Research
First posted: 2008-09-10
Enrollment: 220
Sex: ALL
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: Subjects will be enrolled for a single site, private practice.

Brief summary: This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.


Eligibility criteria: Inclusion Criteria:

* \>18 year old
* currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months
* subjects instill their own eye drops
* subject is able to take HVF tests
* subject will expect to complete the 3 months enrollment period

Exclusion Criteria:

* unable/unwilling to instill own medications
* eye drops are discontinued
* unable to take HVF test
* unable to complete follow-up
* investigators discontinue subject for safety reasons
* not using drops in left eye

Primary outcomes:
measure: Medication adherence measured by MEMS caps
timeFrame: 3 months
measure: Eye drop technique measured by video evaluation
timeFrame: 1 time observation
Secondary outcomes:
measure: Medication adherence measured by self-report
timeFrame: 3 months
measure: Severity of VF damage
timeFrame: 1 test date
measure: Intraocular pressure readings
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Glaucoma Specialists
state: Maryland
Study officials:
affiliation: Glaucoma Experts
name: Jennifer L Stone, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glaucoma Specialists
name: Alan L Robin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glaucoma Specialists
name: Colleen K Protzko
role: STUDY_DIRECTOR
References:
Clinical trial NCT01820546: Cancer Stem Cells in Multiple Myeloma
Official title: Flow Cytometric Definition and Prognostic Effects of Multiple Myeloma Cancer Stem Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New Diagnosed or Relapsed Multiple Myeloma Patients

Brief summary: In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.

Detailed description: The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called "cancer or progenitor stem cell". In multiple myeloma to define immunophenotyping features of these "cancer stem cells" with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.

Eligibility criteria: Inclusion Criteria:

* New Diagnosed or Relapsed Multiple Myeloma
* Routine Bone Marrow Aspiration will be done

Exclusion Criteria:

* Bone Marrow Aspiration is not Needed

Primary outcomes:
measure: Treatment Response
timeFrame: 3 months
Secondary outcomes:
measure: Treatment Response
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Hematology Unit
Study officials:
name: Mehmet Ozen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsui W, Huff CA, Wang Q, Malehorn MT, Barber J, Tanhehco Y, Smith BD, Civin CI, Jones RJ. Characterization of clonogenic multiple myeloma cells. Blood. 2004 Mar 15;103(6):2332-6. doi: 10.1182/blood-2003-09-3064. Epub 2003 Nov 20.
Clinical trial NCT05249946: FoodStep - a Sustainable Model for Food Services and Early Childhood Education and Care
Official title: FoodStep - a Sustainable Model for Food Services and Early Childhood Education and Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Nutrition
Health
Food System
Sustainability
Children
Microbiome
Health Economics
Climate neutrality
Early childhood education
Food catering
Cost-effectiveness analysis
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
name: Natural Resources Institute Finland
name: Laurea University of Applied Sciences
First posted: 2022-02-22
Enrollment: 116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized Trial
Primary purpose: OTHER

Brief summary: Transformation towards a more climate-friendly and healthy sustainable diet will require major changes in the food system: increase in consumption of plant-based foods and only moderate consumption of animal-based foods. In the FoodStep -project, the investigators will develop a sustainable model for food system that reduces the climate impacts of the food system in early childhood education and care. The impact of the changes on children's nutrition, the climate impact of the diet, and the cost of food services will be assessed in a randomised controlled trial. In addition, the effects of the model on the knowledge and attitudes of decision-makers, experts in food service and early childhood education, and families are studied. Based on the project, the model can be applied nationally as part of Finland's climate change mitigation and adaptation strategy. Study aim to a sustainable food system reform through concrete guidelines, communication, and action initiatives.


Eligibility criteria: Inclusion Criteria:

* Are attending a full time daycare

Exclusion Criteria:

-

Primary outcomes:
measure: Change in daycare diet of the children
timeFrame: Before the intervention and 1 year after the intervention
measure: Change in climate impact of Food System model at systemic level
timeFrame: Before the intervention and 1 year after the intervention
measure: Change in food service cost of Food System model at systemic level
timeFrame: Before the intervention and 1 year after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: The Finnish Institute for Health and Welfare
Study officials:
References:
Clinical trial NCT00862446: Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Official title: Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parenteral Nutrition Associated Liver Disease
Keywords: Parenteral nutrition associate liver disease
TPN cholestasis
TPN Associated Liver Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 48
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Detailed description: Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.

Eligibility criteria: Inclusion Criteria:

* Infants in the newborn intensive care unit
* TPN cholestasis of at least 2.5 mg/dl
* Anticipated TPN treatment for at least one month
* signed informed consent

Exclusion Criteria:

* Enrollment in another trial
* Lack of consent

Primary outcomes:
measure: Number of Participants With Resolution of the Direct Hyperbilirubinemia
timeFrame: At discharge or up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at vanderbilt
state: Tennessee
Study officials:
References: