louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01280396: Metabolic Side-effects for Second-generation Antipsychotics
Official title: Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Keywords: metabolic
SGAs
clozapine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2011-01-20
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patients in a public psychiatric out-patient centre

Brief summary: Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as treatment for psychosis. There are increasing concerns about their related metabolic side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a specific condition known as metabolic syndrome. All these side-effects might be associated with the increased risk of cardiovascular diseases and diabetes mellitus.

This study is to analyze the simple physical measurements (weight and height) and venous blood tests (for fasting blood glucose and lipid) results collected routinely since 2008 (recommended by the local hospital authority as a territory-wide "SGAs Monitoring Program") from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient clinic in Hong Kong. The investigators hypothesized that there should be differential risks on metabolic side-effects amongst these SGAs.


Eligibility criteria: Inclusion Criteria:

* was ≥18 years of age
* out-patients
* had received any one of these antipsychotics: aripiprazole, amisulpride, clozapine, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
* consented to provide physical measurements and venous blood samples

Exclusion Criteria:

* not consented to provide venous blood samples and/or physical measurement

Primary outcomes:
measure: development of metabolic syndrome according to IDF criteria
timeFrame: 1 year
Secondary outcomes:
measure: change in BMI
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Western Psychiatric Centre
Study officials:
affiliation: Department of Psychiatry, Queen Mary Hospital
name: Albert Kar Kin Chung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001896: Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation
Official title: A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
EGFR-TKI
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 60
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: This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.

Exclusion Criteria:

* prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 24 mont
Other outcomes:
Locations:
city: Urumqi
country: China
facility: Xinjiang medical university
state: Xinjiang
Study officials:
References:
Clinical trial NCT00522496: Proteomics of Severe Traumatic Brain Injury: A Feasibility Study
Official title: Proteomics of Severe Traumatic Brain Injury: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Keywords: Craniocerebral trauma
matrix metalloproteinase
microdialysis
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Intensive Care Foundation
First posted: 2007-08-29
Enrollment: 8
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: All patients referred to Foothills Medical Centre, the regional trauma centre for Southern Alberta

Brief summary: The purpose of this study is to:

1. Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury
2. Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury
3. Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has GCS less than 9
* Patient requires intracranial pressure monitoring
* Patient life expectancy greater than 72 hours

Exclusion Criteria:

* Patient's TBI is greater than 24 hours old
* Patient is less than 18 years of age
* Patient does not require intracranial pressure monitoring
* Patient has life expectancy less than 72 hours
* Patient has GCS greater or equal to 9
* Patient is currently enrolled in another study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Zygun A David, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07027696: Sexual Health of Women With Genital Mutilation Seen at the Saint-Denis Women's Center
Official title: Sexual Health of Women With Genital Mutilation Seen at the Saint-Denis Women's Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Genital Mutilation
Sexual Dysfunctions, Psychological
Sexual Health
Violence Against Women
Post-Traumatic Stress Disorders
Acculturation
Women&#39;s Health Services
Refugees
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult women who have experienced female genital mutilation (FGM) or are considered to be excised, and who are consulting at the Maison des Femmes (Women's House) of the Saint-Denis Hospital in France. These women are engaged in a multidisciplinary care pathway addressing the consequences of FGM. Most are migrants who have faced various forms of violence, either in their country of origin or during their migration journey.

Brief summary: This study looks at the sexual health of women who have experienced female genital mutilation (FGM) and who are receiving care at the Women's Center at Saint-Denis Hospital. It aims to better understand their sexual experiences, including the impact of past violence and trauma, and to explore how multidisciplinary care (such as psychological and sexological support) can help. The study also looks at what women expect from their care and how they feel about surgical or other types of support.


Eligibility criteria: Inclusion Criteria:

* Women with female genital mutilation (FGM), or considered to be excised, consulting at the Maison des Femmes (Women's House) at Saint-Denis Hospital.
* Women enrolled in the multidisciplinary care pathway for FGM.

Exclusion Criteria:

- Women under the age of 15.

Primary outcomes:
measure: Assessment of the sexual function profile of women with female genital mutilation (FGM) during consensual sexual activity, using a structured clinical sexological evaluation that accounts for histories of violence.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT06824896: A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ
Official title: An Observational Database Study to Monitor Safety-related Endpoints After Marketing of Cecolin®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Adverse Pregnancy Outcomes
Lead sponsor: Xiamen Innovax Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Xiamen University
name: Xiamen Health and Medical Big Data Center
First posted: 2025-02-13
Enrollment: 1322084
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
* Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.

Brief summary: This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).

Detailed description: This study was initiated following the approval of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) (CecolinⓇ) in China. We undertook a retrospective-prospective real-world study to assess the incidence of new-onset autoimmune conditions (10 conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic) and adverse pregnancy conditions (e.g., premature birth, birth defects) among 9-45 yoa females during the pre- and post-marketing period of CecolinⓇ.

Eligibility criteria: Inclusion Criteria:

* Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
* Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.

Exclusion Criteria:

-

Primary outcomes:
measure: autoimmune conditions
timeFrame: through study completion, around 7.3 years
measure: adverse pregnancy conditions
timeFrame: through study completion, around 7.8 years
Secondary outcomes:
measure: other serious diseases
timeFrame: through study completion, around 7.3 years
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Innovax Biotech Co., Ltd
state: Fujian
Study officials:
References:
Clinical trial NCT02484196: Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health
Official title: Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspareunia
Endometriosis
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, and their parteners, affected by endometriosis with dyspareunia, referred to the Obstetrics and Gynecological Department of the University Hospital for the treatment of endometriosis

Brief summary: Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.


Eligibility criteria: Inclusion Criteria:

* Women affected by endometriosis with dyspareunia;
* Women in waiting list for surgery

Exclusion Criteria:

* Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
* Psychiatric diseases
* Refusal or inability to sign the informed consent
* Pregnancy
* Previous gynecological surgery
* End of couple relationship

Primary outcomes:
measure: Quality of sexual life
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02114996: Can a Vocal Stimulus Provoke Spontaneous Breathing in an Ischemic Stroke Patient Dependent on Mechanical Ventilation?
Official title: Phase 1 - Vocal Stimuli to Provoke Spontaneous Breathing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Ventilated by Mechanical Ventilation With Ischemic Stroke
Keywords: mechanical ventilation
ischemic stroke
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2014-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients on mechanical ventilation

Brief summary: Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.

Detailed description: Vocal stimulation may encourage breathing in ventilated patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation that will be our control group.

Eligibility criteria: Inclusion Criteria:

* ischemic stroke men and women older than 18 years old and younger than 80 years old

Exclusion Criteria:

* coma from other reasons other than ischemic stroke hemmorhagic stroke active malignancy renal failure

Primary outcomes:
measure: spontaneous breathing
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04808596: Pulmonary Hypertension Biorepository and Registry
Official title: Pulmonary Hypertension Biorepository and Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Hypertension Due to Left Heart Disease
Pulmonary Hypertension, Primary
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Pulmonary Hypertension, Primary, 4
Pulmonary Hypertension, Primary, 2
Pulmonary Hypertension, Primary, 3
Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Hypertension Group 1-5

Brief summary: Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Detailed description: The aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all WHO groups I-V to be used for future research in these areas. This will be both a retrospective and prospective project. The registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.

Eligibility criteria: Inclusion Criteria:

1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
2. The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization
3. Patient is ≥ 18 years of age or older

Exclusion Criteria:

1. Participant declines to participate (living patients only)
2. Participant is unable to provide informed consent (living patients only)

Primary outcomes:
measure: Collect Clinical Data
timeFrame: From Enrollment to 6 Months
measure: Establish a Biorepository
timeFrame: From Enrollment to 6 Months
measure: Biospecimens Collection
timeFrame: From Enrollment to 12 Months
measure: Collaborate
timeFrame: From Enrollment to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Assistant Professor of Medicine
name: Leslie A Spikes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Pulmonary Research
name: Luigi R Boccardi, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01386996: Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Official title: Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria: Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion criteria

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax of plasma budesonide concentration
timeFrame: within 12 h
measure: Pharmacokinetic parameter AUCt of plasma budesonide concentration
timeFrame: 12 h
measure: Pharmacokinetic parameter Cmax of plasma formoterol concentration
timeFrame: 24 h
measure: Pharmacokinetic parameter AUCt of plasma formoterol concentration
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma Phase I Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen, MSc
role: STUDY_DIRECTOR
affiliation: Orion Corporation, Orion Pharma
name: Kimmo Ingman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02207296: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery
Official title: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Arthroplasty
Knee Arthroplasty
General Anesthesia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Indication to a knee or hip arthroplasty under general anesthesia
* Sinusal rhythm

Non Inclusion Criteria:

* Pregnant women
* Black skin
* Dialysis
* Cardiac arrythmia
* Sepsis
* Use of another hemodynamic monitoring during surgery

Primary outcomes:
measure: Length of hospital stay after knee or hip arthroplasty
timeFrame: Real length of hospital stay expressed as number of day (maximum 60 days)
Secondary outcomes:
measure: Troponin value
timeFrame: Postoperative Day 1 and Day 3
measure: Creatinine value
timeFrame: Postoperative Day 1 and Day 3
measure: Arterial Lactate
timeFrame: 1 hour after end of surgery
measure: Postoperative cardiac complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
measure: Theorical length of hospital stay after knee or hip arthroplasty
timeFrame: Theorical length of hospital stay expressed as number of day (maximum 60 days)
Other outcomes:
measure: Medico economic evaluation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
citation: Fischer MO, Daccache G, Lemoine S, Tavernier B, Compere V, Hulet C, Bouchakour CE, Canevet C, Gerard JL, Guittet L, Lorne E, Hanouz JL, Parienti JJ. The OPVI trial - perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial. Trials. 2015 Nov 4;16:503. doi: 10.1186/s13063-015-1020-7.