louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02295904: Video Analysis of Vaginal Deliveries
Official title: Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Trauma
Keywords: perineum
videoanalysis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 120
Sex: FEMALE
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: pregnant women

Brief summary: Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

Detailed description: Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.

Eligibility criteria: Inclusion Criteria:

* Pregnant women,
* at least 18 years of age (yoa),
* term deliveries (at least 37+0 weeks of gestation),
* vaginal delivery,
* fetal vertex presentation,
* single pregnancy

Exclusion Criteria:

* younger than 18 yoa,
* preterm deliveries,
* cesarean sections,
* fetal malformations,
* maternal disease in form of collagenosis,
* multiples pregnancy,
* vaginal/vulvar/perineal pre-operations (excluding birth trauma),
* perineal birth trauma grade III+IV

Primary outcomes:
measure: adequate support of perineum
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Obstetrics
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Obstetrics
name: Nina Kimmich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01115504: Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
Official title: Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: Thiamine
heart failure
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.

Detailed description: The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.

Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
* Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.

Exclusion Criteria:

* Decompensated heart failure
* Renal failure
* COPD
* Asthma
* Uncontrolled hypertension
* Bradycardia or tachycardia which needs increase or decrease in medications

Primary outcomes:
measure: Dyspnea score
timeFrame: 30 days
Secondary outcomes:
measure: Edema score
timeFrame: 30 days
measure: Systolic function
timeFrame: 30 days
Other outcomes:
Locations:
city: Shahrood
country: Iran, Islamic Republic of
facility: Faculty of medicine, Azad university
state: Semnan
Study officials:
affiliation: Azad university
name: Mehdi Mousavi, Cardiologist
role: STUDY_CHAIR
affiliation: Azad university
name: Said Namazi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00628004: Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
Official title: An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-03-04
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.


Eligibility criteria: Inclusion Criteria:

* The patient has participated in study DK143WS
* The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
* The patient is willing and able to give written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Concomitant participation in other studies

Primary outcomes:
measure: Adverse events
timeFrame: Week 1, 6, 20, 33, 46
Secondary outcomes:
measure: Clinical occurrences
timeFrame: Week 1, 6, 20, 33, 46
measure: Ulcer area reduction
timeFrame: Week 1, 6, 20, 33, 46
measure: Ulcer status
timeFrame: Week 1, 6, 20, 33, 46
measure: Skin condition at healed ulcer location
timeFrame: Week 1, 6, 20, 33, 46
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
Study officials:
affiliation: Aarhus University Hospital
name: Karsten Fogh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03688204: Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer
Official title: Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer: Impact on Risk Estimates, Management Recommendations, Clinical Outcomes, and Patient Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Risk
Keywords: Breast Cancer
Breast Neoplasm
Genetic Testing
Breast Cancer Risk
Cancer Risk
Risk Score
Genetic Risk Score
Polygenic Risk Score
Personalized Risk Score
Lead sponsor: Ambry Genetics
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include 2000 individuals with a family history of breast and/or ovarian cancer who present for genetic counseling at one of the investigative sites. The investigative sites will be clinics that regularly sees patients that meet the above description.

Brief summary: This study aims to assess how a polygenic risk score (PRS) reported with the results of multi-gene panel testing affects the breast cancer risk management recommendations healthcare providers make to their patients. The PRS is a score based on small genetic changes, clinical history, and family history. The PRS is used to estimate remaining lifetime risk of developing breast cancer for patients with no personal history of breast cancer and an overall negative result from MGPT.


Eligibility criteria: Inclusion Criteria:

* Female, age ≥ 18 years
* Willing and able to provide meaningful informed consent
* Willing and able to complete study procedures as described in this protocol
* Electing to undergo multi-gene panel testing for hereditary breast cancer for clinical purposes at the time of consent
* No personal history of cancer (except non-melanoma skin cancer) and meets NCCN guidelines for BRCA1/2 testing based on family history of breast and/or ovarian cancer
* Meets Ambry criteria for clinical reporting of PRS score

Exclusion Criteria:

* Prior germline BRCA1/2 testing
* Not willing to receive PRS
* Personal history of cancer, except non-melanoma skin cancer
* Personal history of allogenic bone marrow/stem cell transplant

Primary outcomes:
measure: Change in Breast Cancer Risk Management Recommendations
timeFrame: First recommendations will be made within 45 days of the initial study visit. Second recommendations will be made within 75 days of the initial study visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Roy and Patricia Disney Family Cancer Center
state: California
city: Orange
country: United States
facility: St Joseph Hospital of Orange
state: California
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
Study officials:
affiliation: Ambry Genetics
name: Brigette Tippin-Davis, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00690404: AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers
Official title: A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: formulation
pharmacokinetic
crossover formulation
food effect
oral solution
healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution


Eligibility criteria: Inclusion Criteria:

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Primary outcomes:
measure: AZ2066 pharmacokinetics
timeFrame: several samples within 72 hrs
Secondary outcomes:
measure: Effect of food on AZD2066 pharmacokinetics
timeFrame: several samples over 72 hrs
Other outcomes:
Locations:
Study officials:
affiliation: Quintiles, Inc. Overland Park, Kansas, USA
name: Eleanor Lisbon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Charnwood England
name: Heather Wray, MB, ChB, FFPM
role: STUDY_CHAIR
affiliation: AstraZeneca , Södertälje, Sweden
name: Ivan Eggens, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04070404: Quality of Preoxygenation in Emergency Surgery
Official title: Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoxygenation
Anaesthesia
Emergencies
Surgery
Keywords: Anaesthesia
Preoxygenation
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients undergoing general anaesthesia for emergency surgery

Brief summary: Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.

The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

Detailed description: Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.

Parameters analysed:

* Preoperative: medical history, physical examination, laboratory findings, anthropometric data
* Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

Eligibility criteria: Inclusion Criteria:

* written informed consent
* patient going for emergency surgery under general anaesthesia
* age \> 18 years

Exclusion Criteria:

* informed consent refusal
* noneligible for preoxygenation before general anaesthesia

Primary outcomes:
measure: Efficient preoxygenation in preset time
timeFrame: 300 seconds
Secondary outcomes:
measure: Factors influencing preoxygenation quality
timeFrame: 300 seconds
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
References:
Clinical trial NCT02026804: Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorder During Pregnancy - Baby Not Yet Delivered
Lead sponsor: Zhejiang Provincial Natural Science Foundation of China
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who had perinatal health care in a Women's \& Children's Health Hospital of zhejiang province, China

Brief summary: The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.


Eligibility criteria: Inclusion Criteria:

* Aged at least 18 years of age
* 8 to 12 weeks of pregnancy
* There is no history of mental illness
* Had perinatal health care in a Women's \& Children's Health Hospital

Exclusion Criteria:

* The obvious body disease
* Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy
* Having severe complications during pregnancy
* Fetal malformation or abortion
* Can't understand the questionnaire
* Without informed consent
* More than 13 weeks of pregnancy
* Less than 18 years of age

Primary outcomes:
measure: Incidence of mental disorders during different periods of pregnancy
timeFrame: from 8 weeks of pregnancy to delivery
Secondary outcomes:
measure: pregnancy outcomes
timeFrame: from 8 weeks of pregnancy to 6 months after delivery
Other outcomes:
Locations:
city: Zhoushan
country: China
facility: Zhoushan Women's & Children's Health Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02271204: Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis
Official title: Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Clinic of Endocrinology and Metabolic Disorders, Macedonia
Sponsor class: OTHER
Collaborators: name: Clinic for Orthopedic Surgery, Skopje
name: General Hospital, Kumanovo
name: General Hospital, Struga
name: Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje
First posted: 2014-10-22
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with postmenopausal osteoporosis in everyday routine practice from selected centers in R. Macedonia

Brief summary: This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)


Eligibility criteria: Inclusion Criteria:

* Patients had post menopausal osteoporosis
* Patients had no contraindication for bisphosphonates
* Patients had been naive for ibandronate therapy
* Patients who have signed informed consent and are willing to share their data for data analysis

Exclusion Criteria:

* Is not Ibandronate naïve
* Hypersensitivity to any component of the bisphosphonates Ibandronate;
* Administration of any investigational drug within 30 days preceding the first dose of the study drug.

Primary outcomes:
measure: Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis
timeFrame: end of observation 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01187004: Extracardiac Complications After Cardiac Surgery
Official title: Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Sepsis
Infections
Acute Kidney Injury
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing major cardiac surgery with cardiopulmonary by pass

Brief summary: Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

Detailed description: To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

Eligibility criteria: Inclusion Criteria:

* cardiac intervention with cardiopulmonary by pass, age \> 18 years old

Exclusion Criteria:

* off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.

Primary outcomes:
measure: Acute Lung Injury After Cardiac Surgery
timeFrame: at seven days after intervention
Secondary outcomes:
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: at 28 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Cardiac Intensive Care Unit, San Giovanni Battista Hospital
Study officials:
affiliation: San Giovanni Battista Hospital, University of Turin
name: Mauro Rinaldi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01505504: Mirtazapine in Alzheimer-associated Weight Loss
Official title: Mirtazapine in Alzheimer-associated Weight Loss: a Retrospective Phase IV Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Weight Loss
Mixed Dementia
Dementia
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with established diagnosis of AD or mixed dementia with reported weight loss

Brief summary: Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has weight loss as a frequent side effect.

The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can counteract weight loss in patients with AD or mixed dementia (AD + vascular).


Eligibility criteria: Inclusion Criteria:

* AD or mixed dementia
* documented weight loss
* mirtazapine 30 mg explicitly prescribed against weight loss

Exclusion Criteria:

* no treatment compliance
* other causes of weight loss
* other interventions against weight loss

Primary outcomes:
measure: body weight
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References:
Clinical trial NCT01842204: Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
Official title: Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernias
Keywords: inguinal hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: BioElectronics Corporation
First posted: 2013-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A monocentric interventional randomized placebo controlled trial evaluating the efficacy of the post surgical and wound care recovery kit.

It's a small device that consists of a thin metal ring that is placed on the skin surface, non-invasively. It's connected with a small battery. When the plastic tag is removed and the button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is created. It influences the receptor-ligand binding at the cell surface and might improve wound healing by diminishing wound edema and inflammation. It possibly helps reducing the inflammatory reaction induced by surgery.

Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at the time of bandage, a kit will be applied at the level of the incision. One group will at random receive a working device, the other half will have a kit without active electromagnetic field.

Postoperative analgesic consumption will be measured in a diary and pain and quality of life will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.

The aim of this study is to evaluate whether the placement of the device reduces the acute postoperative pain and whether it reduces the incidence of chronic groin pain.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient
* Primary, unilateral and bilateral groin hernias

Exclusion Criteria:

* No written informed consent
* Recurrent hernias
* 'Incarcerated' hernias
* pregnant women: reaction of a Pulsed Electromagnetic Field on the foetus is unknown
* Patients with pacemaker or Internal defibrillator

Primary outcomes:
measure: Postoperative analgesic requirement after 1 week.
timeFrame: 1 week after the surgery.
Secondary outcomes:
measure: chronic pain at 3 months post-surgery.
timeFrame: 3 months post surgery.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References: