louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01374477: Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity
Official title: Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Keywords: Preeclampsia in Adolescence
Adolescent
Primipaternity
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 110
Sex: FEMALE
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \< 19 years old who delivered in our institution.

Brief summary: Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy, being a serious health problem around the world.

Previous studies have suggested that there is an association between a short period of exposure to paternal sperm of a new sexual partner and the development of an immunological reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to study the relationship between the primipaternity concept (exposure to male antigens present in semen over a short period of time previous to the pregnancy) and the development of preeclampsia in adolescents.


Eligibility criteria: Inclusion Criteria:

* 19 year old or less
* Pregnancy \> 24 weeks at the moment of delivery

Exclusion Criteria:

* 20 years old or more.
* Pregnancy \< 24 weeks at the moment of delivery

Primary outcomes:
measure: Presence of a primipaternity factor
timeFrame: Two months
Secondary outcomes:
measure: Maternal complications
timeFrame: Two months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957177: Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy
Official title: Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.

Hyperalgesia is measured by von-Frey-Filaments.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective nephrectomy

Exclusion Criteria:

* contraindication against pregabalin
* creatinine \> 2.0 mg/dl
* GGT \>165, AST \>105, ALT \>135
* peptic Ulcus
* haemorrhagic diathesis
* angina pectoris, myocardial infarction
* stroke
* bronchial asthma
* opioid abuse

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Andreas Sandner-Kiesling, MD
role: STUDY_CHAIR
affiliation: Graz Medical University
name: Helmar Bornemann-Cimenti, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384577: Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment
Official title: Multicenter, Open-label, Non-interventional Study (NIS) to Evaluate Patient's Satisfaction and Preference, the Usability of DuoResp® SPIROMAX® and the Impact on Clinical Effects, in the Daily Routine of Asthma and COPD Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 4034
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: Adult asthma or COPD-patients

Brief summary: The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.

Detailed description: The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.

Eligibility criteria: Inclusion Criteria:

* male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
* patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
* patients who recently changed medication to DuoResp® Spiromax or are about to do so
* capacitated person with present declaration of consent

Exclusion Criteria:

* diseases contraindicated in accordance with the summary of product characteristic
* patients who take part in interventional clinical trials parallel or during the last 4 weeks
* patient shows conditions or diseases that might disturb the monitoring according to the physician
* patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
* insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
* patients involved in the planning and construction of the study (Teva staff and employees of the centres)
* patient is incapable of giving consent

Primary outcomes:
measure: Patient Satisfaction and Preference Questionnaire (PASAPQ)
timeFrame: 12 weeks
measure: Practicability of the device
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Teva Investigational Sites
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03308877: Brief Intervention for Justice-Involved Substance Users
Official title: Brief Intervention for Justice-Involved Substance Users: Moderators and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Violence
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-10-13
Enrollment: 132
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 is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.


Eligibility criteria: Inclusion Criteria:

* In Monroe County Pretrial Services Program

Exclusion Criteria:

* none

Primary outcomes:
measure: Percent Days Abstinent
timeFrame: 6 months
measure: Substance Use Consequences (SIP-AD)
timeFrame: 6 months
measure: Violent Charges
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pretrial Services, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05881577: The Effect of Allergic Rhinitis on Educational Outcomes
Official title: The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Ernst & Young
First posted: 2023-05-31
Enrollment: 150000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: children who have been diagnosed with AR before turning 13

Brief summary: The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark.

Detailed description: The aim of the study is to investigate the effect of AR on school performance and examination test grades for children and adolescents diagnosed with AR early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive Danish population registers. This is a retrospective registry analysis that uses Danish registers during 1994 and 2021.

In Denmark, national registers collect data for the entire Danish population from birth to death and have done so for decades. This exhaustive data creates a sound foundation for this study of the impact of school performance caused by AR, as subjects can be traced with high certainty and detail over several years.

Eligibility criteria: Inclusion Criteria:

* The main study population (cases) consists of children who have been diagnosed with AR before turning 13. Diagnosis of AR will be identified by dispensations of prescribed AR medications, ICD-10 codes of AR-related hospitalisations and reimbursement codes for AR-related healthcare contacts in the primary healthcare sector.

At least two dispensed prescriptions of product containing intranasal corticosteroids (INCS) or antihistamines during the same calendar year for two consecutive years OR at least one visit with the primary healthcare sector with registered AR consultations AND at least one dispensed prescriptions of product containing INCS or antihistamines OR at least one contact with the hospital sector with an ICD-10 code for AR (primary or secondary diagnosis).

Exclusion Criteria:

* Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.

Primary outcomes:
measure: Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree
timeFrame: 1994-2021
Secondary outcomes:
measure: Cost of inpatient and outpatient hospitalisation
timeFrame: 1994-2021
measure: Cost of prescription medicine
timeFrame: 1994-2021
measure: Number of inpatient and outpatient visits
timeFrame: 1994-2021
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: ALK Abello
state: Hovedstaden
Study officials:
References:
Clinical trial NCT01019577: Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant
Official title: Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.


Eligibility criteria: Inclusion Criteria:

* Women aged 20 years or older
* Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Primary outcomes:
measure: To assess the tumor response using RECIST Criteria to determine the best overall response and response rate
timeFrame: For a maximum of 9 3-week cycles or until unacceptable toxicity
Secondary outcomes:
measure: To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria
timeFrame: Every cycle
measure: To evaluate the duration of achieved responses
timeFrame: For a maximum of 9 3-week cycles or until unacceptable toxicity
measure: To evaluate time to progression (TTP)
timeFrame: For a maximum of 9 3-week cycles or until unacceptable toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01157377: Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Bladder, Overactive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-07-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* If female, must be of nonreproductive potential
* If male, must agree to use acceptable contraception
* Symptoms of overactive bladder with urinary urgency incontinence
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis)
* History of bladder surgery
* Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
* Previous treatment with botulinum toxin therapy of any serotype for any urological condition

Primary outcomes:
measure: Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
state: Virginia
city: Lyon
country: France
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03448783: Bariatric Surgery and Pharmacokinetics of Apixaban
Official title: Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS Apixaban
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Apixaban
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on apixaban.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Apixaban concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490083: Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL
Official title: Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 80
Sex: ALL
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: Study population will be prospectively enrolled from patients with chronic pancreatitis undergoing ESWL in hospital.

Brief summary: Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal in 70% patients, associated with 85 to 90% pain relief.

Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out which patients will improve and which patients won't improve in terms of pain.

Detailed description: The study will be a single center observational study.

General information of the patient in form of duration of symptoms and duration of diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct stone,size,parenchymal calcification , ductal stricture and its location, using any medications such as antioxidants and pain killers .

The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will receive standard of care during study period, and they won't receive any experimental therapy.

After 6months of ESWL further general information of the patient any addictions, a formal imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and also usage of any medications for decreasing pain.

Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and information investigators will evaluate predictive factors of pain relief after ESWL by logistic regression.

Eligibility criteria: Inclusion Criteria:

* Chronic pancreatitis patients undergoing ESWL

Exclusion Criteria:

* Patients with multiple pancreatic duct stones
* Patients with multiple pancreatic duct strictures
* Pancreatic head mass
* Patients with ascites
* Pregnancy
* Patients not giving consent for participation
* Pseudocyst

Primary outcomes:
measure: Percentage of patients having persistent pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Manu Tandan
state: Telengana
Study officials:
affiliation: Asian Institute of Gastroenterology, Hyderabad, India
name: Nitin Jagtap, MD, DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953883: Proteogenomic Signatures Analysis In Ovarian Cancer
Official title: Proteogenomic Signatures Analysis In Ovarian Cancer, Longitudinal Modification On Tumor Tissue Before And After Platinum-Based Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are prospectively assigned to an intervention consisting of a tumor biopsy.
Primary purpose: TREATMENT

Brief summary: Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients.


Eligibility criteria: Inclusion Criteria:

Newly diagnosed advanced International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater epithelial ovarian cancer addressed to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS);

Availability of freshly frozen tissue and FFPE tissue from both exploratory laparoscopy (baseline) and IDS;

Age between 18 and 80 years;

Estimated life expectancy of at least 4 weeks;

Signed informed consent

Exclusion Criteria:

Non-serous histology at frozen section;

Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment;

Previous diagnosis of cancer within 5 years.

Primary outcomes:
measure: DATA CORRELATION
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Camilla Nero
role: PRINCIPAL_INVESTIGATOR
References: