louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03532477: Bariatric Surgery and Pharmacokinetics of Venlafaxine
Official title: Bariatric Surgery and Pharmacokinetics of Venlafaxine: BAR-MEDS Venlafaxine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Venlafaxine Hydrochloride
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: 2018-05-22
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 the pharmacokinetic effects of bariatric surgery on venlafaxine are investigated.


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: Venlafaxine 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 NCT05020977: Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure
Official title: Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Work-Related Condition
Lead sponsor: Jonkoping University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses and paramedics employed in the ambulance organisation.

Brief summary: The aim is to describe physical activity and blood pressure during work and leisure time among Swedish ambulance personnel, and to relate this to work- and lifestyle factors.

Detailed description: The work environment for ambulance personnel consists of several factors that might have negative effect on health, for example shift work, long working hours, stress and physical demanding work. Associations between these work-related factors and increased risk of disease, for example cardiovascular- and musculoskeletal disease, have been observed in several studies. However, few studies have specifically been focusing on ambulance personnel.

There is lack of knowledge regarding how work environment factors affect physical activity during work and leisure time among ambulance personnel. Further, the knowledge about blood pressure during work and leisure time is limited for this group.

Eligibility criteria: Inclusion Criteria:

* Employed in the ambulance organisation at the time for data collection

Exclusion Criteria:

* Managers and administrative personnel in the ambulance organisation

Primary outcomes:
measure: Blood pressure
timeFrame: 48 hours
Secondary outcomes:
measure: Physical activity
timeFrame: 7 days
measure: Recovery
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Health
timeFrame: baseline, pre-intervention/procedure/surgery
Other outcomes:
Locations:
city: Jonkoping
country: Sweden
facility: Jonkoping University, School of Health and Welfare
Study officials:
affiliation: Jonkoping University
name: Eleonor I Fransson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145053: Drug Use Survey of RESPIMAT in Patients With COPD
Official title: Long Time Survey of RESPIMAT in Daily Clinical Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 361
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300

Brief summary: To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.


Eligibility criteria: Inclusion criteria:

Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.

Exclusion criteria:

There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Week 52
Secondary outcomes:
measure: Effectiveness
timeFrame: Week 52
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Week 0 and Week 52
measure: Cough Frequency
timeFrame: Week 0 and Week 52
measure: Amount of Sputum
timeFrame: Week 0 and Week 52
measure: Shortness of Breath
timeFrame: Week 0 and Week 52
measure: Nocturnal Sleep
timeFrame: Week 0 and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05273853: Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality
Official title: Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypernasality
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.

Detailed description: Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed

Eligibility criteria: Inclusion Criteria:

1. Patient with symptoms of adenoid hypertrophy.
2. High risk to VPI:

   1. Short palate.
   2. Scarred palate after previous tonsillectomy.
   3. Occult submucous cleft.
   4. Deep pharynx.
   5. Repaired cleft palate.

Exclusion Criteria:

* Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).

Primary outcomes:
measure: Speech Outcome
timeFrame: 1 month after operation
measure: Speech Outcome
timeFrame: 3 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag Faculty Of Medicine
name: Mohammed AE Ahmed, Professor
role: STUDY_CHAIR
References:
citation: Rowe MR, D'Antonio LL. Velopharyngeal dysfunction: evolving developments in evaluation. Curr Opin Otolaryngol Head Neck Surg. 2005 Dec;13(6):366-70. doi: 10.1097/01.moo.0000186204.53214.62.
Clinical trial NCT05045053: Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking
Official title: Efficacy of Xiidra in the Management Dry Eye Disease After Corneal Collagen Cross Linking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Corneal Disease
Keywords: dry eye
cross linking
xiidra
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 40
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: dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.

Detailed description: first group of patients were treated with 0.5 % xiidra twice daily and artificial tears for 6 months.Second group treated with artificial tears for 6 months. the treatment starts after corneal collagen cross linking in both groups ,Baseline and post-treatment full ophthalmic examination was done.

Eligibility criteria: Inclusion Criteria:

* corneal collagen cross linking

Exclusion Criteria:

* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers

Primary outcomes:
measure: Change in Break up Time
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: Tarek Elhamaky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380653: Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes
Official title: A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemias
Myelodysplastic Syndromes
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest or, (B) 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest.

Evaluated doses in schedule A: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg Evaluated doses in schedule B: 375mg, 425mg and 475mg
Primary purpose: TREATMENT

Brief summary: The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

Detailed description: The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

Eligibility criteria: Inclusion Criteria:

* Adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities.

Exclusion Criteria:

* Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV positive

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: Through study completion, average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cyclacel Pharmaceuticals, Inc.
name: Judy H Chiao, MD
role: STUDY_DIRECTOR
References:
citation: Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Ravandi F, Westwood R, Green SR, Chiao JH, Boone PA, Cortes J, Plunkett W. Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome. J Clin Oncol. 2010 Jan 10;28(2):285-91. doi: 10.1200/JCO.2009.25.0209. Epub 2009 Nov 23.
Clinical trial NCT04402853: SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients
Official title: SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Tear
Keywords: COVID 19
EYE
Tears
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia

Brief summary: Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.

Detailed description: Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.

At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.

The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions

Eligibility criteria: Inclusion Criteria:

* Hospitalized COVID 19 patients

Exclusion Criteria:

* Patients with respiratory support that interferes with tears sampling

Primary outcomes:
measure: Virus presence in COVID 19 patients tears
timeFrame: 1 day
Secondary outcomes:
measure: Concordance to Naso-Pharingeal Swab
timeFrame: 1 day
Other outcomes:
Locations:
city: Varese
country: Italy
facility: ASST Sette Laghi
Study officials:
affiliation: University of Insubria, Varese
name: Simone Donati, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.
citation: Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.
Clinical trial NCT00384553: Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Official title: Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.

Detailed description: Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.

Eligibility criteria: Inclusion Criteria:

* first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
* pretreatment with systemic therapy
* 18-65 years of age
* Performance status:ECOG 0-2
* Granulocyte count \>1.5/µm3, Platelet count \>100/µm3
* Creatinine -Clearance ≥ 1 ml/sec
* GPT/GOT ≤ 1.5 x normal (except tumour related)
* Bilirubine \< 22 µmol/l
* no participation in another study 3 month before and during this study
* informed consent

Exclusion Criteria:

* Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
* CNS- involvement by lymphoma
* respiratory Partial- or global insufficiency
* cardiac insufficiency (NYHA-Stage 3-4, EF \< 30 %)
* severe neurological or psychiatric disease
* pregnancy
* HIV positivity ,active virus hepatitis, bacterial infection
* No follow up procedures ensured

Primary outcomes:
measure: Toxicity
Secondary outcomes:
measure: remission rate
measure: remission duration
measure: overall survival
measure: relapse free survival
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University of Magdeburg
Study officials:
affiliation: University of Magdeburg
name: Michael Koenigsmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00604253: Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
Official title: Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 362
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.


Eligibility criteria: Inclusion Criteria:

* Duration of type 2 diabetes mellitus for at least one year
* Insulin naive patients
* OHA treatment for at least 12 weeks
* HbA1C between 7.5-10.0%
* Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods

Primary outcomes:
measure: HbA1c
timeFrame: after 36 weeks of treatment
Secondary outcomes:
measure: Plasma glucose profiles
measure: Incidence of hypoglycaemic episodes
measure: Adverse events
measure: Insulin antibodies
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
citation: Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.