louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00548067: Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
Official title: A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.


Eligibility criteria: Inclusion Criteria:

- Patients diagnosed as hypertensive

* Untreated confirmed hypertensive patients (consistent SBP \>140 mm Hg or DBP \>90 mm Hg)
* Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on one drug therapy.
* Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on two drug therapy.

Exclusion Criteria:

* Inability to switch from all prior antihypertensive medications safely as required by the protocol.
* Need for drugs other than study drugs at the time of baseline.
* Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
* Patients on four or more antihypertensive drugs at screening.
* Pregnant or nursing (lactating) women.
* Patients with diabetes mellitus
* Patients with heart diseases and any other disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Potential drug interaction and effect on blood level of drugs when co-administered for 17 days
Secondary outcomes:
measure: Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Novartis Investigative Site
city: Bangalore
country: India
facility: Novartis investigative site
city: Hyderabad
country: India
facility: Novartis Investigative site
city: Mangalore
country: India
facility: Novartis Investigative site
city: Mehasana
country: India
facility: Novartis investigative site
Study officials:
affiliation: Novartis investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816867: Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
Official title: Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: hernia
Treatment
laparoscopic
open technique
Lead sponsor: be Medical
Sponsor class: INDUSTRY
First posted: 2013-03-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a ventral hernia

Brief summary: The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years
* Written informed consent is obtained from patient
* Patient with a primary or incisional ventral hernia

Exclusion Criteria:

* Patient with a recurrent ventral hernia
* Patient with ASA class 5 and 6
* Patient underwent emergency surgery
* Patient is pregnant
* Patient with a known allergy to components of the ePTFE prosthesis
* Patient has a life expectancy less than 1 year
* Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors

Primary outcomes:
measure: Recurrence rate at 12 months determined by clinical examination
timeFrame: 12 months
Secondary outcomes:
measure: Intraoperative complications
timeFrame: peri-procedural
measure: Post-operative complications
timeFrame: up to 30 days
measure: Seroma
timeFrame: 1 month
measure: Freedom from hernia-related reinterventions
timeFrame: 12 months
measure: Late complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Kurt Van der Speeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wen W, Majerus B, Van De Moortel M, Lobue S, Fobe D, Philippart P, Berwouts L, Coteur J, Gabriels K, Van der Speeten K. Laparoscopic ventral hernia repair using a composite mesh with polypropylene and expanded polytetrafluoroethylene: a prospective, multicentre registry. Acta Chir Belg. 2017 Oct;117(5):295-302. doi: 10.1080/00015458.2017.1313526. Epub 2017 Apr 25.
Clinical trial NCT01906567: İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Pre-eclampsia
Severe Preeclampsia
Keywords: cadmium
lead
mercury
preeclampsia
pregnancy
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with preeclampsia

Brief summary: The purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.

Detailed description: The unfavorable effects of heavy metals on human health is well known. The main threats to human health from heavy metals are associated with exposure to lead, cadmium, mercury and arsenic. They may be toxic at the levels previously thought to have no adverse effect on human.In utero environmental exposures can have long term consequences to health and development.İn spite of what is known about the neurotoxicity from exposure to heavy metals, the health effects from co-exposure to these chemicals and the biologically effective doses are not known exactly.

Preeclampsia is associated with increased maternal and infant mortality and morbidity. The exact etiology is not clear. Several evidences indicate that various environmental factors and elements may play a role in pre-eclampsia.

significant increase in Pb, cadmium (Cd), copper (Cu) and magnesium (Mg) and decrease in zinc (Zn) in amniotic fluid are associated with preeclampsia. Pb as this metal has well known adverse effects on renal system and blood pressures Effects of Pb on reproductive system have been studied intensively, e.g. other pregnancy outcome and pregnancy hypertension.

However, the relationship between the severity of pre-eclampsia and heavy metal levels have not been investigated.

The purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

Exclusion Criteria:

known chronic disease multipl pregnancies

Primary outcomes:
measure: increased levels of heavy metals in preeclamptic women
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Education and Research Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: ayse kirbas, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454167: Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications
Official title: Acid Base and Electrolytes Patterns in Drains of Different Operational Wounds and Its Relation to Specific Infections and Seroma Formation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wounds
Infections
Seroma
Keywords: vacum drains
operational wounds
infections
seroma
acid base
glucose
lactate
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all post operational patients who have a vacuum drain/s

Brief summary: Objective- The purpose of this study is to evaluate a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic operational wounds and its relation to infections and seroma formation.

Detailed description: our objective is evaluation of a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacum drains of different plastic operational wounds and its relation to infections and seroma formation.

it is possible that early changes in this values might point out an infection or seroma formation of a wound before clinical signs appear.

Eligibility criteria: Inclusion Criteria:

* all post operational patients who have a vacum drain/s

Exclusion Criteria:

* patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...)
* patients who refuse participation

Primary outcomes:
measure: Histological confirmation
timeFrame: end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: carmel medical center- ISRAEL
name: Nir Gal Or, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419367: Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)
Official title: Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lymphoma, T-Cell, Cutaneous
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and

continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.

The extension phase will begin as soon as the protocol amendment is implemented.


Eligibility criteria: Inclusion Criteria:

* Advanced cutaneous T-cell lymphoma on or following two systemic therapies
* Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
* Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
* Male participants must agree to use 2 adequate barrier methods of contraception
* To be treated on extension phase of study participant must have been treated on the base study for Protocol 042

Exclusion Criteria:

* Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
* Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
* Pregnant or lactating
* Known allergy to any component of the study drug
* Eligible for any other study of vorinostat in CTCL patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04972240: Stability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant
Official title: Evaluation of Stability, Marginal Bone Loss and Occlusal Load Analysis of Customized Posterior Hybrid PEEK Abutments Supported by Short Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Marginal Bone Loss and Loss of Osteointegration of Short Implant
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2021-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant

Detailed description: although short implant solved many clinical problems; it is sometimes associated with loss of osseointegration which is firstly expressed by peri-implantitis and marginal bone loss. Also, PEEK is a very promising material characterized by low modulus of elasticity thus it can act as a shock absorber. Whether constructing superstructure components of short implant from PEEK will improve their performance or not is lacking in the dental literature.

To conduct the present study, the following will be used:

1. Customized screw retained PEEK abutment/crown on a Ti base.
2. Prefabricated titanium abutment.
3. Short implant. The study will be conducted on 12 patients with missing single posterior tooth indicated for short implants) near anatomical structure or atrophic ridge), attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.

Eligibility criteria: Inclusion Criteria:

* 1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.

Exclusion Criteria:

* 1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.

Primary outcomes:
measure: decrease marginal bone loss around short implant
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
Study officials:
References:
Clinical trial NCT01615640: Diffusion Study on Patients With Osteosarcoma
Official title: Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma
Keywords: Osteosarcoma
Response of chemotherapy
Dynamic contrast medium examination
Diffusion-weighted MR imaging
Lead sponsor: Klinikum Stuttgart
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
First posted: 2012-06-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.

Brief summary: The aim of the study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.

Detailed description: Dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging have the potential to measure early cellular and vascular changes that occur in response to chemotherapy and could therefore be early predictors of therapeutic response.

Aim of our study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR imaging in evaluating response to chemotherapy during the preoperative treatment of osteosarcoma. Patients will undergo dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging before, during and after chemotherapy.

Our long-term goal is to use these imaging techniques to develop non-invasive methodologies that would be better predictors of tumor response than the current clinical standard and earlier predictors than histological evaluation of the whole tumor.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of osteosarcoma of all entities
* Written informed consent of patient

Exclusion Criteria:

* No written informed consent
* Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
* Severe, active co-morbidity
* Major medical illnesses or psychiatric impairments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
state: Baden-Württemberg
Study officials:
affiliation: Klinikum Stuttgart
name: Thekla von Kalle, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03568240: Voice Acoustic Properties in People With Obstructive Sleep Apnea Syndrome (OSAS)
Official title: Voice Acoustic Properties in People With OSAS (Obstructive Sleep Apnea Syndrome)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-06-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 men patients

Brief summary: The aim of this study is to examine whether voice acoustic properties has an influence on sleep apnea. Sleep apnea syndrome is defined as a sudden stop of more than ten seconds multiple times during sleep. The syndrome is common especially among men and occurs in 2%-4% of the population aged 30-60. The syndrome diagnosis is performed by an ENT (Ear, Nose and Throat) physician. The diagnosis is based on evaluation of anatomical structures in the sound path (nose and throat, jaw, pharynx and oral cavity) and a Polysomnography (PSG) test which quantifies the number and duration of breathing pauses during night sleep and additional parameters that monitor sleep. The syndrome has many negative consequences for those who suffer from it, including fatigue , lack of concentration, hypertension, diabetes ,heart disease, stroke and even death. Therefore, early diagnosis is important.


Eligibility criteria: Inclusion Criteria:

* 18 years and older men who meet the criteria for disorders such as apnea.
* 18 years old men and older who meet the criteria of snores based on screening questionnaires.
* 18 years old men and older who don't suffer from disorders such as apnea and do not suffer from snoring.

Exclusion Criteria:

* Smoking Patients or smoked in the past.
* Having neurological disorders.
* Having swallowing trouble.
* Having Respiratory problems.
* Having Neuroendocrine problems.
* Having Voice disorders.
* Patients who were previously head or/and neck operated

Primary outcomes:
measure: Compare differences in acoustic properties of phonetics i,a,u, n,m
timeFrame: half hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Itzhak Braverman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906840: Role of Turmeric on Oxidative Modulation in ESRD Patients
Official title: Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Failure
Keywords: Chronic renal failure
Hemodialysis
Oxidative stress
Turmeric
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite advances in prevention of cardiovascular diseases, the incidence of accelerated atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is considered as a major player in uremia associated morbidity and mortality in HD patients. The aim of this study was to evaluate the effects of turmeric on oxidative stress markers in HD patients.

Detailed description: End-stage renal disease (ESRD) is a state of oxidative stress, due to uremic oxidant mediator's accumulation, the activation of phagocytic oxidative metabolism by the dialysis membrane, intravenous iron therapy and the antioxidant depletion caused by hemodialysis (HD). Some trials showed a significant benefit from antioxidant therapy on cardiovascular outcome in HD patients.

Extensive research focused on direct exogenous antioxidants including vitamin C, and vitamin E, in the treatment of cardiovascular disease. Some clinical trials showed no more beneficial effect of exogenous antioxidant supplementation in cardiovascular disease (CVD) and recommended the necessity for a new approach to regulating cellular redox status.

Turmeric (Curcuma longa Linn) is an herb used as a dietary spice and in traditional medicine for centuries. Curcumin, the most active and non-toxic component of turmeric, is a polyphenol, which has been extensively studied for its therapeutic benefits, such as antioxidant. Besides, turmeric has also been effective in attenuation of proteinurea in diabetic nephropathy and lupus nephritis patients.

Curcumin restored the activities of mitochondrial enzymes complexes and thereby attenuated the release of reactive oxygen species. Turmeric appears to be non-toxic to humans even at high doses. However, there is a paucity of information on the effect of turmeric in HD population. We have, therefore, followed up this study to determine the beneficial effect of turmeric on oxidative stress in HD patients.

Eligibility criteria: Inclusion Criteria:

* having the age of 18 years and more,
* receiving 4-hour HD treatments 3 times per week at least for three months,
* administering no other antioxidant medications

Exclusion Criteria:

Primary outcomes:
measure: effects of turmeric on oxidative stress markers
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: