louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03088254: Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin
Official title: A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia With Hypertension
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 126
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.


Eligibility criteria: Inclusion Criteria:

* Dyslipidemia with hypertesion
* msSBP \< 180 mmHg
* msDBP \< 110 mmHg
* LDL-C ≤ 250 mg/dL
* Triglycerides \< 400 mg/dL

Exclusion Criteria:

* At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
* CK normal range ≥ 2 times
* Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
* AST or ALT ≥ 2 times
* Uncontrolled diabetes mellitus (HbA1c≥9%)
* CLcr \< 30 mL/min/1.73m\^2
* K \> 5.5 mEq/L
* Other exclusion applied

Primary outcomes:
measure: change of LDL-C
timeFrame: baseline and 8 weeks
measure: change of msSBP
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Hospital, Seoul
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
Study officials:
References:
citation: Hong SJ, Jeong HS, Cho JM, Chang K, Pyun WB, Ahn Y, Hyon MS, Kang WC, Lee JH, Kim HS. Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clin Ther. 2019 Feb;41(2):233-248.e9. doi: 10.1016/j.clinthera.2018.12.008. Epub 2019 Jan 18.
Clinical trial NCT05542654: The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension
Official title: Foot Massage Applied to Hypertensive Pregnant Women Bakirkoy Doctor Sadi Konuk Training and Research Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Gestational Hypertension
Chronic Hypertension With Pre-Eclampsia
Superimposed Pre-Eclampsia
Keywords: Gestational hypertension
preeclampsia
foot massage
blood pressure
anxiety
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was conducted as a prospective, experimental and randomised controlled research to determine the effect of foot massage applied to pregnant women with hypertension on blood pressure and anxiety levels.

Detailed description: The sample of the research a total of 80 pregnants, 40 interventions and 40 in the control groups, which were randomly selected from hypertension pregnant women who applied to Health Sciences University Istanbul Bakırköy Doctor Sadi Konuk Training and Research Hospital (BEAH). After the participants were given written and verbal information about the research, the intervention group received a foot massage for three days, 15 minutes on each foot, for a total of 30 minutes, while the control group did not receive foot massage. In the research; Participant Promotion Form which contains questions about general health appearances and socio-demographic, gynecological and obstetric story, Vital Finding Monitoring Form to save blood pressure, pulse and breathing numbers restrained before and after foot massage, State and Trade Anxiety Inventory (STAI) which evaluates the level of anxiety, was used.

Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.

Exclusion Criteria:

* Pregnant women who could not communicate in Turkish were excluded from the study.

Primary outcomes:
measure: Blood Pressure
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Training and Research Hospital
Study officials:
References:
citation: Ejindu A. The effects of foot and facial massage on sleep induction, blood pressure, pulse and respiratory rate: crossover pilot study. Complement Ther Clin Pract. 2007 Nov;13(4):266-75. doi: 10.1016/j.ctcp.2007.03.008. Epub 2007 May 8.
citation: Corrigan L, O'Farrell A, Moran P, Daly D. Hypertension in pregnancy: Prevalence, risk factors and outcomes for women birthing in Ireland. Pregnancy Hypertens. 2021 Jun;24:1-6. doi: 10.1016/j.preghy.2021.02.005. Epub 2021 Feb 14.
Clinical trial NCT02851654: Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms
Official title: Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms (BOSO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Blinking
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-01
Enrollment: 24
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 moderate to severe dry eye syndrome from meibomian gland dysfunction

Brief summary: Dry eye syndrome is a benign situation however its impact on patient's quality of live and on health system is not trivial. One problem is the lack of correlation between patient's symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of increased interest in this pathology particularly its frequency. To date no treatment of dry eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while reading on a screen computer and during a face-to-face interview before and after treatment of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe dry eye syndrome (Ocular Surface Disease Index\> 30) following a meibomian gland dysfunction
* Not yet properly treated for a meibomian gland dysfunction

Exclusion Criteria:

* History of other ophthalmological or neurological disease
* Pregnant or breastfeeding women
* Patient under 18 years old
* Patient under legal protection

Primary outcomes:
measure: duration between 2 blinks
timeFrame: 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References:
Clinical trial NCT01460654: Testosterone and Alendronate in Hypogonadal Men
Official title: Testosterone and Alendronate in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypogonadism
Osteopenia
Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
name: Merck Sharp & Dohme LLC
First posted: 2011-10-27
Enrollment: 44
Sex: MALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 60 or above
* Testosterone \<300 ng/dL
* DXA T score \< -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture

Exclusion Criteria:

* Significant liver or kidney disease
* Elevated prolactin level
* Abnormal TSH
* Abnormal 25-Vitamin D
* PSA \> 2.5
* History of malignancy
* Calcium \> 10.6
* Alkaline Phosphatase \> 150
* Fracture within the last 6 months
* History of acute urinary retention
* Hematocrit \< 32% or \> 50%
* Fracture within the past 6 months
* American Urological Association BPH symptom index \> 21
* Sleep apnea
* Abnormalities of the esophagus which delay esophageal emptying
* Significant cardiopulmonary disease

Primary outcomes:
measure: Percent Change in Spine Bone Density From Baseline to 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01084954: Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
Official title: Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
HIV Infections
Keywords: HIV validation helicase-dependent amplification
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infectious Disease Clinic, HIV Positive patients

Brief summary: Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of \>1.0% would make this test unacceptable as a screening test for HIV viremia.


Eligibility criteria: Inclusion Criteria:

* Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic with known HIV infection
* Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms
* Able to provide informed consent
* 18 Years or older

Exclusion Criteria:

* Patient unable to provide informed consent.
* Pregnancy

Primary outcomes:
measure: Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
timeFrame: Participation will last 1 hour for subjects to consent and provide a single blood sample.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Gary Simon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946954: Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence
Official title: Evaluation of Soft and Hard Tissue Changes Following Immediate Implant Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: : Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique for management of Cases With Labial Plate Dehiscence

Detailed description: In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Eligibility criteria: Inclusion Criteria:

* Non-restorable teeth in the esthetic zone with a defect of labial bone.
* Teeth with no acute inflammation.
* Patients are free from any systemic condition that may affect the healing.
* Availability of bone apical and palatal to the socket to provide primary stability
* Good oral health.
* Willingness to sign the informed consent form.

Exclusion Criteria:

Heavy smoker (\> 10 cigarettes/day)

* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* Acute inflammation in the site of implantation and adjacent tissue.
* A history of radiotherapy in the head or neck region.
* Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation

Primary outcomes:
measure: Bucco/facial-palatal ridge thickness
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic bucco-palatal bone changes
timeFrame: 1 year
measure: 3. Radiographic width of bone labial to the implant
timeFrame: 1 year
measure: Radiographic vertical bone changes
timeFrame: 1 year
measure: Esthetic evaluation (The pink esthetic score)
timeFrame: 1 year
measure: Implant stability
timeFrame: 6 months
measure: Gingival Thickness
timeFrame: 1 year
measure: Width of the Keratinized Tissue
timeFrame: 1 year
measure: Midfacial recession
timeFrame: 1 year
measure: Post-Operative Pain
timeFrame: 7 days
measure: Post-Operative patient's Satisfaction
timeFrame: 1 year
measure: Post-operative swelling
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04841954: Hemp Seed Awareness
Official title: Hemp Seed Awareness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hemp is a plant of the Cannabaceae family. Cannabis sativa, derived from female flowers, is the first illicit substance used by adolescents and is a major public health problem. Its psycho-active effects come from tetrahydrocannabinol (THC).

Unlike recreational cannabis, industrial hemp derived from cannabis sativa has a high level of cannabidiol (CBD) but a negligible level of tetrahydrocannabinol. Its seeds are now consumed in various forms and generate increasing interest. Seeds have many nutritional benefits.

It seems important to take an interest in hemp, given the recent expansion of medical cannabis and the increasing use of cannabis for recreational purposes. It is incriminated in various allergies (contact dermatitis, asthma, rhinoconjunctivitis) but also in the occurrence of anaphylaxis to certain foods by cross-allergy in atopic subjects, in association with an Lipid-Transfer Proteins (LTP protein), present in the flower of Cannabis sativa.

Unlike the allergy to recreational cannabis, the allergenicity of hemp seeds is little studied.

Hemp seed can cause severe anaphylactic reactions. In all reported cases, the prick-tests were positive for the seeds. Often, patients had never been in contact with hemp seeds but had already been exposed to cannabis by respiratory or manual routes.

The investigators hypothesize that sensitization by the skin or respiratory route (cannabis smokers, passive exposure to cannabis, workers exposed to hemp, etc.) could lead to the development of a food allergy to hemp seed.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient referred to the Allergology Unit of the Hospital of Angers, in consultation or in Hospitalization - for conducting prick-tests
* Patient affiliated or beneficiary of a social security scheme
* Patient with informed consent

Exclusion Criteria:

* Pregnant women, parturients
* Persons deprived of liberty by administrative or judicial decision
* Persons receiving psychiatric care under duress
* Adults under legal protection measure
* People out of state to express consent
* people not able to understand French language
* Patients whose skin reactivity prevents interpretation of tests (patients who cannot interrupt anti-histamines or have severe eczema)

Primary outcomes:
measure: Positive prick-test
timeFrame: Day 1
Secondary outcomes:
measure: history of hemp use
timeFrame: Day 1
Other outcomes:
Locations:
city: Angers
country: France
facility: MORISSET Martine
Study officials:
References:
Clinical trial NCT07003854: Effects of Mandibular Advancing Device in Obstructive Sleep Apnea
Official title: Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Mandibular advancing device
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:

Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?

Detailed description: This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older)
* Mild/Moderate obstructive sleep apnea
* Sufficient number of teeth( having at least one terminal molar)
* Healthy teeth and Periodontal ligament
* Good physical and mental capability helping the subjects to be able to deal with the appliance.

Exclusion Criteria:

* Severe OSA,
* Central sleep apnea,
* Pregnant females
* Somatic or psychological disease, or medications for psychological conditions.

Primary outcomes:
measure: change in AHI
timeFrame: frpm enrollment to assessment of outcomes at least 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry AinShams University
state: Abbaseya
Study officials:
affiliation: Ain Shams University
name: Rania Mohamed Magdy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05586854: Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
Official title: Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dialysis; Complications
Heparin-induced Thrombocytopenia
Chronic Renal Failure
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional, prospective, multicentre, longitudinal, non-comparative study.
Primary purpose: TREATMENT

Brief summary: This research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia.

Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age.
* Patient on dialysis in a hemodialysis unit of the Ramsay Santé group.
* Patient with diagnosed heparin induced thrombocytopenia.
* Patient whose dialysis sessions benefit from extracorporeal circulation anticoagulation with Orgaran® or its equivalent (Arixtra® or Arganova®).
* Patient informed and having signed his written consent to participate in the study.
* Affiliated patient or beneficiary of a social security scheme.
* Woman of childbearing age with effective contraception, after verification of the absence of active pregnancy (negative pregnancy test)

Exclusion Criteria:

* Patient whose duration of dialysis is less than 1 month.
* Medically unstable or fragile patient.
* Patient participating in another clinical study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
* Pregnant, breastfeeding or parturient women.
* Patient hospitalized without consent.
* Patient with severe hepatic failure

Primary outcomes:
measure: The occurrence, or not, of a success of the dialytic technique.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References: