cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Primary Objective:

- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \< 140 mmHg and Diastolic blood pressure \<90mmHg, at the end of the study

Secondary Objectives:

* To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
* To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 mmHg) of the different dose groups over time
* To determine the incidence and severity of adverse events.

16 weeks

* V1 (week 0): Inclusion visit.
* V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit
* V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,
* V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg
* V5 (Week 16): End of study visit

Eligibility Criteria:
Inclusion criteria :

* Men and women ≥18 years old
* Established essential hypertension
* Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks
* With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements)
* Signed written informed consent obtained prior to inclusion to the study

Exclusion criteria:

* Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on Visit 1
* Known or suspected causes of secondary hypertension
* Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only has one functioning kidney
* Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination
* History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt)
* Severe renal impairment (glomerular filtration rate \<30 ml/min)
* Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine
* Administration of any other investigational drug within 30 days before inclusion
* Presence of any other conditions that would restrict or limit the patient participation for the duration of the study
* Pregnant or breast feeding women
* Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period
* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Influence of GVS on Mental Transformation

Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation.

The investigators here examine in healthy participants, whether there are shared brain mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric transformation, as well as their interaction.

It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation.

Theories of embodied mental rotation suggest overlapping processes between real body and egocentric mental transformations. Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation. Yet, no study so far has investigated which cortical areas are involved in vestibular processing and/or illusory self-motion and mental transformation tasks within the same participants. This however seems crucial, as important individual differences exist for both mental transformation abilities as well as in subjective perception of artificial vestibular stimulation.

The primary objective is to reveal which brain area(s) are involved in the interaction of illusory self-motion (as induced by galvanic vestibular stimulation (GVS)) and egocentric mental transformation, as compared to no illusory self-motion or object-based mental transformation. It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation more than object-based mental transformation.

As previous behavioral studies on such an interaction were always done in a sitting position, a secondary objective is to first replicate previous behavioral mental rotation studies that used GVS, in the Magnetic Resonance (MR) -scanner comparable setting. Moreover, as no brain imaging study so far has investigated subjective illusory motion experience induced by GVS, illusory self-motion will be measured and included in the statistical model to find specific brain regions modulating the illusory self-motion perception.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Written informed consent by the participant
* Right handed

Exclusion Criteria:

* possession of metallic implants, cardiac pacemakers, neuro-stimulators, metal splinter injuries
* claustrophobia
* no ability to lie still in the scanner, e.g. a cold leading to frequent sneezing and subsequent head movements
* history of neurological or psychiatric disorder
* hearing problems
* concomitant medication
* strong motion sensitivity
* vestibular deficits
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.


Eligibility Criteria:
Inclusion Criteria:

Mother:

* Pregnant woman (monofetal or twin pregnancy, whatever the parity)
* Age\> or = to 18 years
* Person affiliated to a social security system
* Person who read and understood the information form and signed the consent form

  * Alcohol exposure group Chronic consumption of at least 30 g of alcohol per week or acute consumption of "binge drinking" type during pregnancy (knowing that a unit of 10 g of pure alcohol corresponds to 25 cl of beer 4 ° 5, 10 cl of wine at 12 °, 3 cl of whiskey, 7 cl of Porto ...)
  * Control group No alcohol consumption during pregnancy
  * Child Informed parents and written consent signed by the father and mother for the child's participation in this research (unless one of the parents does not have parental authority)

Exclusion Criteria:

* Female under 18
* Pregnant woman with clinical suspicion of pre-eclampsia and / or HELLP syndrome
* Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)
* Patient participating in another interventional trial or who participated in another interventional trial during pregnancy
Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms

The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge).


Eligibility Criteria:
Inclusion Criteria:

- Neuropathic pain \> 3 on a 0-10 NRS.

Exclusion Criteria:

* Psychiatric or competing neurological disorders.
* Known allergies to any medications, including local anesthetics.
Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

57 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Glaucome Schafer 1 to 4
* Medicated IOP ≥ 21
* naive of any glaucoma surgery

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia

RATIONALE: New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colorectal neoplasia.

PURPOSE: Diagnostic study to compare the effectiveness of computerized tomographic colonography with that of standard diagnostic procedures in detecting colorectal neoplasia.

OBJECTIVES: I. Compare retrospectively the accuracy of computerized tomographic colonography (CTC) vs pathology and colonoscopy in the detection of clinically important colorectal neoplasia, defined as at least one proven lesion with a diameter measuring at least 1 cm. II. Compare the physician image display preferences and interpretation time across three viewing platforms for CTC images.

OUTLINE: This is a retrospective, multicenter study. Radiologists evaluate each patient's optimal diagnostic computerized tomographic colonography (CTC) data. Patients' CTC findings are evaluated by a radiologist at a central facility using an imaging display software platform from General Electric, Vital Images, or the Mayo Clinic. CTC findings are compared with conventional colonoscopy findings and pathologic analysis. A comparison is made between physician image display preferences and interpretation time across three viewing platforms for CTC images.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: The following case material must be submitted for each patient: No colonic diseases except polyps, cancer, or diverticulosis Optimal diagnostic computerized tomographic colonography (CTC) data with computed tomography acquisition parameters that meet the following minimal standards: Slice thickness no greater than 5 mm Reconstruction interval no greater than 3 mm Pitch no greater than 2 Anatomic coverage of the entire colorectum Supine and prone data sets Complete colonoscopy performed within 30 days following CTC by a board certified gastroenterologist or a physician with at least 3 years of colonoscopic experience Pathology reports for all endoscopically or surgically removed colorectal lesions with the exception of polyps that are inadvertently dropped at the time of retrieval Photograph or videotape record of dropped lesion allowed as proof of its existence All studies are allowed including those with lesions less than 1 cm, lesions at least 1 cm, or no lesions Report documents size, site, stage, grade, and type of colorectal cancers; size, site, degree of dysplasia, and type of colorectal adenomas; and types of other lesions (e.g., inflammatory, vascular, ulcerative) Demographic data including patient's age, sex, ethnic background, symptoms, risk factors, and relevant clinical history

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Acromegaly: Patient And Physician Perspectives

The purpose of the study is to assess the experiences of individuals with acromegaly who are receiving injections as part of their treatment regimen. Another objective of the study is to compare the patients' perception with their doctors' perceptions. The answers are important to help researchers and physicians understand what it is really like to take currently available treatments so that they can make efforts to improve patients' healthcare experiences, reduce treatment burden and, ultimately, improve patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years-old and \<95 years-old
* Patient self-reported acromegaly diagnosis which will be further confirmed by a knowledge screening based on current medications and doses
* Currently on injectable Somatostatin analogues (SSA), Sandostatin® LAR or Somatuline® Depot, for \>=12 months
* Have not had a change in dosage of their acromegaly treatment at the time of or since their last office visit
* Have seen their treating acromegaly physician within the past 12 +/-2 months NOTE: This timeframe allows two additional months for scheduling an appointment with their physician, since most patients should see their acromegaly physician at least once every 12 months
* Ability to read and understand English
* Live and receive acromegaly treatments in the US
* Willing to provide signed informed consent

Exclusion Criteria:

* Previous or current participant in Mycapssa® (octreotide capsules) trial
* Use of Pegvisomant (Somavert®) monotherapy
* Use of Pasireotide (Signifor®)
A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 and older undergoing routine cataract surgery.

Exclusion Criteria:

1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.
3. Subjects with previous ocular trauma or intraocular surgery
4. Subjects with sensitivities to steroids.
5. Women who are not post-menopausal or are of child bearing potential will be excluded.
6. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
7. Subjects with best visual potential in the fellow eye worse than 20/60
8. Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.
9. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery
The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes

To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.

The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Gestational age between 28-37 weeks
* Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal

Exclusion Criteria:

* Patients with multiple pregnancies
* Smoker
* Polyhydramnios
* Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection
* History of PPROM in previous pregnancies
* Evidence of chorioamnionitis in current pregnancy
Assessment of Patient Frailty Prior to Thoracic Surgery

Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

Both gastro-esophageal and lung cancers are major causes of morbidity and mortality worldwide. In Canada the incidence for Esophageal Adenocarcinoma has doubled in the last two decades, while lung cancer is the leading cause of cancer death. Surgery is a treatment option for these patients; however, esophagectomy in particular, is associated with significant morbidity, mortality and adverse effect on quality of life. Despite satisfactory standard preoperative testing to evaluate risk for surgery, some patients experience morbidity and never recover fully from surgery. Frailty assessment may offer a more sensitive measure of a patient's physiologic reserve, which may allow identification of patients who are poor candidates for surgery. There is a lack of consensus of how best to assess frailty prior to surgery. This study aims to analyze frailty assessment as a tool for patient selection for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Esophageal or Lung Cancer who will undergo resectional surgery.

Exclusion Criteria:

* Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded.
* Patients unable to give informed consent
Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Treated hypertension
* Have at least 20 natural teeth
* Presence of any form of periodontal diseases according to guidelines
* Absence of other significant oral infections.

Exclusion Criteria:

* Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
* Individual is pregnant or nursing
* Primary pulmonary hypertension
* Professional oral hygine within past 6 months
* Flu, rhinitis, sinusitis etc. within past 4 weeks
* Use of antibiotics within past 4 weeks
* Hospitalization for any reason within the past 3 months
* Allergic disorders; History of chronic infectious disease,
* Chronic hepatitis B or C infection
* Chronic Obstructive Pulmonary Disease (COPD), tuberculosis
* Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
* Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
* History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
Normal Range of TSH and FT4 in Pregnancy

Physiological changes necessitate the use of pregnancy-specific reference ranges for thyrotrophin (TSH) and free T4 (FT4) to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.

The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs.

The investigator's objective is to establish a rational reference range of serum TSH for the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the Sancaktepe region in Turkey.

Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in the first, second, and third trimester to determine the local specific normal ranges.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Free of pre-existing thyroid disease
* That do not use thyroid interfering medication
* That did not undergo IVF treatment
* TPOAb negative

Exclusion Criteria:

* Adolescent pregnancy
* Patient with pre-existing thyroid disease
* TPOAb positive
* Patient using thyroid interfering medication
* That had IVF treatment
PGL2001 Proof of Concept Study in Symptomatic Endometriosis

This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to initiation of any study related procedures.
* Be a woman of reproductive age between 18 and 45 years inclusive.
* Present with clinical signs suggestive of endometriosis.
* Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion Criteria:

* Be pregnant or currently lactating.
* Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
* Have had any surgical treatment for endometriosis within the last 12 months.
* Have documented significant adenomyosis.
* Have participated in another clinical trial within the 30 days prior to the screening visit.