cyrilzakka/clinical-trials huggingface dataset:
Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.

Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven sarcoidosis
* Mean pulmonary artery pressure \> 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
* Pulmonary capillary wedge pressure ≤ 15 mmHg
* PVR values ≥ 3.0 Woods units
* Forced vital capacity (FVC) \> 40% predicted
* Forced expiratory volume in 1 second (FEV1) \> 40% predicted
* WHO functional class II or III
* Stable sarcoidosis treatment regimen for three months prior to entry into study
* 6 minute walk distance between 150-450 meters
* Stable dose of antihypertensive medications
* On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study
* Non-pregnant females

Exclusion Criteria:

* Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
* Severe systemic hypertension \> 170/95
* Severe systemic hypotension \< 90/50
* History of priapism
* Patients with congestive heart failure (left ventricular dysfunction) LVEF \< 45% by echocardiogram
* Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
* Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli)
* Use within 1 month of an sildenafil or vardenafil
* WHO functional class IV status
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
* Subjects with liver function abnormalities (ALT or AST \> 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
* Advanced kidney failure (GFR \< 30 ml/min at screening or at baseline)
* History of hypersensitivity reaction or adverse effect related to tadalafil
* Pregnant or lactating women
* Concomitant use of nitrates (any form) either regularly or intermittently
* Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
* Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above
Valproic Acid Sodium Salt in Bipolar Disorder

* To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug;
* To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels.
* To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups.
* To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls;
* To determine the relationship between these effects of valproate and clinical improvement;
* To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview,
* being currently euthimic (for at least one month), manic-hypomanic and having YMRS points of 15 or more, or being in depressive episode and having HAM-D21 points of 15 or more
* being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)

Exclusion Criteria:

* female who are pregnant or planning to be pregnant, nursing
* having known hypersensitivity to study drug
* being given any psychotropic agent other than benzodiazepine within the last two weeks
* active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month)
* having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder
* having unstabilised hepatic or renal disorder, thyroid or blood disease
* having history of cerebral surgery
* existence of a degenerative neurologic disease or epilepsy
* having pacemaker
* having a prosthesis able to magnetic effect in eye, brain or sites near to these regions
* homicide thougths or severe catatonia required to be hospitalized
* having mixed episode

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?

Glucocorticoids and especially cortisol exhibit a pronounced diurnal variation. Levels peak around 8 am and may decrease around two to three times during the day reaching a nadir during the evening and early in the night.

Ovulation has been described as a controlled inflammatory event. Following release of the oocyte, termination of the inflammatory reaction needs to take place in order for the follicle and the developing corpus luteum to avoid further damage. It has been suggested, that locally enhanced cortisol availability may play a role in limiting tissue damage and by acting as anti-inflammatory agents mediating repair and remodeling. The aim of the present study is evaluate the concentration of cortisol and cortisone in sets of serum and follicular fluid samples collected simultaneous and at different times of the day (8.00 a.m. and 8.00 p.m.) and compare the levels with the time of the day at which they are collected.


Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF / ICSI - treatment

  * Age ≥ 18 years and ≤ 35 years
  * Body weight: 19 - 29 kg/m2
  * Ovarian reserve parameters in the adequate age - range, determined by Anti-Muellerian-Hormone (AMH) and Antral Follicle Count (AFC) (Shebl 2011, Hamdine 2015)
  * Regular cycle (25-35 days)

Exclusion Criteria:

* Age \< 18 years and \> 35 years

  * Body weight \< 60 kg and \> 90 kg
  * Ovarian reserve parameters outside the adequate age - range, determined by Anti-Muellerian-Hormone (AMH) and Antral Follicle Count (AFC) (Shebl 2011, Hamdine 2015)
  * Proven poor responder in preceding IVF-treatment-cycle, according to the Bologna criteria: at least two of the following three features must be present:

    (i) Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response) (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol) (iii) An abnormal ovarian reserve test (i.e. AFC \< 5-7 follicles or AMH \< 0.5 -1.1 ng/ml)
  * Two episodes of POR after maximal stimulation are sufficient to define a patient as a poor responder in the absence of advanced maternal age or abnormal ORT
  * Diagnosis of polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
  * Endometriosis stage 3 or 4 AFS (American Fertility Society)
  * Irregular cycle (\< 25 days and \> 35 days)
  * Treatment with GnRH-analogues during the previous 6 months
  * Intake of contraceptive pill (OCP) or any hormonal treatment during the last 3 months
Treatment Outcome of Uveitis in Autoimmune Diseases

reviewing the outcomes of patients with uveitis caused by autoimmune diseases treated at Assiut University Hospital at the Ophthalmology and Rheumatology and Rehabilitation Departments.

Autoimmune uveitis (AU) is an inflammation of the uvea caused by either an autoimmune reaction to self-antigens or an innate inflammatory reaction secondary to an external stimulus. Corticosteroids are considered the gold standard in management of acute AU, but it is necessary to combine them with other immunosuppressive drugs. Finally, biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab) are also showing very promising results. Follow-up visits of subjects with uveitis must be frequent and focused on monitoring the recurrence of acute outbreaks, , if any. They should be aimed to determine the evolution of inflammatory signs until their complete resolution, thus ensuring the least possible consequences. After the initial phase of the treatment, the duration of use of the maintenance medication is directly related to the diagnosis, treatment and control of the underlying disease. This will help to determine if a patient is badly controlled and requires a more aggressive therapeutic plan. Also, a complete physical exam must be done each time the patient sees to the physician in order to monitor ophthalmological complications or development of adverse effects secondary to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Uveitis with clinical features of autoimmune disease;

Exclusion Criteria:

* Other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;
The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial

A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual \[TAU\] (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 16 years or more
* Able to read and write in an Arabic
* Able to consent
* Diagnosed with schizophrenia
* Volunteers

Exclusion Criteria:

* Learning disability
* Not able to read or write
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.

TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

Exclusion criteria:

1. CVC in place for \>72 hours
2. Patient requires anticoagulation for other indications
3. Concomitant use of dual antiplatelet therapy
4. Major bleeding event in the last 4 weeks
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
6. Known pregnancy or plan to become pregnant in next 3 months
7. Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
9. Known thrombocytopenia (platelet count \< 50x 109/L) in the previous 3 months
10. Known allergy to rivaroxaban
11. Life expectancy \<3 months
12. History of condition at increased bleeding risk including, but not limited to:

    1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
    2. Chronic hemorrhagic disorder
13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
14. Refused or unable to obtain consent
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.


Eligibility Criteria:
Inclusion Criteria:

* Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery

Exclusion Criteria:

* Allergy to Aminoglycosides
* Patients who received Aminoglycosides treatment less than one month prior the surgery
* Pectoralis major flap reconstruction
* Latissimus dorsi flap reconstruction
Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Participants

The primary objectives of this study are to evaluate the effect of AMG 510 on the pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of metformin on the PK of AMG 510 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
2. Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
3. Females of nonchildbearing potential.

Exclusion Criteria:

1. Inability to swallow oral medication or history of malabsorption syndrome.
2. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
3. Poor peripheral venous access.
4. History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
Volumetric Analysis of Resorption Types on CBCT

More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.

The aim of this study was to investigate the volumetric and linear analysis, and to present the axial classification of root resorptions using cone beam computed tomography (CBCT).

A total of 43 teeth of external cervical resorption (ECR) (n=27), external replacement resorption (ERR) (n=4) and internal root resorption (IRR) (n=12) were identified from 34 patients. The volume of resorption and total tooth, the widest lengths of these resorptions, and the amount of thinnest dentin thickness around them were measured and compared according to age and sex. Additionally, the eight regional axial classification was performed and the percentages in these regions were evaluated. Significance was set at p=0.05 for statistical analysis.

More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.

Eligibility Criteria:
Inclusion Criteria:

* Cases of resorption that had CBCT images

Exclusion Criteria:

* those presenting pathologic lesions, congenital/developmental anomalies or teeth with root canal filling
* those whose CBCT scans failed to present satisfactory quality.
* Additionally, SR, TAP, and EIR cases were excluded because their true dimensions could not be completely determined before resorption.
Effectiveness of Scaling and Root Planing in Deeper Pockets

This study will retrospectively evaluate the outcomes of scaling and root planing over a two year time period. The study will focus specifically on the effectiveness of SRP in pockets with an initial pre-treatment pocket probing depth of ≥ 5 mm and ≤ 8 mm. The study will also examine the response to SRP of all initial pocket depths, i.e., those PPD that fall below or above those in the indicated range, to verify the findings of previous studies.


Eligibility Criteria:
Inclusion criteria:

* All patients treated by dental students who have the required data
* 14 or more permanent teeth
* Have at least 2 molars (excluding third molars)

Exclusion Criteria:

* All third molars and second molars next to a partially impacted third molar
* Smokers
* Diabetes
* Immunocompromised patients (HIV/AIDS; chemotherapy; systemic steroid therapy, etc.)
* Pregnancy during treatment or during the follow-up periods
* Diagnosis of Alzheimer's or dementia
* Diagnosis of oral mucous membrane disease (BMMP, Lupus, erosive lichen planus, etc.)
* Patients that have received periodontal surgery following SRP
A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.

A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

A study to collect survival status of CA046 subjects who were know to be alive at the last report of vital status for CA046 - approximate timeframe - end of March, 2013. Once consent is given, on a quarterly basis, information on status will be collected to include:

* Vital Status
* Date of disease progression
* Subsequent anticancer therapy for pancreatic adenocarcinoma

Eligibility Criteria:
Inclusion Criteria:

* Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data)

Exclusion Criteria:

* Consent refused for any reason
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Parturients candidates for mechanical induction of labor

Exclusion Criteria:

* Suspected amnionitis
* Vaginal discharge
* Pre induction pyrexia
* Immunocompromised parturients
PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES?

This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices.

BACKGROUND AND AIMS

Bleeding from esophagogastric varices (EV) is a major complication of portal hypertension. Beta-blockers are a well-established cornerstone of portal hypertension treatment. Band ligation is the best endoscopic treatment to prevent EV bleeding. The exact benefit of beta-blocker association to band ligation remains to be defined, especially for primary prophylaxis. This prospective randomized controlled trial will compare EBL with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices. PATIENTS AND METHODS: The patients with high-risk varices will be randomly allocated to EBL plus propranolol (Group I) or EBL alone (Group II). EBL will be performed at 3-week interval till obliteration of varices. In Group I, incremental dosage of propranolol (sufficient to reduce heart rate to 55 beats/min or 25% reduction from baseline) will be administered and will be continued after obliteration of varices until the end of the study. The follow-up of patients will be 2 years. The primary outcome of this study will be EV recurrence during two years of follow-up. The secondary outcomes will be EV eradication, bleeding before eradication, mortality and complications during the same follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis with esophageal varices
* Age between 18 and 78 years
* Accept to participate

Exclusion Criteria:

* Portal hypertension by schistosomiasis
* Contraindications for propranolol use
* Do not accept to participate