cyrilzakka/clinical-trials huggingface dataset:
Luteal Phase Support in Insemination Cycles

This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 cycles in each group. A total of 255 cycles in 167 patients are finally recruited. In the first group, the patients will be treated with triptorelin (Gonapeptyl®) in their luteal phase. As for the other group, the patients will undergo the luteal phase without any supportive medication. This study is going to clarify the role of the gonadotropin agonist (triptorelin acetate, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* - Patients with ovarian stimulation cycles preparing to insemination
* Patients with medical ovarian stimulation protocols including GnRH agonist, aromatase inhibitors and different combinations of GnRH agonists and aromatase inhibitors are included
* Patient's willingness to participate in the study

Exclusion Criteria:

* - Failure in the ovarian stimulation cycle
* Failures in executing the insemination
* Failures in giving the sperm sample
* Major troubles in sperm parameters leading to an inadequate sample to accomplish intrauterine insemination
* Patients with primarily planned progesterone luteal support
Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

The purpose of this study is to collect data on the clinical and functional outcomes of surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy. It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for recurrent CTS will compare favorably to published data regarding alternative types of surgeries for the same condition.

Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but reported rates of symptom recurrence are not uncommon. Many surgical techniques have been proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence, however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.

This study will evaluate clinical and functional outcomes using information from pre- and post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years)
* Patient of The Plastic Surgery Group/Hayes Hand Center
* Previous diagnosis of Carpal Tunnel Syndrome
* Diagnosis of Recurrent Carpal Tunnel Syndrome
* Underwent primary carpal tunnel release
* Undergoing isolated flexor tenosynovectomy as secondary procedure

Exclusion Criteria:

* Had incomplete primary release of transverse carpal ligament
* Had documented neuroma upon re-exploration
* Had other soft tissue tumor within carpal tunnel or providing reasonable contribution to neurologic symptoms
* Experienced fracture or other traumatic injury to wrist after primary carpal tunnel release
* Diagnosis of osteomyelitis, infectious tenosynovitis or other infectious etiology to area of interest after primary procedure
* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory arthropathy
Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients

It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure

Exclusion Criteria:

* Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
Low Dose Chest Computed Tomography (CT) Screening

This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner. Depending on the findings of the initial CT scan, we will then either repeat the scan in 1 year, or if indicated, send you for further scans or a biopsy. The information collected in this study will help researchers and clinicians in providing more concrete recommendations and screening guidelines for future survivors of Hodgkin's disease who have had similar exposures to radiation and/or chemotherapy and smoking.


Eligibility Criteria:
Inclusion Criteria:

1. 5 years or longer from initial Hodgkin's disease diagnosis
2. Current age 18 or older
3. Received mediastinal irradiation and/or alkylating-agent based chemotherapy
4. Smoking history of 10-pack years or more, or current smoker

Exclusion Criteria:

1. Patients with a history of lung cancer
2. Patients currently receiving treatment for another cancer diagnosis (patients with another cancer, but currently disease-free and not receiving treatment are eligible)
3. Patients with known diagnosis of any metastatic cancer
4. Pregnant women. Female patients must: be at least one year post-menopausal, have had a hysterectomy, or have a serum pregnancy test to confirm that they are not pregnant. These measures must be taken in order to avoid doing a CT scan of a pregnant woman.
Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion

The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

Each patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 12 years;
* Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.
* signing of informed consent

Exclusion Criteria:

* Cleft lip and/or palate.
* Craniofacial syndromes.
Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo

The purpose of this study is to investigate the effect of a 12-week candesartan treatment compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp.

To investigate the mechanisms underlaying the diabetes-preventing effect of candesartan with respect to possible impact on insulin sensitivity, beta cell function and adipose tissue function and distribution. For this purpose comparisons will be performed with hydrochlorothiazide and placebo treatment. It is hypothesized that candesartan will improve insulin sensitivity as compared to hydrochlorothiazide and possibly also in comparison with placebo and that this could be explained by altered fat tissue function or distribution or by an altered sympathetic to parasympathetic balance in the autonomic nervous system. Hydrochlorthiazide is chosen as comparator because thiazides are a recommended firs-line therapy in hypertension. This drug class has some detrimental effects on glucose tolerance and in insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Male and female 18-70 years old
* Diagnosed hypertension and abdominal obesity (waist circumference greater than or equal to 102 cm (M) or 88 cm (F)

Exclusion Criteria:

* Uncontrolled hypertension
* Treatment with more than two concomitant antihypertensive medications
* Diabetes Mellitus
* Other endocrine disorder
* Severe liver disease
* Severely reduced renal function
* Malignant disease
* Alcohol or drug abuse
* Severe psychiatric illness
* History of stroke, myocardial infarction, unstable angina pectoris, participation in another clinical trial less than two months prior to screening visit
* treatment with anti-obesity drugs
* anti-inflammatory drugs or immunosuppressive drugs
The Effects of Foods on Cell Damage Study

Studies have shown that certain compounds inside vegetables can reduce the risk of cancer. Carrots in particular have an association with reduced incidence of colorectal, bladder and breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated cells that have shown a reduction in cancer cells as well as inflammatory markers which have been associated with an increased risk of cancer. These polyacetylenes have not been well studied in the human body and it is unclear whether they are able to affect the biomarkers of health (disease) including DNA damage and inflammatory markers. The aim of this research project is to determine whether eating a portion of white carrots every day for 6 weeks can lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6 weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.


Eligibility Criteria:
Inclusion Criteria:

* Non -smokers
* BMI between 18.5 and 30

Exclusion Criteria:

* smoking
* taking anti-inflammatories
* taking aspirin or aspirin-like drugs
* antibiotic use in the last 3 months
* metabolic conditions or conditions affecting the metabolism or digestion
Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia

The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method

All patients will be asked about their data and their general medical history, and will be underwent on one hand, a complete neurological examination including the degree of neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r) or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a complete ophthalmological examination too, including the patient's graduation, pupillary and ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell 28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see possible anatomical alterations in both macula and optic nerve. The follow-up of these explorations will be repeated in all cases at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS letters).
* Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less than 2 diopters.
* Transparent optical media: Opacity of crystalline \<1 according to Lens Opacities Classification System (LOCS) III.
* Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade\> III).
* Availability and collaboration to carry out the tests of the exploratory protocol.
* Acceptance of informed consent.

Exclusion Criteria:

* Previous intraocular surgeries of less than 6 months of evolution. Patients with refractive surgery using the LASIK or LASEK technique will not be excluded.
* Physical or mental difficulties to perform reliable and reproducible perimeters.
* Pathology and / or ocular malformations, angular or optic nerve anomalies.
* Any retinopathy or maculopathy.
* Intraocular pressure (IOP)\> 21 mmHg.
* Signal-to-noise ratio in OCT less than 5/10.
* Failure to meet any inclusion criteria.
* Mental retardation or any other limitation in obtaining informed consent.
Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

The primary objective of this study is to investigate the impact of continuous renal replacement therapy and intermittent renal replacement therapy on microbubble / cerebral microemboli generation in a cohort of critically ill patients with dialysis-dependent acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 yrs.
* Signed IC

Exclusion Criteria:

* Heart disease (PFO, ASD, VSD, severe valvular disease)
* Atrial fibrillation
* Cerebrovascular pathology
* Missing temporal bone window
* Allergy to plastic contained in the investigative device (transcranial Doppler)
* Chronic kidney disease
* Pregnancy
* Participation in another study
Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge

In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery????

PICO P- Horizontal deficient alveolar ridge in Anterior Maxillary Region I- Computer guided surgical cutting guide C- Conventional alveolar ridge splitting O- Clinical outcome and radiographic outcomes Primary outcome: Accuracy In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.

In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) Secondary outcome: Thickness of buccal cortical plate In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)

Eligibility Criteria:
Inclusion Criteria:

* Partial edentulous in the aesthetic zone.
* Patient with bucco-lingual bone width is 3 mm or greater but \< 6mm
* Normal alveolar bone height
* Adequate oral hygiene
* Free of soft tissue or dental pathology
* Patients accepting to participate in the study

Exclusion Criteria:

* Patient medically compromised.
* Uncooperative patient.
* Poor oral hygiene and periodontal disease.
* Patients who smoked and pregnant women
* Systemic disease directly affecting bone healing
* Atrophic ridges (1.5 mm or less)
* History of radiotherapy \& treatment with bisphosphonates.
Evaluation of the Uterine Cavity After Operative Hysteroscopy

This study will focus on evaluation of the uterine cavity after operative hysteroscopy using three-dimentional tranvaginal ultrasonography and office hysteroscopy to detect and residual or recurrent abnormalities or intrauterine adhesions to optimize the results of operatve hysteroscopy in different uterine pathologies such as uterine polyps, fibroids, adhesions in addition to mullerian anomalies especially septate uteri.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in reproductive age group
2. Patients already selected for operative hysteroscopy
3. Patients accepted to share in the study
4. Patients accepted to come for follow up ( within 3 months after the initial operative procedure, at least after 4 weeks

Exclusion Criteria:

1. Patients outside the age of reproduction
2. Patients with negative findings at operative hysteroscopy
3. Patients refused to share in the study
4. Patients not available for follow up
5. Infection
6. pregnancy or design of pregnancy
Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria:

* previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions
* intake of glucocorticoids in the past one year
* major illnesses of heart, lung, kidney, and liver.
Effect of Probiotic Bifidobacterium Bifidum PRL 2010 in the Prevention of Atopic Dermatitis in Children

This study evaluates the effect of supplementation with Bifidobacterium bifidum PRL2010 during pregnancy in preventing atopic dermatitis in children. Pregnant women with a history of atopy or family history of allergies will be randomized to receive either the probiotic or a placebo. Outcomes include the incidence and severity of atopic dermatitis in infants up to 12 months of age.

Atopic dermatitis (AD) is a growing public health concern due to its increasing prevalence and significant impact on quality of life. This randomized, double-blind, placebo-controlled pilot study investigates the efficacy of Bifidobacterium bifidum PRL2010 in preventing AD when administered during pregnancy. Women aged 18-45 with a history of atopy or family history of allergies will be recruited and randomized into two groups: one receiving the probiotic and the other receiving a placebo. The intervention will begin at the 36th week of pregnancy and continue postpartum during breastfeeding for two months. Infants will subsequently receive the same treatment from the 3rd to 6th month of life. Outcomes include the presence and severity of AD assessed using the SCORAD index and additional allergy tests at 3, 6, and 12 months of age. This pilot aims to assess feasibility, safety, and initial efficacy data for future larger-scale studies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18-45 years.
* Presence of allergic manifestations or a positive family history of allergies.
* Normal pregnancy without complications (e.g., no risk of eclampsia or gestational diabetes).
* Residing in Rome.
* Non-smoker and non-smoking partner.
* Absence of pets.
* Planning natural childbirth.
* Intention to breastfeed for at least 3 months.

Exclusion Criteria:

* Complications during pregnancy (e.g., preterm birth before 36 weeks).
* Infants with necrotizing enterocolitis or congenital, chronic, or metabolic diseases.
* Immunodeficiencies in mother or child.
* Failure to meet any inclusion criteria during the study period.
Pain Assessment in the Intensive Care Unit

Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. Consequently, pain assessment is highly challenging in these ICU patients. This is a prospective observational study assessing 3 behavioral pain scales in the ICU.

The hypothesis of this proposal is that one of the three ICU pain scales has a more important reliability than the others. Such a scale could be recommended to be used to measure pain intensity in ICU patients not able to communicate.

The aims of this observational study are to measure and compare the psychometric properties of Behavioral Pain Scale (BPS), Critical Care Pain Observation Tool (CPOT) and Non Verbal Pain Scale (NVPS) at baseline and following repositioning procedure in the ICU

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* not comatose, defined by a Richmond Agitation Sedation Scale (RASS) ≥ -3, i.e. between -3 and +4
* not able to self-report accurately their pain intensity using a visually enlarged 0-10 numeric rating scale

Exclusion Criteria:

-neurological deficits (acute or chronic) that prevent observation of the muscle tonus or movement. For example:

* Quadriplegia
* Current use of Neuromuscular blocking agents
* Severe brain injuries
A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or probable AD
* Patient must have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions
* Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study
* Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit and weekly during the previous 2 weeks prior to Baseline
* If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must be on stable doses for 3 months prior to the Baseline visit and during the study
* Patient is willing and able to provide informed consent. If the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative

Exclusion Criteria:

* Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder
* Patient is unable to communicate verbally
* Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
* Patient has had a myocardial infarction in the last six months
* Patient has moderate to severe congestive heart failure
* Patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).