cyrilzakka/clinical-trials huggingface dataset:
Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe bronchial asthma.

Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like carbamazepine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of carbamazepine efficacy in treatment of patients with mild-to-severe bronchial asthma.

Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Out patients
* Bronchial asthma has been known at least for 1 year
* Absence of long-term remissions of asthma (lasting more than 1 month)
* Poorly controlled asthma, due to various reasons
* Non-smokers

Exclusion Criteria:

* Presence of concomitant acute or chronic severe diseases
* Abnormal baseline haematology, blood chemistry or urinalysis
* Allergy or adverse reactions to investigational drug
* Age younger than 16 years old
* Long-term history of smoking
* Pregnancy or lactating
DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain

Patients with neuropathic pain of multiple etiologies and a control cohort of patients with the same neuropathic entities who did not develop neuropathic pain are examined clinically, phenotyped with QST and questionnaires. Both groups are analyzed in order to find risk factors for painful neuropathy.

Patients with probable (presence of a combination of symptoms and signs of neuropathy include any two or more of the following: neuropathic symptoms, decreased distal sensation, or unequivocally decreased or absent ankle reflexes) or confirmed (presence of an abnormality of NC or validated measure of small fiber neuropathy with class 1 evidence with corresponding symptoms) neuropathy are included. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm. Patients with probable or definite neuropathic pain are classified as painful neuropathy, those with unlikely neuropathic pain classified as painless neuropathy (with concomitant nociceptive pain of other origin, e.g. headache etc.). Patients with possible neuropathic pain are excluded from analysis as are patients with skin lesions or dermatological disorders in the areas to be tested upon QST, with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc. Inclusion was restricted to patients with polyneuropathy to make the investigated patient sample as homogenous as possible.

Age, gender, BMI, ethnicity, years in education, family history of chronic pain, etiology of neuropathy, presence of early traumatic events and hospital admissions, smoking and alcohol habits, pain characteristics (von Korff, BPSI, NPSI), emotional well-being (PROMIS depression/ anxiety), personality (TIPI, IPIP, PCS), severity of neuropathy are assessed and QST performed.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of Polyneuropathy

Exclusion Criteria:

* Patients with polyneuropathy and possible neuropathic pain
* Patients with skin lesions or dermatological disorders in the areas to be tested upon QST
* Patients with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc.
Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial

Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks.

Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol.

Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.


Eligibility Criteria:
Inclusion criteria:

For babies

* Diagnosis of congenital heart disease up to 3 months old.
* Stable clinical condition (with medical clearance to receive the intervention), For parents
* Parents are literate
* Acceptance of the Responsible to participate in the research.
* Have a mobile device capable of sending and receiving messages and videos.

Exclusion criteria:

For babies

* Suspected or diagnosed genetic syndrome;
* Musculoskeletal or neurological malformation associated
* inability to establish a primary caregiver as in the case of baby under state supervision.

for parents

* Illiteracy
* Presence of deafness, blindness or physical disability, when another family member cannot be responsible for the application of the protocol.
Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients

Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.


Eligibility Criteria:
Inclusion Criteria:

* Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
* Glasgow coma scale of 9 or less
* Controlled mechanical ventilation required
* Intracranial pressure monitoring required for clinical reasons

Exclusion Criteria:

* age under 16 years old
* clinical signs of brainstem lesions
* patients with withdrawal order or for whom organ donation is under discussion
* major haemodynamic instability
* High carbon dioxide alveoloarterial gradient (\>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 \< 150 mmHg)
* Patients included in another interventional clinical study
Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.

ActiCIDP is a monocentric academic study. Patients with Chronic inflammatory demyelinating polyradiculoneuritis may be included on a voluntary basis.

The investigators plan to include a group of approximately 40 patients with CIDP.

The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

On each visit, participants will undergo a clinical examination with MRC sum score, a mISS score and a I-RODS score.

They will perform few tests 6-minutes walk test (6MWT), a myogrip measurement, and a 9 Hole Peg Test (9HPT) and will answer to some questionaires (mISS, INCAT and PGIC).

Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CIDP or possible CIDP based on 2021 EAN/PNS criteria2.
* Treated with IVIg (≤1g/kg/3-8week)
* Clinically Stable disease for 3 months (according to treating physician opinion).
* No treatment withdrawal failure within 1 year
* Age over 18 years

Exclusion Criteria:

* Significant cognitive or communication disorders
* Surgery or serious traumatic injury ≤ 6 months
* Non ambulant patient
* Current participation to a therapeutic trial
* Anti-myeline antibodies (anti-MAG) positive or nodo-paranodopathy
* Other autoimmune disease that requires Corticosteroids, IVIg, Plasma Exchange treatment
* Pregnancy or breastfeeding
* Any other condition that, according to the investigator, could significantly interfere with patient evaluation or safety.
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
* Have radiologic evidence of disease progression or recurrence either

  * On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
  * On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
* Must be deemed appropriate for treatment with ET
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets

Exclusion Criteria:

* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
* Have symptomatic or untreated central nervous system metastasis
* Have received any systemic therapy between disease recurrence/progression and study screening
* Have received more than 1 line of therapy for advanced or metastatic disease.
* Have received prior chemotherapy for metastatic breast cancer (MBC)
* Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders \[SERDs\] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide

Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor


Eligibility Criteria:
Inclusion Criteria:

* Patients with cT2-T3a prostate cancer

Exclusion Criteria:

* Men\>75 years
* Men\<18 years
* Prior hormonal therapy
* Prior radiation or chemotherapy
* Prior investigational agents
* Life expectancy \> 10 years
* Prior malignancy within the last five years
* Any other serious medical or psychiatric condition
Sperm Quality in Consecutive Sperm Samples After 4-7 Days and 2 Hours of Sexual Abstinence

The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for ART treatment.


Eligibility Criteria:
Inclusion Criteria:

* male age between 18 and 50
* able to understand and read Danish

Exclusion Criteria:

* complete azospermia
* significant psychological illness
* significant cardiovascular disease
Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content

Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal intensive care unit acquired morbidity such as NEC and the late onset sepsis.

It is often difficult to obtain sufficient quantities of human milk from mothers of preterm infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use galactogogues in an attempt to increase milk production. Fenugreek (Trigonella foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the pea family. Our experience at the NICU is that around 30% of preterm mothers desperately looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe) as food supplement. Although widely recommended, there is limited evidence to support the effectiveness of fenugreek as a galactogogue.

The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has any effect on macronutrients composition of breast milk and whether fenugreek is transferred to the infant via mother milk. In addition any changes in mother and infant health status will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy mothers 7 to 14 days postpartum,
* Mothers of preterm infants under 38 weeks of gestation,
* Mothers with poor milk supply documented by professional lactation consultants.

Exclusion Criteria:

* Mothers with mastitis,
* Mothers with breast engorgement,
* Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production,
* Mothers who are taking medications (Diuretics, Pseudoephedrine, - Anticholinergics, Warfarin or any anticoagulant, An estrogen-containing birth control pill),
* Mothers with Diabetes mellitus,
* Mothers who have had breast surgery that could alter milk synthesis or production,
* Mothers diagnosed with Polycystic Ovary Syndrome,
* Mothers diagnosed with Asthma or atopic disease,
* Mothers who are known to be allergic to peanuts or soybeans,
* Mothers whose milk supply per 24 hours exceeds 600 mL,
* Mothers with hypo/hyperthyroidism
Obsidio™ Conformable Embolic Registry

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age
* Signed informed consent\*
* Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
* Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure

Exclusion Criteria:

* Patient has a life expectancy \< 30 days
* Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
* Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
* Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
* HbA1c ≤ 12%, as assessed by the central laboratory
* Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
* Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
* No evidence of total PVD in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
* Presence of epiretinal membrane in the study eye
* Presence of foveal ischemia in the study eye
* Presence of pre-retinal or vitreous haemorrhage in the study eye
* Presence of iris or angle neovascularisation in the study eye
* Any active ocular / intraocular infection or inflammation in either eye
* Aphakic study eye
* Uncontrolled hypertension in the opinion of the Investigator
* Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability
Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

This study evaluates the demineralized bone matrix in "Hallux valgus".

Demineralized bone matrix use for filling in the space removed bone in open wedge osteotomy and correction. The purpose this study is to test therapeutic benefits of demineralized bone matrix.

Investigator will recruit thirty patients. Total evaluation period will be 12 months. In this period, investigator will examine correction rate, fusion rate, functional test, adverse event.

Eligibility Criteria:
Inclusion Criteria:

* (1) The patient ranging in age from 20 to 75 years
* (2) Has to be operated over 5mm osteotomy for correcting hallux valgus.
* (3) The patients who were able to comply with the research protocol.

Exclusion Criteria:

* (1) Bursitis in metatarsal bones has affected surgery.
* (2) Has rheumatism
* (3) The patient who has clinical sign of infection on the operated site at pre-screening
* (4) Patient who has failure of peripheral blood circulation caused by chronic disease and neurological symptoms
* (5) In the opinion of investigator, the patient is not suitable to participate in this study
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer

The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.

The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.

The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years, ≤ 75 years
2. Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
3. PSA value \< 20 ng/ml within 6 weeks before enrolment.
4. Gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
5. Adequate renal function: Creatinine \< 1.5 times upper limit of normal.
6. Adequate hepatic function: Aspartate Transaminase (ASAT), Alanine Transaminase (ALAT) and Alkalase Phosphatase (ALP) \< 1.5 times upper limit of normal.
7. Negative dipstick for bacteriuria.
8. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
9. Patients that has been scheduled for prostatectomy

Exclusion Criteria:

1. Ongoing or previous hormone therapy for prostate cancer.
2. On-going or previous therapy within 12 month of finasteride or dutasteride.
3. On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
4. Use of pace maker or other electronic devices
5. Symptoms or signs of acute prostatitis.
6. Symptoms or signs of ulcered proctitis
7. Severe micturation symptoms
8. On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
9. Concomitant systemic treatment with corticosteroids, or immune modulating agents.
10. Known immunosuppressive disease (e.g. HIV, diabetes).
11. Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.