cyrilzakka/clinical-trials huggingface dataset:
To Study the Efficacy & Safety of Oral NA-921 (Bionetide) in Girls and Women with Rett Syndrome

To study the efficacy \& safety of oral Bionetide versus placebo in girls and women with Rett syndrome

A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of NA-921 (Bionetide) for the Treatment of Girls and Women with Rett Syndrome

Primary Objective • To investigate the efficacy and safety of treatment with oral NA-921 (Bionetide) versus placebo in girls and women with Rett syndrome

Key Secondary Objective • To investigate the efficacy of treatment with oral NA-921 (Bionetide) versus placebo on ability to communicate in girls and women with Rett syndrome

Co-Primary Endpoints

* Rett Syndrome Behavior Questionnaire (RSBQ) total score - Change from Baseline to Week 12
* Clinical Global Impression-Improvement (CGI-I) Score at Week 12

Key Secondary Endpoint

Change from Baseline to Week 12 in:

• Communication and Symbolic Behavior Scales Developmental Profile™ Infant-Toddler Checklist- Social Composite Score (CSBS-DP-IT Social)

Eligibility Criteria:
INCLUSION CRITERIA:

* Female subjects 5 to 20 years of age, inclusive, at Screening
* Body weight ≥12 kg at Screening
* Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
* Has classic/typical Rett syndrome (RTT)
* Has a documented disease-causing mutation in the MECP2 gene
* Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening
* Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. Subject must not be pregnant or breastfeeding.
* The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
* Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening

EXCLUSION CRITERIA :

* Has been treated with insulin within 12 weeks of Baseline
* Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
* Has a history of, or current, cerebrovascular disease or brain trauma
* Has significant, uncorrected visual or uncorrected hearing impairment
* Has a history of, or current, malignancy
* Has a known history or symptoms of long QT syndrome

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function

This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.

Solifenacin is an anticholinergic drug that is commonly used for lower urinary tract symptoms such as urgency, frequency and urge urinary incontinence. Solifenacin use and sexual function improvement is presented in some research, but the correlation between the improvement in sexual function and LUTS symptoms is yet not investigated. Also the effect on sexual function in premenopausal vs postmenopausal women are unknown.

Eligibility Criteria:
Inclusion Criteria:

* Women presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that are planned to start treatment with Solifenacin 5 mg (Vesicare 5mg).
* Patients agreed to involve in the study, having discussed other treatment options and possible side effects of the medication.
* Informed consent obtained

Exclusion Criteria:

* urinary tract infection
* stress urinary incontinence
* urinary retention
* grade 2 or above pelvic organ prolapse according to POP-Q scale
* Solifenacin contraindications such as narrow angle glaucoma, allergy of Solifenacin or other components of the drug.
Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

The aim of this study is to evaluate and compare the regenerative potentials of Injectable Platelet-Rich Fibrin (I-PRF), Platelet-Rich Fibrin (PRF), and Blood Clot (BC) as different scaffolds regarding:

Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical lesion, and apical closure).

Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.


Eligibility Criteria:
Inclusion Criteria:

* Necrotic immature permanent anterior teeth.
* Teeth not indicated for post/core final restoration.
* Radiographically: The root has incomplete development with an apical opening of more than 1 mm.

Exclusion Criteria:

* Medically compromised patients with blood and immunity disorders. Family history of autoimmune disorder. Also, patients with physical or mental handicapping conditions.
* Teeth with questionable restorability of the remaining crown/root structure.
* Pathological tooth mobility.
* Radiographically: Evidence of root fracture or root resorption (external or internal).
Effect of Piroxicam on Ovulation

In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation).

Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals.

With regards to the tolerability of the study drug subjects will be asked regularly how they feel.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent available before any study specific tests or procedures are performed
* Healthy female subject
* Age: 18 to 35 years (inclusive) at the first screening visit
* Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit
* Confirmation of the subject's health insurance coverage prior to the first screening visit
* Willingness to use non-hormonal methods of contraception during the study
* Ability to understand and follow study-related instructions
* Adequate venous access

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
* Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past
* History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation
* Regular intake of medication other than hormonal contraceptives
* Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU)
* Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure
* Time point "onset of LH surge" in the pre-treatment cycle not determinable
* Time point "ovulation" in the pre-treatment cycle not determinable
* Lacking suitability for frequent TVU examinations
* History or presence of suffering from hay fever
Investigation of Factors Causing Knee Hyperextension During Walking in Chronic Stroke Patients

In this study, it is aimed to examine the factors that cause knee hyperextension in chronic stroke patients. Although the presence of weakness or spasticity in the quadriceps muscle, weakness or spasticity in the plantar flexors, and weakness of the dorsiflexors, hamstrings and gastrocnemius muscle are shown in the literature as the cause of hyperextension of the affected knee in hemiplegic patients, there is a comprehensive study that shows the effect of both muscle strength and spasticity in the lower extremity muscles. there are no studies.

The hypotheses of the study are:

Hypothesis 1:

H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

Hypothesis 2; H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

Hypothesis 3; H0: There is no relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

H1: There is a relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-65
* At least 6 months have passed since the stroke
* Ambulation with or without a walking aid (walker, cane, or tripod)
* Being between 0-3 points according to the Modified Rankin Score
* Getting a score of 24 or higher on the Mini Mental Test
* Presence of hyperextension in the stance phase of gait
* Volunteering to participate in the study

Exclusion Criteria:

* Having a history of more than one stroke
* Known presence of dementia
* Having a known orthopedic, psychiatric or other neurological disease
* Having a situation that prevents communication
* Having a history of surgery involving lower extremities and gait
Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery

The aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.

A consecutive series of patients scheduled for elective cardiac surgery is included in the study. Delirium screening is performed using Intensive Care Delirium Screening Checklist. Preoperative cognitive state is evaluated with Mini-Mental State Examination. Information of possible risk factors is collected from patient's history and chart. The Snoring, Tiredness, Observed apnea, high blood Pressure-Body mass index (BMI), Age, Neck circumference and Gender questionnaire (STOP-BANG questionnaire) is used for obstructive sleep apnea screening.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery
* patient spends more than 1 day in the intensive care unit after the surgery

Exclusion Criteria:

* refusal to participating in the study
* documented severe central nervous system, cognitive or psychiatric disorder
* unable to be screened with Intensive Care Delirium Screening Checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients)
Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:

Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.

Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.

Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.

Eligibility Criteria:
Inclusion Criteria:

* must be ≥ 18 years of age.
* histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV) -previously treated with mastectomy

Exclusion Criteria:

* pregnant or breast feeding.
* cannot tolerate lying supine for breast ultrasound examination.
* mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent DCIS or invasive breast cancer
Palliative Care Consultation to Improve Communication for Patients Considering Surgery for a Pancreatic Neoplasm

This clinical trial evaluates a palliative care consultation for improving communication between providers and patients considering surgery for a pancreatic neoplasm. Pancreatic operations have known complications that can affect quality of life. Palliative care has been shown to improve patient reported quality of life and functional outcomes. Receiving a palliative care consultation may improve communication and decision making for patients considering surgery for a pancreatic neoplasm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive usual care and undergo evaluation by a tumor board within 14 days of baseline.

ARM II: Patients attend a palliative care visit over 60 minutes to discuss their illness, quality of life, fears and concerns and communication preferences within 7 days of baseline. Patients also undergo evaluation by a tumor board within 14 days of baseline.

After completion of study intervention, patients are followed up 7 days after the tumor board visit and 90 days after initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Pancreatic neoplasm pathology
* Ability to read, write, and speak in English
* Has decisional capacity
* Expected to be seen and discussed at PCSC and seeing a surgeon as part of their tumor board evaluation

Exclusion Criteria:

* Metastatic pancreatic neoplasm
* Currently incarcerated
* Currently is or previously has received palliative care, or are unwilling to forego palliative care for the first 90 days post randomization
* Evidence of any behavior, condition, or circumstance (including, but not limited to: blindness, deafness, serious behavior or mental health conditions, discontinuing curative treatment, lack of access to technology, etc) that would interfere with their ability to complete study procedures as noted within the chart
Clinical Performance Evaluation of DxN HBV Assay

The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.

Same as brief summary.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline
* Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks

Exclusion Criteria:

* Co-infection with HIV or HCV at enrollment
* Subject has decompensated liver disease or liver cancer
* Prior participation in study
* Current or planned participation in an investigational drug or device study
The Italian Registry of Malnutrition in Oncology

The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL.

This is a multicentric longitudinal observational study on a cohort of newly diagnosed cancer patients, candidate for active treatment. In Italy, no reliable data are still available with regards to the actual implementation of adequate nutritional support management in cancer patients; only "real-world" data collected by administrative databases are available in the context of nutrition in oncology, and this somehow limits the possibility to interpret the evidence from a clinical point of view. Hence, the purpose of the intestigators is to collect "real world" clinical data on malnutrition in oncology at the national level, in order to strengthen the evidence and concretely improve nutritional care practices in oncology.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* New diagnosis of the following cancers: head and neck, oesophagus/stomach, colorectal, hepato-biliary, pancreatic, lung, prostate, other urogenital, breast, gynaecological and, soft tissue sarcomas and melanomas; patients with a new diagnosis of metastatic disease will be also included;
* Eligible for active treatment;
* Written informed consent to participate in the study.

Exclusion Criteria:

* Impossibility to undertake the expected measurements;
* Impossibility to guarantee the attendance of the follow-up visits.
Improving Pregnancy Outcomes With Progesterone

This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.

Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner.

Individual participants will be followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* less than 24 0/7 weeks of gestation
* viable intrauterine singleton pregnancy confirmed by ultrasound
* antibody-confirmed HIV-1 infection
* currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy
* ability and willingness to provide written informed consent
* intent to remain in current geographical area of residence for the duration of study
* willing to adhere to weekly study visit schedule

Exclusion Criteria:

* confirmed prior spontaneous preterm birth
* multiple gestation
* known uterine anomaly
* planned or in situ cervical cerclage
* major fetal anomaly detected on screening ultrasound
* indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)
* threatened abortion, preterm labor, or ruptured membranes at time of enrollment
* known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information
* prior participation in the trial
* any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.
Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.

The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.

A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
* Patients who had more than 20 teeth in the mouth;
* Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
* NCL in the facial surface of the teeth with sometimes a small part extending interproximally; Patients with good periodontal heath.

Exclusion Criteria:

* Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
* Tooth with the NCL with the absent of antagonist;
* NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
* Presence of caries or restorations in the area to be treated;
* Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
* Unwillingness to return for follow-ups or refuse to participate.
Inhibition of Non-histaminergic Pruritus Applied Using 3 Different Pruritogens

With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours) application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive days (24 hours apart). All sessions will be identical.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamine medications or pain killers.
* Skin diseases
* Hypersensitivity to papaya and mango fruit, cashew nuts and rubber latex
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
* Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.