cyrilzakka/clinical-trials huggingface dataset:
Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia

The goal of this clinical trial is to test the use of voice personalization through artificial intelligence (AI) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (PWA). The main question the study aims to answer is:

- What is the impact of personalized voice on speech entrainment in PWA compared to traditional speech entrainment?

Speech entrainment is a technique used by speech-language pathologists to improve the speech production of PWA. Traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. This study proposes the use of one's own voice (digitally altered) to improve speech production.

The study uses a mobile health approach to administer speech entrainment treatment through a mobile app.

* Smartphones with the mobile app pre-installed will be mailed to participants at no cost.
* Participants will complete treatment in the comfort of their homes.
* The experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-70 years old
* Dominant English-speaking
* Aphasia due to left hemisphere stroke

Exclusion Criteria:

* Individuals with aphasia due to other causes such as dementia, Alzheimer's disease and Parkinsonism
* Non-dominant English adult speakers
* Persons with significant difficulties with language comprehension
* Persons with concomitant cognitive disability
* Persons with uncorrected sensory deficits.
Diagnostic Prediction of Pancreatic Masses

The goal of this observational study is to learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. The main question it aims to answer is:

What features, in the perspectives of clinical manifestation, laboratory tests, and imaging, can differentiate different kinds of pancreatic masses (AIP, PPL and PDAC)?

Participants will not be given any interventions since this is a retrospective observational study.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients presenting with pancreatic masses and eventually diagnosed with PPL, AIP, or PDAC (confirmed by pathologic results).
Terlipressin in Septic Shock: Effects on Microcirculation

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 µg∙kg-1∙h-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UI∙min-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of septic shock
* Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Present or suspected acute mesenteric ischemia
* Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)
A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose

To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female 18 to 65 years of age at Screening, inclusive
* Body mass index (BMI) 18.5 to 32 kg/m\^2, inclusive
* Body weight 50 to 100 kg, inclusive
* Females must be of non-childbearing potential
* Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later

Exclusion Criteria:

* Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
* History of alcoholism or drug addiction within 6 months prior to CRU Check-in
* Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in
Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment

Multiple myeloma (MM) is a haematological malignancy characterized by the accumulation of proliferating antibody producing plasma cells in the bone marrow. In the last few years many studies have emphasized the biological complexity and heterogeneity of MM as a result of both genetic and epigenetic aberrations. Che-1/AATF (Che-1) is a transcriptional cofactor involved in cell cycle regulation, apoptosis, DNA damage and stress response. it can be hypothesized that Che-1 might contribute to the establishment of the MM malignant phenotype by sustaining global transcription through its ability to modulate chromatin accessibility.

The prospective study on MM human samples aims to understand the involvement of Che-1 in the transcriptional regulation and chromatin remodeling during the pathology. To this goal the main objectives are:

* Characterization of Che-1's role in chromatin remodeling and global gene expression
* Study in vivo and in vitro of Che-1 involvement in MM tumorigenesis
* Evaluation of Che-1 as a possible therapeutic target


Eligibility Criteria:
Inclusion Criteria:

* MM Patients

Exclusion Criteria:

* No exclusion criteria
Ranibizumab for Diabetic Traction Retinal Detachment

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.


Eligibility Criteria:
Inclusion Criteria:

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events
Nordic Pancreatic Cancer Trial (NorPACT) - 1

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC).

Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear.

The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Resectable adenocarcinoma of the pancreatic head
* T1-3, Nx, M0 (UICC 7th version, 2010)
* Cytologic or histologic confirmation of adenocarcinoma
* Age \> 18 year and considered fit for major surgery
* Written informed consent
* Considered able to receive the study specific chemotherapy

Exclusion Criteria:

* Co-morbidity precluding pancreaticoduodenectomy
* Chronic neuropathy ≥ grade 2
* WHO performance score \> 2 • Granulocyte count \< 1500 per cubic millimetre
* Platelet count \< 100 000 per cubic millimeter
* Serum creatinine \> 1.5 UNL (upper limit normal range)
* Albumin \< 2,5 g/dl
* Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
* Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
* Percutaneous tumor biopsy
* Any reason why, in the opinion of the investigator, the patient should not participate
* Pregnancy
* Breastfeeding
Open Label Trial of Acamprosate in Bipolar Alcoholics

The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-65
* Meet DSM-IV criteria for current (past 90 days) alcohol dependence
* Meet DSM-IV criteria for bipolar I or bipolar II disorder
* Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
* Must be able to remain free from alcohol for at least 3 days prior to medication initiation
* Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
* Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments

Exclusion Criteria:

* Individuals with a primary psychiatric disorder other than bipolar disorder
* Individuals with an uncontrolled neurologic condition that could confound the results of the study
* Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
* Participants with creatine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
* Concomitant use of other psychotropic medications not allowed per the protocol
* Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
* Current suicidal or homicidal risk
* Baseline scores of \> 35 on the Montgomery Asberg Depression Rating Scale and/or \> 25 on the Young Mania Rating Scale
Translational Investigation of Growth and Everyday Routines in Kids

The purpose of this study is to determine the effect of severe obesity on physical activity, sedentary behavior and cardiometabolic risk factors during childhood and adolescence and whether these associations are modified by race. Additionally, the study will investigate the contributions of (total, regional, and depot-specific) fat accumulation on changes in physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and adolescence.

The proposed study will establish a prospective pediatric cohort to identify intervention targets based on the location, timing, barriers, and facilitators of current physical activity and sedentary behavior in a child's day. The project will be a prospective examination of 340 African American and White girls and boys aged 10 to 16 years, including 50% who are classified as severely obese. State-of-the-art technology will be used including accelerometry to quantify physical activity, magnetic resonance imaging to quantify fat accumulation, and geographic position system and ecological momentary assessment to identify environmental and socio-emotional barriers and facilitators. In further detail, this study will examine the following objectives:

Objective 1: Determine the effect of severe obesity on physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and adolescence and whether these associations are modified by race.

Objective 2: Investigate the contribution of (total, regional, and depot-specific) fat accumulation on changes in physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and adolescence.

Objective 3: Determine barriers and facilitators of physical activity that are related to obesity, including environmental and socio-emotional factors.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-16 years
* Body weight \< 500 lbs.
* Ability to understand instructions and complete all study procedures

Exclusion Criteria:

* Pregnant
* On a restrictive diet due to illness
* Significant physical or mental disabilities that impede walking, wearing accelerometer or GPS, or responding to EMA.
Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.

The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* erupting permanent molars (that are not in full occlusion)
* not special children
* children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)

Exclusion Criteria:

* presence of cavitated caries lesions
* presence of enamel defects (hypoplasias)
Handgrip Strength (HGS) With HGS Asymmetry Are Associated With All-cause Mortality and Hospital Readmissions

Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function.

We sought to explore the associations between maximal HGS with HGS asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (PLOS) among elderly patients with gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* with gastric cancer
* aged ≥60 years
* were scheduled to undergo radical surgery for the first time

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy
* combined with other types of malignant tumors
Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

The purpose of this study is to:

1. compare structural variations observed in the calf and foot of the clubfoot mouse model(pma)with human clubfoot patients antenatally and postnatally;
2. identify features that might be used in future large scale studies to delineate a subtype of human clubfoot associated with lack of response to standard 'Ponseti' manipulation treatments.

Clubfoot is a medical condition of the foot known to doctors as "Congenital Talipes Equinovarus (CTEV)", which affects at least 2 per 1000 Scottish births (ISD data). Affected babies are born with one or both feet in an abnormal position. Treatment with plaster casts, and occasionally with surgery, is necessary to get the foot into a normal position.

We know from our animal and clinical studies and published work that the normal processes of development of the foot continue through pregnancy and postnatally. Clubfoot has never been studied by MRI antenatally in humans, and examination of the foot before birth may offer aetiological clues, not apparent from a single postnatal scan. Additionally, robust information that will help to understand which features of clubfoot in utero predict a truly affected fetus could be very useful for the clinical care of those suspected to be affected at a 20 week scan. This study will provide preliminary data to determine whether the usefulness of MRI in this context should be explored in future studies.

Eligibility Criteria:
Inclusion Criteria:

Group A - pregnancies suspected to be affected by clubfoot on detailed scan. Group B - neonates / infants with clubfoot. Age Preferably under 3 months). Group C - neonates / infants without clubfoot.Preferably under 3 months). Group D- young adults who have undergone treatment for clubfoot and are not undergoing further active treatment. Age range 14-30 years.

Group E - young adults without known lower limb pathology. Age 14-30 years.

Exclusion Criteria:

For all groups the exclusion criteria are any contraindication to MRI scanning.
Cardiotoxicity of Adjuvant Trastuzumab

Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood that can indicate heart damage. Finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor genes predict for TRC.


Eligibility Criteria:
Inclusion Criteria:

* Female 18 years or older
* Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression
* Primary surgery less than twelve weeks prior to registration
* LVEF\>50% as assessed by transthoracic echocardiogram or gated heart pool scan
* Eastern Cooperative Oncology Group Performance Status 0-2
* Adjuvant systemic treatment plan comprises at least three cycles of anthracycline chemotherapy AND 52 weeks of trastuzumab
* Before patient registration, informed consent must be given according to local regulations.

Exclusion Criteria:

* Pregnancy
* Distant metastases from breast cancer
* Any systemic chemotherapy prior to study entry
ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.

The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be selected:

  1. Be older than 18 (including 18) and younger than 75 (including 75);
  2. The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
  3. The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
  4. The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.

Exclusion Criteria:

* Subjects will be excluded if they meet any of the following criteria:

  1. The patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month);
  2. Women of childbearing age who have positive pregnancy test result and lactating women;
  3. Allergic to anesthetics;
  4. Bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion.
  5. Visible intraluminal lesions found during bronchoscopy;
  6. Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
  7. Patients with a pacemaker or defibrillator;
  8. Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
  9. Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.