cyrilzakka/clinical-trials huggingface dataset:
Evolution of Cochleovestibular Schwannomas

Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.

The secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg
* patients consenting to participate

Exclusion Criteria:

* intra-labyrinthical extension
* treatment before the 3 MRIs
* no injection of gadolinium
* atypical diagnosis
Addressing Treatment Nonresponders

The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.

Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.

Eligibility Criteria:
Inclusion Criteria:

* Native English Speaking
* Pass pure tone hearing screening or medical report of normal hearing
* 2-3 years at start of study
* MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale \<10th percentile

Exclusion Criteria:

* Parental report of other diagnoses
* Enrolled in concurrent treatment elsewhere
* Nonverbal IQ \<75 as measured by the Bayley Scales
* Parents unable to consistently bring child to treatment sessions.
Fortified Hospital Food as Nutritional Support

Background:

The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.

The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.

Methods:

The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* patients at nutritional risk, according to the NRS-2002 system
* patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
* well-functioning gastrointestinal tract
* anticipated length of hospitalization of more than 3 days

Exclusion Criteria:

* terminal patients
* dysphagia
* food allergy or intolerance
Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

Eligibility Criteria:
Inclusion Criteria:

* Age 30-50 years
* all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.

Exclusion Criteria:

* contraindications to dinoprostone or misoprostol,
* active PID,
* history of pelvic/ ovarian endometriosis,
* females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers

To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.


Eligibility Criteria:
Inclusion Criteria:

Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.

1. Age: 20-30 years old
2. Body weight: 50-80 kg
3. Obesity index: within +/-20% of the standard body weight
4. Those who have received screening examinations listed in protocol within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
5. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic

Exclusion Criteria:

1. Those who have a history of allergic reaction or hypersensitivity to drugs
2. Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
3. Those who have ingested alcoholic drink within two days before the administration of the investigational product
4. Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
5. Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
6. Those who have a history of liver or renal disease
7. Those who are judged as ineligible for the clinical study by the investigator.
Exercise Program for Arteriovenous Fistula Maturation

Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC).

Unfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter.

The aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* with chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) \<30 milliLiter/minute (mL/min))
* with follow-up at the University Hospital of Lyon Sud
* who choose hemodialysis as renal replacement therapy

Exclusion Criteria:

* contraindication for arteriovenous fistula (AVF) surgery
* refusing AVF creation
* prior vascular access
* antecedent of IV substance abuse
* active cancer
* inability to perform handgrip exercise
* physical or mental disability limiting follow-up possibility
* inclusion in an other interventional study
* no social welfare
Hyrax Vs. Invisalign Palatal Expander Clinical Study

The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.


Eligibility Criteria:
Inclusion Criteria:

* Subject ages 6-11 years old
* Subject must need maxillary expansion
* Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar

Exclusion Criteria:

* Subjects with palatal exostosis/surface aberration/ cleft palate
* Subject's dentition not compatible with device or allergy to device materials
* Subject with active caries, periodontal disease, TMD
Acoustic Analytic Apps for Smart Telehealth Screening - Creating a Big Data

To develop and validate a library of cough spectrum from a target of 1000 cough acoustics. Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. Cough acoustic in absence of respiratory disease is also included.

This is a prospective observation cohort study recruiting children below the age of 16 years old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well patients without active coughing.

Cough is a common presentation in childhood. It is one of the early symptom of respiratory disease such as upper respiratory tract infection, cough variant asthma, allergic rhinitis, bronchitis and pneumonia. These conditions are common ailments in childhood. The history of cough and description of cough given by caretakers and patients are often vague and assessment of cough quality is often subjective. The quality of cough is often assigned a dichotomous category of dry cough and wet cough.

Computer assisted cough analysis has been developed in recent years to aid subjective classification of cough. The sound spectrum and frequencies of cough is being researched to better define the quality of cough. The quality of cough gives meaningful information about the state of the respiratory status. Cough sound analysis has been shown to rapidly diagnose pneumonia in humans using cough sound analysis and in differentiating wet and dry cough.

The investigators hypothesize that each respiratory pathology will have its spectral cough characteristics. Analysis of cough spectrum and comparing to a library of cough spectra data will be able to aid differentiation of the underlying conditions for the various cough spectrum and hence facilitating management.

The study aim is to develop a computer processing technique of cough sounds and determine their spectral characteristics for the common causes of cough to derive an assisted assay of cough spectrum for an objective assessment of cough.

Eligibility Criteria:
Inclusion Criteria:

* Cough arm 1.Children age 16 years old and below with cough at presentation- Patients presenting with active or chronic or residual cough

Well arm

1.Children age 16 years old and below and Well with no cough presentation.

Exclusion Criteria:

1. Children with severe behavioral
2. Droplet isloated cases as determined by protocol of hospital
Dose-response of Albuterol in Asthmatics

The purpose of this study was to determine the lung function response after increasing doses of albuterol (a bronchodilator) in children and adults with asthma.

Inhaled short-acting b2-agonists (SABA) are the most potent bronchodilators used today to treat acute symptoms of asthma and albuterol, a partial b2-agonist, is the most frequently prescribed asthma medication in the US. Although universally used in for acute asthma symptoms, SABA have been associated with a significant degree of interpatient variability. Many studies have characterized the SABA dose to bronchodilator response relationship under controlled conditions. However, few studies have explored the magnitude and sources of bronchodilator response variability, and no studies have characterized the dose versus bronchodilator response relationship using population pharmacokinetic/pharmacodynamic (PPK/PD) modeling. In the present study, we characterized the relationship between inhaled doses of albuterol and bronchodilation in 81 children and adults with moderate to severe persistent asthma using a population pharmacodynamic approach. The purpose of this study was to obtain estimates of the pharmacodynamic parameters that characterize the dose-response curve, including maximal dose for bronchodilation, and to quantify and identify sources of interpatient pharmacodynamic variability.

Eligibility Criteria:
Eligibility Criteria:

* Well-defined history of physician diagnosed asthma
* Any ethnic background
* 8 to 65 years old
* Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender
* No oral corticosteroid use, emergency room visits, or hospitalizations within the previous 3 months
* Nonsmokers or less than a 5 pack-year history with no smoking in the previous year
* Normal physical exam and no confounding diseases were selected
* Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for 8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn, nedocromil, and inhaled corticosteroids for 2 hours prior to the study.
Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes

The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.

The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese
* English-speaking
* diagnosis of type 2 diabetes (HbA1c \> 6.5%)
* regular access to the internet and text messages

Exclusion Criteria:

* taking diabetes medications other than metformin
* being pregnant or breastfeeding
* currently undergoing cancer treatments
* untreated serious mental illness
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation

This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary;
* No muscle disorders;
* Must be able to swallow tablets
Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease

This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in Parkinson's disease patients.

The primary outcomes will be feasibility of pairing 10 PT training sessions for PB\&G with rTMS therapy immediately following PT treatment session. Secondary outcomes will be exploratory, documenting differential clinical effects of two 'active' rTMS compared to 'sham' rTMS, to investigate ability to improve motor and functional recovery outcomes. Outcome measures will be a combination of assessments regularly conducted during PT treatment sessions validated in people with PD (these will doubly serve as our study measures) and several PD oriented outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD confirmed by a neurologist with expertise in movement disorders;
* Hoehn and Yahr stage 2 to 4;
* On L-Dopa and/or Dopamine Agonist daily treatment regimen;
* On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3 months;
* Posture, locomotion and balance deficits requiring at least 10 sessions of PT.

Exclusion Criteria:

* History of seizure disorder, including febrile seizures, fainting spells or syncope of unknown cause(s);
* Neurological disorder other than PD including stroke (mild-to-moderate micro vascular disease is allowed), traumatic brain injury, brain tumors, hydrocephalus;
* Major or unstable medical illness;
* Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
* Untreated depression; or Beck Depression Inventory (BDI)\>22
* Taking any of the following medications within the four weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, bupropion, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, and theophylline;
* History of moderate or severe dementia, or history of Mini Mental State Examination (MMSE) \<20 or Montreal Cognitive Assessment (MoCA) \<22;
* Physical therapy treatment contraindications as determined by physiotherapist.
IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)

The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women,
* Caucasian, Oriental or Multiracial
* not previously diagnosed for osteoporosis.

Exclusion Criteria:

* Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
* and having used oral or parenteral glucocorticoids (\>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda

The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.

Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.

The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.

Eligibility Criteria:
HIV-infected participants

Inclusion Criteria:

1. HIV-infected adult (≥18 years)
2. Willing to provide informed consent
3. Willing to receive follow-up counselling at home

Exclusion Criteria:

1. Previous or current receipt of HIV care from an ART provider
2. On-going participation in other health-related research
3. Intending to change residence in the next 6 months
4. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

HIV-uninfected participants

Inclusion criteria:

1. HIV negative adult (≥18 years)
2. Willing to provide informed consent
3. Willing to receive follow-up counselling at home

Exclusion criteria:

1. Intending to change residence in the next 6 months
2. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
Sweat Evaporimeter Measurement

The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction within a spectrum of patients expressing various degrees of cystic fibrosis disease.

The investigators overall goal is to determine whether the evaporimeter technique of measuring beta-adrenergic induced sweat rate is capable of accurately and reliably identifying different levels of CFTR dysfunction, as a prerequisite before advancing this technique as biomarker assay into clinical trials.

Preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in CF obligate heterozygotes; and absent in CF patients carrying severe mutations on both alleles. Further, test- retest experiments suggest good intra-individual reliability. All these features satisfy the required criteria for a biomarker assay that is capable of assessing small increments in CFTR function in vivo in clinical trials designed to assess the effectiveness of correctors and potentiators of CFTR channel activity. Therefore, to provide additional evidence of the value of this novel technique the investigators will determine the accuracy and reliability of evaporimetry to measure Beta-adrenergic induced sweating in subjects with a range of CFTR channel activity.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ages 18 years and older.
2. Subject with or without confirmed diagnosis of CF.
3. Written informed consent obtained from subject.

Exclusion Criteria:

1. Patients who are participating in clinical trials evaluating the safety, efficacy or clinical outcome of drugs that may alter the CFTR Cl channel function will be excluded.
2. Any subject with a known hypersensitivity to any agonist used in the study or subjects receiving any drug (e.g. theophylline, antihypertensive agent) that might interfere with the investigations.
3. Subjects with active dermatitis or other chronic skin condition such as psoriasis or a strong allergic history.
4. Patients with a history of cardiac disease (including arrhythmias or hypertrophic obstructive cardiomyopathy).
5. CF patients with severe malnutrition (BMI\<18 kg/m2).
6. CF patients with severe lung disease (FEV1\<25%).
7. Subject who has been treated for pulmonary exacerbation or other acute illness within one week of the study procedure.
8. Any medical condition that, in the opinion of the investigator, will interfere with accurate conduct of the study.
9. Subjects who are pregnant or lactating.
10. Subject who is not able to stop inhalation therapy of β -adrenergic drugs 12 hrs before starting each test.