cyrilzakka/clinical-trials huggingface dataset:
Individually-guided Hearing Aid Fitting

This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.

The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.

Eligibility Criteria:
Inclusion Criteria:

* sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
* frequency pure-tone average (PTA) of ≥ 30 dB HL.
* Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.

Exclusion Criteria:

* recent (within last 12 months) hearing aid use
* conductive loss (air-bone gaps \> 10 dB at any frequency and/or abnormal immittance) -
* scoring \< 23 on the Montreal Cognitive Assessment
* Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
* Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
* Significant history of otologic or neurologic disorders
* Non English speaking participants
* Any clinically significant unstable or progressive medical condition
* Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center

A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center


Eligibility Criteria:
Inclusion Criteria:

1. The informed consent form (ICF) should be signed before conducting any research-related operations
2. Age ≥18 years
3. Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
4. The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

Exclusion Criteria:

1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study

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Effects of Weight Loss in Obese Difficult-to-treat Asthmatics

Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients.

Study design: interventional, open label, randomized

Patients selection

Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old will be recruited from the outpatient clinics of the Pulmonary Division of the University of Sao Paulo Hospital.

Difficult to control asthma will be defined as patients who do not achieve asthma control (according to GINA) despite best treatment regimen and checked adherence after at least three months of treatment.

Intervention: Patients will be divided in two groups: asthma treatment plus weight loss program or asthma treatment alone for 6 months without drug dose changing.

Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control questionnaire, lung function tests, serum and sputum inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Difficult-to-treat asthma
* Body mass index \> 30kg/m2

Exclusion Criteria:

* Subjets older than 65 years
* Current smoking
* Past smoking history (\> 10 pack-year)
* Pregnancy
* Contraindication for Orlistat or Sibutramine
FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

FLT(3'-Deoxy-3'-\[F-18\]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* Abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome
Weight Loss Intervention Before Total Knee Replacement

The purpose of this study is to compare the efficacy in a group of patients who must follow the current procedure for treatment of artificial knee, compared with a group of patients who must undergo an 8-week weight loss program before surgery. 1 year after surgery the investigators will examine whether there are differences between the two groups' quality of life and functional capacity.

Background In Denmark the numbers of primary total knee arthroplasty (TKA) operations annually increase. In the year 2000 was performed approximately 2,500 operations and in 2008 was performed more than 7,500 total knee arthroplasty operations, and there appears in all countries to be similar tendency. Meanwhile, the prevalence of overweight and obesity has increased markedly over the last 50 years. Approximately 13% of the Danish population is obese. For several years the association between obesity and knee osteoarthritis (OA) has been recognized, and osteoarthritis is the most frequent indication for total knee arthroplasty(80%).

The purpose of this study is to investigate whether weight loss interventions before primary total knee arthroplasty will improve quality of life and functional level, reduce pain and risk of early and late postoperative complications.

Sample size Significance level is set to 5% by using a 2-sided analysis and the power is set at 80%. Based on an expectation of a difference in patient-reported outcome scores in between the groups at 8%, as measured by SF-36 12 months postoperatively, standard deviation (SD) 13 must be include 41 participants in each group. To allow a drop-out rate of 20% the group size increases to 51 participants in each group. In total 102 participants.

Statistical analysis, The two groups scores at 12 months postoperatively, and the two groups' change in the primary outcome measurer, from 1 week before surgery to 12 months postoperatively, compared with t-test or Mann-Whitney test rang sum depending on data distribution.

Eligibility Criteria:
Inclusion Criteria:

* All patients recommended for primary total knee replacement.
* Body mass index \> 30.
* Must be motivated for weight loss.
* Must be able to read and understand Danish.

Exclusion Criteria:

* Rheumatoid arthritis.
* Patients who are operated on both knees during the project period can only participate once.
* Planned obesity surgery.
Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression

"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.

Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".

"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.

Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction).

We want first to analyze the allelic association between SNPs of 5-HT, HPA and neurodevelopment genes and PPD with a case control association study We then analyse the interaction between maternal stressors during pregnancy and SNPS of our candidate genes (CRHR1, 5-HTT, TPH, BDNF, HMCN1).

3000 Caucasian mothers are included after pregnancy in 8 maternities and are evaluated at the inclusion, at 8 weeks and at 1 year with DIGS, FISC, EPDS and HAD, Stressful life events (Paykel). Blood are collected for all subjects for DNA extraction.

At week 8 and 1 year after pregnancy we search PPD with EDPS and DSM-IV criteria of depression".

Eligibility Criteria:
Inclusion Criteria:

* Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

* Age \<18 years old, schizophrenia or mental retardation
Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia

Context/background: people affected by fibromyalgia see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.

Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, lumbar pain, quality of life, phase angle and body composition in patients with Fibromyalgia.

The participants of experimental group will conduct 5 sets of 10 inspirations per day, 5 days per week, through 8 weeks.

Methods: 40 volunteer patients, female, with fibromyalgia will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 20) and a control group (n = 20). The Maximum Inspiratory Pressure (PIM), the quality of life, lumbar pain, phase angle and body composition will be measured.

Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 inspirations, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP

After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.

Eligibility Criteria:
Inclusion Criteria:

* subjects with fibromyalgia

Exclusion Criteria:

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Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta

Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy


Eligibility Criteria:
Inclusion Criteria:

1. Women with BMI at or under 35 Kg/m2.
2. Women having previous two cesarean section or more.
3. Women with gestational age more than 32 weeks with viable fetus.
4. Women with any degree of placenta previa .
5. Patient with morbidly adherent placenta on cesarean scar only.

Exclusion Criteria:

1. Patient who are haemodynamically unstable before skin incision.
2. Patient with clinically evident intraamniotic infection.
3. Patient with previous history of bladder injury .
Caregiver Support Model & Psycho-Education Program On Empowerment: Development and Validation

This Project aims to provide social workers and relevant human service professionals with a comprehensive, scientific, and validated service model and suggest a sustainable support framework on the working process of helping and empowering family caregivers of frail elders, reducing caregiving distress, and enhancing caregivers' quality of life.

The proposed Project consists of two parts to be conducted in 1 year. The first part focuses on the development and validation of Caregiver Support Model (CSM) with a Randomized Controlled Trial (RCT) study. The second part develops and validates a psycho-education program on empowering family caregivers with another Randomized Controlled design. In the first year, the Project Team have (1) developed and designed different components of the Caregiver Support Model (CSM), including a comprehensive need assessment tool, personalized Caregiver Intervention Plan Guidelines and Template, and online database on caregiver services and community resources, (2) designed a five-session psycho-education program on empowerment. The Caregiver Needs Assessment (CNA) tool was also pilot-tested with 320 community caregivers. Results from the survey, together with the systematic review on caregiver support, will form the backbone of the later CNA implementation. The working model will be validated using RCT design with 400 family caregivers recruited through 4 collaborating NGOs. At the same time, a psycho-education program on empowerment will be developed and validated using RCT design with another 190 caregivers.

Participants of CSM will be randomly assigned to CSM intervention and non-CSM intervention which is the usual practice of case handling by centre staff. Randomization will be based on centres to prevent exchange of information between the two groups, and thus causing contamination. Outcome data will be measured at 3 time-intervals: case intake, 3-month, and 6-month.

Participants of the psychoeducation program on empowerment (PPE) will be randomly assigned to the program group and the non-program group. For the former a 5-session psychoeducation program will be administered. For both groups, outcome measures will be collected at pre, post, and 3-month after post test.

Eligibility Criteria:
CSM Inclusion Criteria:

* Primary family caregivers aged 21 or above;
* Have not received major/ intensive services in the past three months;
* Providing care for elderly aged 60 or older;
* Care recipient has at least one difficulty in activities of daily living or instrumental activities of daily living that needs help from the caregiver (scored 3 or higher on at least one of the items in the ADL/IADL Checklist).

PPE Inclusion Criteria:

* Primary family caregivers aged 21 or above;
* Family caregiving in stable situation or care recipient passed away within 2 years;
* Have not received systematic psychoeducation in the past three months.
Fetal Thymus Volume of Dichorionic Diamniotic Twin

In some studies of fetal thymus volume, fetal stress factors; infection, preterm premature premature rupture of membranes, preeclampsia, preterm delivery risk.

Generally, there is a direct correlation between fetal growth and thymus volume and it was observed that thymus volume decreased in pregnancies accompanied by fetal stress factors.The aim of this study was to measure fetal thymus volume in second trimester twin pregnancies and to investigate whether there is a statistically significant correlation between preterm birth risk pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days

Exclusion Criteria:

* Single pregnancy,
* first and third trimester pregnant women,
* urinary tract infection, immune system diseases
* fetuses with intrauterine genetic and / or multiple morphological diseases
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.

To determine the effect of rosuvastatin on plasma lipids, lipoproteins, and endothelial function in HIV-infected patients on stable lopinavir/ritonavir therapy and to evaluate the safety of combined use of rosuvastatin and lopinavir/ritonavir. Also to determine the effect of lopinavir/ritonavir on the pharmacokinetics of rosuvastatin compared to historical controls an to determine the effect of rosuvastatin on the pk of lopinavir/ritonavir compared to historical controls and by intrapatient comparison.

Eligibility Criteria:
Inclusion Criteria:

* use of lopinavir 400mg/ritonavir 100mg bid \> 3months
* HIV-1 RNA \<400cop/mL
* fasting total cholesterol \> 6.2mmol/L

Exclusion Criteria:

* history of sensitivity/idiosyncrasy to the drug or compounds used
* history or current condition that might interfere with absorption,distribution metabolism or excretion
* pregnant or breast-feeding
* serum transaminase levels \>3 times upper limit of normal, creatinine clearance \<60ml/min
* fasting plasma triglycerides level \>8.0 mmol/L
* history of statin-related rhabdomyolysis or inheritable muscle diseases in family history
* clinical symptoms of myopathy or abnormal CK level
* change in antiretroviral medication within the 3 months immediately preceding first dose of rosuvastatin
* use of any statin or fibrate within 6 weeks immediately preceding first dose of rosuvastatin
* concomitant use of medications that interfere with rosuvastatin or lopinavir pharmacokinetics
* active hepatobiliary or hepatic disease
* hypothyroidism
* alcohol abuse
* japanese or chinese patients
Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.

Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.


Eligibility Criteria:
Inclusion Criteria:

* Age limits to \> 18 years
* Collection of the informed consent (patient or legal representant)
* Affiliation or recipient with the mode of social security

  - Groupe anévrysme rompu
* Patient porteur d'un anévrysme rompu

  - Groupe anévrysme non rompu
* Patient porteur d'un anévrysme non rompu

Exclusion Criteria:

* Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker ...)
* Claustrophobia
* Women pregnant or Breast-feeding
* Patient participating in an other study
* Patient have participated in a study in the 3 months before the inclusion
* In period of exclusion relative to another protocol
* Person with majority age protected by the law (supervision or trusteeship).
* Patient not reading the french language
* Patient or representant for whom it impossible to give accurate informations
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.

To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients

Eligibility Criteria:
Inclusion Criteria:

* Suspected lung cancer on chest CT or histologically proven NSCLC
* Participant is being considered for the conventional/neoadjuvant/targeted chemotherapy or surgery
* At least one measurable primary or other intrathoracic lesion \>= 2cm, according to RECIST
* Performance status of 0 to 2 on the ECOG scale
* Age 20 years or older
* Able to tolerable PET/CT and CT imaging required by protocol
* Able to undergo percutaneous needle biopsy before and after chemotherapy
* Able to give study-specific informed consent

Exclusion Criteria:

* Poorly controlled diabetes
* Contraindication for CT contrast agent
New Options for Preoperative Anesthesia in Intrauterine Needling

The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* clinically indicated intrauterine transfusion
* red cell alloimmunisation

Exclusion Criteria:

* severe adipositas
* suspicion of structural anomalies
* fetal hydrops
* contraindication for remifentanil
Microflora and Metabolomics of Crohn's Disease Patients

The purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states.

This study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in Crohn's disease patients with different course states.

Eligibility Criteria:
Inclusion Criteria:

1. individuals who were clear and signed the informed consent.
2. Male and female.

Exclusion Criteria:

1. Any one who can not provide accurate information.
2. Any one who denies the study.