cyrilzakka/clinical-trials huggingface dataset:
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.


Eligibility Criteria:
Inclusion Criteria:

* On CHD dialysis for more than 6 months
* Adequately dialyzed (Kt/V \> 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V \> 1.0 but \< 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
* Suboptimal nutritional status identified by one of the following criteria:

  1. Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
  2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
  3. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:

     1. Serum albumin less than 4.0 g/dl
     2. Serum transferrin concentration less than 250 mg/dl
     3. Serum prealbumin concentration less than 32 mg/dl
  4. Subjective Global Assessment Score less than 5.

Exclusion Criteria:

* Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
* Refusal to sign a consent form
* On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.
Artificial Intelligence in Diagnosing Dysphagia Patients

In this prospective study we extracted acoustic parameters using PRAAT from patient's attempt to phonate during the clinical evaluation using a digital smart device. From these parameters we attempted (1) to define which of the PRAAT acoustic features best help to discriminate patients with dysphagia (2) to develop algorithms using sophisticated ML techniques that best classify those i) with dysphagia and those ii ) at high risk of respiratory complications due to poor cough force.

This study was prospective study, and patients who visited the department of rehabilitation medicine in a single university-affiliated tertiary hospital with dysphagic symptoms from September 2019 to March 2021 were included.Voice recording was performed at the enrollment with blinded assessment, where the participants first visited the rehabilitation department with chief complaints of dysphagia. The cough sounds were recorded with an iPad (Apple, Cupertino, CA, USA) through an embedded microphone.

From the acoustic files we extracted fourteen voice parameters that include the average value and standard deviation of the fundamental frequency (f0), harmonic-to-noise ratio (HNR), the jitter that refers to frequency instability, and the shimmer that represents the amplitude instability of the sound signal.

Machine learning algorithms and sophisticated deep neural network analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria

1. Suspected swallowing disorder who were referred for swallowing assessment
2. Dysphagia attributable to brain lesion including stroke

Exclusion Criteria:

1. Participants who were unable to perform phonation
2. Participants who had no VFSS or standardized swallowing assessment results
3. Participants with no spirometric measurements
Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

The study compares the effect of abdominal massage vs. visceral manipulation on constipation status and quality of life in adults.

Chronic idiopathic constipation (CIC) is considered a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. It has a great impact on the quality of life and on the healthcare system and represents an important financial strain .


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sex with age ranges (20-40) years old.
* having a diagnosis of functional constipation according to Rome IV criteria onset of constipation symptoms from 6-12 months .
* having body mass index 18.5-29.9 kg/m2 , waist height ratio \</=0.5
* Subjects bothered by their constipation

Exclusion Criteria:

* Pregnancy.
* Having comorbidities (chronic pelvic pain, neurological (Parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
* Health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
* Malignancy, acute inflammation, intestinal tumor
* History of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
* Visual, auditory or cognitive problems which may prevent participation to the study.
* Tumor, presence of skin problems in the application area
* Presence of laxative use for functional constipation in the last four weeks or patients on laxative therapy.
* Alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)
Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size

Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um).

This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.

Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed.

Inclusion criteria:

* Subjects over 18 years old.
* Acceptance of participation through a signed consent form.
* Asymptomatic subjects

Exclusion criteria:

* Subjects refusing to participate or sign the consent form.
* Subjects with prior history of breast surgery or biopsy with markers.
* Subjects with breast prostheses.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance of participation through a signed consent form.
* Asymptomatic subjects

Exclusion Criteria:

* Subjects refusing to participate or sign the consent form.
* Subjects with prior history of breast surgery or biopsy with markers.
* Subjects with breast prostheses.
* Subjects with biopsy marker clips
Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals

Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide.

In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019.

Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis.

The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.


Eligibility Criteria:
Inclusion Criteria:

* Child (1 to 17 years old)
* Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
* Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.

Exclusion Criteria:

- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.
A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.

This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
* Childhood onset (under age of 13) of atopic dermatitis.
* Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
* Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
* Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.

Exclusion Criteria:

* Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
* Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
* Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
* Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
* Use of systemic corticosteroids within 4 weeks of randomization.
The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress

Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance; however, the mechanisms associated with these performance decrements and their potential synergies remain unclear. While the majority of research suggests that the observed fatigue is related to the central nervous system, the influence of changes in cerebral blood flow (CBF) and associated changes in cerebral alkalosis (estimated by end-tidal partial pressure of carbon dioxide; PETCO2) remains unexamined. In response to hyperthermia, humans hyperventilate as means of heat dissipation, resulting in a hypocapnia (reduced PETCO2) mediated decrease in CBF and consequently, cerebral alkalosis (increased cerebral pH). Previous research suggests that hyperventilation induces changes in neural excitability and synaptic transmission; however, it remains unclear if these changes are related to hypocapnia mediated decrease in CBF or decreased PETCO2 or both.

The purpose of the proposed research program is to examine the influence of changes in CBF and cerebral alkalosis on neuromuscular function during passive heat stress. The research project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each manipulation, neuromuscular function will be evaluated and compared to baseline (normothermic) conditions using a repeated measures design.

It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF or increases in core temperature.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 yrs old; healthy males

Exclusion Criteria:

* diagnosed medical condition; NSAID allergy; smoker; high altitude exposure; implants
Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer

The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:

* Which are the "omics" biomarkers that characterize the early stage of lung cancer?
* How to Translate Laboratory Data into Clinical Data?

For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile.

All partecipants will sign the Informed Consent before the sampling procedures. In addition, they will complete the clinical questionnaire containing medical history, smoking history and psychological evaluation.We will conduct the trial according to the ICH Good Clinical Practice (GCP) guidelines. Keeping accurate and consistent records is essential to a cooperative study.The IEO Data Management Office will responsible of the study database and data management.

Eligibility Criteria:
Inclusion Criteria:

1. Lung cancer group

   * Diagnosis of early stage - lung cancer
   * Signed Informed Consent
   * Completed questionnaire
2. Healthy subjects

   * high risk individuals (heavy smokers, subjects with pulmonary disease non-cancer related or with a familiar history of lung cancer disease)
   * Recent (within 6 months) negative Chest X-ray or CT scan

Exclusion Criteria:

Both groups

* No previous chemo or radiotherapy for lung cancer
* No previous malignancies within last 5 years
* No abuse of alcohol (no more than 1 litre of wine for day).
* No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
PIK3CA Mutational Status Assessment

Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.

Evaluate the effectiveness and concordance of molecular methods in identifying mutations affecting the PIK3CA gene both on paraffin tissue sections of the tumor and on liquid biopsy of patients with breast cancer treated at the IEO. The molecular test on the liquid biopsy of same patient could bring an important benefit considering that the withdrawal of this biomaterial turns out to be less invasive than a biopsy performed on an organ

Eligibility Criteria:
Inclusion Criteria:

* • Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.

  * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
  * Participants should be at advanced or metastatic setting prior to treatment.
  * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
  * Patients must be accessible for follow-up.

Exclusion Criteria:

patients already treated with different treatments like chemotherapy, hormone therapy etc

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Palatability (Energy I Pilot)

A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste.

The aim of the pilot study was to test for differences in palatability ratings of the four menus that will be administered during the ENERGY I project. During the pilot study, palatability ratings were collected for each meal (breakfast, lunch, and dinner) from four different menus that were served to participants during the main ENERGY I trial. The menus consist of three diets that vary in dietary fat and energy density: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. In addition to these three menus, the menu from the baseline period of the trial will also be tested for palatability.

Eligibility Criteria:
Inclusion Criteria:

* You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.
* your body mass index (BMI) is between 25 and 30 kg/m2, inclusive
* For females, if you have regular menstrual periods, with no less than 28 day cycles.

Exclusion Criteria:

* you have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.
* You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).
* You have symptoms of depression or excessive dietary restraint.
* You have an allergy to one or more of the test foods.
Evaluation of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy Results in Patients with Lipedema

The aim of the study is to evaluate the results of the Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in patient diagnosed with lipedema.

The collected content will be transferred over SPSS 21.0. The normality distribution of the data will be evaluated with the Shapiro-Wilk Test. Data will be displayed as mean±standard deviation, median (1st quartile-3 quartile), or number(percent). In comparisons between the two consuming variables before and after exercise, if the values fit the normal distribution, the "paires sample t test" is used, if not, the Wilcoxon test is used. In the comparison of 3 groups, one-way ANOVA will be applied if it is normally distributed, and if it does not fit the normal distribution, the Kruskal Wallis test will be applied. Post-hoc analysis was planned for the printer, which was determined to determine the method statistically. To compare categorical protections is to use the Chi-square test. P \< 0.05 will be considered future.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years or older
* Being diagnosed with lipedema according to Wold criteria
* Having type 1, 2 and 3 lipedema
* Having stage 1, 2 and 3 lipedema

Exclusion Criteria:

* Known rheumatic, endocrinological, neuromuscular, dermatological disease, kidney failure, liver failure and malignancy
* Having undergone surgery for lipedema
* Having poor circulation, open wound or infection in the lower extremities