cyrilzakka/clinical-trials huggingface dataset:
The Effect Of Occupational Therapy On Sensory-Based Feeding Problems

Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.

Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.

Eligibility Criteria:
Inclusion Criteria:

* ASD
* Feeding problems
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

This is a research study for patients that have an advanced cancer that is confined mostly to the abdominal cavity and have failed treatment with conventional therapy, or for which no standard treatment exists. The purpose of this study is to determine the dose of a chemotherapy drug (called irinotecan) that can be administered safely into the abdominal cavity. We also wish to identify the side effects of irinotecan when it is administered directly into the abdomen. In this study, we will also determine the levels of irinotecan in the blood and in the abdominal cavity.

Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It is approved by the FDA for the treatment of colon cancer. It appears that some other chemotherapy drugs are more effective and may have less side effects when they are administered directly into the abdomen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent, metastatic, or residual cancer with disease confined mostly to the peritoneal cavity. Patients with asymptomatic extra-peritoneal disease are eligible.
* Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis only (documented by cytology or during surgery) are eligible. Patients with ovarian cancer and disease manifested only by an elevated CA-125 are also eligible.
* Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to 2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3 x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.
* SWOG performance status 0-2
* Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation therapy.
* Patients must use an approved method of birth control.

Exclusion Criteria:

* Medical, social, or psychological factors which could prevent patient from receiving treatment.
* Prior therapy with intra-peritoneal irinotecan
* Significant intra-peritoneal adhesions detected clinically or by prior surgical exploration
Performance of IGRAs for TB Infection Diagnosis in Elderly

Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.

TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.

Principal outcome:

- 3 tests performance for active TB diagnosis in patients older than 75 years-old

Secondary outcomes :

* concordance between IGRAs.
* non-concordant results analysis
* concordance of IGRAs results with time of TB-infection
* biobank

Methodology :Diagnostic test performance study

Eligibility Criteria:
Inclusion Criteria:

* Age \> 75 years
* Consent signed
* hospitalized patient with start treatment of Tuberculosis disease
* French social right

Exclusion Criteria:

* Tuberculosis disease treatment since 7 days
* No 3 months follow-up possible
* Immunosuppression
Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease

This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
* Mini Mental State Examination (MMSE) score of 21-26, inclusive
* Clinical Dementia Rating global score of 0.5 or 1
* Rosen-Modified Hachinski Ischemia Score less than or equal to 4
* Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
* Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
* Caregiver willing to participate and be able to attend clinic visits with patient
* Ability to ingest oral medications

Exclusion Criteria:

* Significant neurological or psychiatric disease other than Alzheimer's disease
* Participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
* Any contraindications to MRI (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). Patients with contraindications to MRI may undergo computed tomography (CT) on approval by sponsor.
* Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG dose) in the cohort undergoing a PET scan.
* Previous exposure to investigational or non-investigational therapies for Alzheimer's disease within 6 months of screening
* History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
* Women of childbearing potential
* Uncontrolled blood pressure and/or blood pressure above 160/100
* Prescription medical food intended for dietary management of the metabolic processes associated with Alzheimer's disease.
* Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage.
* Patients with unstable, uncontrolled diabetes (HbA1c \> 7.7%) and those requiring insulin.
Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.

Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.

This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants are aged 18-75;
* Colonoscopy biopsy confirms colorectal adenocarcinoma;
* Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
* The tumor is staged cT1-4aNxM0 by preoperative imaging;
* Participants have no local complications before surgery.

Exclusion Criteria:

* Previous history of malignant colorectal tumor;
* Multiple primary colorectal tumors;
* Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
* Patients undergoing neoadjuvant therapy before surgery;
* With contraindications to laparoscopic surgery;
* Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
* Other malignancies were diagnosed within the past 5 years;
* History of severe mental illness;
* Pregnant or lactating women;
* With uncontrolled infection before surgery.
Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening

This study aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing.

The study population will consist of patients presenting to one of the three outpatient gynecology clinics within the Banner University Medical Center system for either a routine or follow up cervical cancer screening. Eligible subjects will be informed of the study and asked to consent to participate in accordance with standard informed consent protocol.

The subject will undergo a Papanicolaou screening test, using both a spatula and a cytobrush and collected in a Thinprep specimen container according to the manufacturer's instructions. This specimen will be used for standard-of-care cytology. A second specimen will then be obtained in an identical fashion, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy.

The second specimen will be taken from the clinic for processing in preparation for UV microscopy. A sample of the specimen will be smeared onto a UV slide and images taken. The UV images will be then analyzed to extract the following features for determining the stage of cervical lesion:

* Cellularity: The density of cells in the sample. A high cellularity indicates an abnormal growth of cells.
* Nuclear features: The size and shape of the nuclei in the cells. Abnormal nuclear features, such as enlarged nuclei or irregular chromatin distribution, can indicate the presence of a cervical lesion.
* Cytoplasmic features: The appearance of the cytoplasm in the cells. Abnormal cytoplasmic features, such as vacuolation or hyperchromasia, can indicate the presence of a cervical lesion.
* Cellular architecture: The organization and arrangement of the cells in the sample. Abnormal cellular architecture, such as loss of polarity or crowding of cells, can indicate the presence of a cervical lesion.

A second subject arm will consist of patients presenting to colposcopy clinic for colposcopy due to LSIL or HSIL findings on a screening Pap test. Subjects with test results of ASCUS or ASC-H will be excluded. A cervical cytology specimen will be taken from these subjects using both a spatula and a cytobrush, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy in a manner identical to the second specimen processing described above. Participants will then undergo colposcopy according to the standard of care based upon their prior cytology results.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for cervical cancer screening.
* Patients presenting for follow-up for positive cervical cancer screening.

Exclusion Criteria:

* Patients who do not, or no longer, require cervical cancer screening
Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion

Clinicians consider lumbar disc herniation more prominently in the differential diagnosis than piriformis syndrome, as it is the most common cause of sciatica, and this canalizes them to overlook that the sciatic nerve may be compressed by the piriformis muscle, below the L4-L5-S1 intervertebral disc levels.

As far as is known, there are no 'patient series' in the literature regarding the incidence of Piriformis syndrome in Lumbar Disc Herniation, only one case report has been found. This clinical study aims to reveal that Piriformis syndrome may also be present in patients with disc herniation on Magnetic Resonance Imaging (MRI), and that sometimes it may even be the main cause of sciatic nerve pain.

In this study, the participants between the ages of 18-65, who were diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging and protrusion) by having a Lumbar MRI at the Faculty of Medicine Sports Medicine outpatient clinic, were reached through their contact numbers, and those who had not previously undergone waist/hip surgery and those who described unilateral sciatica complaints (hip-leg-foot pain and numbness) during the interview were invited to Yüzüncü Yıl University Faculty of Medicine Sports Medicine polyclinic and Lasegue's, Flexion Adduction Internal Rotation (FAIR) and Freiberg's tests were performed.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Having unilateral sciatica
* Having disk herniation in the form of bulging or protrusion in a previous Lumbar Magnetic Resonance Imaging (MRI)

Exclusion Criteria:

* Having bilateral sciatica
* Having disc herniation in the form of extrusion or sequestration in a previous Lumbar Magnetic Resonance Imaging (MRI)
* Previous back and/or hip surgery
Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction

The MeDIAGSTOLE project aims to develop diagnostic tools for heart failure with preserved ejection fraction (IC / FEp), a pathology that is difficult to diagnose and to manage clinically in the absence of targeted treatment . The IC / FEp concerns the elderly population with comorbidities such as hypertension, obesity, anemia and atrial fibrillation. In the absence of specific biomarkers, clinical diagnosis is based on serum markers of heart failure with reduced ejection fraction (IC / FEr). The identification of new biomarkers, genetic and / or cellular, specific for IC / FEp would be an important innovation.


Eligibility Criteria:
Inclusion Criteria group 1 (ejection fraction ≥ 50%) :

* Age \> or = 65,
* heart failure (NT-proBNP ≥ 450 pg/mL during hospitalization or follow-up)
* echocardiography showing an ejection fraction ≥ 50%,
* patients already hospitalized and followed in cardiology consultation,
* patients agreeing to sign informed consent,
* patient affiliated to french health care system.

Inclusion Criteria group 2 (ejection fraction \< 50%) :

* Age \> or = 65,
* heart failure (NT-proBNP ≥ 450 pg/mL during hospitalization or follow-up)
* echocardiography showing an ejection fraction \< 50%,
* patients already hospitalized and followed in cardiology consultation,
* patients agreeing to sign informed consent,
* patient affiliated to french health care system.

Inclusion Criteria group 3 (without heart failure) :

* Age \> or = 65,
* patients already hospitalized and followed in cardiology consultation for one of the following pathology : stable coronaropathy without heart failure, arterial hypertension without heart failure, auricular fibrilation without heart failure
* patients agreeing to sign informed consent,
* patient affiliated to french health care system.

Exclusion Criteria for all groups:

* Hemodynamic instability (cardiogenic shock),
* any condition leading to a prognosis of less than 7 days,
* Known hepatocellular insufficiency, or known hepatic cirrhosis
* ASAT / ALAT\> 10N excluding cardiac cause
* Any conditions that may put the patient at risk or increase the risk of non-compliance with the protocol or lost to follow-up according to the opinion of the investigator
* Patient under legal protection, under guardianship or under curatorship
* Inability to give the subject informed information
* Pregnant or breastfeeding woman
A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin

The aim of this project is to study the role of transient receptor potential (TRP-) channel V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal Ultraviolet-B damage. Moreover, in this project the investigators want to evaluate if the capsaicin-desensitization action can still be induced in a skin area pretreated with topical, local anesthetic lidocaine.

In this project the Ultraviolet- B pain model, a model using type B ultraviolet rays to induce a first-degree sunburn, will be used to induce a non-specific inflammation in the skin. This model is well-known to produce both peripheral and central hyperalgesia through sensitization of peripheral and central nociceptors. Capsaicin, the active substance in chili peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of 8% capsaicin patch causes profound desensitization to painful heat stimuli and itch provocations. Therefore, the investigators would like to monitor the development of unspecific UVB-cutaneous inflammation and consequent neurogenic flare in a capsaicin pre-treated area. Moreover the investigators want to test if pre-treating the skin with lidocaine can reduce the pain associated with the capsaicin application without affecting its desensitization action.

Eligibility Criteria:
Inclusion criteria:

* Healthy men and women
* 18-60 years
* Caucasian descent (only in sub-study 1)
* Speak and understand English

Exclusion criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Moles or tattoos in the area to be treated or tested.
* Exposure of the irradiated area to UV radiation (e.g., sun) 48 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
* Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.


Eligibility Criteria:
Inclusion Criteria:

* Onset of STEMI \<12 hours
* Anterior wall STEMI or Killip grade II-III or LVEF \<50%
* Undergoing primary PCI

Exclusion Criteria:

* Signs of infection (clinical judgement plus leukocyte count \>15,000)
* STEMI mechanical complication
* Moderate-severe valvular disease
* Allergic to doxycycline
* Refuse to join the trial
A Study Evaluating the Efficacy and Safety of HSK3486

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy;
2. Male or female patients, ASA grade I\~III, aged ≥ 18 and≤ 70;
3. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
4. the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤100;
5. Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

Exclusion Criteria:

1. Patients were contraindicated in general anesthesia.
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
3. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.
4. Patients with a history of drug or ethanol abuse with the past 3 months.
5. Patients with respiratory management difficulties.
6. Patients in receipt of any investigational drug within 30 days before screening.
7. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours before screening.
8. Abnormal laboratory results consisting of any of the following:

1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5) serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.

10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason)
Evaluation of the Presence of SENS-401 in the Perilymph

The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.

The study is a Phase IIa, open-label, randomized and controlled study investigating repeated twice-daily administration of oral SENS-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.

After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).

Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.

Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.

Eligibility Criteria:
Main Inclusion Criteria:

Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:

1. Adults aged from 18 years and older;
2. Meets the locally approved indication for cochlear implantation. The individual must have freely consented to the cochlear implant surgery before being offered to participate in the SENS-401-203 study;
3. Signed and dated written informed consent;

Main Exclusion Criteria:

Individuals will be excluded from the study if any of the following main exclusion criteria apply:

1. Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min
2. Any condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study
3. Unable or unwilling to comply with the protocol requirements
4. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction