cyrilzakka/clinical-trials huggingface dataset:
Mitochondrial Biomarkers in Huntington's Disease

The objective of this study is to discover a panel of mitochondrial metabolomics biomarkers for Huntington's disease.

This investigator-initiated, single-site longitudinal study seeks to assess the utility of mitochondrial metabolomics -- panels of small molecules that affect mitochondrial function -- to diagnose pre-symptomatic, pre-manifest, and symptomatic Huntington's disease and serve as biomarkers for HD severity and progression. It also seeks to demonstrate that this novel biomarker in the blood has comparable value to the same analysis in spinal fluid. This research study involves 3-4 visits over 18 months. Forty volunteers with HD and 25 volunteers without HD will be included. Volunteers who have HD will have a physical examination and blood draw at each study visit. Some participants will also volunteer for optional lumbar puncture.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 85
* Montreal Cognitive Assessment score \>10
* HD subjects had onset of HD symptoms after the age of 20
* HD subjects with Diagnostic Confidence Level (DCL) of 0-3 (pre-symptomatic or pre-manifest) must have at least 40 CAG repeats on one HTT allele
* HD subjects with Diagnostic Confidence Level (DCL) of 4 (manifest) must have at least 36 CAG repeats on one HTT allele
* Controls are asymptomatic without family history of HD or have \<36 CAG repeats on both HTT alleles with family history of HD

Exclusion Criteria:

* HD subjects who did not already have genetic testing are excluded from this study
* Pregnancy or plans to become pregnant during the study
* Investigational drugs within 3 months of screening visit
* Alcohol or illicit drug abuse or dependence
* Other genetic or neurological disorders
* Other medical or psychiatric illness that in the investigator's judgement will prevent ability to tolerate or undergo study procedures
* For those volunteering for lumbar puncture (LP), bleeding disorders or excessive bleeding, anticoagulation, aspirin if unable to safely stop taking it at least 7 days prior to LP, other antiplatelet medications, inability to tolerate LP, allergy to local anesthetic or chlorhexidine, major lumbar spine deformity, low platelets or abnormal coagulation factors PT/APTT
Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients

This is a multi-center, single-blind, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus.

As one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. Since 2016, Zhongshan Hospital has set up the Internet-based glucose management system (iGMS) to monitor plasma glucose of diabetes patients, and further set up an Artificial Intelligence Assisted Insulin Titration System (iNCDSS) to recommend insulin regime in 2019. Previous single-center clinical trial (NCT04053959) have indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.

This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists.

This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 and above years old;
* Subjects who had been diagnosed with type 2 diabetes;
* Subjects who are on diabetes treatment for at least 3 months;
* HbA1c: 7.0%-11.0%.

Exclusion Criteria:

* Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
* Subjects who change the insulin regimens during hospitalization;
* BMI ≥ 45kg/m2;
* Women who are pregnant or nursing;
* Subjects with severe cardiac, hepatic, renal or general diseases;
* Subjects with psychiatric disorders or impaired cognitive function;
* Subjects with severe edema, infections or peripheral circulation disorders;
* Patients treated with surgery during hospitalization;
* Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)

The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.

Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy
* Measurable or evaluable disease
* Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

* Concurrent serious medical illness
* Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
* Active diarrhea
* Known history of coagulation disorder
* Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications
* Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes
* Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208
Olfactory Disfunction and Co-ultraPEALut

Olfactory dysfunction is common among patients with Corona-Virus-Infection-Disease (COVID)-19, and up to 30% of patients may report persistent disorders of smell or taste as a long-term sequelae. This randomized-controlled study has addressed to compare the efficacy of neuro-protective and anti-inflammatory agents palmitoylethanolamide (PEA) and Luteolin(Treatment) with control (olfactory training) in a cohort of patients who present persistent smell disorders after resolution from Covid-19 and negative swab for 4 months at least.

Patients ages 18 to 70 years with confirmed history of COVID-19 (positive nasopharyngeal swab for SARS-CoV-2) and subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative COVID-19 nasopharyngeal swab are eligible.

All patients will undergo nasal endoscopic examination to look for presence of polyps, masses, anatomic blockage, or other pathology which presence will require exclusion from the study. Patients then will be evaluated at the baseline with Sniffin' Sticks (Burghardt®, Wedel, Germany) prior to initiating olfactory training and/or supplement treatment (T0). One group received daily olfactory training, patients in the supplement group additionally received a daily oral tablet that contained PEA 700 mg and Luteolin 70 mg (Glialia ®, Epitech pharmaceutical, Milano, Italy), or 1 dose of PEA-LUT only or aTwo Dose of PEA-LUT.

Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days

Eligibility Criteria:
Inclusion Criteria:

* 18 to 90 years with confirmed history of COVID-19 (positive nasopharyngeal swab for SARS-CoV-2)
* subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative COVID-19 nasopharyngeal swab

Exclusion Criteria:

* previous history of olfactory-gustatory disorders
* impaired cognitive function
* history of neurodegenerative disease
* medical therapy with possible effects on olfactory function
* presence of rhinological disorders (sinusitis, rhinosinusitis, sinonasal polyposis, atrophic rhinitis, allergy)
* history of chemo-radiotherapy of the head and neck region
* history of stroke or neurotrauma
* severe nasal blockage from stenosis of deformity
* severe psychiatric illness (e.g. schizophrenia, bipolar disorder, olfactory hallucination)
* previous sinonasal
* nasopharyngeal tumors.
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).

The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
3. Participants must have measurable disease as defined in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Participants must have clinical laboratory values within a prespecified range.

Exclusion Criteria:

1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
2. Participants who defer transplant due to personal preference.
3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:

   * focal radiation and/or
   * a short course of corticosteroids as defined in the protocol.
5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1.
7. Participants who have uncontrolled intercurrent illness.
8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.

NOTE Other protocol defined inclusion/exclusion criteria apply.
Choroidal Thickness Association With Primary Angle Closure

A chinese study shows that chinese population eyes with a primary angle closure have a greater choroidal thickness than normal eyes.The increase of choroidal thickness would be associated to this primary angle closure.

Usual ophtalmic consultation for glaucoma with primary angle closure

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Primary angle closure confirmed by gonioscopy
* interpretable images for choroidal thickness measure
* interpretable images by Ultra Bio Microscopy (UBM)

Exclusion Criteria:

* Acute crisis for angle closure
* Rethinopathy (diabetic or hypertensive)
* Histories of intra-eye surgery
* Great myopia
* Hypermetropia
* retinal pathology
The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting

The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.


Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Admission for cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion

Exclusion Criteria:

* pregnant
* prisoner
The Effect of Early Mobilization on Postoperative Recovery in Abdominal Surgery

Objectives: This study will be conducted to determine the effect of early mobilization on postoperative recovery in abdominal surgery patients..

Methods: This research is a randomized controlled experimental study. In the Gastrointestinal Surgery Department, a total of 130 patients will be included, consisting of 65 experimental group and 65 control group, who are scheduled for abdominal surgery in the study. In the study, data will be collected using a survey form, Numerical Rating Scale, gradual mobilization chart in the first 24 hours after surgery, and Postoperative Recovery Index (PoRI-TR). On the day before the surgery, the experimental group will receive early mobilization training. On the day of the surgery, vital signs, oxygen saturation, and pain intensity will be assessed before the first mobilization. Pain control will be ensured before mobilization. Each mobilization will be carried out in accordance with the gradual mobilization schedule within the first 24 hours after surgery. Following the Enhanced Recovery After Surgery (ERAS) protocol recommendation, mobilization will be provided outside of bed for a total of 2 hours, with durations increasing by the hour on the day of surgery under the supervision of the researcher: 5, 15, 25, 35, and 40 minutes. Mobilizations for patients showing signs of orthostatic hypotension will be postponed by 30 minutes. On the days following the surgery, patients will be informed to spend 6 hours outside of bed. The control group will receive routine care procedures. The second part of the questionnaire will be administered on the day of the surgery for both the experimental and control groups, and the PoRI-TR will be applied at the 25th hour after surgery. Data will be collected through face-to-face interviews within 20-25 minutes. The data obtained from the research will be evaluated using the SPSS 22.00 program. The normality of the data will be determined by Skewness-Kurtosis tests. Based on this result, either parametric or non-parametric tests will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are conscious,
* Without cognitive or mental problems,
* Undergoing elective abdominal surgery,
* Aged 18 and above,
* Without physical limitations preventing early mobilization,
* Without active bleeding,
* Without cardiovascular or respiratory diseases,
* Classified as American Society of Anesthesiologists (ASA) class I or II,
* Literate patients
* Volunteering

Exclusion criteria:

* Patients undergoing oncologic surgery who spend the first 24 hours in the intensive care unit due to post-operative care,
* Emergency surgery patients due to the absence of pre-operative preparation phase,
* Patients who are healthcare workers due to their knowledge about early mobilization
Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty

This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:

·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?

The secondary questions are:

* What is the length of stay in hospital for each group?
* What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.

The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.

Eligibility Criteria:
Inclusion Criteria:

* Indication of total primary hip arthroplasty
* ASA I-III
* BMI\<40 kg/m2

Exclusion Criteria:

* Inability or refusal to sign informed consent
* Known allergies to any of the drugs used in the study
* Hepatic or renal insufficiency
* Gastritis or gastroduodenal ulcer
* Opioid dependency
* Coagulopathy
* Pregnancy
* Scars in the surgery and fascia iliaca block areas
* Clinical evidence of peripheral neuropathies.
Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3

Objectives and evaluation criteria:

The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.

The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.

Research plan and procedure:

Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:

* Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
* Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.

Number of research participants:

As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test.

Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week.

Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.

Research duration:

Inclusion period: 5 days, Monday to Friday Participation period: 3 days (from day 0 to day 2) Study duration: 7 days


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
* Anticipated hospital stay \> 48 hours

Exclusion Criteria:

* Patient hospitalized for more than 24 hours,
* Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
* No mastery of French
* Patient hospitalized for sleep pathology (evaluation or treatment),
* Patient hospitalized in an intensive psychiatric care room,
* Patients hospitalized under duress,
* Patient opposition,
* Patient under guardianship or curatorship.
Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7-Ag

The study aims to:

1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using confocal laser endomicroscopy.
2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo immunohistochemistry .

Gastric cancer remains the world's second leading cause of cancer-related death. Improved prognosis essentially depend on earlier diagnosis. Gastric monoclonal antibody MG7 has been validated as a specific antibody in gastric cancerous tissue. Conventional evaluation of MG7 antigen expression is immunohistochemistry, which is time-consuming, and the immunoreactivity can be affected by storage and fixation of tissue. Confocal laser endomicrosopy enables visualization of the cellular and subcellular structures in vivo. Thus this study aims to achieve molecular imaging of MG7 antigen in gastric cancer in vivo using confocal laser endomicroscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients with endoscopically diagnosed gastric cancer

Exclusion Criteria:

* Patients who are allergic to fluorescein sodium
* Patients who are unwilling to sign or give the informed consent form
* Patients with giant tumors or obvious GI tract bleeding which make it hard or impossible to observe the lesions
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding
A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics

Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period 2, after a washout period of at least 5 days, each subject will receive oral doses of tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3 to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants must be 18 to 60 years of age, inclusive, at the time of signing the informed consent document (ICD)
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* History of hypersensitivity to rosuvastatin., asymptomatic, seasonal allergies at the time of dosing).
* Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg, rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is longer) prior to dosing