cyrilzakka/clinical-trials huggingface dataset:
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).

The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).

Eligibility Criteria:
Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver.
* The patient is an outpatient.
* The patient has probable AD.
* The patient has mild to moderate AD.
* Stable treatment with an AChEI.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
* The patient has evidence of clinically significant disease.
* The patient's current AChEI therapy is likely to be interrupted or discontinued during the study.
* The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.
Lactate Metabolism in the Hypoperfused Critically Ill

Investigating lactate metabolism in critically ill patients whom are hypoperfused by preforming metabolomics via liquid chromatography-mass spectrometry.

Lactate concentration is well known to be directly correlated with risk of death during admission to intensive care. However, lactate by itself is not considered toxic. The study is observational. The breakdown of lactate is being investigated by collecting blood- and urinsamples from patients with hyperlactatemia as a result of hypoperfusion. Levels of lactate, and known as well as unknown metabolites will be identified and quantified by metabolomics. Metabolomics is performed using a combination of liquid chromatography and mass spectrometry. Data will be analysed via statistical analysis to investigate corelations between lactate, a given metabolite and hard outcome such as mortality. And thereby lay the groundwork for potential further research regarding specific lactate-metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sepsis/septic shock or severe heart failure.
* Clinical and paraclinical signs of hypoperfusion in relation to abovementioned diagnosis.
* Metabolic acidosis with s-lactate equal-to-or-above 4 mmol/l.
* Incapacitated

Exclusion Criteria:

* Only regional hypoperfusion such as a leg.
* Receiving intravenous lactate as part of treatment.
* Going in to dialysis. The exclusion is only during dialysis treatment.
Factors Associated With Pain Threshold in Young Adults With Chronic Neck Pain

The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* To be examined by specialised physicians and diagnosed with chronic neck pain, to be physically and mentally fit to participate in the study.

Exclusion Criteria:

* The presence of instability in the neck joints, trauma within the last year, severe osteoporosis, previous neck surgery, physical therapy within the last 6 months, neurological findings or radiculopathy were determined.
Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

This study propose neoadjuvant chemotherapeutic role by erlotinib.

It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.

Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.

So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer
* Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women
* Age ≥ 18 years and ECOG performance 0\~1
* Has measurable lesion by RECIST 1.1
* No previous chemotherapy or radiation therapy
* Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr \< 1 x UNL or creatinine clearance \> 60 ml/min, Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL
* Written informed consent form

Exclusion Criteria:

* Pulmonary carcinoid tumor
* Previous chemotherapy or radiation therapy
* Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
* Known allergic history of erlotinib
* Interstitial lung disease or fibrosis on chest radiogram
* Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
* Pregnant or nursing women
Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

Participants who undergo laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR) will demonstrate greater improvement bowel symptom scores compared to participants who undergo LSCP alone at 3 months postoperatively.

Those who provide informed consent will be randomized into either laparoscopic sacrocolpopexy (LSCP) alone or laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR). Participants will be randomized with equal probability to the LSCP only arm or LSCP plus PR arm.

The surgical technique for LSCP will be similar to that described by Paraiso et al. for LSCP \[14\] and by Elliott et al. for robot-assisted LSCP \[15\], with minor variations. A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, will be used with all SCP procedures.

PR is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with PR. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure.

Participants will also complete questionnaires and undergo an endovaginal ultrasound (using a 9-16 MHz, 360° rotational transducer, type 8838, BK Medical, Peabody, MA) prior to surgery and three months following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female Gender
* Able to complete English language questionnaires
* Able to complete study visits for 6 months
* Bowel symptom score (PFDI-O) score ≥ 3
* Posterior vaginal bulge ≤2cm beyond the hymen

Exclusion Criteria:

* Age \< 21
* Pregnancy
* History of colorectal surgery
* History of pelvic radiation
* Inflammatory bowel disease
* History of prior SCP
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must have provided written informed consent
* Age 18-75 years;
* BMI 17-28 kg/m2
* Male or female with a diagnosis of PBC, by at least two of the following criteria:

  1. History of AP above ULN for at least six months;
  2. Positive AMA titers (\&gt;1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.
* Not receiving UDCA treatment before enrollment, ALP\&gt;ULN

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT or AST \&gt; 5×ULN, TBIL \&gt; 3×ULN.
* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
* Allergic to fenofibrate or ursodeoxycholic acid.
* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
* Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
* Planned to receive an organ transplant or an organ transplant recipient.
* Needing Liver transplantation within 1 year according to the Mayo Rick score.
* Any other condition(s) that would compromise the safety of the subject or compromise
Mahana Tinnitus Pilot

The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.

Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.

Eligibility Criteria:
Inclusion Criteria:

* Participant scores ≥ 25 on the Tinnitus Functional Index.
* Participant has experienced symptoms of tinnitus for at least 3 months.
* Participant is at least 18 years of age at the time of consent.
* Participant resides in the United States.
* Participant is able to speak, read, and understand English.
* Participant has access to an iOS or Android smartphone with the ability to complete study tasks.
* Participant is able to commit the time required to complete therapy modules and study assessments.

Exclusion Criteria:

* Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI).
* Participant has been hospitalized for psychiatric reasons within 12 months of screening.
* Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.
Dental Support and the Second Stage of Labor Among Multiparous Women

To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.

Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.

The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton gestation
2. Multiparous women
3. Term gestation (\>37+0/7 weeks)
4. Signed written consent to participate in the study
5. Maternal age 18-45 years
6. Normal vital signs
7. Noraml cardiotocography and biophysical profile at admission

Exclusion Criteria:

1. Multiple gestation
2. Nulliparous women
3. preterm gestation (\<37+0/7 weeks)
4. Refusal to participate
5. Maternal age \<18 or \> 45 years
6. Normal vital signs
7. Abnormal cardiotocography and biophysical profile at admission
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA

(Neo)adjuvant treatment approaches and outcomes


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years old

  -. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples
* Early HER2-negative BC (stages 2 and 3)
* Compliance with at least 1 of the criteria for BRCA1/2 testing in accordance with the clinical guidelines of the Ministry of Health of the Russian Federation
* Unknown BRCAm status or negative BRCAm PCR test
* Performed surgical treatment (not more than 7 months before inclusion)

  -. High risk of recurrence according to one or more criteria:
  1. incomplete pathomorphological response (in case of neoadjuvant therapy)
  2. CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
  3. presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
  4. ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
  5. Any other high risk criterion according to investigators opinion
* The presence of postoperative or biopsy FFPE

Exclusion Criteria:

* Participation in another clinical study with an investigational product during the last 3 months
* Confirmation that the subject was already included in this study before
* Absence of a written informed consent form; Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database
Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters

This study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters.

PRIMARY OBJECTIVES:

I. Identification of thyroid nodules by vibro-acoustography - Determine detection rate.

II. Evaluate the specificity of VA in differentiating malignant and benign of thyroid nodules - Compare the result to that of ultrasound (US).

III. Assess diagnostic value of Shear Wave Ultrasound Vibrometry (SDUV) and Comb Push shear elastography (CUSE) in differentiation of thyroid nodules - correlate SDUV and CUSE results to pathology.

IV. Test and compare the results shear wave imaging with new FDA approved ultrasound device called SuperSonic Imagine Aixplorer.

V. Assess diagnostic value of Shear Wave Ultrasound Vibrometry (SDUV) and Comb Push shear elastography (CUSE) in differentiation of palpable and sonographically detectable cervical lymph nodes or non-thyroidal neck masses.

VI. Assess the diagnostic values of ultrasound quantitative microvessel imaging for differentiation of thyroid nodules and cervical lymph nodes.

VII. Assess the response to alcohol ablation on patients with recurrent thyroid cancer on thyroid bed or new lymph nodes on neck.

OUTLINE: This is an observational study.

Patients undergo ultrasound imaging on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Male and female patient volunteers ages 8 and up who are suspicious for thyroid cancer

  * Patients who have palpable and sonographically detectable lymph nodes or nonthyroidal neck masses and are referred to Radiology Department or Endocrinology for fine-needle aspiration biopsy (FNAB)
  * Patients 18 and up who were previously diagnosed with thyroid cancer and treated with thyroidectomy and recently diagnosed as having recurrence nodes on thyroid bed or on their neck

Exclusion Criteria:

* Because thyroid cancer is rare under the age of 8 years, children younger than this age are excluded from the study
* Having FNAB or surgical biopsy on thyroid in less than two weeks for thyroid nodule detection group
* Having FNAB or surgical biopsy on cervical lymph nodes or non- thyroidal masses for this group of patients
Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders.

the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.

This is a pilot study for which 15 patients with myopathies will be included. The primary objective of the study is to assess the safety and tolerance of a system for communication named P300 speller. The P3Speller is a brain computer interface (BCI) that records the brain electric activity with the use of electroencephalography (EEG) and analyzes it in real time in order to identify slight changes generated in relation to a visual stimulation (evoked potentials). The identification of such brain potentials is translated into a digital command for a spelling device. The secondary objective of this study is to compare the efficacy of this spelling device with a more traditional assisitve technology called scanner interface. A scanner interface uses single clicks that can be obtaines with an adequate interface which exploits the remaining muscular activity from a patients.

Every patient will use each interface (P300 sepller and Scanning) with a randomized order. Results will bec o,pared in terms of information flow from the patient to the computer expressed in bit rate per minute.

Eligibility Criteria:
Inclusion Criteria:

* Adult older than 18y.o., diagnosed with neuromuscular disease, stable vital signs and informed consent

Exclusion Criteria:

* History of seizure, brain damage, sight or auditory dysfunction, Atopic dermatitis, skin hypersensitivity to gold, patient under guardianship, illiterates or not able to cooperate , cognitive dysfunction
* Steinert disease, Merosine negative disease, Alpha-dystroglycanopathies
Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain

Research questions/hypotheses

1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management?
2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?


Eligibility Criteria:
Inclusion Criteria:

* \>18 years, pain experienced
* \>3 months, proficiency in English

Exclusion Criteria:

* previous mindfulness experience
* severe cognitive impairment
* profound hearing difficulties
Cervical TsDCS on Stroke Patients

The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.


Eligibility Criteria:
Group Stroke:

Inclusion criteria:

1. age over 18 years;
2. first ischemic/hemorrhagic stroke (within 30 days of onset);
3. mild-to-moderate stroke (NIHSS scale score\<16).
4. residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
5. ability to give informed consent and understand instructions.

Exclusion criteria:

1. severe spasticity (Ashworth Scale score \> 2);
2. severe aphasia;
3. severe neglect;
4. history of disabling neurological disease;
5. history of epilepsy;
6. significant comorbidities;
7. contraindications to tsDCS.

Healthy Group:

Inclusion criteria:

1. age over 18 years;
2. equalized in age with the patient group.

Exclusion criteria:

1. history of stroke progress;
2. history of severe neurological disease.
Genetic Polymorphism and Parkinson's Disease in Taiwanese

To observe and analyze the correlation between Single Nucleotide polymorphisms (SNPs) and the incidence of Parkinson's disease in Taiwanese.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease (case subjects are diagnosed by the presence of at least three of the five following primary signs: rest tremor, bradykinesia, rigidity, impaired postural refluxes, and the presence of a sustained L-dopa response.)
* Healthy volunteers without Parkinson's disease

Exclusion Criteria:

* Cases showing atypical features, including multiple system atrophy and progressive supranuclear gaze palsy, or secondary causes of Parkinsonism, such as neuroleptic drugs, infection, tumor, previous cerebrovascular accident and known toxins
Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer

The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.

Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).

Eligibility Criteria:
Inclusion Criteria:

1. All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
2. Male or female, age \> 18 years, \< 75 years.
3. Patients had not received PD-L1 inhibitors in first-line treatment.
4. KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months;
5. No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:

   1. Blood routine test:

      Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
   2. Blood biochemical test:

Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart \>; 6) The subject has good compliance, and can cooperates with follow-up.

Exclusion Criteria:

-