cyrilzakka/clinical-trials huggingface dataset:
Neuromodulation on Motor Function in Parkinson's Disease

The aims of the present study was to analyze the effect of consecutive sessions of Transcranial direct current stimulation associated to kinesiotherapy about gait performance of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).

This study consist by interventions involving screening followed by evaluation, where volunteers were subjected to the many tests: history, session III of the Unified Scale Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same day, the subjects underwent assessment of brain excitability to determine motor threshold and amplitude of the motor evoked potential (MEP). The randomization of the volunteers was conducted by an external search through opaque envelopes ordered according to a random distribution. The subjects were divided into two groups : control group , this group submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait training , and Experimental group, subjected to the stimulation by Transcranial Direct Current sessions (active tDCS ) and gait training.

Eligibility Criteria:
Inclusion Criteria:

* Main eligibility criteria were idiopathic Parkinson's disease
* Both sex
* Hoehn and Yahr stage I to III
* Showing mild to severe gait disturbances
* Stable medication usage
* Age 40 to 80 years
* And absence of cognitive impairment and disorders interfering with participation in cueing therapy.

Exclusion Criteria:

* Presence of chronic disabling pathologies of lower limb
* Presence of pacemaker or severe cardiovascular conditions
* A history of tumor, prior neurosurgical brain
* Intervention, or severe cardiovascular conditions, including the presence of a pacemaker
* A diagnosis of epilepsy or major psychiatric disorders.
* Participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded.
* Participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.
Effect of Pectoralis Minor on Endurance

The aim of this study evaluate the effects of dominant and non-dominant pectoralis minor (PM) length on scapular and core muscle endurance in the absence of scapular dyskinesia.


Eligibility Criteria:
Inclusion Criteria:

* volunteered to participate in the study
* and did not have scapular dyskinesia according to the evaluations made

Exclusion Criteria:

* did not want to participate in the study
* and those with previous neurological or orthopedic upper extremity disorders,
* pain problems in any part of their body,
* previous abdominal surgery,
* and had communication problems
Roll-over Study to Allow Continued Access to Ribociclib

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

Eligibility Criteria:
Key inclusion Criteria:

1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
3. Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

1. Permanent discontinuation of ribociclib in the parent study
2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end
Enhancing Cognitive Training Using tDCS

Cognitive rehabilitation involves enhancing an individual's capacity to process information to improve their everyday functioning. One common form of intervention is computerised cognitive training (CT); however, efficacy results have been mixed. This research aims to investigate a novel method for enhancing outcomes from CT through combining CT with transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain stimulation. In this study we aim to determine the efficacy of this approach through comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in healthy participants. We hypothesise that tDCS combined with CT will have greater generalisability effects than the other conditions.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy right-handed subjects aged 18 to 40

Exclusion Criteria:

* Concurrent medication likely to affect mental performance
* History of drug or alcohol abuse or dependence current or in the last 3 months
* Any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke
Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Melanoma

TUPRO-Melanoma is the first project of the Tumour Profiler (TUPRO) research collaboration, which in the long-term aims to generate data that will help to understand and report the individual tumour biology and the clinical parameters for patients with advanced malignancies using innovative molecular technologies and computational analyses for in-depth molecular profiling. TUPRO-Melanoma is an exploratory project that aims to establish a comprehensive platform for in-depth tumour profiling in patients suffering from advanced melanoma. Aims of this platform are to establish logistics and algorithms for integrative analyses and discover new molecular biomarker profiles/patterns.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECOG performance status ≤2 (not bedridden for more than 50% of waking hours)
* Stage III or IV cutaneous melanoma, or rare melanoma subtypes at any stage that require systemic therapy
* Written informed consent according to national legal and regulatory requirements prior to any project specific procedures

Exclusion Criteria:

* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the sponsor-project leader or site project leader may interfere with the project or affect patient compliance
* Legal incompetence
Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users

The purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 19 years of age
* Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg)
* Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings
* Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded
* Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period
* Signature of the written informed consent

Exclusion Criteria:

* Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs
* Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them
* Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period
* Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus
* Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome
* History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years
* History of malabsorption within 3 months prior to screening period
* Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test
* Patient who is needed continuously to take antithrombotic agents , anti- coagulant , anti- choline agents, prostaglandins , mucosal protective agents , methotrexate, antidepressants , iron treat agents during clinical test.
* Patients with clinical meaningful laboratory test results
* Known alcohol and/or any other drug abuse or dependence
* Pregnant or lactating women
* Women planning to become pregnant
* Within 1 month, patients who have been taken other clinical test drug
* Patients who are judged by investigator that participation of the study is difficult
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 to 65
* Females must be of non-childbearing potential or practicing birth control
* Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion Criteria:

* Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
* Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
* Is associated with any currently ongoing research study
Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer, head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe nephrotoxicity, which particularly affects the proximal tubule epithelial cells (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity, although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing antioxidant, which not only acts as a precursor of glutathione but also as a direct antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a low-cost, easily available drug with a very good safety profile and therefore can be added as a support medication during treatment with cisplatin. The investigators plan to administer 1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6 days, with an objective to ascertain its nephroprotective role in population receiving Cisplatin/-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult female outpatients with non-hematological malignancies (Breast, ovary and head and neck squamous cell carcinomas)
* Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never received platinum based Chemotherapy in past and were now scheduled to receive high-dose cisplatin chemotherapy.
* Patients were required to have estimated glomerular filtration rate (GFR)(according to Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal Blood Counts, Liver, and kidney function tests

Exclusion Criteria:

* Patients who had poor performance status i.e., ECOG Performance Status 3 or 4
* Who declined to participate at any time during the course of the study
* Patients having hepatic failure (Liver Function tests \>3 times of upper limit normal)
* Patients who did not tolerate the use of NAC or were administered the drug \<70% of the time
* Patient who were receiving concurrent nephrotoxic drugs, or having history of Hypersensitivity to N-Acetyl cysteine.
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmation of Mantle Cell Lymphoma (ML)
* Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
* Must have normal organ function
* Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy
* Patients with prior exposure to obatoclax
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding
CE Mark Study for the Harpoon Medical Device

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient referred for mitral valve surgery
* Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure
* Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
* Degenerative mitral valve disease
* Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
* Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

* Age \< 18 years
* Infective endocarditis
* Anterior or bileaflet prolapse
* Functional MR
* History of Mediastinal Radiation
* Inflammatory (rheumatic) valve disease
* Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
* Symptomatic coronary artery disease
* Cardiogenic shock at the time of enrollment
* ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
* Evidence of cirrhosis or hepatic synthetic failure
* Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
* Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
* Previous cardiac surgery, or surgery on the left pleural space
* Left ventricular, atrial or appendage thrombus
* Severely calcified mitral leaflets
* Recent stroke (\< 6 months) with permanent impairment
* EuroScore (for mitral valve repair) \> 8%
* Patients with contraindications to Transoesophageal echocardiography
* Severe left or right ventricular dysfunction
* NYHA Class IV
* Renal insufficiency CKD stage 3b or worse (GFR \< 45 ml/min/1.73 m2)
* Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
* Patient with non-cardiac co-morbidities and life expectancy \< 1 year
* Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks).

Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.

Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period.

Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.

Eligibility Criteria:
Inclusion Criteria:

* The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
* The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
* Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
* The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
* The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
* The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

Exclusion Criteria:

* The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
* The patient is experiencing an acute exacerbation of his/her psychotic symptoms
* The patient has not responded to treatment with clozapine

Other protocol defined inclusion and exclusion criteria may apply
Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese

It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation.

The previous study (not published) showed that CG underestimated 24 hour measured urine creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to establish a estimated creatinine clearance equation fitting in Taiwanese.

Besides, there are lots of studies discussing difference between CG and MDRD. We have found that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis which characteristics of patients the difference are largest or smallest.


Eligibility Criteria:
Inclusion Criteria:

* age above or equal to 20 year-old adults
* had 24 hour urine creatinine collection

Exclusion Criteria:

* lack of at least one :sex, diagnosis, age,weight, height
* serum creatinine beyond linear test range
* with extreme weight or height
* with acute kidney injury or specific diagnosis
* with extremities of daily urine creatinine excretion
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants are eligible to be included in the study only if all the following criteria apply:
* Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
* Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
* In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:
* Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
* Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
* Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
* Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease