cyrilzakka/clinical-trials huggingface dataset:
A Study of Lurasidone HCl in Subjects With Schizophrenia

The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Males or female aged at 20-75 years old
2. Subjects who are diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
3. CGI-S≦4 (at both screening and baseline)
4. Subject is judged by the investigator to have been clinically stable for at least 4 weeks prior to baseline and in need for a switch from their current antipsychotic treatment due to insufficient clinical response or poor tolerability (side effects, metabolic complications, etc.).
5. If the subject recruits from OPD, the subject should be intolerant to the AE or is insufficient in current antipsychotics treatment by investigator's judgment.
6. Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
7. Subject is able and agrees to remain off (or stable dosage) prior antipsychotic medication during the study period as defined by this protocol.
8. In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
9. Subject is willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject has clinically substantial risk of suicide or violent behavior as judged by the investigator.
2. Subject with the past history of neuroleptic malignant syndrome, water intoxication, paralytic ileus or dementia related psychosis
3. Subjects is active pregnancy (must have a negative pregnancy test at screening) or nursing (must not be lactating).
4. Subject has received treatment with MAO inhibitors within 14 days prior to the screening (Visit 1).
5. Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 1 month prior to signing the informed consent.
6. Subject is unstable or critical untreated medical illness by the judgment of investigators.
7. Subject who is otherwise considered ineligible for the study by investigator. For example, subjects experienced serious medical condition including known clinically relevant laboratory abnormalities, and hypersensitivity to Lurasidone.
8. Subjects who were considered resistance to treatment for psychotic symptoms by the investigator.
9. Total daily dose of pre-switch antipsychotic was exceeded the equivalent of haloperidol 12 mg/day.
10. Subjects have received long depot neuroleptics within 4 weeks prior to enrollment. Or, subject was treated with clozapine for refractory psychosis within 1 month of enrollment.
11. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study. Subject requires treatment with a drug that consistently prolongs the QTc interval.
Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients \> 18 years
* Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
* Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
* BP thresholds at visit 1:

  * For patients previously treated and uncontrolled: 140≤ office SBP\<180 mmHg
  * For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
* BP thresholds at visit 2 (for all patients):

  * 160≤office SBP\<180 mmHg AND
  * 155≤home SBP\<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Exclusion Criteria:

* Women of child-bearing potential not using any effective methods of contraception
* Severe hypertension (office BP ≥ 180/110 mmHg)
* Impossibility to stop abruptly previous antihypertensive treatments at visit 1
* Patients previously untreated or patients treated with two or three antihypertensive medications
* History or evidence of a secondary form of hypertension
* History of hypersensitivity to ACEi or renin inhibitors
* History of heart failure, stroke or coronary heart disease
* Serum potassium ≥ 5.2 mmol/l

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Resection Techniques for Pancreatic Tumors

The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint.

The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.

The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
* Patients 18 years old or older

Exclusion Criteria:

* Patients that have not undergone pancreatic resection surgeries
* Patients under 18 years of age
Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension

The subject of the study is evaluation of factors affecting to exercise intolerance in spiroergometry in women over 40 years of age with hypertension and association and relationship between the parameters of physical performance and prognosis in this group of patients.

The 185 women over 40 years of age hospitalized for arterial hypertension in the Department of Cardiology will be included in the study, including: the study group who demonstrated maximal oxygen consumption measured during incremental exercise indexed per kilogram - VO2max\<17 ml/kg/min and a second group who presented VO2max\>17 ml/min/kg.Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of arterial hypertension, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, non-invasive assessment for central arterial pressure waveform analysis and body mass analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or older than 40 years
* Arterial hypertension (HA) diagnosed according to the 2018 European Society of Cardiology (ESC) guidelines of HA \[1\]
* Current HA hospitalization

Exclusion Criteria:

* Severe hypertension
* Diagnosis of heart failure or typical symptomatic heart failure
* Left ventricular ejection fraction (LVEF) \<50%
* Documented: hyperandrogenism, hyperestrogenism, insulin resistance, premature ovarian failure, polycystic ovary syndrome
* Past myocardial infarction
* Diagnosis of cardiomyopathy (hypertrophic, dilated, restrictive, peripartum, arrhythmogenic)
* Lysosomal storage disorders
* Stroke, transient ischemic attack, Intracerebral hemorrhage in medical history
* Severe hyper- and hypothyroidism
* Pregnancy and lactation
* Chronic kidney disease (IV, V stadium according to National Kidney Foundation) and dialysis treatment
* Documented neoplastic process
* The patient's inability to cooperate and/or provide informed consent to participate in a research
* Alcohol and drug abuse
* Active autoimmune disease
* Treatment using immunosuppressants, cytostatic drugs, glucocorticosteroids, or antiretroviral drugs
* A history of bone marrow transplant or other organ transplant, treatment with blood products within the last 6 months
* Active systemic infection
* Hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) carrier or positive for hepatitis B surface antigen (HBSAg) or antibodies to HCV
* Surgery or serious injury within the last month
* Patients who did not express their informed consent to participate in the study
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.

2 groups (200 per group); control group receives no prophylactic antipyretic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.

Exclusion Criteria:

* Body weight \< 4.5 kg
* Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
* Children with any disease that affects the immune system or gastro-intestinal tract
* Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
* Children with contraindication to paracetamol treatment.
The Ideal LiST Session Frequency Protocol for CPPS Treatment

The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups.

Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week.

Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week.

National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit.

Adverse events will be reported during the treatment and follow up period.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must 18 to 60 years of age.
2. Participant has signed and dated the appropriate Informed Consent document.
3. Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months

Exclusion Criteria:

1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
2. Participant has a history of prostate, bladder or urethral cancer.
3. Participant has undergone pelvic radiation or systemic chemotherapy.
4. Participant has undergone intravesical chemotherapy.
5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.
6. Participant has undergone prostate surgery or treatment.
7. Participant with penile or urinary sphincter implants.
8. Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
10. PSA\>3 and age \> 40 years
11. Positive (suspicious for malignancy) digital rectal examination (DRE).
Reliability of Algometry in Swimming Athletes

In the competitive swimming scenario, there is a significant incidence of pain, which can be justified by the high levels of training that exposes athletes to constant stress. In this way, the quantification of pain and its monitoring becomes extremely important for clinical practice. A commonly used tool with easy access and clinical applicability, capable of measuring the pain threshold (PT) in a standardized manner is the pressure algometer. However, there is a shortage in the literature of studies that evaluate the reliability of this instrument in healthy swimming athletes. Objectives: Evaluate the intra and inter-examiner reliability and to describe the profile of the PT measurements measured by the algometer in swimming athletes. Methods: It is a reliability study, and will be composed of fifty young athletes members of swimming teams, of both genders, aged between 12 and 20 years. The evaluation will be carried out on the same day and in 2 steps: (1) Test and (2) Retest. In the first step, through a third examiner, the participants will be subjected to marking of points in pre-determined muscles and in points of referred pain. Next, they will perform the PT assessment through the algometer by two other distinct and trained examiners. The interval between each examiner will be five minutes with the participant at rest. After five minutes the test was performed, the step retest will begin, which will have the same procedures as in the previous step. The statistical package SPSS Statistics 23.0 will be used to conduct the analyzes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy swimming athletes

Exclusion Criteria:

* Being an alcoholic and/or consuming drugs and/or smoking;
* Anti-inflammatory and / or analgesic drugs less than 24 hours before the test;
* Presenting anemia, inflammatory process, diabetes, cardiovascular disease;
* Episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months;
* In addition to swimming for less than two years.
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
* Metastatic disease previously treated with a gemcitabine-based regimen

Exclusion Criteria:

* Locally advanced disease
* More than one prior chemotherapy-line for advanced pancreatic disease
* Prior treatment with fluoropyrimidines for advanced pancreatic cancer
* Eastern Cooperative Oncology Group (ECOG) performance status \>or= 2
* Poor kidney, liver or bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Unable to swallow capsules
* Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines
* Concurrent participation in another clinical trial or treatment with any other anticancer therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Activ C European Multicenter Study

Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.

The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and motion of the cervical disc. Its concept is based on a ball and socket joint, anchored between adjacent vertebral bodies. The modular prosthesis comprises the following elements: an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The UHMWPE inlay is securely fixed in this inferior component. The second element is the superior CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a ball joint with the inlay of the inferior plate component.

The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means (spikes and grooves on the superior end plate, a small keel on the inferior end plate), whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating.

The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic single-level cervical degenerative disc disease with neck and/or arm
* pain and/or neurological deficit, confirmed by MR scan
* Single-level surgery and single-level implantation of prosthesis between C3 and C7
* Age between 18 - 65 years at the time of surgery
* Pre-operative disc space height of the segment to be operated of at least 3mm
* Unsuccessful adequate conservative treatment
* Patient understands the conditions of the study and is willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient signed Informed Consent

Exclusion Criteria:

* Major facet joint degeneration at the segment to be operated on
* Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (\<2°))
* Pre-operative disc space height of the segment to be operated on of less than 3mm
* Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
* Previous trauma to the segment to be operated on resulting in compression or bursting
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
2. Male or female patients≥50 yrs. of age.
3. Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
4. The CNV area≥50% lesion area on FFA in the study eye at screening visit.
5. BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.

Exclusion Criteria:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
2. Subretinal hemorrhage\>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area\>50% total lesion area and/or involved of macular fovea;
3. Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
4. Presence of active intraocular or periocular inflammation or infection;
5. Prior any treatment of following in the study eye:

   * Anti-VEGF(Vascular Endothelial Growth Factor) therapy or anti-complement therapy within 3 months prior to screening;
   * Laser photocoagulation within 3 months prior to screening;
   * Photodynamic therapy or vitreoretinal surgery;
   * Intraocular glucocorticoid injection within 6 months prior to enrollment;
6. Presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
7. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
8. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
9. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
10. Other conditions unsuitable for enrollment judged by investigators
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury

The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized cognitive remediation treatment versus a computer-based control. Both the study and the cognitive remediation treatments meet the criteria of Non-Significant Risk.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 - 50 years of age at the time of consent
2. Subjects must have a diagnosis of mTBI
3. Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
4. Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
5. Subjects must be fluent English speakers.
6. Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.

Exclusion Criteria:

1. Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
2. Subjects must not be in-patients.
3. Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
4. Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
5. Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
6. Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
7. Subjects must not be judged to be lacking effort.
8. Subjects must not have problems performing assessments or comprehending or following spoken instructions.
9. Subjects must not be enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study.