cyrilzakka/clinical-trials huggingface dataset:
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the incidence of using anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute dystonia or parkinsonism to test the hypothesis that these two medications have different EPS incidence in EPS intolerant population.

Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant anticholinergic drugs. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients.

Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity (\>4) of global impression of extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of concomitant anticholinergic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-65 y/o;
* Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age;
* Meet schizophrenia criteria of DSM-IV;
* Fulfill DSM-IV neuroleptic-induced acute dystonia or parkinsonism research criteria, the severity of acute dystonia or parkinsonism was greater than moderate degree (\>4) assessed by global impression of Extrapyramidal System Rating Scale (item 43 and 44 of ESRS);
* Patients or legal responsible people agree to join study and sign informed consent

Exclusion Criteria:

* Had other axis I diagnosis of DSM-IV;
* Unstable major systemic diseases;
* Had neurological disorder influenced to EPS assessment;
* Substance abuse or dependence other then coffee or tobacco within 6 months before study
Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.

This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, \& treatments

Children's information will be collected in the registry for a maximum of 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent is obtained from the children's parent(s) / legal guardian(s) before any study-related activity is carried out
2. The child is able to provide written informed assent, where this is required according to national legislation, before any study related activity is carried out
3. The child has been diagnosed as having achondroplasia documented by clinical diagnosis
4. The child is between 0 years and 10 years of age, inclusive, on the date of consent / assent
5. The investigator has considered the family and prospective participating child being able to comply with the study procedures

Exclusion Criteria:

1. The child has a diagnosis of hypochondroplasia or any short stature condition other than achondroplasia (eg, spondyloepiphyseal dysplasia congenital \[SEDC\], pseudoachondroplasia, trisomy 21)
2. The child has any medical condition that may impact growth or where the treatment is known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism, insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac disease, systemic lupus erythematosus \[SLE\], juvenile dermatomyositis, scleroderma, and others), autonomic neuropathy, or inflammatory bowel disease
3. Treatment in the previous 12 months prior to consent and assent with growth hormone, insulin-like growth factor 1 (IGF-1), anabolic steroids, or any other drug expected to affect growth velocity
4. Any surgery that affects the growth plate of the long bones that is planned, or has occurred in the past 18 months
5. Participation in any interventional study (investigational product or device) for treatment of achondroplasia or short stature
6. Has had bone-related surgery impacting assessment of anthropometric measurements or is expected to have it during the study period. Children with previous limb-lengthening surgery may enroll if surgery occurred at least 18 months prior to the date of consent/assent and healing is complete without sequelae as determined by the investigator
7. Has any condition that in the view of the investigator places the child at high risk of poor compliance with the visit schedule or of not completing the study.
8. Any concurrent disease or condition that in the view of the investigator would interfere with study participation
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents

The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
* An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
* A history of usual migraine duration of \>2-hours untreated for the 3 month prior to screening

Exclusion Criteria:

* A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
* Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
* Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has uncontrolled hypertension
The Effects of Online Rheumatological Rehabilitation Education in Intern Physiotherapy Students

The aim of the study is to investigate the effect of online rheumatological rehabilitation training on readiness, clinical decision making and perceived self-efficacy in intern physiotherapy students. In the study, online rheumatological rehabilitation training is planned. Online rheumatological rehabilitation training will be video-based via the Edpuzzle application and interactively via the zoom application. Online trainings are planned for 15-person intern physiotherapy student groups 4 days a week, 2 hours a day, for 4 weeks on a case-based basis. In the study, readiness, clinical decision making and perceived self-efficacy levels will be evaluated in intern physiotherapy students before and after online rheumatological rehabilitation training.


Eligibility Criteria:
Inclusion Criteria:

* To be taking Rheumatological Rehabilitation internship course

Exclusion Criteria:

* To have taken the Rheumatological Rehabilitation Internship course before, but failed to complete it successfully
* Lack of internet access
A Study To Look At The Safety Of SB-681323 In Healthy Adult Subjects After Intravenous Administration Of A Single Dose

SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis. This study will explore the safety of this drug and its blood levels when given in intravenous form to healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male aged between 25 and 55 years, inclusive, at the time of screening.
* Body weight = 60 kg and a Body Mass Index within the range of 19 to 32 kg/m2 inclusive.
* Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
* Have no significant abnormality on clinical examination.
* Show no abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical examination.
* Demonstrate a clinically normal 12-lead ECG at screening
* Liver function tests within the reference range at screening (ALT, AST, ALP, GT and bilirubin)
* Do not show evidence of pre-study HIV and hepatitis B and C at screening
* Do not show a positive pre-study urine drug screen

Exclusion Criteria:

* Taken prescription or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) before the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
* Show a history or evidence of drug or alcohol abuse.
* Show a history of increased liver function tests (ALT, AST, bilirubin) above upper limit of normal (ULN) in the past 6 months (if known).
* Demonstrate a history of regular alcohol consumption exceeding an average weekly intake of \> 21 units (or an average daily intake of greater than 3 units). 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine.
* Have a history or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* Exposure prior to the first dosing day to more than 3 new medicinal entities within 12 months or has participated in a study with a new medicinal entity within 3 months or any other study within 2 months.
* If participation in the study will result in the subject having donated more than 450 mL blood within a 3 month period.
* On physical examination the subject is observed to have poor venous access.
* An unwillingness of subjects to abstain from sexual intercourse with women; or unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of investigational product until completion of the follow-up procedures.
A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure

The purpose of this study is to determine if the use of home blood pressure monitors plus nurse telephone monitoring is more effective than the use of blood pressure monitors alone in improving control of high blood pressure in an urban medical clinic.

Participants will all have home blood pressure monitors, education session on controlling their blood pressure and will be randomized to recieve 6 months of intensive telephonic on a set monitoring schedule or no telephonic follow up. Phone calls will be weekly for 4 weeks, then every 2 weeks for 8 weeks then monthly for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with essential hypertension
* systolic blood pressure \>140 mm Hg (130 if diabetic) OR diastolic blood pressure \> 90 mm Hg (80 if diabetic)on at least 2 clinic visits prior to randomization
* BP at time of screening is \> than systolic 140 (130 if diabetic) or diastolic 90 (80 if diabetic)
* patient is prescribed at least 1 antihypertensive medication
* Patient is fluent in English
* Patient is easily accessible by telephone

Exclusion Criteria:

* persons with stage 4 or 5 chronic kidney disease or end stage renal disease on dialysis
* Patients with a terminal illness
* Patients with severe dementia or serious mental illness
* Inability to preform self blood pressure monitoring
* Patient lacks a functioning home phone or personal cellular phone
* Pregnant or planning to get pregnant
* Arm circumference exceeds the allowable limit on the largest home BP monitor cuff
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
* Atrial fibrillation documented by ECG at the start of study drug infusion.

Exclusion Criteria:

* Previous exposure to K201
* QTcF (Fridericia correction) \>440 ms
* QRS interval \> 140 ms
* Paced atrial or paced ventricular rhythm on ECG
* History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
* History of amiodarone (oral or IV) in the last 3 months.
* Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
* History of failed electrical cardioversion at any time in the past
* History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
* History or family history of Long QT Syndrome
* History of ventricular tachycardia requiring drug or device therapy
* Ejection fraction of 40% or less.
A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors

This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Participants with histologically/cytologically confirmed locally advanced or metastatic, non-resectable solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
* Part 2: Participants with histologically/ cytologically confirmed locally advanced or metastatic, non-resectable solid tumors known to be FAP+ whose disease has progressed despite standard therapy or for whom no standard therapy exists
* Part 3: Participants with histologically confirmed recurrent or metastatic, non-resectable confirmed FAP+ sarcoma with two or fewer prior regimens for advanced disease
* All participants must have tumor tissue that can be imaged for pharmacodynamic assessments and from which a pre- and on-treatment biopsy can be safely obtained
* An archival tumor sample must be available for retrospective FAP expression analysis
* Measurable disease as determined by RECIST v1.1
* World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
* Recovery from all reversible AEs of previous anti-cancer therapies to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia (any grade) and Grade \<=2 sensory peripheral neuropathy
* Negative pregnancy test

Exclusion Criteria:

* Primary central nervous (CNS) tumors or CNS tumor involvement
* Major surgery or any other prior anti-cancer treatment within 4 weeks prior to study Day 1.
* Received wide-field radiotherapy \<= 4 weeks or limited-field radiotherapy \<=2 weeks prior to starting study drug
* Known hypersensitivity to any of the components of RO6874813 or to the contrast agents used in the study
* Another invasive malignancy in the last 2 years except for those with a minimal risk of metastasis or death
* Any other conditions or diseases that would contraindicate participation in the clinical study because of safety concerns or compliance with clinical study procedures
Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds

This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group（silver ions dressing）, with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 to 80 years old (including 18 and 80 years of age), gender not limited;
* in patients with type 2 diabetic foot, in 1999 the WHO diagnostic criteria, diabetic foot screening period or three months before randomization glycated hemoglobin (HbA1C) was detected in 10% or less;
* the target body ankle brachial index of at least 0.8, without intermittent claudication walkers;
* the target ulcer must have the following characteristics: A) according to the Wagner ulcer classification system for level 1 or level 2 B) ulcer is located in the foot, ankle and shin before; C) wound area of 2-5 cm2; D) has existed at least 4 weeks before randomization; E) if you have multiple wounds, select into the set standard and area is one of the biggest intervention and evaluation of the wound.The rest of the wound conventional treatment is not included in the study;If there are two or more wounds are the biggest, choose the worst into classification research;If there are two or more wound area and the classification, choice wound area are the longest study; F) without visible pus and necrotic material;
* voluntary to participate in this clinical study, cooperate a doctor to conduct research, and sign the informed consent.

Exclusion Criteria:

* with clear surgical indications, such as vascular occlusion, bone exposed, abscess, osteomyelitis, etc;
* into the group of the first 3 months of vascular reconstruction or angioplasty;
* impaired liver function (ALT and AST 3 times more than normal limit, AST, aspartate amino transferase;ALT: alanine aminotransferase);
* serum creatinine greater than 2 times the upper limit of normal value;
* serum albumin \< 2.0 g/dL;
* is undergoing immunosuppressive medication;
* Various malignant tumor patients ;
* of pregnant women, nursing mothers, or in the near future with family planning; ● with nerve, mental disorders and can't cooperation or unwilling to partners, has a history of alcoholism, drug abuse, and failed to quit;
* into the group of the first 3 months participated in other clinical subjects; Cartesian bacteria cell wall
* to use red, skeleton or silver products are taboo, allergies or known allergies;
* researchers believe that patients should not participate in this study to other situations.
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.


Eligibility Criteria:
Inclusion Criteria:

* Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
* On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.

Exclusion Criteria:

* Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
* Patients who have received a parathyroidectomy or ethanol infusion within the prior year
* Patients taking drugs that affect iPTH, calcium or bone metabolism
* Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
* Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Fluid Optimization in Liver Surgery

The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.

To reduce bleeding, hepatectomies are performed with low central pressure (CVP) combined with extrahepatic control flow.

This management can lead hemodynamic instability and reduction in oxygen delivery so an advanced monitoring should be used.

This study analyzes hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III

Exclusion Criteria:

* Cirrhosis
* systolic ventricular contractility or diastolic relaxation alterations
* ischemic or valvular diseases
* absence of sinusal rhythm
* impaired renal function
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus

According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).

A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables.

At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.

Eligibility Criteria:
Inclusion Criteria:

* The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.

Exclusion Criteria:

* 1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.