cyrilzakka/clinical-trials huggingface dataset:
A Study on the Outcome and Its Influencing Factors in Patients With Borderline Personality Disorder

Borderline personality disorder (BPD) is a difficult chronic mental illness. This diagnosis is common in Western countries. Our researchers want to study the outcome and its influencing factors of BPD for the first time in China. Patients with BPD who had been hospitalized in Wuhan Mental Health Center were selected as the subjects. The researchers retrospectively collected the most recent hospitalization data of these patients, and then prospectively follow up them for 2 years to see how their condition will change. By analyzing all data, researchers hope to know deeply about the development law of this illness, and to provide evidence for releasing these patients' suffering.

This study is an ambispective cohort study. The information collected in the retrospective part mainly included demographic data, comorbid psychiatric diagnosis, psychotherapeutive and pharmacotherapeutive data, times of hospitalization and patients' contact information. The above data were derived from electronic medical records. After informed consent, prospective follow-up was initiated primarily by telephone interviews and web-based questionnaires, or by in-person assessments at hospital return visits. Enrolled patients will be followed up at 6-month intervals after the first follow-up to assess psychiatric diagnosis, social function, and quality of life. The researchers are senior psychiatrists, all of whom received training on the use of questionnaires and inter-investigator consistency before the follow-up.

Cox Proportional Hazard Model is used to analyze the influencing factors of remission of BPD, and Generalized Estimating Equation Model is used to analyze the influencing factors of the patients' social function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD based on ICD-10 (F60.3)

Exclusion Criteria:

* Comorbidity with severe physical disease
* Comorbidity with neurological diseases such as epilepsy
* Comorbidity with mental retardation
Digital Based Home Care Service for Ostomy Patients

This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on patients' quality of life.

This study will include patients who have undergone colorectal cancer surgery and received either a colostomy or ileostomy, provided they are comfortable using digital devices like smartphones. Patients will be randomly assigned to either the intervention group, receiving stoma care through a smartphone application, or the conventional group, receiving standard outpatient-based care. The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The app provides patients with information on diet, physical activity, stoma care, emotional support, and daily living needs. Both groups will be assessed for outcomes at the time of enrollment, and at 1 and 6 months. Outcome measures include stoma-related complications such as peristomal dermatitis, dehydration, acute renal failure, readmission due to stoma-related issues, and quality of life and emotional state assessments using EQ-5D-5L and Stoma Quality of Life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years or older
* Patients who have a colostomy or ileostomy after surgery for colon cancer
* Patients who do not have difficulty using a smartphone

Exclusion Criteria:

* Patients younger than 19 years
* Patients aged 80 years or older
* Patients who do not know how to use a smartphone
* Patients with cognitive impairments
* Patients with pre-existing psychiatric disorders
* Patients who have undergone emergency surgery
* Patients who already have stoma-related complications
Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.

Exclusion Criteria:

* multiple pregnancy

  * gestational age \< 36 weeks

    * preexisting or pregnancy-induced hypertension

      * Morbid cardiovascular impairments

        * Cerebrovascular disease

          ⑥ Known fetal anomaly

          ⑦ Contraindications to spinal anesthesia

          ⑧ Any sign of onset of labor

          ⑨ Body weight \< 45 kg or body weight \> 90 kg

          ⑩ Height \< 145cm or height \> 180cm
Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients

The purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to thrombopoietic agents in vitro and in vivo.

Wiskott Aldrich Syndrome is an X-linked disease characterized by immunodeficiency, eczema and thrombocytopenia; a milder form of the disease known as X-Linked thrombocytopenia also exists. The thrombocytopenia in both WAS and XLT is characterized by: severe thrombocytopenia with platelet counts frequently less than 10-30,000/ul; small platelets which may be dysfunctional; and, as a result, a high rate of serious bleeding including intracranial hemorrhage.

Because eltrombopag has been shown to be remarkably efficacious in substantially increasing platelet counts in a high percentage of ITP patients, this study seeks to effectively treat patients who exhibit similar pathologies, as well as evaluate the state of platelets in patients with WAS and relate it to clinical bleeding. It also aims to demonstrate whether eltrombopag administered daily will enhance stem cell function, increase platelet production and platelet count, and reduce bleeding in patients with WAS.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible for study entry, subjects must comply with the following:

* Males from 3 months old to 80 years old
* Signed written informed consent obtained prior to study entry
* Clinical diagnosis of WAS or XLT
* Platelet levels less than 100 x 109/L
* Adequate renal and hepatic function (creatinine and bilirubin less than or equal to 1.5 x IULN, AST and ALT less than or equal to 2.5 x IULN)

Exclusion Criteria:

Any patient is ineligible for study entry if he/she:

* Over the age of 80
* Women (only males are eligible)
* fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study or until at least 6 months after treatment
* Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS), clopidogrel or ticlopidine, warfarin or other vitamin K antagonists, unfractionated or low molecular heparin within 7 days of first infusion
* Red blood cell transfusion in the past four weeks
* Elevated (\> 1.5 x ULN) prothrombin time (PT) or partial thromboplastin time (PTT)
* New York Heart Classification III or IV heart disease. Other severe cardiovascular or cardiopulmonary disease, including COPD.
* Known HIV infection, hepatitis B or C infection
* Any infection requiring antibiotic treatment within 3 days
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
* Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.

The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes

Eligibility Criteria:
Inclusion Criteria:

* The subject has given written, informed consent and is available for the duration of study
* Histologically or cytologically confirmed diagnosis of breast cancer
* Male or female aged ≥ 18 years
* Females subjects of child-bearing potential must have a negative urine pregnancy test
* Female subjects must be non-lactating and non-breastfeeding
* Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing

Exclusion Criteria:

* Known hypersensitivity to either of the study drugs or their excipients
* Inability to undergo venipuncture and/or tolerate venous access
* Pre-existing clinically significant peripheral neuropathy
* Positive laboratory exclusion test (HIV, HBsAg, or HCV)
* Treatment with investigational agents or participation in clinical trial within 30 days of study entry
CAB Versus Medical Therapy in Patients With AF and HF With Different EF Categories

This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.

Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
* At least 18 years old and not older than 80 years old.
* Able and willing to give informed consent.

Exclusion Criteria:

* History of AF treatment with class I or III AAD, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
* Previous left atrial ablation.
* Previous cardiac surgery including prosthetic valves.
* Permanent pacemaker or defibrillator implant.
* Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
* History of previous myocardial infarction or percutaneous intervention during the last 3 months.
* Any history of previous transient ischemic attack, prolonged reversible ischemic neurological deficit, and/or stroke.
* Known intracardiac thrombus formation.
* Pulmonary vein stent.
* Known cryoglobulinaemia.
* Active systemic infection.
* Hypertrophic cardiomyopathy.
* Life expectancy is ≤1 year.
* Reversible cause of atrial fibrillation (eg, hyperthyroidism or alcoholism).
* Abnormal long or short QT intervals, signs of Brugada syndrome, known family history of inherited ion channel disease, and/or arrhythmogenic right ventricular dysplasia.
* Chronic obstructive pulmonary disease with detected pulmonary hypertension and/or any other evidence of significant lung disease.
* Contraindication for oral anticoagulation.
* Pregnant women or woman of childbearing potential with inadequate birth control.
* Women who are breastfeeding.
* Any significant congenital heart defect corrected or not corrected; however, patent foramen ovale is allowed.
* Thrombocytosis (platelet count \> 600,000/μL) or thrombocytopenia (platelet count \< 100,000/μL).
* Untreated or uncontrolled hyperthyroidism or hypothyroidism.
* Renal dysfunction with glomerular filtration rate \< 60 mL/min.
* Unstable angina pectoris.
* Symptomatic carotid stenosis.
* Myxoma based on laboratory abnormalities.
* Sarcoidosis.
* Unwilling to unable to comply with the study procedure and follow-up schedule due to any disease condition.
* Legal incapacity or evidence that the patient cannot understand the purpose and risks of the study, including inability to comply fully with study procedures and follow-up.
* Employed by Medtronic, or the department of an investigator, or close-familial relative of an investigator.
* Enrolled or planning to participate in a potentially confounding drug or device trial during this study.
Intraoperative Pleth Variability Index (PVI) Variability

Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG) signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can have significant amount of baseline variability which appears to oscillate at a very low frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline oscillations.

PVI is derived from the infrared photoplethysmography signal. Intraoperatively during mechanical ventilation it reflect fluid responsiveness which is a surrogate endpoint of intravascular volume.

PVI signal appears to have significant baseline variability which can not be explained by rapid changes in intravascular fluid volume. The baseline PVI changes also appear to oscillate at a very low frequency, much below any previously identified spontaneous vascular oscillations.

The aim of this study is to investigate weather the PVI variability originates from changes in the infrared photoplethysmography signal or if they are possibly due to the algorithm calculating PVI.

Eligibility Criteria:
Inclusion Criteria:

* Neurosurgical patients for tumor resection
* neurointerventional patients
* general anesthesia with mechanical ventilation
* communicates in english (consent)
* over 18 years of age

Exclusion Criteria:

* unable to sign consent
* less than 18 years of age
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma

One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. Survival was less in patients with high rather than low circulating androgen levels. Thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. In this trial, we will pilot this concept.

The purpose of this study is to assess the potential for combined androgen blockage (Leuprolide and Flutamide), given with suramin (a growth factor inhibitor) to improve the clinical outcome(s) in a cohort of patients with bulky metastatic prostate cancer. Combined androgen blockage is currently the standard of care for such individuals. Suramin has shown reproducible activity in individuals with androgen independent disease. Since these two approaches are independent of one another - on the molecular level, and in clinical results - it is hoped that the combination of these two approaches will result in improved response rates and in improved survival.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.

Patients must be 18 years of age and an SGOT/SGPT within 2 times of normal.

Patients must have stage D2 prostate carcinoma or State D1 disease with a Gleason grade 7 or above (poorly differentiated).

No other malignancy except curatively treated basal cell cancer of the skin.

Performance status ECOG of 0-3.

Ability to give informed consent.

No history of bleeding diathesis. Patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.

No history of cerebrovascular event, either thrombotic or hemorrhagic.

No current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. Patient cannot be on calcium channel blockers such as Nifedipine, Diltiazem, or Verapamil.

No clinical or radiographic evidence of brain metastases.

Patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.

Patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.

Patients must have adequate hepatic function (bilirubin less than 1.5mg%).

If the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.

Patients must not have received chemotherapy.

An absolute granulocyte count greater than 1,500; platelet count greater than 100,000; Fibrinogen greater than 200 mg/dl; Hgb greater than or equal to 9 gm/dl.

Reliability of the patient to take oral medication, go home and return for follow-up and treatment.
A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects

The primary objectives of this 2-part drug interaction study are as follows:

* To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the blood) of selexipag and its metabolite ACT-333679 (Part I).
* To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 (Part II).

Because non-clinical studies have shown that selexipag and its active metabolite, ACT-333679, are substrates for cytochrome P450 2C8 (CYP2C8), the present clinical study aims at investigating the effect of a strong inhibitor (gemfibrozil) and a moderate inducer (rifampicin) of CYP2C8 on the pharmacokinetic of selexipag and ACT-333679 as recommended by the FDA's Guidance for Industry Drug Interaction Studies (FDA, 2012).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Male subjects aged between 18 and 55 years (inclusive) at screening.
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening.
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests at screening.

Exclusion Criteria:

* Any contraindication to gemfibrozil or rifampicin treatment.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might put the subject at risk of participation in the study or interfere with the absorption, distribution, metabolism or excretion of the study treatments.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Hemodynamic Effect of Left Tilting in Cesarean Delivery

The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block

Aortocaval compression (ACC) by the gravid uterus is a known physiological phenomenon that is classically claimed to cause supine hypotension in full term pregnant women. ACC has been also mentioned as a possible cause of post-spinal hypotension (PSH) in parturients undergoing cesarean section (CS); however, the evidence for the value of left lateral tilting of parturient in improving hemodynamics is not clear.

The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block (SAB).

Hemodynamic variables will be taken before SAB in three angles (zero angle, 15 degree angle, and 30 degree angles) of left lateral tilt.

Patients will receive normal SAB after prophylactic vasopressor adminstration (either 15 mg ephedrine or 1.5 mcg/Kg phenylephrine intravenous bolus) then hemodynamic variables will measured again after SAB in the same three angles. The sequence of the tilting angles will be randomized.

Another measure will be taken after delivery of the fetus. SAB will be done in sitting position under complete asepsis using 25 g spinal needle with crystalloid infusion of 500 mL. SAB will be achieved by intrathecal injection of 10 mg hyperbaric Bupivacaine plus 25ug fentanyl. Success of SAB will be tested within five minutes after drug injection. SAB will be considered successful if adequate block reached T4 dermatome.

Cardiac output and stroke volume will be measured using electrical cardiometry device.

Eligibility Criteria:
Inclusion Criteria:

* full term parturients scheduled for cesarean delivery

Exclusion Criteria:

* BMI \> 35 Kg/m2, polyhydramnios, history of impaired cardiac contractility, valvular heart disease, cardiac arrhythmias, hypertensive pregnancy disorders
A Phase 3 Clinical Study of KHK4827

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the week 12 evaluation of Study 4827-002

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
Assessment of N-95 Facemask for Use in COVID-19 Pandemic in Case of Shortage of Personal Protective Equipment

The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System


Eligibility Criteria:
Inclusion Criteria:

1. All individuals older than 18 years of age, and willing to participate in the study

Exclusion Criteria:

1. Individuals with known severe COPD/emphysema, Obesity Hypoventilation or hypercapnic condition
2. Individuals with allergy or reactions to latex or masks
3. Individuals reporting dyspnea or unable to breathe comfortably in these masks
4. Claustrophobic individuals
5. Inability to create a proper Seal while inhaling through a closed filter (See Below)
6. Individuals who cannot safely apply and remove these masks
Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.

Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject, 19 years of age or older
* Subjects who signed informed consent
* Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion Criteria:

* Subject who has clinically significant medical history
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product