cyrilzakka/clinical-trials huggingface dataset:
Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for intravenous use in clinical settings of the following diseases:

1. T-cell acute lymphocytic leukemia (T-ALL)
2. T-cell lymphoblastic lymphoma (T-LBL) Also, "any adverse events involving neurological disorder, hypotension, and blood disorder and their details" are to be investigated as an item of particular concern. In addition, subject outcome (alive or dead) at one year after the start of treatment will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)

Exclusion Criteria:

* Subjects with hypersensitivity to nelarabine
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.

PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.

PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity.
* CD4 count 200-500 cells/mm3.
* AZT naive status (\<= 4 weeks of prior AZT).

Exclusion Criteria

Patients with the following prior condition are excluded:

History of intolerance to AZT.

Prior Medication:

Excluded:

* More than 4 weeks of prior AZT.
* Any prior antiretroviral treatment other than AZT.
The Impact of Thoracic Paravertebral Nerve Block At Different Positions on Pain Relief in Patients Undergoing Single-Port Thoracoscopic Partial Lung Resection

Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain.

Multiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (TPVB), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. This can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery.

By comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 70 years old

  * BMI ≥ 18 and ≤ 28

    * American Society of Anesthesiologists (ASA) physical status classification I-II ⑷ Patients scheduled for elective thoracoscopic lung resection (including lobectomy, segmentectomy, and wedge resection) ⑸ Patients who agree to participate in this study and sign the informed consent form

Exclusion Criteria:

* Patients who refuse to undergo nerve block

  * Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency requiring postoperative admission to the ICU for continued treatment (EF \< 40%, FEV1/FVC \< 40%)

    * Abnormal coagulation function ⑷ History of allergy to anesthetic drugs

      * History of chronic alcohol use, chronic pain, or long-term use of psychotropic medications ⑹ Scars, infections, or tumors at the puncture site ⑺ History or family history of malignant hyperthermia ⑻ Refusal to participate in this study or inability to cooperate with follow-up or poor compliance

Termination criteria:

* Failure to comply with the predetermined study protocol ⑵ Occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture

  * Changes in the patient's condition ⑷ The patient's unwillingness to continue participating in the study
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication

Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy.

In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally.

The patients participating in this study are monitored for 12 months after implantation.


Eligibility Criteria:
Inclusion Criteria:

* EF less than 35 percent
* CAD or dilatative Cardiomyopathy
* Sinus rhythm
* NYHA III or IV, stable recompensated
* QRS more than 120ms
* LBBB
* Patient signed Consent Form
* Age more than 18 and less than 80 y

Exclusion Criteria:

* permanent atrial Fibrillation
* permanent AV-Block II or III
* Tricuspidal- and or artificial aortic valve
* Indication for ACB or ACB less than 3 months ago
* myocardial infarction less than 3 months
* hypertrophic obstructive Cardiomyopathy; constrictive Pericarditis
* heartfailure with iv catecholamine therapy
* Manifested, uncontrolled, Hypo- oder Hyperthyreosis
* Severe renal insufficiency with Creatinine more than 2,5 mg per dL
* patients, who did not sign the consent form
* General medical conditions, which restrict the patient compliance
* Participation in another study
* life expectancy less than 1 y
* Age less than 18 y or more than 80y
* Pregnant women or Women of childbearing age
Survival of Different Core Build-up Materials

The purpose of this study is to compare three different core build-up materials for dental use. The study hypothesis is that there is no differences in survival rate of the different core build-ups.

Core build-ups replace dental structures which are decayed through caries or tooth fractures. Often there are necessary before insertion of dental restorations. In clinical practice, there are two main material groups: glass ionomer cements and composites. Because of there good physical properties the composite materials claimed to fulfill the expected criteria of core build-ups. However, some of these composite core build-ups get lost before insertion of definite prosthetic restorations. The current prospective, randomized controlled study should investigate the survival rate of three different composite materials: "Rebilda DC", "Clearfil Core DC / Plus" and "Multicore Flow". The statistical analysis will performed with logistic regression performed by the institute of institute of Medical Biometry and Informatics, university of heidelberg. The study hypothesis is that there is no differences in the survival rate.

Eligibility Criteria:
Inclusion Criteria:

* patients need a single crown or fixed dental prostheses
* patients are able to signed inform consent form, more than 18 years,

Exclusion Criteria:

* no pregnant women
* insufficient oral hygiene
Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients with Forward Head Posture.

The aim of this study is to compare the effects of a 12-session telerehabilitation program based on Specific Neck Exercises (SNE) with Spinertial to a control group on range of motion, cervical proprioception, and posture in subjects with forward head posture, post-intervention, after one month of follow-up, and after two months of follow-up.

Epidemiological evidence suggests that a sedentary lifestyle is associated with various musculoskeletal conditions, including neck pain. Sedentary behavior during work hours is closely linked to the craniovertebral angle (CVA). Forward head posture, associated with increased vertebral load, predisposes individuals to early onset of degenerative changes, cervical pain, and disability, as well as decreased endurance and strength of the cervical musculature.

Patients with cervical pain may exhibit various clinical manifestations, including weakness of the deep cervical musculature, reduced cervical range of motion (ROM), and cervical disability. Numerous pathologies are described to manifest with localized pain in the cervical region, as well as weakness of the deep cervical musculature and reduced craniovertebral angle (CVA). Examples include cervicogenic dizziness, cervicogenic headache, tension headache, cervical radiculopathy, cervical instability, or chronic mechanical cervicalgia.

The sensorimotor control system is a crucial component of the cervical spine. The deep musculature of the cervical region contains a large number of neuromuscular spindles and mechanoreceptors, providing information about the movement of the head and enhancing dynamic stability during neck movements. The density of neuromuscular spindles in the deep musculature is particularly high, suggesting a significant role in the fine motor control of the cervical spine. Impairment of cervical posture, decreased craniovertebral angle (CVA), proprioception, and alterations in the sensorimotor control system associated with neck pain contribute to recurrence and chronicity.

Eligibility Criteria:
Inclusion Criteria:

* Forward head posture (craniovertebral angle less than 50º).
* Deep flexor strength deficit in craniocervical flexion test.
* Deep extensor strength deficit in neck extensor muscle endurance.
* ≤ 14 score in Neck Disability Index.

Exclusion Criteria:

* Have received cervical treatment during the last six months.
* Presence of any red flag, neurological, or cognitive impairment (inability to - - understand the questionnaires or examination).
* Have received cervical manual therapy treatment during the last six months.
* History of cervical trauma or surgery during the last year.
* Chronic neck pain occurring during the last six months (intensity: visual analogue scale \>3/10, frequency \>2 days/week, duration \>3 hours/day).
Investigation of the Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia

In this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students.

H01: There is no difference between the four groups in terms of satisfaction with learning.

H02: There is no difference between the four groups in terms of Self-Confidence in Learning.

H03: There is no difference between the four groups in terms of Motivation scores in Teaching Materials.


Eligibility Criteria:
Inclusion Criteria:

* Being a registered student in the midwifery department,
* Having the ability to manage normal birth,
* Having a smart phone, tablet or computer with internet connection,
* Agreeing to participate in the research

Exclusion Criteria:

* to suspend education.
* Having received formal training on shoulder dystocia management.
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects

To evaluate the effect of 6-month administration of CP-945,598 on:

* weight loss and waist circumference,
* blood pressure, cholesterol, glucose
* other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-Î± and hsCRP
* the relationship between the concentration of the drug on the blood and the above parameters
* physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
* Body Mass Index (BMI) Â³30 and \<40 kg/m2, for subjects with no additional
* co morbidities; BMI Â³27 kg/m2 and \<40 kg/m2, for subjects with co morbidities \[history of essential hypertension and/or dyslipidemia defined as high LDL (Â³160 mg/dL) or high total cholesterol (Â³240 mg/dL)\];

Exclusion Criteria:

* Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
* Subjects with type 2 diabetes or fasting blood glucose concentration Â³126 mg/dL;
* Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
* Subjects on prescription and non-prescription appetite or weight modifying drugs
Risk Prediction Model for Severe Autoimmune Encephalitis

A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.

To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.

Eligibility Criteria:
Inclusion Criteria:

* age 14-80 years
* no restriction on gender
* meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
* within 3 months of AE
* patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf

Exclusion Criteria:

* no lumbar puncture performed for CSF antibody testing
* did not receive immunotherapy
* pre-onset modified Rankin Scale (mRS) score ≥3
Preventing Failed Extubations

More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

Spontaneous breathing trials (SBTs) with pressure-support ventilation are commonly used to determine if mechanically ventilated patients are ready for extubation. However, 10-25% of all patients who pass a spontaneous breathing trial and are extubated will require re-intubation . Extubation failure is associated with an up to 50% increased risk of death independent of other risk factors and patient characteristics . Currently proposed methods for identifying patients who pass an SBT but are at high risk of reintubation perform poorly when applied in a real-world setting . Thus, there is a critical need to develop new methodologies for identifying patients at high risk for extubation failure.

Respiratory system mechanics, such as compliance, driving pressure, and plateau pressure, can identify patients at risk of poor outcomes, including prolonged mechanical ventilation and death. However, respiratory system mechanics are not commonly measured during spontaneous breathing trials, and the relationship between respiratory mechanics during an SBT and extubation failure is not known. This is due in part to long-standing concerns that accurate measurements of plateau pressures, and thus driving pressures and compliance, cannot be made in spontaneously breathing patients.

The objective of this study is to determine if respiratory compliance measured during a spontaneous breathing trial is a feasible method for identifying patients at increased risk of extubation failure.

Eligibility Criteria:
Inclusion Criteria:

* Extubated in participating ICU during study period

Exclusion Criteria:

* Previously extubated during hospitaliztion
* Extubation as part of transitioning to comfort measures
Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological Profiling of the Tumor Microenvironment in Risk Stratification of Recurrence

This pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples (cohort 2)

For the experiments proposed in the project the following will be used:

Court 1: tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective); Court 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transfer to the Regina National Cancer Institute Elena, IRE-IFO.

Clinical data

The following data will be collected for each patient:

* Age, ethnicity, parity, luxury habits, level of education, marital status, height, weight, index of body mass
* Data on previous clinical history, previous gynecological-obstetric pathologies and any treatments, current comorbidities and medical therapies

For Cohort1 patients only:

* Data relating to the neoplastic pathology: histotype, grading, FIGO stage
* Data on oncological follow-up: any intra- or post-operative complications, any therapies adjuvants, type and data of any recurrence/metastasis, type of treatment if any recurrence, date and manner of death.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1: Oncology patients

* Age \>18 years
* Histological diagnosis of endometrial hyperplasia with and without atypia, endometrial carcinoma endometrioid histotype at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma who undergo surgery;
* Adequate biological material to be able to carry out the planned analyses;
* Written informed consent (only for patients in the prospective part and/or in follow up/traceable);
* For the retrospective part: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 36 months).

Cohort 2: Patients with ongoing spontaneous abortion

* Age \>18 years;
* Diagnosis of ongoing spontaneous abortion which is subjected to an instrumental review procedure of the uterine cavity, under hysteroscopic guidance;
* Adequate biological material to be able to carry out the analyzes previously described;
* Written informed consent.

Exclusion Criteria:

* Comorbidities not controlled with adequate medical therapy;
* Infections of the endometrial cavity (pyometra);
* Synchronous tumors;
* Neoadjuvant treatments;
* Previous radiation treatments on the pelvic region.
Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

The objective of this study is to administer music therapy to patients in the pediatric intensive care unit (PICU) in order to observe how music affects patient agitation, vital signs, and overall recovery in the unit.

This study is a prospective randomized controlled study to observe patients who have been admitted to the PICU with an altered state of agitation according to the Richmond Agitation Sedation Scale (RASS). These patients will be administered music therapy during a controlled setting in the day to observe whether the introduction of music therapy helps reduce the patient's level of agitation, improving their vital signs and overall recovery in the unit. Once patients are enrolled and have signed consents, patients will receive a headset with music or dead air. Therapy times will be selected so that there are minimal disruptions. Total time will be 2 hours daily, once in the morning and once in the evening. The treatments for session 1 and session 2 of the day will be the same (i.e. Music/ Music, No music/No Music).

The investigators hypothesize that applying music therapy in the PICU will decrease agitation, length of stay, and narcotic administration, and normalize heart rate, respiratory rate, and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* PICU patient at Oishei Children's Hospital of Buffalo
* \>4 years of age, \<18 years of age
* Patients with RASS of +1

Exclusion Criteria:

* Documented underlying psychological disorders
* Diagnosed with sever developmental delay
* Prior narcotic dependence
* Underlying medical conditions affecting heart rate, blood pressure, or neuromuscular system
* Chemically paralyzed patients
* Anyone with an aneurysm
* Patients who are deaf in both ears
* Ear bone fractures or other middle/inner ear trauma or major ear avulsion as determined by physician
* Hemodynamically unstable patients
* Patients facing imminent death