cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.

In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.

This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
2. Patients were required to have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
3. No performance criteria were required for entry onto the study.
4. The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast in three series, as well as diffusion imaging.
5. Symptoms \& signs of less than 3 months duration

Exclusion Criteria:

1. Children were not eligible if they had received any prior therapy other than steroid
2. The diagnosis of exophytic brainstem glioma
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients

The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.

As an essential component of parenteral nutrition, fat emulsion has been used more than 30 years. It provides energy and essential fatty acids. Commercial fatty emulsion products mostly come from soy bean. The omega 6 fatty acids make up with the major fatty acids of this fat emulsion, and lack of omega 3 fatty acids generally. The imbalance of these two types of fatty acids may impact with negative clinical outcomes.

There are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA).Few clinical studies found its clinical efficacy in recently years. A commercial product of omega 3 fat emulsion by Fresenius-Kabi was registered in Europe at 1998. There is no any clinical trial in Asia to elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical trial in the world.

Currently study is the first large scale, randomized, double blind and multi-center clinical trial to elaborate the impact of fish oil fat emulsion in Asia and Europe.

Eligibility Criteria:
Inclusion Criteria:

* Post-operative male and female cancer patients
* Require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(BMI 20-25)
* Sign an informed consent

Exclusion Criteria:

* Diabetes Mellitus
* Abnormal fatty metabolism (TG\>200mg/dl or cholesterol\>240mg/dl )
* Renal dysfunction (Cr\>1.6mg/dl or BUN\>30mg/dl)
* Liver dysfunction (ALT\>60U/L or TBIL\>1.2mg/dl)
* Lienectomy
* Temperature\>37.5°C
* Undergoing hormone therapy
* Pregnancy
Promotion of Well-being of Young Adult Brain Cancer Survivors

The purpose of this study is to evaluate the effectiveness of an Internet-based, behavioral activation intervention to promote well-being in a young adult survivors of childhood brain tumor.

Participants will be recruited through the Children's Brain Tumor Foundation who will share the study announcement with their young adult members and social media. Eligible participants will complete a baseline battery survey via Qualtrics. The investigators will recruit 120 participants. The survey will take approximately 30 minutes to complete. Participants will be randomly assigned to an experimental group or control group. The experimental group will take an Internet-based behavioral activation intervention. The intervention has four modules and will be administered via Qualtrics. A link to each module will be sent to the participants via e-mail. Participants will have one week to complete each module. Once a participant completes a module, the next module link will be sent after 3 days. A reminder will be sent at 7 days and 10 days until the module is complete. Each module will take approximately 30 minutes to complete. The experimental group may continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will have an opportunity to take the intervention once data collection is complete. Both groups will be asked to complete a battery of surveys at the end of the intervention and intermittently over a 3-month period.

Eligibility Criteria:
Inclusion Criteria:

* History of childhood brain tumor
* Ages of 18 and 30 years.
* Have regular access to the Internet
* Provide an e-mail address

Exclusion Criteria:

* Those that do not meet the inclusion criteria.
Liposomal Bupivacaine for Postoperative Pain After Craniotomy

Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old;
* Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach;
* ASA grade I \~ III;
* Sign informed consent.

Exclusion Criteria:

* Previous history of combined drug allergy;
* Patients with a history of severe chronic pain;
* Long-term history of analgesic drug use;
* Patients with aphasia and other inability to cooperate with the scale were evaluated;
* Patients with mental system diseases;
* Patients with incomplete function of vital organs (heart, lung, liver, kidney);
* History of drug and drug abuse;
* BMI≥35kg/m2;
* Pregnant or lactating patients.
Cessation Clinical Trial

The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Current tobacco use (past 30-day use of one or more of the following: cigarettes, cigars, little cigars, cigarillos, e-cigarettes, or oral nicotine products)
* US residence
* Active text message plan (phase 2 only)

Exclusion Criteria:

* Age 25 or above (phase 2 only)
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.

OBJECTIVES:

* Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
* Determine the toxic effects of this regimen in these patients.
* Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
* Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose de-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value
* Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
* Lactic dehydrogenase less than 2 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* HIV negative
* No active uncontrolled bacterial, viral, or fungal infection
* No nonmalignant systemic disease that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No prior irinotecan

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control
* No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture)

Surgery:

* See Disease Characteristics
* At least 2 weeks since prior major surgery

Other:

* No concurrent anticoagulants except warfarin or subcutaneous heparin
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).


Eligibility Criteria:
Inclusion Criteria:

* Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
* Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
* Positive for anti-double stranded DNA (anti-dsDNA) and low complement
* Subjects with stable nephritis may be enrolled
* 18 years of age or older

Exclusion Criteria:

* Severe active central nervous system lupus
* Malignancy within past 5 years
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
* Comorbidities that would interfere with evaluations of study drug effect
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
* History of active tuberculosis or a history of tuberculosis infection
* Pregnant or nursing
Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?

For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :

* Study of clinically unsuspected injuries discovered on WBCT
* Description
* Predictive factors
* Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.


Eligibility Criteria:
Inclusion Criteria:

Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 :

* Older than 18 y.o.
* WBCT performed,
* Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria
* Normal physical exam of the chest, abdomen and pelvis,
* GCS score of 15

Exclusion Criteria:

* Opposition of the patient to the use of their CT-scan for research
* Patients who are under legal protection
* Patients who are incarcerated
the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness

Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness.

Patients who have shock of all kinds of reasons usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high fatal risks. The cardiac function of these patients requires special attention. Fluid responsiveness is a comprehensive reflection of preload and cardiac function, which provides guidance on how to conduct fluid replacement therapy. When patients have fluid responsiveness, it means that after fluid resuscitation therapy, the patients' cardiac output will increase and tissue perfusion will improve, bringing benefits to patients themselves. Therefore, it is of vital significance to evaluate the presence of fluid responsiveness in patients before fluid therapy in clinical practice. Passive leg raising(PLR) is a commonly used method in clinical practice to evaluate patients' fluid responsiveness. But its accuracy is affected by the way the leg lifting is performed.

This project is aimed to explore the impact of different ways to perform passive leg raising on the accuracy of evaluation of fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.

Exclusion Criteria:

* (1) Age \< 18 years old, or \> 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.
Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome

To evaluate whether probiotics PS23 can improve the symptoms of patients with long COVID-19 ; also to evaluate the effects on blood cortisol and inflammation-related indicators in patients.

It is expected that a total of 120 subjects will be recruited within 3 years after IRB approval, divided into two groups of 60 subjects, respectively consuming PS23 heat-treated bacteria or placebo, and completing the 6-week period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged above 20 years old and below 65 years old.
2. Those who consciously have long COVID-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher.
3. Those who received the confirmation SMS or the COVID-19 rapid test positive 4 weeks ago.

Exclusion Criteria:

1. Have taken antibiotics within one month or are receiving antibiotic treatment.
2. Have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, Yakult and other related foods).
3. Cancer or immunocompromised patients undergoing treatment.
4. Those who are allergic to lactic acid bacteria products.
5. Diagnosed with dementia before being diagnosed with COVID-19.
6. Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-19.
7. The investigator judges that it is not suitable to participate in the researcher.
Comparison of IMES Versus DN on ATrPs of AC

The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 60 year of both genders
* Diagnosed patients of stage 3 Adhesive capsulitis with type I and II diabetes
* Involvement of at least 3 shoulder girdle muscles in Active MTrPs (subscapularis, latissimus dorsi, deltoid (anterior, middle, posterior)
* Active MTrPs in shoulder girdle muscles (subscapularis, supraspinatus, deltoid (anterior, middle, posterior), teres minor, latissimus dorsi)
* Reproduction of the patient's symptoms at active trigger point, Taut band, Hypersensitive spot, Referred pain pattern, local twitch response
* Minimum 60 degrees of active/passive shoulder abduction range of movement.

Exclusion Criteria:

* Systemic inflammatory joint disease of shoulder joint (RA, OA polymyalgia rheumatic)
* Cerebral Vascular Accident
* Fibromyalgia, neurological deficits of upper limb (Nerve root entrapment, Cervical radiculopathy, Thoracic outlet syndrome)
* History of Fracture, Dislocation, Acute soft tissue injury, Acute bursitis
* Avascular necrosis of humeral head or visceral referred pain to shoulder
* Pregnancy, Hypothyroidism, skin infection
* Patients who are using Antiplatelet Therapy with in past 3 days of study
* Extreme fear of needles
Intrathecal Dexamethasone and Labor Analgesia

To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.

This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I,II patients schedueled for normal vaginal deliveries
* age between 18-35 years old

Exclusion Criteria:

* Patients who refused to participate
* complicated pregnancies
Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.

Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)
* Diagnosis of malnutrition

Exclusion Criteria:

* Pregnant or breast feeding
* Implanted defibrillator or pacemaker
* History of pancreatic Cancer
* Any other malignant tumor disease within the last 3 years
* Concomitant liver cirrhosis
Predictive Factors of Graft Detachment Following Dmek

The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with DMEK surgery

Exclusion Criteria:

* all associated eye surgery other than cataract surgery
* all existing anterior segment anomalies