cyrilzakka/clinical-trials huggingface dataset:
FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma

This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The primary objective of the study is to determine the optimal interval between SGN-15 and docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical response rate, duration of response, and survival data will be collected.

SGN-15 is a mAb-drug immunoconjugate comprised of the chimeric anti-Lewis Y (LeY) mAb BR96, conjugated to doxorubicin. The LeY antigen is found as a glycoprotein at the cell surface on 90% of carcinomas of the lung. SGN-15 induces its antitumor effect through binding to the cell surface LeY antigen. It is then rapidly internalized with release of doxorubicin inside the cell allowing the relative sparing of tissues normally affected by non-specific chemotherapy.

The study is open to patients with good performance status (ECOG 0\<=2) with stage IIIB or IV NSCLC which is not potentially curable by surgery or combined modality therapy and who have received no prior lung cancer chemotherapy for metastatic NSCLC.

Patients will be registered into one of two treatment sequences and wil receive SGN-15 and docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of rest.

Arm A will receive a combination os SGN-15 and docetaxel on the same day. Arm B will receive the combination of SGN-15 followed by the docetaxel 3 days later. All patients will undergo PET imaging prior to treatment and on Day 22.

Patients achieving a clinical response or stable disease as determined by physical examination and/or traditional restaging studies (using established RECIST criteria) after one 4 week cycle of therapy are eligible to receive continued cycles of SGN-15 and docetaxel on the same schedule until clinical or radiographic disease progression or toxicity occurs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed stage IIIB or IV NSCLC with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
* Patients must have an ECOG performance status of less than or equal to 2
* -Patients must have a tumor block available for documentation of LeY antigen expression by immunohistochemistry
* -FDG-PET imaging must be completed at a PET center approved by Seattle Genetics
* Patients must have adequate bone marrow and hepatic function

Exclusion Criteria:

* -Prior cytotoxic therapy for metastatic NSCLC
* -Those with serious underlying non-malignant disease
* -Patients with peripheral neuropathy \> Grade 2 are excluded from study
* -Patients with IDDM or NIDDM
* Patients with known active viral, bacterial, or symptomatic fungal infection
* Concomitant with other antineoplastic or experimental agents
A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain

This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 19 years, \< 75 years
2. VAS score for diabetic peripheral neuropathy pain ≥ 30
3. Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
4. Type II DM patient and HbA1c ≤ 10 %
5. Written informed consent

Exclusion Criteria:

1. Patient with hypersensitivity to pregabalin
2. Patient on anti-epileptic drugs
3. Patients with pain caused by other factors than diabetic peripheral neuropathy
4. Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
5. AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
6. Drug-abusing patient
7. Severe depression or uncontrolled abnormal mood and behavioral changes
8. Pregnant and breast-feeding woman
9. Patients who participated in other clinical trials for investigational products within 30 days of screening
10. Patients deemed to be ineligible to participate in the trial by investigator
Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.

Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405

Eligibility Criteria:
Inclusion Criteria:

* English speaking women
* Over the age of 18
* Between twelve and twenty-eight weeks of gestation
* Identify as experiencing sleep disturbances will be recruited.

Exclusion Criteria:

* Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
* Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
* Currently taking prescribed medications for sleep problems
* Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
* Smoking, drinking alcohol or drug use during pregnancy.
Exploration of New Nursing Models for Urological Surgery

Patients undergoing urological surgery often need to be provided with targeted nursing care to ensure that the therapeutic effects can be fully realized, however, the traditional nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry of Health proposed a project named the High-Quality Care Project to improve nurse and patient outcomes through the transformation of the nursing care delivery system in hospitals. This study aims to compare the new nursing model and the traditional nursing, and to explore a more effective nursing model for urological surgery.

Patients who underwent urological disease diagnosed and treated in our department were included in this study. The patients were randomly divided into two groups through the random number table method, with a 1:1 ratio. The control group received traditional urological care. The study group comprised 3 subgroups, and each subgroup received different nursing model. All the three new nursing models, including high-quality nursing (primary nursing), Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.

High-quality nursing refers to effective nursing measures in multiple aspects and dimensions, provided to patients according to their actual conditions by centering on the patients throughout their ongoing treatment, strengthening the primary nursing care, and fully implementing the nursing responsibility including managing complications and providing long-term support and information, to ensure patient satisfaction and to improve the patient's quality of life. Clinical care pathway includes multidisciplinary care plans that provides detailed guidelines for patients with specific clinical problems, and the Roy adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a comprehensive framework to guide nursing care for patients with chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

1. patients with a definite diagnosis of urological disease confirmed by pathological examination or imaging;
2. patients with definite surgical indications;
3. patients with complete follow-up information.

Exclusion Criteria:

1. patients with hepatic or renal dysfunction or serious organic lesions in other organs;
2. patients with associated lymph node and distant metastases;
3. patients who withdrew during the study;
4. patients with incomplete case and follow-up data.
Total Knee Arthroplasty and Clinical Findings

Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.

Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA group (study group) and 22 patients (female/male:13/9) with \<grade 4 osteoarthritis were included in the control group. Systemic venous blood samples of the patients were taken to evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score was used to evaluate the functional status. Valgity and malaligment measurements were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken once from patients in the control group, and twice in pre-op and post-op sixth weeks from study group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
* Patients without surgical indication, lower than 4 OA severity included in the control group

Exclusion Criteria:

* Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study
Randomized Controlled Trial of Time-Restricted Feeding (TRF) in Acute Ischemic Stroke Patients

Many preclinical studies have demonstrated the beneficial effects of intermittent fasting (IF) in a wide range of neurological and cardiovascular diseases. This pilot study aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS).

Specific Aims This project is to conduct a pilot, phase II randomized clinical trial which aims to investigate the safety and compliance as well as efficacy of one specific IF intervention called time-restricted feeding (TRF; 16 hours fasting daily) in patients with acute ischemic stroke (AIS) The primary endpoint is the safety and compliance of 4 weeks of TRF in AIS patients.

The secondary endpoints are the efficacy of 4 weeks of TRF compared to normal eating (NE) on plasma and imaging biomarkers and functional outcome at 3 months post-stroke.

This study will determine whether compared to NE control:

1. TRF (16 hours fasting daily) is safe and well-tolerated in patients with AIS.
2. TRF improves functional outcome compared to NE in AIS patients. (3) TRF decreases plasma pro-inflammatory cytokines including metallopeptidase (MMP)-9, interleukin (IL)-6, and tumor necrosis factor alpha (TNF) in plasma compared to baseline and NE in AIS patients.

(4) TRF improves diffusion tensor imaging on MRI at 3 months post stroke compared to baseline and NE in AIS patients.

(5) TRF changes plasma exosome components, metabolomics and lipidomics compared to baseline and NE in AIS patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute ischemic stroke onset within 10 days
2. Age between 20-80 years.
3. Mild stroke severity (NIH stroke scale ≤ 6).

Exclusion Criteria:

1. Large hemispheric (\> 1/2 middle cerebral artery territory) or cerebellar (\>3 cm in diameter) infarct
2. Receiving intravenous rt-PA (alteplase) or endovascular thrombectomy
3. Severe stenosis (\> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory.
4. Body mass index ≤ 24.
5. Active cancer.
6. Diabetes mellitus (ex. HbA1C \> 7% or taking oral hypoglycemic agent or insulin)
7. Active gastrointestinal bleeding.
8. Active infection, concurrent steroid usage or specific endocrine disorders.
9. Pre-stroke modified Rankin Scale \> 2
10. Not willing to participate the trial.
Evaluation of the AIIS Using Hip Ultrasound(AIISUS)

The anatomy of the acetabulum is well described in the past literature, yet the understanding of the clinical importance of the anatomical morphology of the AIIS has grown in recent years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this classification, three types AIIS are identified based on the relationship between the distal extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the AIIS using standard AP pelvis examination is misleading and requires additional imagery, a specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT or MRI.

The objective of this study is to evaluate AIIS morphology using ultrasound as compared to golden standard (MRI)


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to

hip related complaints

Exclusion Criteria:

* Patient refusal

  * Inability to consent
  * Unavailable 3d imaging the hip joint
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder

To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
* Aged 18-60 yeats old

Exclusion Criteria:

* Comorbidity with mental retardation
* Comorbidity with psychotic disorder
* Comorbidity with antisocial personality
* Comorbidity with autism spectrum disorder
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Pre-eclampsia;
* Puerperium.

Exclusion Criteria:

* Associated maternal diseases;
* Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
* Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
Compare the Perioperative Analgesic Effect of Ultrasound Guided Thoracic Paravertebral Block and Ultrasound Guided Serratus Anterior Block in Patients Undergoing Thoracotomy

The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.

randomized, comparative study General anesthesia will be conducted

Eligibility Criteria:
Inclusion Criteria:

* : Patients 20 to 60 years old
* ASA physical status of class II and III.

Exclusion Criteria:

Patients with severe respiratory disease

* preexisting neurologic deficit
* allergy to any of the study drug
* kypho-scoliosis
* presence of local infection
* on current chronic analgesic therapy, having history of opioid dependence'
* patient refusal
* inablity to communicate with the investigators
* who will require postoperative mechanical ventilation .
Effects of Balance Exercises Performed With Different Visual Stimuli

The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS.

The study aims to examine the effects of balance exercises applied with virtual reality glasses, stroboscopic glasses, and visual-based metaphor imaginary on individuals with MS, on their balance functions, coordination skills, and quality of life, and to compare these exercises with both traditional balance exercises, and compare each of them on motor learning, based on their effects on representational areas in the brain, and balance.

Eligibility Criteria:
Inclusion Criteria:

* ages of 18-50
* diagnosis of MS by a neurologist according to McDonald 2017 criteria (Carroll, 2018)
* Being between 2.5 and 4.5 on the Expanded Disability Status Scale (EDSS)
* Not having had an attack in the last 3 months
* Absence of spasticity severe enough to affect treatment (spasticity in any joint of the upper extremity and lower extremity is \<2 according to the Modified Ashworth Scale)
* Getting ≥ 24 points from the Standardized Mini Mental Test (SMMT)

Exclusion Criteria:

* hearing or vision problems
* pregnancy
* Having changed medication in the last 3 months and using medication containing the active ingredient Fampridine
* Participating or participating in a regular physiotherapy and rehabilitation program in the last 3 months
* other accompanying neurological, orthopedic or vestibular disorders
* an upper or lower extremity contracture that prevents exercises
* History of epileptic seizure, migraine or vertigo attack in the last 6 months
Nutritional Intervention for Biliary Atresia

Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some liver macronutrient metabolic pathways. The medium-chain triglyceride formula (MCT) in enteral nutrition has advantages: (1) It has a fast metabolism in the liver and possesses the advantage of being an innate energy source; (2) It can share metabolic pathways with some other fatty acids (DHA, EPA), and can promote the synthesis of phospholipids, etc. Therefore, EN containing the MCT formula is regarded as an important approach to alleviate growth retardation in BA children and improve the nutritional status of patients. This study aims to observe the effect of intensified enteral feeding with a high MCT formula during the perioperative period compared to traditional oral feeding on the prognosis of children with biliary atresia. The method adopted is a prospective, two-arm, open-label, multicenter, and interventional real-world study.


Eligibility Criteria:
Inclusion Criteria:

* 1. Infants under 3 months old; 2. Children clinically diagnosed with biliary atresia and in need of Kasai surgery; 3. The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up.

Exclusion Criteria:

* 1. Low birth weight infants or very low birth weight infants; 2. Complicated with life-threatening diseases of various organ systems; 3. Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance; 4. Patients who have participated in other clinical trials within the last month; 5. Any other conditions that the researcher deems unsuitable for participation in this trial.
Metabolic Screening in Patients With Donnai-Barrow Syndrome

This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).

The purpose of this study is to better understand the role of certain nutrients and vitamins in promoting the healthy development of individuals with Donnai-Barrow Syndrome. The investigators hope that the information gained by studying the metabolism of children with Donnai-Barrow Syndrome and their family members will lead to significant advances in the treatment of this disease.

Eligibility Criteria:
Inclusion Criteria:

All individuals affected with Donnai-Barrow Syndrome
Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM).

SDF-1, an important cytokine for neovascularisation is cleaved by (dipeptidyl peptidase IV) DPPIV.

The aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor vildagliptin (Galvus®) on endothelial function as well as number and functional activity of progenitor cells in patients with documented diabetes mellitus.

The peptidase CD26 (DPPIV/dipeptidyl peptidase IV) removes dipeptides from the amino terminus of proteins and thereby inactivates these cleaved proteins. It was shown, that CD26 cleaves SDF-1 into a non-mitogenic molecule. Inhibition or deletion of CD26 leads to an increased homing of hematopoietic progenitor cells to the bone marrow after transplantation by increasing the invasion capacity of these cells {Campbell et al. 2008; Christopherson et al. 2004}.

The cytokine SDF-1 is released in response to hypoxia, is crucial for progenitor cell homing and recruitment of cells for neovascularisation. Invasion capacity is closely related to the cytokine SDF-1 and the SDF-1 receptor CXCR4 {Ceradini et al. 2004}. The in vivo neovascularisation capacity of progenitor cells is closely correlated to their functional capacity as SDF-1 induced invasion or colony-forming capacity {Heeschen et al. 2004; Britten et al. 2003; Assmus et al. 2007}.

Therefore, the aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor vildagliptin on endothelial function as well as number and functional activity of progenitor cells in patients with documented diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type 2 under stable medication
* HbA1c between 7% an 10%
* age between 18 and 80 years
* signed informed consent

Exclusion Criteria:

* Atrial fibrillation (plethysmographic recordings can only obtained in sinus-rhythm)
* CAD with reduced left ventricular ejection fraction (LVEF \<45%)
* Pregnancy, chronic or acute infection, fever
* Diabetes mellitus type 1
* Newly diagnosed diabetes, uncontrolled diabetes
* Neoplasm
* Known allergy to study drug
* Severe liver/kidney disease
* HIV, Hepatitis
* Participation at other studies within the last 30 days
Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Diabetes diagnosed for one year or more
2. Latino or Black ethnicity/race
3. Speak and read English or Spanish
4. Eligibility for Medicaid

Exclusion Criteria:

1. Significant developmental disability
2. Serious psychiatric disorder
3. Another serious chronic illness