cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Disease confirmation of MDS.
2. Between 5% and 30% blasts in the bone marrow.
3. Received treatment for cytopenias within 2-months
4. ECOG ≤ 2.

Exclusion Criteria:

1. Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
2. Received chemotherapy/radiotherapy within 4 weeks of study registration.
3. Received prior bone marrow transplant.
4. 5q- chromosomal deletion in malignant cells.
Neurodevelopmental Therapy for Spastic Cerebral Palsy

This study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. To investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with Spastic Cerebral Palsy.

A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was adopted to collect data. Sample selection was completely based on inclusion and exclusion criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. While patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and posture and postural ability scale (PPAS) were used as data collection tools.

Eligibility Criteria:
Inclusion Criteria:

* • A diagnosed Spastic Cerebral Palsy (patient's diagnosis of CP confirmed by an expert pediatrician neurologist)

  * Spastic CP
  * No other severe abnormalities such as seizure
  * Aged 2-6 years
  * Both Genders

Exclusion Criteria:

* Medical procedures likely to affect motor function such as botulinum toxin injections
* Orthopedic remedial surgery
* Mental retardation, or a learning disability.
Soluble Vascular Endothelial Growth Factor Receptor 2 as Predictor of Benefit From Bevacizumab Beyond Progression in Metastatic Colorectal Cancer

A growing amount of reports has consistently evidenced that a sustained inhibition of the angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic colorectal cancer (mCRC) patients.

In the last decade different biologic agents targeting angiogenesis have been approved for the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently, solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even beyond the first progression to a bevacizumab-containing regimen. In particular, two phase III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line switching the chemotherapeutic regimen in patients already treated with bevacizumab in first-line. Preliminary experiences evidenced that circulating levels of angiogenesis-related markers are significantly modulated during first-line chemotherapy plus bevacizumab. In particular, a wide variability of plasma soluble Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and retrospective data suggest that benefit from the continuation of bevacizumab may be restricted to patients with high levels of soluble VEGFR-2 at the first evidence of disease progression. This study aims at prospectively validating those retrospective data.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of ≥ 18 years of age
* Progressive disease during or after first-line chemotherapy plus bevacizumab, including fluoropyrimidine alone (5-fluorouracil or capecitabine), fluoropyrimidine in combination with oxaliplatin (XELOX or FOLFOX regimen) or irinotecan (FOLFIRI regimen) or with oxaliplatin and irinotecan (FOLFOXIRI regimen);
* No more than 3 months from the last administration of bevacizumab and evidence of progressive disease are allowed;
* Measurable disease according to RECIST 1.1.
* Indication to second-line treatment with a bevacizumab-containing second-line regimen (second-line XELOX, FOLFOX, FOLFIRI and FOLFOXIRI plus bevacizumab are allowed);
* Neutrophils 1.5 x 109/L, Platelets 100 x 109/L, Hgb \>9 g/dl
* Total bilirubin 1.5 time the upper-normal limits (UNL) of the institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase 2.5 x UNL, 5 x UNL in case of liver metastases
* Creatinine clearance \>50 mL/min or serum creatinine 1.5 x UNL
* Urine dipstick of proteinuria \<2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate \<1 g of protein/24 hr
* Will and ability to comply with the protocol
* Written informed consent to study procedures.

Exclusion Criteria:

* Patient unable to give consent
* Absolute contraindications to the use of bevacizumab.
Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp

A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.

Eligibility Criteria:
Inclusion Criteria:

* Control group: subjects with no evidence of colorectal adenoma or colorectal cancer
* Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.
* Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma

Exclusion Criteria:

* Subjects age under 18 years
* Previous history of colorectal neoplasms
* Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents
* Denial to participate in this study
Isokinetic Training Versus Treadmill Training on Muscle Strength and Gait in Children With Lower Limb Burns

Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth factors so it results in new vessel in-growth that improves blood supply, increases cell proliferation, accelerates tissue regeneration and healing and regain muscle strength

To evaluate the efficacy of isokinetic training against treadmill training in improving muscle strength and gait in children having lower limb burns. Methods: Sixty children from both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30 percent of their total body surface area (TBSA) participated in this study, their ages ranged from 8 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) with trained to use the isokinetic device while group (C) received the same conventional physical therapy program of group (A and B) and used treadmill training. The children participated in this study were assessed by Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and after the treatment program three sessions per week for 12 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 8 to 16 year
* Complaining from 2nd degree lower limb burns (≥30 % of their TBSA).
* Capable of standing and walking independently.
* Clinically and medically stable.
* Sufficient cognition demonstrating understanding the requirements of the study.
* No history of lower extremity surgery.

Exclusion Criteria:

* Visual and/or auditory defects.
* Significant shortening and/or deformity of lower extremities.
* Other neurological problems that affect balance or mentality (e.g. epilepsy).
* Advanced radiographic changes include (bone destruction, bony ankylosis, knee joint sublaxation and epiphysial fracture).
* Congenital or acquired skeletal deformities in the lower limbs.
* Cardiopulmonary dysfunction.
Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients

Subclinical inflammation is a common phenomenon in patients receiving maintenance hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to metabolic acidosis, volume overload, and / or non-sterile dialysate.

As important antioxidants, vitamin C was prominently consumed by oxidative stress and inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C level.

It was documented that inflammation was associated with increased risk of cardiovascular morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had anti-inflammation effect on behalf of its electron receiving ability, the investigators made a hypothesis that vitamin C supplementation can reduce inflammation status in patients on maintenance dialysis

Objective A cross-over study is designed to elucidate if oral vitamin C supplementation can reduce inflammation status in maintenance dialysis patients with low vitamin C level and high CRP level.

Patients, Methods and Expected results Patients About 100 dialysis patients were recruited. Patients will be divided into two groups, and will be followed for at least 6 months.

Methods Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.

Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.

The demographics were recorded. Plasma Vitamin C was measured by high-performance liquid chromatography. Serum albumin, prealbumin, high-sensitivity C-reactive protein (hsCRP), ferritin, hemoglobin will be measured.

Expected results There may be positive effect of vitamin C supplementation on inflammation in maintenance dialysis patients with vitamin C deficiency and high CRP level.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving maintenance hemodialysis or continuous ambulatory peritoneal dialysis, and dialysis vintage more than 3 months
* Patients aged between 18 and 80 years older
* VitC \< 4ug/ml and hsCRP \> 3mg/L
* for HD patients, Kt/V \> 1.2 per session, at least 3 sessions per week, 4 hours per session
* for PD patients, Kt/V \> 1.7 per week
* age and gender matched health control

Exclusion Criteria:

* Active autoimmune disease, malignancy, hepatitis
* Positive HIV serology
* Any kind of acute infection within one month, chronic infection
* Currently using steroids or immune-suppressants
* Pregnancy or breast feeding
Post-market Observational Study Zenith® t-Branch™

The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.

Both retrospective and prospective patients will be enrolled

Eligibility Criteria:
Inclusion Criteria:

* Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
* Signed informed consent

Exclusion Criteria:

* Inability or refusal to give informed consent by the patient or a legally authorized representative
Skin-to-skin Contact in Healthy Term Infants

This is a prospective, single-blind, randomized controlled clinical trial study to investigate short- and long-term effects of mother-infant skin-to-skin contact in healthy term infants, in order to provide supporting data for emphasizing mother-infant skin contact and family-centered care in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Babies born at Korea University Anam Hospital
* Term infants (37 weeks or more)
* Infants with a birth weight of 2,500g or more
* Healthy infants with an Apgar score of 7 or higher at 5 minutes
* Mothers and infants without severe acute complications, such as requiring intensive care treatment immediately after delivery

Exclusion Criteria:

* Preterm infants born at 37 weeks of less gestation
* Low birth weight infants weighing less than 2500g at birth
* Mothers under the age of 20
* Unmarried mothers
* Multiple pregnancies (twins or triplets)
* Parents do not consent to participation in the study
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has received pneumococcal vaccine \>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD).
* Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
* Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
* Has a coagulation disorder contraindicating intramuscular vaccination.
* Has a known malignancy that is progressing or has required active treatment.
* Has received PPSV23 followed by either PCV15 or PCV20.
* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
* Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
* Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
* Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients of any ethnic origin ≥18 years old at index date;
2. Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date;
3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date;
4. Patients with at least 6 months of data coverage in the medical records prior to the index date;
5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
6. Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation.

Exclusion Criteria:

1. Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;
2. Patients who started cenobamate within an EAP;
3. Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
4. Patients with specific syndrome (e.g. LGS and Dravet);
5. Pregnancy or lactation;
6. Patients without self-judgement ability;
7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.
18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor

To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer.

This is a prospective, single-center, two arms, open label, non-randomized study to evaluate the ability of 18F-AlF-FAPi-04 to detect FAP expressing cells in patients with solid tumor, evaluate its biological distribution characteristics, impact on clinical treatment plans, and evaluate imaging differences between different probes. Taking histopathology and imaging follow-up as gold standard, the sensitivity, specificity, and accuracy of 18F-AlF-FAPi-04 PET/CT will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Obtain/sign informed consent.
2. Age ≥18 years, male or female patients.
3. Histologically or cytologically confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases.
4. Cohort 1: Patients with operable or borderline operable resection, scheduled for primary lesion resection and peripheral lymph node dissection, and suspected presence of peripheral lymph node or distant metastasis; The pathological results of the primary lesion and lymph node dissection were obtained.

   Cohort 2: Patients with confirmed or suspected postoperative recurrence or advanced metastasis by routine imaging had at least one measurable lesion; Patients who can undergo imaging follow-up for 3 to 6 months or can undergo pathological biopsy.
5. The ECOG score is 0-2
6. Patients with adequate organ function.

Exclusion Criteria:

1. Previously received FAP-targeted radioligand therapy.
2. Patients are participating in any other clinical trials or receiving investigational drugs.
3. Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system.
4. Patients with other malignancies that may interfere with disease assessment, who have a prior history of malignancy but have been adequately treated, who have not been treated for more than 3 years prior to enrollment, and who have no evidence of recurrence are eligible to participate in the study.
5. Comorbidities with serious or poorly controlled medical conditions, including but not limited to hard-to-control infections, known active hepatitis B or C, or other conditions that investigators believe may impair study participation or collaboration.
6. A physical or psychiatric history that may interfere with the purpose and evaluation of the study, or any condition in which the investigator determines that the patient is incapable of cooperating with imaging and procedures.
7. Patients who do not consent to effective contraception or restricted sexual practices.
8. There are other conditions that the investigator deems unsuitable for participation in the trial.
A Study of Omega-3 as a Treatment for Major Depression

The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.

The study will be a 6 week, parallel-group, double-blind randomized controlled trial of the efficacy of Omega-3 as a monotherapy for depression. People aged 21-65 who have major depression but are not currently on an antidepressant or planning to take an antidepressant in the next 14 weeks will be recruited. Participants will be randomly allocated to receive Omega-3 (fish oil) or placebo (paraffin oil) for 6 weeks. Participants will be followed up weekly and will be asked to rate their mood daily for the 6 week study period. Blood samples will be taken pre and post treatment to measure change in omega-3 levels. At the end of 6 weeks all participants will receive a further 8 weeks supply of omega-3.

Eligibility Criteria:
Inclusion Criteria:

* Must meet DSM IV criteria for non-psychotic major depression lasting at least 6 weeks or dysthymia.
* Must be under the care of a mental health practitioner.
* Must be able to give informed consent.
* Must be able to attend the Black Dog Institute.

Exclusion Criteria:

* Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration.
* History of psychosis or mania/hypomania or personality disorder.
* Non-English speaking or otherwise unable to provide historical information.
* Having taken Omega-3 dietary supplements in the last 3 months.
* Taking antidepressant medication for depression.
* History of allergy to n-3 PUFA supplements, finfish or shellfish.
* Pregnancy, breast feeding or planning to become pregnant during course of study.
* Post-natal depression.
* Current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.
* Unstable thyroid function
* Hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of omega-3 polyunsaturated fatty acids.
* Coagulopathy or anticoagulant treatment.
* Patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who are not likely to be able to comply with the study protocol.