cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
* Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
* Eligible male and female subjects aged 18-75 years.
* Lung function capacity capable of tolerating the proposed lung surgery.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Available tissue of primary lung tumor.

Exclusion Criteria:

* Presence of locally advanced, inoperable or metastatic disease.
* Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
* Participants with active, known or suspected autoimmune disease.
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).

Other protocol defined inclusion/exclusion criteria apply
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1

1. Healthy male Japanese subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
2. Healthy skin on which reddening can be easily recognized in the area of the test fields.

Cohort 2

1. Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of screening, and in generally good health except for AD.
2. Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).
3. Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous access areas).
4. Has an Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion Criteria:

Cohort 1

1. Subjects who have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
2. Subjects who have psoriasis and/or active AD/eczema.
3. Subjects who have a history of AD.
4. Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
5. Known sensitivity to any of the components of the investigational products.
6. History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic and household articles.

Cohort 2

1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent dermatological conditions other than AD), significant physical examination or laboratory findings that may interfere with study objectives, in the Investigator's opinion.
2. Has unstable AD or a consistent requirement for strong to strongest potency topical corticosteroids to manage AD signs and symptoms.
3. Has a significant active systemic or localized infection, including known actively infected AD.
4. Has a history or evidence of clinically significant or severe allergies (eg, seasonal, pet dander, environmental, food) requiring acute or chronic treatment.
5. Has recent or anticipated concomitant use of topical or systemic therapies that might alter the course of AD.
6. Has a history of recent (within 4 weeks of Day 1) sunbathing, tanning bed use, or ultraviolet (UV) light B therapy (UVB) or psoralen plus UVA \[PUVA\]).
7. Has a known sensitivity to any of the components of crisaborole ointment 2%.
8. Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).

The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.

The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.

The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.

The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).

Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.

Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.

Eligibility Criteria:
Inclusion Criteria:

* Woman within 48 h post partum
* Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
* Able to read and understand the Norwegian language
* Signed informed consent

Exclusion Criteria:

* Anemia not attributable to iron deficiency
* Contraindications for any of the study drugs
* Treatment with drugs, dietary supplements or natural remedies containing iron
* Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
* Assessed as requiring blood transfusion(s)
Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

The prospective BoHemE study is designed to evaluate the correlation between bone marrow function and skeletal health in elderly patients (\>= 60 years) with or without pre-existing myelodysplastic syndromes (MDS).


Eligibility Criteria:
Inclusion Criteria Group 1 (MDS group):

* Age ≥60 years
* With known or suspected MDS (according WHO, \<20% blast count)
* Written informed consent

Inclusion Criteria Group 2 (control group):

* Age ≥60 years
* Undergoing elective knee or hip replacement therapy
* Normal blood count (defined by Hb ♀ \>12 g/dL, ♂ \>13 g/dL; ANC \>1.8x10\^9/L; PLT \>100x10\^9/L)
* Written informed consent

Exclusion Criteria Group 1 (MDS group) + 2 (control group):

* History of bilateral total hip replacement prior to study
* Control group only: diagnosis of MDS or AML prior to study
* Dementia defined as MMSE score of \<24
* Renal insufficiency with an eGFR \<30 mL/min
* Liver cirrhosis Child-Pugh B or C
* Active infection (HIV, hepatitis B or C, tuberculosis)
* Heart insufficiency NYHA III or IV or severe cardiac valve disease
* Prior allogeneic stem cell transplantation
The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty

Percutaneous epidural neuroplasty (PEN) is an effective interventional treatment for radicular pain. But in some cases with wire catheter like Racz catheter, contrast runoffs were not shown to the foramen. This study will show that contrast runoff will affect the results of PEN and in cases which contrast runoff are not shown, additional transforaminal epidural blocks will affect the results of PEN by reviewing medical record, retrospectively.

Medical records will be investigated in cases of PEN with wire type catheter from May 2016 to August 2018. About one hundred cases will be enrolled. Analysis will be performed. It will be compared 1) Success rate of Runoff group and Nonrunoff group in lumbar spine, 2) Success rate of Runoff group and Nonrunoff-NonTransforaminal group in lumbar spine. 3) Success rate of Runoff group with nonrunoff-transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine. 4) Success rate of Nonrunoff-Transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 80 years old
* Patients with a herniated disc, spinal stenosis
* Patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections
* Patients who are performed percutaneous epidural neuroplasty with wire type catheter.

Exclusion Criteria:

* Incomplete medical record
* Contraindication to percutaneous epidural neuroplasty
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality

Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs.

Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs. Some authors consider that this type of low back pain may be caused by leg length inequality (LLI) in these patients, which resulted from poor gluteal neuromuscular control or muscles' imbalance.

In consideration of few studies have been done for investigating the effects of gluteal muscles control training in LBP. Thus, the purpose of this study is to investigate the effect of additional gluteal muscles control training on improving functional LLI in patients with LBP. We hypothesized that gluteal muscle control training would be more effective in self-reported pain, and their functional disability would be improve after 6-week training program than control training group.

Eligibility Criteria:
Inclusion Criteria:

* non-specific LBP (from inferior rib margin to the gluteal fold)
* more than 3 months
* Visual Analog Scale ≧5 (in past one month)
* pelvic innominate rotation (anterior rotation in dominant side)

Exclusion Criteria:

* history of fracture or surgery
* congenital anomalies in the spine, pelvis, or lower limbs
* recent trauma, tumor, pregnancy or scoliosis
* lower extremity paresthesia, unknown weakness
* bowel and bladder dysfunction
* predominant lower extremity pain with standing
* presence of system illness, no reasoning weight loss, predominant night pain
* specific sacroiliac joint dysfunction
Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.

The "Dental Team" at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* radiation concerning the oral cavity
* follow-up at the Dental Team

Exclusion Criteria:

* refused approval
* survival prognosis under one year
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease

The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* Aged \>=30 years at study entry -\>=1 year registration prior to the 'index date'

Exclusion Criteria:

* Free from previous atherosclerotic events
* No heart rate measurement after their 'index date' of eligibility to entry the study
Prevention and Control of Healthcare-Associated Infections

Bundling infection control interventions should decrease incidence of Healthcare-Associated Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand


Eligibility Criteria:
Inclusion Criteria:

* The patients hospitalized to general medical wards

Exclusion Criteria:

* The patients hospitalized less than 48 hours
Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Postmenopausal Women

Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes, urogenital pain, headache and pains in the musculoskeletal system. That happens due to the decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of the peripheral nervous system promotes modulation of nociceptive incentives and release of endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve stimulation (TENS), by directly stimulating the central nervous system, has presented results of manipulation of the autonomic system, being observed change in heart rate and cognitive improvement in dementia. Given this possibility, the present study aims to investigate whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate autonomic and psychophysical changes in healthy postmenopausal women.

Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on autonomic and psychophysical parameters in postmenopausal women.

Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected according to inclusion and exclusion criteria previously established. The autonomic and psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively), as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep Quality Index). After application of the scales, the participants will be subject to active Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as randomization. All the research subjects will be invited to participate in the study and sign an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.


Eligibility Criteria:
Inclusion Criteria:

* To be in the period of post-menopause;
* Do not have chronic diseases or comorbidities in drug treatment;
* Accept to participate in the study and sign the free and informed consent form.

Exclusion Criteria:

* Start continuous medication during the study period;
* Display cognitive problems that make it difficult to understand the questionnaires and proposals;
* History of alcohol or drug abuse in the last 6 months;
* History of neurological disorders;
* History of cardiac arrhythmias;
* History of moderate or severe head injury;
* History of neurosurgery;
* Uncompensated systemic diseases, and chronic inflammatory diseases (diabetes, lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome);
* History of uncompensated hypothyroidism;
* History of personal cancer, past or treatment.
* Wish referred to leave the study at any time.
* No attendance to the stages that make up the research.
Functional Organ Preservation Surgery

This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.

This prospective study compare the following items between two groups:

* Functional outcomes: laryngeal, pharyngeal, and quality of life
* Oncological outcomes: survivals, locoregional controls
* Combined imaging and molecular biomarkers with follow-up data

The functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:

* Radical tonsillectomy or other oropharyngeal resection
* Partial laryngectomy or pharyngectomy
* Transoral laser microresection
* Transoral robotic surgery (TORS)
* Reconstructive surgery may be combined with primary resection
* Neck dissection may be indicated in some patients
* Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports.

The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx
* Resectable tumors without distant metastases
* age range: 18-80 years
* Pretreatment Karnofsky performance scale \> or 70%
* Operable patients
* No significant loss of pretreatment larynx and pharyngeal functions

Exclusion Criteria:

* Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)
* Other organ-site cancers
* Low-performance status or non-operable patients
* Non-resectable or distant-metastatic tumors
* Extensive primary or neck nodal diseases
* Significant pretreament loss of laryngeal or pharyngeal functions
* cT1N0 glottic carcinomas
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma

RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.

OBJECTIVES:

* Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
* Evaluation of the immune response of patients treated with this regimen.
* Evaluation the progression-free survival of patients treated this regimen.
* Evaluate the adverse events of this regimen in these patients.

OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of 1 of the following:

  * Mantle cell lymphoma
  * Marginal zone lymphoma
  * Follicular lymphoma
  * Small lymphocytic lymphoma/chronic lymphocytic leukemia
  * Multiple myeloma
  * Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
  * Diffuse large B-cell lymphoma
* Adequate sample size and lymphoma cell content in the fresh tissue collected
* No bulky or progressive disease

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
* No autoimmune disease or atopic allergy
* No HIV positivity
* No other malignancy

PRIOR CONCURRENT THERAPY:

* Not specified
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy

The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 7 years old - 21 years old
* been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.
* are able to communicate through written words
* are able to follow a 3- steps directions, and follow study directions and procedures.

Exclusion Criteria:

-