cyrilzakka/clinical-trials huggingface dataset:
Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg) infusion for prevention of taxane induced neuropathy in patients with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles or every week for 12 weeks.

Chemotherapy induced peripheral neuropathy (CIPN) is a major dose limiting side effect of many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of functional abilities. Calcium and magnesium infusions were shown to decreased the incidence and intensity of neuropathy symptoms related to oxaliplatin.

There are currently no effective drugs or treatment modalities for the prevention or treatment of taxane related neuropathy. Given the morbidity of taxane induced neuropathy and the safety of Ca/Mg infusion, it is reasonable to assess the feasibility of this intervention in woman with stage I-III breast cancer receiving adjuvant or neo-adjuvant paclitaxel treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. Calcium gluconate and magnesium sulfate, 1 g of each agent in 100 ml D5W will be infused over 30 minutes, immediately before and after each dose of paclitaxel. The Ca/Mg infusion will be given through the same line used for giving chemotherapy.

The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls. Secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-Tax score, taxane-related neuropathy pain as measured by the Brief Pain Inventory-Short Form (BPI-SF), and measure of cognitive impairment using FACT-cog score.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* History of stage I-III breast cancer
* Patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week for 12 weeks or given every two weeks for 4 cycles
* Serum magnesium level ≤ UNL
* Serum calcium level ≤ UNL
* Serum creatinine ≤ 1.5 x UNL
* Signed informed consent

Exclusion Criteria:

* Pre-existing peripheral neuropathy of any grade
* Current treatment for arrhythmias
* Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or concurrent treatment with other neuropathic chemotherapy agents
* Current narcotic use
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP

Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma。The majority of refractory patients have PD-L1 expression due to P53 mutations, some of which account for about 10% of DLBCL.Our department has found that in refractory DLBCL with high PD-L1 expression, cedilizumab monotherapy is also more effective and has reversed chemotherapy resistance.The aim of this study was to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.

This study is a randomized, open, multicenter clinical study to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.In this study, patients with P53 mutation with PD-L1 expressing DLBCL were selected to be randomised 1:1 into 2 groups: group A Sindilizumab + R-CHOP and group B R-CHOP. Sindilizumab was administered on day 10 after chemotherapy to avoid interference from prednisone.At the end of 6 cycles, Group A treatment effective maintenance treatment with Sindilizumab for 6 months as indicated.Each patient's tumour tissue was tested for mutations and ctDNA after allocation, and ctDNA and peripheral blood free PD-L1 levels were monitored dynamically during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Ages≥18 years, ≤ 80 years.
2. Patients with primary treatment of DLBCL.
3. Histopathologically confirmed diagnosis of diffuse large B-cell lymphoma.
4. At least one measurable lesion according to the 2014 Lugano criteria.
5. ECOG physical status score of 0, 1 or 2.
6. Laboratory tests meet the following criteria unless judged to be due to lymphoma:

   1. Routine blood tests: (in the absence of growth factor support therapy or blood transfusion within 7 days) haemoglobin ≥ 90 g/L, absolute neutrophil value ≥ 1.5 x 109/L, platelet count ≥ 90 x 109/L.
   2. Liver biochemistry: serum creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; glutamate transaminase and glutamic oxalacetic transaminase ≤ 2.5 x upper limit of normal.
   3. Coagulation: INR and APTT ≤ 2.5 times the upper limit of normal values.
7. Consent to use contraception during the trial and for 3 months after its completion.
8. Expected survival ≥ 3 months.

Exclusion Criteria:

1. Suffering from other untreated malignant tumours.
2. Cardiovascular disease that remains unstable under pharmacological control .
3. With severe interstitial lung disease.
4. With cognitive impairment.
5. Patients with uncontrolled autoimmune disease.
6. Presence of uncontrolled active infection.
7. Expected survival time \< 3 months.
8. Lactating women and subjects of childbearing age who do not wish to use contraception.
9. With poor adherence or unable to follow up regularly.
Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)

Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* History of opthalmic disease or surgery
* History of brain disease or surgery
* Known ICP elevation
* Known IOP elevation
* Presence of lung bullae on chest x-ray
* History of pneumothorax
Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand

Observation study of patients with chronic rhinitis or chronic urticaria in Thailand

All patients presenting with symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per years or symptoms of chronic urticaria for at least 6 weeks will be asked to complete the case report forms asking for details of symptom characteristics, risk factors, personal habits, underlying diseases, and quality of life at the first visit. Investigation results, final diagnosis, and therapeutic interventions will also be recorded by the responsible allergist. On every follow-up appointment, patient symptoms, aggravating factors, medication use and side effects will be completed by patients. New findings, associated diseases, and prescriptions will be completed by allergist. The unfilled variables by patients will be asked in the following visit. Any "non-reported" variables those are unable to retrieve will be treated as missing data for data analysis. The estimated sample size is about 200 new cases per year.

Patient demographic data, clinical presentations, and associated diseases will be reported. The association between clinical characteristics and quality of life will be analyzed. The relationship between clinical manifestations and therapeutic outcomes will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Have symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per year or symptoms of chronic urticaria for at least 6 weeks

Exclusion Criteria:

* Less than 15 years of age
VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.

Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).

The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.

The study was designed to test the impact of the intervention in each of two cohorts:

1. Infants not breathing well 30 seconds after birth
2. Infants breathing well 30 seconds after birth

Randomization and analysis is stratified by gestational age category:

1. 23 0/6 to 25 6/7 weeks' gestation
2. 26 0/7 to 28 6/7 weeks' gestation

Eligibility Criteria:
Inclusion Criteria:

* 23 0/7 - 28 6/7 weeks' gestation at delivery

Exclusion Criteria:

* Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
* Suspected severe fetal anemia
* Monochorionic or monoamniotic twins
* Multiple gestation greater than twins
* Decision made for comfort care only
* Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
* Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants

The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardized questionnaires. On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to assess the prevalence of depression with RA in approximately 1000 participants.

VADERA I is regarded as interventional epidemiologic study. The study was considered as interventional because of the use of the questionnaires and interview for the diagnosis of depression. VADERA II is a cross-sectional epidemiologic study.

Eligibility Criteria:
Inclusion Criteria:

* VADERA I: Participants diagnosed with RA, who did not suffer from a concurrent, manifest depressive disorder and had been scheduled for a RA consultation at one of the participating clinics
* VADERA II: All participants diagnosed with RA who were able to complete the questionnaires and had been scheduled for a RA consultation at one of the participating clinics
Iodine Status and Characteristics of Papillary Thyroid Cancer

The effect of iodine on papillary thyroid cancer has been controversial for many years. The investigators designed a cross-sectional study and aimed to explore the relationship between the serum and urine iodine levels and the clinical and molecular characteristics of papillary thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 18\~65 years old, gender not limited;
* Living in the residential area for at least 5 years;
* Patients diagnosed clinically with thyroid cancer and scheduled for thyroid surgery, with pathological diagnosis of papillary thyroid cancer;
* Complete clinical data: including general information, relevant laboratory tests, pathological reports, surgical reports, ultrasound reports, etc.

Exclusion Criteria:

* Pathological diagnosis of other types of thyroid cancer;
* Diagnosed with other types of cancer;
* There are serious comorbidities of the heart, liver, and kidneys;
Esthetic Outcomes of Single Immediate Implant Placement

A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.

In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap.

In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures.

In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.

Eligibility Criteria:
Inclusion Criteria:

* Single non-restorable tooth in the anterior maxilla
* Intact buccal plate or \<5mm fenestration

Exclusion Criteria:

* Pregnancy
* Current smokers \>10 cigarettes/day
* Parafunctional habits
* Malocclusion or intent of orthodontic therapy in the future
* Severe periodontal disease
Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes various techniques like stroking, petrissage manipulations.

Background: Neonatal intensive care unit (NICU) is a specialized unit created for sick and premature newborns. There are various painful procedures through which neonates have to undergo during the NICU stay. The most common procedure is the blood tests for the laboratory investigations which include the heel lancing and venipuncture. Pain is the one of the cause of the development of the acute stress in neonates soft tissue therapy has considered as the major contributory factor of in reducing the procedural pain among neonates admitted NICU. There is no documentation on soft tissue therapy in managing procedural pain in neonates.

Purpose: To determine the effects of soft tissue therapy in managing procedural pain among neonates admitted in NICU.

Methods and materials: The study will recruit neonates who underwent for various painful procedures in NICU such as venous and arterial puncture, capillary puncture, pulmonary mechanical ventilation, tracheal intubation, removal of adhesive tapes, the introduction of various drains etc. Preterm, Term, Full terms Neonates Stable Neonates. The samples will be taken via stratified random sampling technique. Neonates with unstable vitals are to be excluded from the study.

Discussion: To best of our knowledge, this will be the first study determining the effects of soft tissue therapy in procedural pain on neonates admitted in NICU. The role of neonatal physiotherapist in NICU is to provide diagnosis and treatment to admitted newborns. Massage therapy is considered as an effective management technique in pain management. In this study soft tissue therapy will be applied to neonates especially in context with procedural pain. There are various painful procedures performed to check the prognosis of neonates.

Keywords: Neonatal; Newborns; Infant; NICU; Procedural pain; Massage therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Neonates who underwent various painful procedures in NICU such as venous, arterial and capillary puncture, mechanical ventilation for pulmonary causes, tracheal intubation, adhesive tapes removal, insertion of various drains etc.
2. Preterm, Term, Post terms Neonates
3. Stable Neonates.

Exclusion Criteria:

1. Post-Surgical cases
2. Parents of Neonates who are not willing to enroll their infant in study.
3. Neonates with congenital anomalies.
4. Neonates with extreme low birth weight.
Improving Door-to-Balloon Time in STEMI

The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.

Please see Circulation. 2007;116:67-76

Eligibility Criteria:
Primary Study Inclusion Criteria:

* ST-elevation myocardial infarction patients who undergo percutaneous intervention within 24 hours of ED arrival

Exclusion Criteria:

* Patients who are inpatients

A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents

The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.

Eligibility Criteria:
Inclusion Criteria:

* General good health
* History of recurrent herpes labialis with at two recurrences during the last twelve months

Exclusion Criteria:

* Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
* Significant skin condition that occur in the area of herpes recurrences
* Nursing or/and pregnancy
* Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)
Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.

This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Male and female preterm neonates less than 37 weeks gestational age
* Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) .
* Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings .
* Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool
* Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis.
* Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC

Exclusion Criteria:

* Term and post term neonates
* Neonates with congenital infections
* Neonates with major congenital anomalies
* Neonates with stage III NEC
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease

Alzheimer's Disease (AD) is the most frequent neurodegenerative disease associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered the first molecular event occurring in AD: as already showed in an animal model, a low-dose radiotherapy (RT) course is capable of reducing AD-associated amyloid-β plaques and improve cognitive function. This pilot study wishes to investigate in 10 patients with a diagnosis of prodromal or early probable AD and with evidence of amyloid pathology the effectiveness of a short course low dose RT radiotherapy to reduce amyloid deposits in the human brain using molecular imaging (18F-Florbetapir) to show the effectiveness of the treatment on the specific target.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the clinical trial and give an informed consent
* Clinical diagnosis of prodromal AD, or mild or moderate AD
* Ability to undergo neurocognitive assessment at baseline visit, alone or accompanied by a caregiver
* Amyloid PET scan positivity
* Ability to follow the 5-days RT regiment, alone or accompanied by a caregiver

Exclusion Criteria:

* Inclusion in another disease modifying clinical trial
* Previous therapeutic brain irradiation
* Evidence of vascular cognitive impairment on Magnetic Resonance Imaging (MRI) (Fazekas score \>1 and Wahlund score \>=10/30)
* Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
* Evidence of substance abuse (alcohol and/or other drugs) with a dependence during the previous 12 months (DSM-IV criteria)
* Presence of subdural hygroma's, subdural hematomas or hydrocephalus
* Significant psychiatric comorbidity as assessed during the clinical evaluation by the neurologist/geriatrician in charge
* Active or recent (within 3 months) cerebral infection/haemorrhage
* Immunocompromised status
* Prior history of seizure
* Dermatological skin disease of the scalp
* Women who are pregnant or breast feeding or who intend to become pregnant during the course of the study;
* Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;