cyrilzakka/clinical-trials huggingface dataset:
Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).

HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year. The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously. The safety, survival effect and peripheral T-lymphocyte subsets of combination therapy group will be recorded and compared with those of MWA group.

Eligibility Criteria:
Inclusion Criteria:

1. single HCC of 5 cm or smaller;
2. three or fewer multiple HCC with a maximum dimension of 3 cm or less;
3. absence of portal vein thrombosis or extrahepatic metastases;
4. Child-Pugh classification A or B;
5. tumor accessible via a percutaneous approach. white blood cell count \>2 x 109/L, platelet count \>40 x 109/L,serum creatinine \<110 μmol/L, aspartate aminotransferase \<3 times the upper limit, serum bilirubin \<2.5 times the upper limit, prothrombin time \<19 seconds.

Exclusion Criteria:

1. pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
2. active uncontrolled infection; concurrent systemic corticosteroid treatment;
3. systemic autoimmune disease;
4. clinically significant ischemic heart disease or cardiac failure;
5. and chemotherapy or radiotherapy within the preceding 6 months
Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex

The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.

Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.

Primary outcome: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium.

Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* ASA physical status 1 or 2
* weight BMI 18.5-24.9
* otorhinolaryngological surgeries

Exclusion Criteria:

* major surgery associated with massive blood loss or fluid replacement
* any known allergy to magnesium sulphate or any other study drugs
* pregnant
* anatomical malformations expected to result in a difficult intubation;
* known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction
* administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications)
* hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia
Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.


Eligibility Criteria:
Inclusion Criteria:

* 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital
Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery

Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Lower troponin release has been correlated with better long term event free survival in both cardiac and non cardiac surgery. A recently completed meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high risk patients undergoing elective non-cardiac procedures.

Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin release, the incidence of myocardial infarction and/or long term morbidity in patients at low to moderate risk of postoperative cardiac complications, who are undergoing noncardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

Any patient undergoing non-cardiac surgery is eligible if s/he: 1.) is ≥45 years old;2.) Has an expected length of stay ≥48 hours; AND3.) Fulfills any 2 of the six criteria for high cardiac risk as defined by the revised Cardiac Risk Index.(see details in protocol)4.) Informed consent

Exclusion criteria:A patient will be ineligible for this study if s/he:1) Prior adverse reaction to sevoflurane (MH patient) or propofol.2) Previous coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding five years with no evidence of cardiac ischemia since the procedure; or3) Has concomitant life-threatening disease likely to limit life expectancy to \<30 days. -
Standard Versus Comprehensive Care for Post Acute Kidney Injury

The investigators aim to compare between standard versus comprehensive care for post-acute kidney injury who are admitted with acute kidney injury at least stage 2 or receive renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Acute kidney injury at least stage 2 OR
* Received renal replacement therapy

Exclusion Criteria:

* Post kidney transplantation
* End-stage renal disease
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers

Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
* Have received all standard EPI immunizations according to national immunization programme.
* Written informed consent by parent.
* Mother HIV-1/2-uninfected.

Exclusion Criteria:

* Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of \<37.5 °C ).
* Axillary temperature of ≥ 37.5 °C at the time of vaccination.
* Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
* Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
* Invasive bacterial infections (pneumonia, meningitis).
* Any other on-going chronic illness requiring hospital specialist supervision.
* Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
* Any history of anaphylaxis in reaction to vaccination.
* Research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
* Likelihood of travel away from the study area.
* Untreated malaria infection.
* Any other clinical evidence of infection.
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan


Eligibility Criteria:
Inclusion criteria:

* Male or female participants 60 years of age and older at the time of consent.
* Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)

Exclusion criteria:

* History of microbiologically proven invasive disease caused by S pneumoniae.
* Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
New York City (NYC) Health eHearts Pay for Quality Pilot

Do monetary incentives in small independent primary care practices improve the delivery of preventive services as recommended by U.S. Preventive Services Task Force (USPSTF) guidelines for cardiovascular health?

The NYC DOHMH received a private donation from the Robin Hood Foundation to provide monetary incentives to small practices for improving their delivery of preventive services in neighborhoods experiencing health disparities.

Practices recruited by NYC DOHMH to adopt an electronic health record will be randomized to receive monetary incentives for improving both patient outcomes and delivery of care on: aspirin therapy, blood pressure control, cholesterol control, and smoking cessation intervention. The set of quality measures are referred to the ABCS.

The NYC DOHMH will be collecting provider surveys on their experience on quality measurement and participation in other pay-for-performance programs, as well as transmit aggregated information on their performance on the ABCS to DOHMH on a monthly basis.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care Providers

Exclusion Criteria:

* Specialists
* Pediatricians
* Obstetricians
* Gynecologists
Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma

The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in terms of loco-regional control, toxicities and quality of life.

Concurrent chemo-radiotherapy is a common and conventional method of treating locally advanced head and neck squamous cell carcinoma (HNSCC). In locally advanced HNSCC it has been proved to be superior to radiotherapy alone. On the other side accelerated fractionation radiotherapy (AFRT) is a proven practice to improve cure rate in head and neck cancers. Yet it has not been compared with Concurrent Chemoradiotherapy (CRT) in locally advanced HNSCC and hence this study is aiming to compare CRT versus AFRT.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20 - 60 years old
2. Karnofsky performance scale score 70 or above
3. Biopsy proven squamous cell carcinomas (SCC) of oropharynx, larynx and hypopharynx
4. TNM stages- Stage III -IVB
5. Informed consent (in prescribed form under institutional guidelines)

Exclusion Criteria:

1. Lack of histopathological proof of malignancy (HNSCC)
2. Doubtful follow-up and/ or non-compliance
3. Previous oncologic therapy with surgery, radiotherapy or chemotherapy
4. Uncontrolled comorbid conditions e.g hypertension, diabetes mellitus, chronic obstructive pulmonary disease, coronary artery disease
Video Game Playing on Lunch-time Food Intake in Children

The purpose of this experiment is to investigate the effect of video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without video game playing. Subjective appetite will be measured at 0, 20, 35 and 65 minutes.


Eligibility Criteria:
Inclusion Criteria:

* healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* girls
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients

The purpose of this research is to assess the safety profile and clinical benefit of Awar-Awar leaf active fraction as a complementary therapy in chemotherapy of stage IV breast cancer

The study uses a double blind design and randomized controlled trial that compares the safety and clinical efficacy profiles of 3 treatment groups (each consists of 97 subjects who received chemotherapy for 6 cycles). The treatment group was given FADA at a dose of 800 mg/day and 2000 mg/day compared to the placebo group. Interim analysis is carried out after 25% of the subjects completed 3 cycles of chemotherapy; whereas interim analysis II is carried out after 50% of the subjects completed 3 cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Female, at least 18 years old
* Welfare scale 0, 1, and 2 (ECOG - WHO)
* Patients with stage IV breast cancer who have histopathological data according to the TNM Classification of Malignant Tumors (TNM) from American Joint Committee on Cancer (AJCC) 8th edition 2017
* Patients who are willing to participate in the test and sign an informed consent
* Patients who undergo breast cancer chemotherapy with luminal B sub-type or triple negative with anthracycline base
* Patients who are willing and able to fill out a questionnaire
* The patients who are willing and able to comply with the test protocols during the test

Exclusion Criteria:

* Unable to meet the test protocol
* Patients with liver and kidney disorders
* Patients with other diseases/disorders that are meaningful according to the investigators will be excluded from the test
* Patients with cancer that has metastasized to the brain
* Pregnant women and breastfeeding mothers
* Patients with the ejection fraction smaller-than or equal to 55%
Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

Abnormal gait is a common issue in children with CP. As a result of motor weakness and a lack of voluntary motor control. Furthermore, gait in children with cerebral palsy is characterized by a slower walking speed, a shorter stride length, and more time spent in double support. Deficits in postural control constitute a major limitation to the motor development in children with CP. The performance of static and dynamic tasks, such as sitting, standing, and walking, is limited in these children due to postural instability. Postural control deficits in CP are caused by altered sensory processing, motor impairment, and biomechanical alignment, which result in altered neuromuscular responses.

HBO2 therapeutic benefits in CP are attributed to an increase in dissolved oxygen in plasma and tissue, which aids tissue regeneration, So, the purpose of this study was to investigate the long-term effects of hyperbaric oxygen therapy on spatiotemporal gait parameters and functional balance skills in children with CP.

This was a randomized clinical trial. Thirty-nine children with spastic cerebral palsy with ages ranging from 5 to 10 years referred from local pediatric rehabilitation centers participated in this study. All children were classified randomly using sealed envelopes into two groups (Control and Study groups). The children in the control group received traditional physical therapy and the study group received the same traditional physical therapy in addition to hyperbaric oxygen therapy. Written informed consent from the child's legal guardian was obtained. The study was authorized by the Ethics Committee for Research at Cairo University in accordance with the ethical standards of the Declaration of Helsinki. PBS was used to assess functional balance and GAITRite was used to assess spatiotemporal gait parameters. Measurements of functional balance and spatiotemporal gait parameters were taken three times: at the start of the intervention, eight weeks later, and six months after cessation of HPO2 therapy to assess the long-term effect.

Eligibility Criteria:
Inclusion Criteria:

* medically free by their doctor.
* being able to tolerate a hyperbaric oxygen hood.
* being able to blow through a straw, or swallow on command.
* having spasticity ranging from 1 to 1+ on the Modified Ashworth Scale
* level I or II on the Gross Motor Function Classification System (GMFCS).
* being capable of understanding and following instructions

Exclusion Criteria:

* Previous HBO treatments.
* botulinum toxin A treatments.
* thoracic surgery within 6 months.
* major changes to spasticity medications within 3 months.
* unstable epilepsy.
* pulmonary dysfunction.
* cardiovascular disease
Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy

STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.

PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.

HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 years or older
* Pathologically confirmed invasive unilateral breast carcinoma
* A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
* Will be or is treated with mastectomy
* Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
* Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
* pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
* Written informed consent

Exclusion Criteria:

* Clinically node positive pre-operative
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* Solitary parasternal sentinel lymph node metastasis (pN1b)
* Bilateral breast cancer
* Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
* Evidence of metastatic disease
* History of invasive breast cancer
* Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
* Pregnant or nursing
* Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies \> 5 years before randomization
* Unable or unwilling to give informed consent
Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives.

Lay Summary:

This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians.

One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.


Eligibility Criteria:
Inclusion Criteria:

* 16-45 years of age
* Diagnosis of BD (clinically euthymic) according to the DSM-5
* Diagnosis of PMDD according to the DSM-5
* Regular menstrual cycles
* No contraindication to use oral contraceptives
* Capable of consent for treatment

Exclusion Criteria:

* Smoking and over the age of 35
* Current or recent (last month) use of systemic estrogen or progesterone treatment
* Severe reactions to hormone treatment
* Pregnant or breastfeeding
* Current substance use disorder
* Oophorectomy or hysterectomy
* Current unstable medical conditions
* History of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.