cyrilzakka/clinical-trials huggingface dataset:
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator.

The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected.

All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women defined as either:

  1. at least 2 years without menstrual period
  2. patients older than 50 with serological evidence of post-menopausal status
  3. hysterectomized patients of any age with FSH confirmation of post- menopausal status
* pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:

  1. Screen-detected
  2. Low to intermediate nuclear grade
  3. \< 2.5cm in size
  4. Resected with negative margins at \>3mm)
* clinically N0 or pN0 or sentinel node negative breast cancer

Exclusion Criteria:

* previous radiation therapy to the ipsilateral breast
* presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment

The purpose of this study is to evaluate the effectiveness of home exercise on quality of life and physical fitness of elderly women with breast cancer patients undergoing cancer treatment.

Cancer has excelled as a leading cause of mortality. It is particularly serious in the elderly due to increased risk of functional impairment and present comorbidities. The physical exercise appears as a promising intervention in the various stages of the treatment, mitigating the adverse effects in short- and long-term the oncologic treatment. Its regular practice after a diagnosis of breast cancer is associated with 40 % to 50 % lower rates of mortality. Produces metabolic and morphological changes that may make it an important option in the treatment, prevention, and recovery process of these patients. In this context the present study aims to verify the effectiveness of home exercise on quality of life and physical fitness of elderly undergoing treatment for breast cancer. This study it's a Randomized Clinical Trial. Data will be collected at the Department of Oncology at the Professor Fernando Figueira Integral Medicine Institute (IMIP), which serves patients in the public health system (SUS) from the metropolitan area of Recife, State of Pernambuco. will be held from March to December 2015. Will be studied elderly diagnosed with breast cancer undergoing treatment in the Adult Oncology Service of IMIP. For the analysis of means and frequencies, the investigators intend to use descriptive statistics and the results will be displayed in graphs and tables. For inferential statistical analysis, the investigators intend to use the Student's t test, or the Mann - Whitney test, according to the normality of the sample. For categorical variables, contingency tables are constructed of type 2x2. Chi-square tests of association with Yates correction and Fisher's exact test will be used. The risk ratio (RR) will be calculated as a measure of the relative risk of different outcomes according to the realization of one or another approach to exercise and control group. The Software Stata 12.0 will be used for data processing and will be accepted at p \< 0,05. The project meets the requirements of the National Board of Health and was approved by the IMIP Research Ethics Committee. Patients who agree to sign the Instrument of Consent will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis with stage I or II;
* Being in treatment for breast cancer (chemotherapy; radiotherapy and / or hormone therapy).

Exclusion Criteria:

* Absolute contraindication for physical exercises;
* Severe depression diagnosis using the Geriatric Depression Scale;
* Malnutrition (wasting grades I, II and III), detected by body mass index (BMI), according to the WHO criteria.
Covid-19 Anxiety and Phobia Levels of the Parents

A pandemic that originated in the Wuhan region of China in December 2019 was detected as a new type of coronavirus disease called coronavirus 2019 (COVID-19). In the first phase of the outbreak, specialists explained ways to maintain physical health . However, pediatric surgical procedures and anesthesia applications continued during this period. Surgery in pediatric patients is an unpleasant and potentially 'threatening' experience, often followed by preoperative anxiety due to the child's illness, hospitalization, fear of anesthesia - especially the time of anesthesia induction - and the surgery itself . Anesthesia is a stressful procedure for the child and the entire family. Both the COVID-19 pandemic and the surgical procedure are reflected in the symptoms of anxiety, fear or acute stress disorder for children and their families. As the disease spread, investigators started to emphasize the importance of protecting mental health. Identifying factors that contribute to significant preoperative anxiety levels in pediatric patients and their parents can help healthcare professionals choose the most appropriate from a variety of alternative strategies for anxiety control. This study was planned to evaluate the COVID-19 anxiety and phobia levels of the parents of pediatric patients are scheduled to undergo surgery under general anesthesia in Turkey.

The population of the study was created from the parents of pediatric patients who were scheduled for surgery under general anesthesia between May 2020 and September 2020 at Selcuk University Department of Anesthesiology and Reanimation. The data were obtained through face-to-face interviews before the child was taken to surgery after the necessary explanations were made to the parents of the children by the researchers. To enable the parents to answer the questions easily, a separate room in the relevant clinic was used for the interviews. The characteristics of the children and parents, supplementary data of the parents regarding the child's illness, and contact information were obtained. Participants were asked to complete a sociodemographic data form, the Coronavirus Anxiety Scale (CAS), and the COVID-19 Phobia Scale (C19P-S).

Eligibility Criteria:
Inclusion Criteria:

* Parents of pediatric patients with American Society of Anesthesiologists classification (ASA) I-II, aged 1-12 years who were administered anesthesia to undergo surgery were included in the study.

Exclusion Criteria:

* Parents of children with ASA III or higher risk, expected to have difficult intubation, serious complications related to intraoperative surgery or anesthesia (e.g. respiratory depression, myocardial depression, cardiac arrhythmia, bronchospasm, laryngospasm, anaphylactic reaction, hypotension, bleeding), and could not communicate were excluded from the study.
TIVA, Inhalation Anesthesia, and Surgical Site Infection

The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal surgery under the general anesthesia by different general anesthetic technique: inhalation versus total intravenous anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.

Exclusion Criteria:

* None
Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity

We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study.

Patients with cancer under chemotherapy and integrated Western and Chinese medicine were enrolled in this observational study. The assessment of radial pressure pulse (RPP) was performed before and after chemotherapy. The correlation between the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) of the RPP at six diagnosis positions and the blood cell counts before and after chemotherapy were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer diagnosed through pathological histology
* Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine
* Patients with an Eastern Cooperative Oncology Group Performance score of 0-2
* Patients having normal liver and kidney functions and electrocardiography and eligible for chemotherapy with normal bone marrow hematopoietic function
* Patients who were voluntarily involved in this study

Exclusion Criteria:

* Cases that did not meet the inclusion criteria
* Patients who could not cooperate with pulse diagnosis
* Patients with underlying diseases such as chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
* Patients with severe infection
* Patients with severe cachexia
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2

This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years and ≤ 80 years.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
* Adequate organ function.
* Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
* HER2 overexpression defined as HER2 IHC 2+ or 3+.
* Measurable disease according to RECIST 1.1.

Exclusion Criteria:

* Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
* History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)

Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a self-administered questionnaire carried out by the patient before each chemotherapy cure. The objective is to secure the quality of patient care and to detect the appearance and / or aggravation of geriatric fragilities.

Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment:

* Number of D-FOGs filled in: comparison with the number of patients included in the study and the number of visits of each patient.
* Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of visits of the patient for a chemotherapy cure (HDJ or HDS).
* Number of criteria entered by D-FOG: comparison with the total number of criteria to be filled in
* Criterion analysis of D-FOG

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and over
* Carriers of diagnosed cancer (excluding hematology)
* Whatever the location, uniqueness or multiple, duration of development and treatment status (adjuvant, neoadjuvant, locally advanced or metastatic)
* Seen in nursing consultant
* Beginning an oncological treatment
* Supported for oncology day hospital (HDJ) or weekly (HDS) chemotherapy
* Patient not opposed to participate in the study

Exclusion Criteria:

* Patients under 75 years of age
* Having not had an IDE ad consultation
* During oncological treatment
* Receiving Oral Therapy or hormone therapy alone
* Treated by radiotherapy alone or surgery alone
* Not attending a day or week oncology hospital
* Refusal to participate in research
Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode.

The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

After written information and consent, patients are randomised in two groups: NAVA first or PSV first.

They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.

A standardised set of 1 hour of non-invasive ventilation is started. Depending on the randomisation group, patients start with a 30 minutes set of NIV with NAVA settings or with a 30 minutes set of NIV with PSV settings. A 30-minute watch-out period is then delivered with no mechanical ventilation.

Then a second 30-minute set of NIV in the other settings (NAVA or PSV depending on the randomisation) is delivered.

During each set of NIV, flow, volume, pressure and EADi are recorded during 10 minutes, after a 10-minute period of equilibration. Recordings will be processed by two blind investigators in order to count the number of asynchronies. In case of disagreement between investigators, a third one will be interviewed.

Eligibility Criteria:
Inclusion Criteria:

* - Patient older then 18 years
* Patient requiring first non invasive ventilation set because of acute respiratory failure

Exclusion Criteria:

* Patients protected by the law
* Pregnant women
The Effect of Diflunisal on Familial Amyloidosis

The purpose of this study is to determine if diflunisal can prevent progressive lower leg nerve damage in patients with familial amyloidosis polyneuropathy.

Funding Source - FDA Office of Orphan Products Development (OOPD); National Institute of Neurological Disorders and Stroke (NINDS)

Familial amyloidosis polyneuropathy (FAP) is a rare, lethal, autosomal dominant, neurodegenerative disease characterized by misfolding of variant transthyretin tetramer (TTR) - a transport protein produced by the liver. The disease causes TTR to become unstable, triggering amyloid fibrils to form and leading to peripheral and autonomic nerve dysfunction.

Currently, the only treatment for FAP is a liver transplant, which is expensive and risk-filled. Medicines are needed to treat this disease. Previous in vitro (in a test tube) studies have shown that a common anti-inflammatory drug called diflunisal stabilizes TTR, preventing the formation of amyloid fibrils.

The goal of this 2-year randomized, double-blind, placebo-controlled research study is to establish whether diflunisal can stop the nerve damage, or peripheral neuropathy, resulting from amyloid production in patients with FAP. Scientists already know that diflunisal prevents formation of amyloid in the test tube. This study will determine if the drug can block amyloid production in FAP patients.

Participants will be randomly chosen to receive either diflunisal or an inactive (placebo) pill twice daily for 24 months. Participants will be carefully monitored through 7 follow-up visits, either at the study center or with individual primary care physicians. Participating in the study does not preclude patients from being listed for liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* Biopsy proven amyloidosis
* Genotyping of variant transthyretin
* Signs of peripheral or autonomic neuropathy

Exclusion Criteria:

* Use of other non-steroidal anti-inflammatory drugs
* Other causes of sensorimotor polyneuropathy
* Anticipated survival \<2 years or liver transplantation in \<1 yr
* Liver transplantation
* Profound nerve, heart or kidney impairment
* Pregnancy or unwillingness to use contraception by women of childbearing age
* Active or recent gastrointestinal bleeding
* Non-steroidal or aspirin drug allergy/hypersensitivity
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.


Eligibility Criteria:
Inclusion Criteria:

* Part A: participants with recurrent or refractory non-CNS solid tumors
* Part B: participants with recurrent or refractory CNS tumors
* Measurable or evaluable disease
* No other therapeutic options
* Performance Status: Karnofsky ≥50% for participants \>16 years and Lansky ≥50 for participants ≤16 years

Exclusion Criteria:

* Active or recent history of serious bleeding events
* Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses
* Active or recent history of hypertensive crisis or hypertensive encephalopathy
* Active non-healing wound or bone fracture
* History of solid organ transplant
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years


Eligibility Criteria:
Inclusion Criteria:

* Durie-Salmon stage IIA-IIIB multiple myeloma
* Age \> 18 and ≤ 65 years
* Previously untreated myeloma
* Presence of a sibling (potential donor)
* Bilirubins \< twice normal;ALAT and ASAT \< four times normal
* Left ventricular ejection fraction \> 40%
* Creatinine clearances \> 40 mL/min
* Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) \> 40% and/or need for continuous oxygen supplementation
* Karnofsky performance status \> 60%
* Patients must give written informed consent

Exclusion Criteria:

* Age \> 65 years
* Previously treated myeloma
* Absence of a sibling (genetic randomisation cannot be applied)
* Karnofsky performance status score \< 60%
* HIV-infection
* Pregnancy
* Refusal to use contraceptive techniques during and for 12 months following treatment
* Patients unable to give written informed consent
* PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Eligibility Criteria:
Inclusion Criteria:

* Doctor diagnosed asthma
* Acute asthma exacerbation
* Treatment with systemic corticosteroids and nebulized albuterol
* Ages 5 to 17 years

Exclusion Criteria:

* Other acute or chronic lung disease