cyrilzakka/clinical-trials huggingface dataset:
Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Age ≥18 years and ≤ 75 years.
3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
4. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
5. No contraindications to CT scanning.
6. No evidence of distant metastasis (FIGO stage IVB).
7. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
8. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

Exclusion Criteria:

1. With common iliac MLNs.
2. Tumor extended to the lower third of the vagina.
3. Tumor spread to mucosa of the bladder or rectum.
4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
5. Prior malignancy.
6. History of previous radiotherapy to the abdomen or pelvis.
7. Pregnancy or lactation.
8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
9. Active infection with fever.
10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan

Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.

A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.

This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them.

Nurse-led case management integrates a multi-component intervention comprised of health education and professional advice, as well as referral of clients to other health care team members, discussion of daily life plans, making an appointment for the next clinic, and conducting follow-up sessions by telephone.

Eligibility Criteria:
Inclusion Criteria:

* being at least 20 years old at the time of recruitment
* being able to express opinions in either Mandarin or Taiwanese, and
* having a diagnosis of rheumatoid arthritis (RA).

Exclusion Criteria:

* Those having no cognitive impairment and severe complications will be excluded.
CO Monitoring for Tobacco Cessation in Quitlines

The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.


Eligibility Criteria:
Inclusion Criteria:

* Daily cigarette smokers calling into participating quitlines
* 18 year or older
* Reads and speaks English
* Has a smartphone with a data plan
* Willing to download and use study app
* Willing to use CO monitor

Exclusion Criteria:

• Pregnant or breast feeding
The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.

After anterior cruciate ligament (ACL) injury, the involved quadriceps may demonstrate weakness due to decrease in quadriceps activation. However, elapsed time from the injury may affect muscle strength by restoration of the quadriceps activation. The injury is characterized by joint instability that leads to decreased activity, unsatisfactory knee function, and poor knee-related quality of life in the short term, and it is associated with an increased risk of osteoarthritis on the knee. This study was designed to compare muscle strength, questionnaire and knee function in patients with different exercise training.


Eligibility Criteria:
Inclusion Criteria:

* cruciate ligament rupture patients

Exclusion Criteria:

* Central nervous or peripheral neuropathy, or those with cardiovascular disease.
Immersive Virtual Reality Environment for Complex Cognitive Skills Curricular Training in Liver Surgery

Investigators hypothesize that a virtual reality (VR) environment enhances general surgery residents' performance compared to Desktop Interface (DI)-based visualization of 3D models in decision making for patients with liver tumors. To determine this, a proficiency-based stepwise training curriculum for preoperative planning has been developed using both modalities. The overall objective of the curriculum is that by the end of the training program, residents would be able to formulate a treatment plan for patients with liver tumors.


Eligibility Criteria:
Inclusion Criteria:

• General surgery residents irrespective of their postgraduate year

Exclusion Criteria:

* No inform consent
* Residents of other specialties
Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

Procedures performed under regional anesthesia, especially peripheral nerve blocks (PNB) have increased markedly in recent decades. However, like any technical procedure, these techniques carry an implicit risk of complications.

The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.

Introduction. The number of procedures performed under regional anesthesia, especially peripheral nerve blocks (BNP) have increased notably in recent decades due to the improvement in pain control and the quality of post-anesthetic recovery that they provide. However, like any technical procedure, these techniques carry an implicit risk of complications.

Purpose. The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.

Material and methods. The postoperative results regarding the complications of regional anesthesia of peripheral nerves will be evaluated in a national audit of a prospective observational cohort in which hospitals at the state level in which these regional techniques are routinely performed will participate. A minimum sample size has been calculated on a population of 100,000 patients and a 95% confidence interval of 1,390, assuming a complication rate of 0.2% based on previous publications.

Inclusion criteria correspond to patients older than 18 years scheduled for surgery with a peripheral regional anesthesia technique as the basis of anesthesia or as part of a multimodal analgesic strategy.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* ASA I- IV
* Being scheduled for surgery with peripheral and/or fascial nerve blocks as the basis of anesthesia or as part of a multimodal analgesic strategy.

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Contraindication for performing the regional technique (People with infections in the area of the skin where the puncture must be performed, allergy to anesthetics, severe blood coagulation disorders, previous nerve damage).
* Motor or sensory deficit prior to surgery in the metameric area susceptible to performing the block.
Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection

All patients will undergo in vitro fertilization.

Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.

Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.

clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

PATIENTS AND METHODS

Protocol Outline:

The Study:

Study site:

Ain Shams University Maternity Hospital.

Study Design:

A prospective Cohort study.

Study setting:

The study will be conducted at Ain Shams University Maternity Hospital.

Study population:

The study will include all women planned to undergo IVF due to unexplained infertility.

Methodology:

The study will be approved by the hospital ethics committee.

All included women will undergo the following:

* History taking.
* General and abdominal examination.
* Vaginal examination and assessment
* Pelvic ultrasound.
* Routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile.
* Preoperative senior anesthetist assessment.
* Hysteroscopy.

All patients will undergo IVF.

Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.

Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.

clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

Measurement of Outcomes

1. serum 25 (OH) D levels.
2. Number of oocyte.

   Most studies put the optimal number of retrieved oocytes between 10 and 15.
3. The implantation rate:

   Calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100.
4. Number of gestational sac.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 35 years old.
* Body mass index between 20 - 30.
* Unexplained infertility .
* Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
* Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
* Fresh embryo transfer of 2 or more blastocysts stage.
* Embryo transfer on day 5 after fertilization

Exclusion Criteria:

* Women younger than 20 years old or older than 35 years old.
* Previous one or more failed IVF.
* Uncorrected congenital or acquired uterine anomalies.
* Other causes of infertility rather than unexplained infertility.
* Less than 2 embryo transfer, cleavage stager frozen embryo transfer.
School Gardens and Physical Activity

The purpose of this study is to determine whether school gardens affect children's physical activity.

New York State schools were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline data collection.

Eligibility Criteria:
Inclusion Criteria:

* schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
* schools did not already have a school garden

Exclusion Criteria:

-
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)

To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).

The study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games). Moodify is comprised of a novel continuous performance task (CPT) to improve cognitive slowing and lethargy often present in cases of major depressive disorder. This training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB Study No. 1126399). Moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.

Eligibility Criteria:
Inclusion Criteria:

* Participants must 18 to 85 years or older and not pregnant
* Participants must be fluent in English
* Participants must be able to engage with computerized cognitive tasks as required in order to participate in this study.
* Normal vision (or corrected to normal vision)
* Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
* Participants must meet diagnostic criteria for MDD

Exclusion Criteria:

* Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard
* Participants unable to perform neuropsychological evaluations
* Participants cannot comprehend or follow instructions
* Participants not capable of giving informed consent
* Participants who appear to be intoxicated or under the influence of a controlled substance
* Participants with a history of significant medical diseases or multiple neurological events of the head
* Participants with serious or unstable medical illness (e.g. cardiovascular, hepatic, renal, endocrine, neurologic disease)
* Participants with a history or current diagnosis to specific Diagnostic and Statistical Manual (DSM)-IV psychiatric illness such as (but not limited to): organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder Not Otherwise Specific, bipolar disorder, substance dependence and substance abuse
* Participants with a history of seizure disorder
WHO Fetal Growth Charts

Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.

Against this background, WHO made it a high priority to provide fetal growth charts for estimated fetal weight and common ultrasound biometric measurements intended for worldwide use. WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that fetal growth differs significantly between countries. Growth was to a small extent influenced by maternal age, height, weight, and parity, and by fetal sex. The study suggested that these WHO charts for growth are more suitable for international use than those commonly applied today. However, the differences between countries, with maternal factors, and with fetal sex mean that these growth charts may need to be adjusted for local clinical use to increase their diagnostic and predictive performance. In our setting, we are using the charts built in the ultrasound machines based on studies done in western countries. So, it is prudent now to implement the WHO fetal growth charts in our setting

Eligibility Criteria:
Inclusion Criteria:

* They have body-mass index between 18-30;
* They have a singleton pregnancy;
* Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual period.
* They have no history of health, environmental or economic constraints likely to impede fetal growth; need for long-term medication (including fertility treatment); smoking currently or in the previous 6 months; recurrent miscarriage; and any previous baby delivered pre-term (\<37 weeks) or with a birth weight \<2,500g b. Exclusion criteria:
* Multiple pregnancy
* Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)
Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver

Introduction and Aim: With the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. However, the problems experienced by individuals caring for cancer patients are often ignored. The most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. Although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. The aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers.

Materials and Methods: The study was conducted as a double-blind placebo-controlled design. After the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands was moved around the foot for the same periods but no deep stimulation was applied. On the fourth day, a sociodemographic diagnostic form, state anxiety scale and Richard-Campbell Sleep Scale were administered to the participants by a blinded researcher. Data were analyzed with SPSS 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

Introduction and Aim: With the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. However, the problems experienced by individuals caring for cancer patients are often ignored. The most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. Although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. The aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers.

Materials and Methods: The study was conducted as a double-blind placebo-controlled design. After the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands were moved around the foot for the same periods but no deep stimulation was applied. On the fourth day, a sociodemographic diagnostic form, state anxiety scale, and Richard-Campbell Sleep Scale were administered to the participants by a blinded researcher. Data were analyzed with SPSS 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

Eligibility Criteria:
Inclusion Criteria:

* care to cancer patients at least for 6 months

Exclusion Criteria:

* decline to participate in study
Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety information on gilotrif use.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
3. No further treatment option is available.
4. Male and female patients age ≥18 years.
5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.

Exclusion Criteria:

1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
5. Bilirubin ≥1.5 mg/dl
6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
8. Pregnancy or breast feeding.
9. Pre-existing Interstitial Lung Disease (ILD).
10. Patients suitable to be included into afatinib clinical trials