cyrilzakka/clinical-trials huggingface dataset:
Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments

Patients with cancer or hematological malignancy are susceptible to present acute complications linked to their disease or to their specific treatments (dyspnea, sepsis, coma, hemorrhagic syndrome). Emergency physicians are in first line when these complications arise and have to face with some complex situations in which informations about patient malignancy or prognosis may be lacking. Nowadays, there is very few epidemiological data published concerning how cancer patient use Emergency Departments (EDs) and cancer patient care delivery in the EDs.

Thus, an observational multicenter prospective cross-sectional study is conducted to study the prevalence of cancer patients admitted to French EDs, and to describe the different reasons for cancer patients to seek care in EDs with their prevalence and underscore those linked to cancer or treatment complication


Eligibility Criteria:
Inclusion Criteria:

* adult patients (age \>=18 years)
* with active malignancy or a history of cancer in remission within the last 5 years
* being attended in one of the 400 French emergency centers participating in the study during the 3-day study period

Exclusion Criteria:

* opposition to participate
Optimization of Diet Before Surgery (OptiSurg)

The overarching goal of this project is to assess whether a controlled short-term Time restricted feeding (TRF) intervention leads to metabolic benefits, improves recovery after vascular surgery and that TRF is safe. Participants suffering from intermittent claudication (Fontaine stage II peripheral artery disease, PAD) will be randomly assigned to a 2-week TRF or active control dietary advices before open surgical revascularization. Prior to the surgery, the investigators will assess the eating patterns of participants with an innovative smartphone application ('app') which is less intrusive and more reliable than food diaries/questionnaires to assess eating behavior and patterns. In the second part of the study, the investigators will investigate whether a short term TRF intervention improves surgical recovery, in the short-term (1 month, primary endpoint) and long-term (optional, up to 1 year), as part of the routine clinical follow-up. This proposal builds on established expertise in the biology of dietary intervention, surgery, and study of eating patterns in human.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Fontaine stage II peripheral artery disease planned for open femoral endarterectomy
* Body mass index ≥ 20 kg/m2
* Smartphone compatible with the app (iOS or Android systems)
* Hypertensive (or on 1 or more blood pressure lowering medication)
* Hypercholesterolemia (or on 1 or more lipid lowering medication)

Exclusion Criteria:

* Diabetes on insulin therapy or sulfonylureas
* Fontaine stage III and IV peripheral artery disease
* Prior revascularization on the index leg within 14 days of the qualifying revascularization.
* Major surgery in the past 3 months
* Myocardial infarction or revascularization (PTA, stent, CABG) in the past 3 months
* Major illness / fever over the previous month, active cancer
* On a diet / weight management or prior bariatric surgery
* Major mental illness, unable to give consent, inability to follow study procedures (language barrier, dementia)
* Current shift work or travel abroad planned in the next month
* Major sleep disorder
* Enrolled in another interventional clinical trial
* Ongoing pregnancy
ANSiStim Study for Active Labor Pain

The specific aim of the study is to do comparison between ANSiStim and Placebo for pain relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative patients with good pain relief .

Pain during labor is caused by contractions of the muscles of the uterus and by pressure on the cervix. This pain can be felt as strong cramping in the abdomen, groin, and back, as well as an achy feeling. Some women experience pain in their sides or thighs as well. Most women have an epidural or spinal during labour or after the birth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women on an Active Labor

Exclusion Criteria:

* Cardiac Pacemaker or any other implants
* Psoriasis
* Diminish mental capacity
Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis

The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development.

Patient with gingivitis were retrospectively evaluated. The number of periodontal supportive therapy were recorded other than gingivitis periodontal parameters over 5-years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gingivitis

Exclusion Criteria:

* Diagnosis of Periodontitis
* Pregnancy
* Systemic diseases
Virtual Parental Presence on Induction

Our goal in this study is to investigate the feasibility and acceptability of virtual parental presence of parents on anxiety in children at induction of anesthesia at Cincinnati Children's Hospital, an institution whose use of parental presence on induction is deeply ingrained in our culture, and to determine the impact of coaching of parents either prior to arrival at the hospital vs. on the day of surgery on efficacy of virtual parental presence on induction. Our primary hypothesis is that virtual PPIA is both feasibile for the smooth induction of general anesthesia and is acceptable to parents, patients, and anesthesia providers at our isntutition. Our secondary hypothesis is that the coaching of parents prior to virtual PPIA enhances the effect of video parental presence at induction of anesthesia on children's anxiety and that coaching prior to arrival at the hospital will allow for increased ease and use of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Children from ages 4 years to 12 years old
* ASA physical status I, II or III
* Planned inhalational induction
* Children presenting from home prior to surgery (not an inpatient)
* English speaking parents and child

Exclusion Criteria:

* children with developmental delay
* children with psychological / emotional disorders
* children with altered mental status
* children with language barrier
* children who are not accompanied by someone able to consent (ie legal guardian)
* children who are inpatient prior to surgery
* children with expected difficult intubation/airway
* children presenting for emergency surgery
* family history or personal history of malignant hyperthermia / risk of MH
* consent not obtained or withdrawl of consent
* children with past history of violent behaviors during induction of anesthesia
* cancellation of surgery
* patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precuations in the operating room
* receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) midazolam, ketamine, and/or dexmedetomidine.
Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients

Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

Observational study of 20 adult postoperative cardiac surgery patients. The observation will last from 0 to 2. postoperative day. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods in the ICU and the ward.

Eligibility Criteria:
Inclusion Criteria:

* Adult cardiac surgery patients, informed consent

Exclusion Criteria:

* Poor co-operation, age less than 18 years
A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education

Resistance training done at home and protein supplementation may be the most effective and easiest to implement interventions to reverse frailty and build resilience. However, it is not common practice to offer and support such interventions in primary care.

This study provides an opportunity to assess the effectiveness of an optimised intervention with community-dwelling adults aged 65 and over, whose baseline clinical frailty score is not worse than mild (i.e. 5 or less), evaluate improvements in health outcomes and demonstrate how the intervention may be incorporated efficiently in clinical practice. The results are intended to encourage mainstream adoption of practical interventions to reverse clinical frailty and build resilience in primary care.

An intervention with ten recommended resistance exercises and dietary guidance on protein consumption has been derived from findings of our systematic review and meta-analysis and optimised through a patient and public involvement (PPI) process and feasibility study.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or older at baseline
* Rockwood clinical frailty scale score 4 or 5 (vulnerable or mildly frail)
* Able and willing to provide informed consent and to comply with the requirements of this study protocol

Exclusion Criteria:

* Rockwood clinical frailty scale score \> 5
* End of life care
* Persons in residential care home
* Concurrent malignancy CKD stage 3 or 4
* Coded diagnosis of severe dementia as per GP or consultant geriatrician diagnosis or baseline Montreal Cognitive assessment (MoCA) score \<= 10
* Persons unable to engage in discussion on frailty due to acute care needs or determined to be inappropriate by GP (e.g., needing transfer to ED or acutely unwell or disorders resulting in intolerance of the intervention)
* Subjects unable to provide written informed consent
Single Case Research Design: Teacher Outcomes

A training given to teachers will include reviewing the intervention manual, live modeling, and discussing intervention fidelity. The PI and a rater will use the Strategic and Interactive Signing Instruction. fidelity checklist to rate teacher faithfulness to each component of Strategic and Interactive Signing Instruction. across a session. Frequency and doses of additional training (e.g., coaching) will be documented in order to track procedures that effectively increase teacher faithfulness to implementation of Strategic and Interactive Signing Instruction.

The PI will work with teachers to increase SISI implementation fidelity through a noncurrent multiple baseline design across teacher participants. Four teachers who serve deaf children between 5 and 8 years old will be recruited from a school of the deaf. SISI fidelity checklist will be used to observe teachers' business-as-usual instruction during language arts time to establish three stable data points in baseline. Each component of SISI is rated with a score of 1 (fully implemented), .5 (partially implemented), or 0 (did not implement) and reported as percentages (e.g., 20% of SISI components implemented). The PI will provide a 1-day training on SISI implementation. Teacher 1 will begin to implement SISI for three weeks, and then Teacher 2 will start implementing on Week 4. Teachers 3 and 4 will start implementing on Week 7 and 10 respectively. All sessions are video recorded and uploaded to Swivl, a cloud storage service, which will be accessed by the PI and another inter-rater daily for fidelity monitoring purposes. During this refinement period, the PI is available to provide additional coaching or co-teaching to increase teacher fidelity. Meanwhile, the PI will track children's progress in meeting their target sign language skills. If progress is found to be inadequate, refinements will be made to the intervention design. Similarly, if data collection protocols are not robust, refinements will be made to the protocols. These changes will be tested immediately and monitored for their impact on desired outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels

Exclusion Criteria:

* Not teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies


Eligibility Criteria:
Inclusion criteria:

* May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
* Prior treatment with hormonal therapy is allowed.
* Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
* Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
* Must be \>/= 18 years of age
* Life expectancy of \> 8 weeks
* Must have recovered from side effects of previous treatment
* Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
* Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
* Able to swallow and retain oral medications
* Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

* Pregnant or lactating females
* Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
* Concurrent disease or condition that would make the patient inappropriate for study participation
* Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
* Uncontrolled infection
* Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI \< 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
* Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
* History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
* History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
* Known DPD deficiency
VNS-supplemented Motor Retraining After Stroke

The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.

Eligibility Criteria:
Inclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

1. Diagnosis of first ever stroke
2. At least 6 months after stroke onset
3. Motor-evoked potentials in hand/arm muscles
4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.

   ALL INDIVIDUALS:
5. Between the ages of 18 and 75 years old

Exclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators

   ALL INDIVIDUALS:
2. Neurological disorder(s) influencing movement (besides stroke)
3. History of seizure or epilepsy
4. Metallic brain implants
5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
6. Pregnant or expecting to become pregnant
7. Difficulty maintaining alertness and/or remaining still
8. Silicone or plastic allergy
9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures

Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.

The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.

The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.

The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of vascular complications.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who undergo to diagnostic coronary procedures

Exclusion Criteria:

* Acute ST-elevation myocardial infarction
* Previous coronary artery bypass graft surgery
* Hemodynamic instability
Breakfast and Metabolism in Men

This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* No medication
* Athlete (elite or professional)

Exclusion Criteria:

* Diet-related conditions
* Food allergies
* Does not regularly consume protein supplements
* Claustrophobic
* Underweight
Complementary and Alternative Medicine Usage Among Participants Enrolled in Phase I Oncology Clinical Trials

Primary Objective:

· The primary objective is to estimate the prevalence of use of complementary and alternative medicine (CAM) in patients with advanced malignancies who are seen in the Phase I clinic at MD Anderson Cancer Center (MDACC).

Secondary Objective:

· Examine the association between prevalence of CAM use and demographic and socioeconomic characteristics (age, gender, race, income, and education level), participation in a phase I clinical trial, disease characteristics (diagnosis), patients' perceptions about their prognosis, physicians' information and permission for patients' CAM use, decision-making, and types of CAM used by patients.

This survey study is intended to estimate the prevalence of use of CAM in patients who are currently being treated in the Phase I Clinical Trials Program at University of Texas MD Anderson Cancer Center. The survey includes questions about socioeconomic characteristics (age, gender, race, income, and education level), patients' diagnosis and patients' perceptions about their prognosis, physicians' information and permission for patients' use of CAM, patients' use of CAM (yes or no), decision-making (purpose of CAM use), resources and types of CAM.

Patients will be asked to drop the questionnaire into a box in a specified location after completion of the questionnaire. Accrual is expected to be 50-100 patients per month. This survey is expected to finish in 6 months.

Eligibility Criteria:
Inclusion Criteria:

1) Patients with a clinical diagnosis of malignancy who are seen in the outpatient oncology clinic.

Exclusion Criteria:

1) Presence of any clinically relevant condition that, in the opinion of the investigator/ coordinator, would interfere with completing the study including, but not limited to, visual problems, cognitive impairment or acute mental illness.
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.


Eligibility Criteria:
Inclusion criteria:

1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer\[NSCLC\]
2. Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
3. A known wild-type EGFR status
4. Patients 18 years of age or older

Exclusion criteria:

1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
2. Prior treatment with EGFR targeting small molecules or antibodies
3. Radiotherapy or surgery within 4 weeks prior to study entry
4. Active brain metastasis
5. Known pre-existing interstitial lung disease
6. History or presence of clinically relevant cardiovascular abnormalities
7. Cardiac left ventricular function with resting ejection fraction of less than 50%
8. Absolute neutrophil count\[ANC\] \< 1,500/mm3
9. Platelet count \<100,000/mm3
10. Creatinine clearance\<60ml/min or serum creatinine \>1.5 times upper limit of normal
11. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
12. Pregnancy or breast-feeding
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age range 18 and over.
* Patient with acute neck pain meeting baseline pain intensity level and duration

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.
* Patient with chronic neck pain as defined as pain for 3 months or longer
* Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
* Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis