cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

Through a scientific and standardized multicenter, randomized, and controlled study method, the investigators evaluated the clinical efficacy and safety of acupuncture in the treatment of breast cancer-related insomnia, with a view to providing a reliable theoretical basis for the treatment of breast cancer-related insomnia with acupuncture.

Insomnia associated with breast cancer is one of the most common symptoms among breast cancer patients, which seriously affects the life quality of breast cancer patients. Therefore, how to better improve their life quality and insomnia symptoms is of important clinical significance. Previous studies have shown that acupuncture may be beneficial for improving sleep disorders in cancer patients. However, the available clinical evidence is mixed, and clinical studies on acupuncture for breast cancer-associated insomnia lack well-designed, high-quality clinical evidence. The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture for breast cancer-associated insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for breast cancer in the 2022 V2 edition of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (8th edition) for breast cancer staging criteria meet the diagnostic criteria for breast cancer with TNM stage I to III; meet the diagnostic criteria for insomnia within the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and insomnia related to the cancer itself or to cancer-related treatment occurred after breast cancer diagnosis and lasted for at least 1 month.
* Female patients aged 18-75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Sleep severity index scale (ISI) score ≥ 8.
* Predicted survival of ≥ 6 months.
* Patients had never received acupuncture treatment.
* No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment.
* Consent to participate in this study and sign a written informed consent.

Exclusion Criteria:

* Combination of more serious heart, liver, kidney, and other major diseases. f applicable, indicate if participant eligibility is based on self-representation of gender identity.
* Patients who are pregnant or breastfeeding.
* Those with planned surgery during the trial.
* Previous history of drug abuse or addiction.
* Those who have taken sedative-hypnotic drugs or antipsychotic drugs 2 weeks prior to the baseline visit, or received other treatment for insomnia (e.g., cognitive behavioral therapy, etc.) 3 months prior to the baseline visit, which may affect the efficacy of the observation.
* Insomnia due to cancer pain with an numeric rating scale (NRS) score ≥ 4, or insomnia due to other physical diseases.
* Long-term night work or irregular rest and relaxation.
* Ulcers, abscesses, skin infections, etc. at the site of needling.
* Participation in other clinical medical trial studies within the last month.
Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II

Comparison of indirect calorimetry by Q-NRG (Cosmed) with Deltatrac II (Datex)

The aim of the present study is to compare the measured resting energy expenditure by Q-NRG (Cosmed) with Deltatrac II (Datex), in healthy volunteers.

Q-NRG is a new device. It is relevant to compare its results with the blog standard calorimeter, the Deltratrac II.

The study will include sports healthy subjects. The could benefit from the determination of their resting energy expenditure in order to adapt their nutritional intakes.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult
* sport practice \> 1h per day at moderate intensity

Exclusion Criteria:

* refusal to participate
* unable to give a consent
Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer

Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .

In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient who has signed a consent to participate;
* Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
* Patient affiliated to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria:

* Patient who had emergency colon cancer surgery
* Person in an emergency situation or unable to express their consent.
* Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons
Symptomatic Carotid Outcomes Registry

The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be \<5%.

This study will only be evaluating clinical care and no interventions will be done specifically for this research.

* Informed consent from patient or legally authorized representative.
* Participant survey/questionnaire completion at baseline, 6 and 12 months after enrollment
* All data collected will be entered into a secure research data registry created for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years plus stroke or TIA ipsilateral to 50-99% ICA stenosis

In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk

Clinical Reduced Stroke RISK:

1. Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
2. Female sex
3. Most recent stroke or TIA \>1 week ago

Radiologic Reduced Stroke RISK:

1. Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
2. Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
3. For patients with TIA: brain MRI shows no DWI lesion

Exclusion Criteria:

Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration \<6 minutes

Alcohol and substance abuse within the prior 24 months

Clinically significant bleeding diathesis (platelet count \<100K, prothrombin time \>14 seconds)

Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)

Left ventricular ejection fraction \<20%

Known allergy or intolerance to aspirin or clopidogrel

Life expectancy less than 12 months

Moderate/severe dementia (Mini-mental or MOCA score \<22

Modified Rankin score of \>4

Nonatherosclerotic cause of carotid stenosis

Most recent symptomatic event \>180 days from the time of enrollment

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Psychatric Impact of Miscarriage in Assiut University Hospital

Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).

Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).

While the clinical management of miscarriage and its physical complications have been extensively discussed; the psychological impact of this traumatic event of loss is usually overlooked especially in developing countries (8-11). Moreover, there are behind-the-scene factors that trigger or correlate to the development of psychiatric morbidities following miscarriage (12,13). Factors as sociodemographic, marital satisfaction, social support, individual's coping resources, history of infertility and previous miscarriage vary across different population samples, also vary in their influence on women's psychological resilience after traumatic events as miscarriage. No previous studies addressed this topic in Egyptian population.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women 18:45 years old presented by intrauterine pregnancy loss before \<= 26 weeks gestation

Exclusion Criteria:

* Ectopic pregnancy or vesicular mole
* previous diagnosis of psychatric disorder
* unwell to give consent
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.

There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.

The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;


Eligibility Criteria:
Inclusion Criteria:

* open globe trauma

Exclusion Criteria:

* endophthalmitis at the beginning
Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients

This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia that have been stable for 3 months.

Exclusion Criteria:

* Women who can become or are currently pregnant or lactating.
* Hypersensitivity to iloperidone or related drugs.

Other protocol-defined inclusion/exclusion criteria may apply.
The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano

This is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care.

Through a 12-month mixed methods, observational cohort study, investigators from Maseno University, University of Minnesota (UMN) and OHR-EKC will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care among patients seeking care at 9 health centers on Mfangano Island, as well as the preliminary impact and feasibility/acceptability of the HN approach for improving access to MNH services and shortening delays in care.

Eligibility Criteria:
Overall Inclusion Criteria:

* Must be ≥18 years of age as of the date of study eligibility, or qualify as an emancipated minor (ie: person aged less than 18 years who was married, pregnant, or a parent, consistent with Government of Kenya guidelines and previous research such as Kenya AIDS Indicator Survey-KAIS)
* Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents \>99% of the adult population)
* Must be willing to share confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system.
* Must have the ability to provide informed consent.

Emergency Cohort-Specific Criteria:

- Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency, or appropriate family member in the case that patient is not able to participate in interview due to death or illness or other circumstance.

Birth Planning Cohort-Specific Criteria:

- All pregnant women who register a birth plan through the Health Navigation Birth Planning service will be eligible to enroll in the Birth Planning Cohort

Focus Group Cohort-Specific Criteria:

- All participants from the emergency cohort and the birth planning cohort will be eligible, as well as CHW volunteers, and OHR-EKC and MoH health facility staff

Exclusion Criteria:

* Individuals under the age of 18 and who do not qualify as emancipated minors
* Individuals who do not speak either English, Dholuo or Swahili
* Individuals who are not comfortable sharing confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system.
Degrees of New ICT Use Among Surgical Patients

In recent years, the trend is for the patient to participate in their care. The development of new technologies together with the opportunities to exchange information, control one's own health and the possibility of communication between the team and the patient have increased. This is a prospective study trying to know the real use of ICT (information and communication technologies) among our surgical patients, its ability to use it and the differences in terms of gender, age or social range between others


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years scheduled to surgery in our Department

Exclusion Criteria:

* Inability to read
* Inability to understand messages
* Emergency surgery
Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has had a self-reported oculo-visual examination in the last two years.
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
* Is willing to wear contact lens in both eyes for the duration of the study;
* Has a minimum astigmatism of - 0.75, determined by refraction;
* Can be fit with the two study contact lens types in the powers available;
* Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
* Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
* Has clear corneas and no active\* ocular disease

Exclusion Criteria:

* Is participating in any concurrent clinical trial;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study measure;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
* Has known sensitivity to fluorescein dye or products to be used in the study;
* Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery.
* Has participated in the PIANO (i.e. EX-MKTG-83) Study.
Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand

If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful device when endotracheal intubation is necessary.

Therefore, if the appropriate position of the light beam is determined and the distance of the light source suitable for intubation using the lightwand is obtained from anatomical structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because it can prevent unnecessary deep insertion or shallow insertion that can cause damage to anatomical structures during intubation.

Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.

However, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.

The prodcedure is as follows.

1. FOB examination and check position of light below 1cm from vocal cord
2. lightwand intubation aimed at checkpoint
3. measurement of distance from thyroid cartilage/cricoid cartilage to light point

Eligibility Criteria:
Inclusion Criteria:

* impossibility of neck extension
* trismus
* weak teeth

Exclusion Criteria:

* previous history of larynx or neck surgery
* no informed consent
Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year


Eligibility Criteria:
Inclusion Criteria:

* pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
* date of diagnosis not longer than 8 weeks ago

Exclusion Criteria:

* severe cardiac impairment
* bone metastasis inducing skeletal fragility
* other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.