cyrilzakka/clinical-trials huggingface dataset:
Migraine Research with Smartwatch Application

This clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. Participants will also document migraine attacks, triggers, and symptoms through a digital migraine diary app. By combining continuous smartwatch data, the migraine diary and the implementation of questionnaires, the study seeks to provide a comprehensive understanding of how migraines and their treatments impact daily life and patient outcomes.

Migraine is one of the most prevalent neurological disorders globally, significantly affecting patients' quality of life. However, due to the complexity of monitoring triggers and symptoms, determining the most effective individualized treatment regimen can be difficult. In this observational study a total of 55 patients with episodic or chronic migraines have been observed over a six-month period, with continuous data collection from both smartwatch and migraine diary app. Clinical health questionnaires were completed at baseline (V1), 3 months (V2), and 6 months (V3), assessing the impact of migraine attacks on daily functioning. The data gathered from the smartwatch (Withings ScanWatch) includes activity-related metrics (step count, minutes of activity at various intensity levels), basic cardiovascular measurements (heart rate), and sleep data (total sleep duration, sleep quality, etc.). Additionally, the Migraine App allows patients to document the precise timing of migraine attacks, associated symptoms, potential triggers, and the medications taken, including their effectiveness. The MIRA study aims to explore the potential of wearable devices and digital health tools to systematically identify migraine triggers and physiological responses through continuous monitoring. By integrating both clinical assessments and digital data, this study seeks to provide a comprehensive, longitudinal understanding of migraine dynamics and their impact on daily life.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following criteria to be eligible to participate in the study:

* ≥ 18 years of age
* Diagnosed migraine syndrome
* Possession and ability to use a smartphone (Android 8.1 or later, or iOS 12.3 or later)

Exclusion Criteria:

* Missing informed consent
* Unwillingness or inability to use the smartphone app
* Comorbidity leading to impaired comprehension or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be at the discretion of the investigators.
KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer

This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.

PRIMARY OBJECTIVES:

I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study.

SECONDARY OBJECTIVES:

I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point.

OUTLINE:

Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy.

After completion of study treatment, patients are followed up at 1 and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ \[DCIS\])
* Status post-lumpectomy, -quadrantectomy, or -mastectomy
* Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
* Total dose \>= 40Gy
* Dose per fraction \>= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
* Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
* Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist
* Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
* Patients who are able and willing to sign protocol consent form

Exclusion Criteria:

* Prior radiation to the involved breast or chest wall
* Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
* Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
* Patients undergoing partial breast irradiation
* Patients who have undergone MammoSite® or any other form of brachytherapy
* Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
* Patients who are pregnant or breastfeeding
Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* All patients were required to give written informed consent
* To have received a previous treatment with anthracyclines and taxanes
* Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
* At least 4 weeks since the last previous antineoplastic treatment
* Patients must have recovered from all previous toxicities
* Karnofsky Performance status \>= 70%
* Adequate hematological, renal, cardiac and hepatic function
* Life expectancy of at least 12 weeks
* Patients able to comply and to receive an adequate follow-up

Exclusion Criteria:

* Only bone metastases
* Active infection
* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy
* Insufficient renal function (creatinine clearance \< 60ml/min)
* Clinically unstable brain metastasis
* Pregnancy or lactation
* Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
* Abnormal liver function (bilirubin \> 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase \>2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
* Males
* Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent.

At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems:

* Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.


Eligibility Criteria:
Inclusion Criteria:

* hosipital patients

Exclusion Criteria:

* No
Incidence of Refeeding Syndrome in Consecutively Admitted Patients

The incidence and main risk-factors analyzed in consecutive in-patients in the departments og gastroenterology and ear-nose and throat diseases (cancer in radiation therapy)

Patients with either parenteral- or tube feeding enter the study to assure sufficient nutrition.

During hospitalization patients were monitored with daily blood samples and clinical evaluation of symptoms in addition to the coverage of energy and protein in percent of estimated needs.

Refeeding phenomenon was defined as a decrease in plasma phosphate after the initiation of nutrition.

Refeeding syndrome as refeeding phenomenon and one or more relevant symptoms in addition (hypotension, cardiac arrhythmia, edema, confusion)

Eligibility Criteria:
Inclusion Criteria:

* planned tube- or parenteral nutrition (complete or supplementary)
* \> 18 years
* written consent

Exclusion Criteria:

* Renal insufficiency (p-creatinine \>200 micromol/l)
* Lack of ability to communicate (registration of nutritional intake etc)
A Study of Pharmacodynamic and Genetic Parameters of Abira-DES Study Participants (NCT02217566) - Participants With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Following Unresponsive Treatment With Diethylstilbestrol

The primary purpose of this study is to evaluate the influence of HSD3B1 (1245C) germline variant and potential pharmacodynamic markers on abiraterone activity in participants with metastatic castration-resistant prostate cancer after unresponsive use of diethylstilbestrol.


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of prostate adenocarcinoma without neuroendocrine or small cell differentiation and was a participant in the Abira-DES study (NCT0221756), which includes: diethylstilbestrol pretreatment for castration-resistant prostate cancer with evidence of disease progression or grade 3/4 toxicity with diethylstilbestrol; metastatic disease confirmed by bone examination or metastatic lesions by computed tomography or magnetic resonance
* Abiraterone acetate therapy during the Abira-DES study (NCT0221756), and peripheral blood samples have been collected from at least of the three proposed study timepoints
* Must sign, and/or his/her legally acceptable representatives, where applicable, must sign the ICF allowing the use of clinical data and biological samples in accordance with local requirements. For deceased participants who did not provide consent prior to death, permission to research their information must meet local requirements

Exclusion Criteria:

- Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)
Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.

Low back pain is considered to be chronic if it has been present for longer than three months.

This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.

The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.

The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".

Realization of the protocol :

1. Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
2. They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.

An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).

Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.

Feedback :

Assessments conducted by the using of self - questionnaires:

* Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;
* Sent by mail at 3 and 6 months

The expectations and fears will be evaluated by means of individual interview or focus groups. To avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of SPA Therapy).

Eligibility Criteria:
Inclusion Criteria:

* - Both sexes
* 60-80 years old
* Realizing a SPA Therapy of 3 weeks.
* Presenting a mechanical pain of the rachis lumbar vertebra \> 3 months
* Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
* Cooperation and understanding allowing to conform in a strict way to the conditions planned by the study
* Acceptance to participate in the study (non-opposition)

Exclusion Criteria:

* - \< 60-year-old patients or \> 80 years
* Inflammatory, tumoral, traumatic or infectious rheumatism
* Surgery of the back
* SPA Therapy dating less than 6 months
* Evolutionary slipped disc
* Disorders(confusions) of the concentration or the compression of the written or oral French language making impossible the realization of the study
* The pain estimated by the digital scale = 0 in the inclusion
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire duration of the study, able to be contacted by phone, and able to complete all study procedures, including completion of an electronic diary (e-diary).
* Men and women who are able to have children, must use a reliable method of birth control for the duration of the study.

Exclusion Criteria:

* Any major illness that would substantially increase the risk associated with participation in the study, or interfere with the evaluation of the study objectives - this is determined by the local physician.
* Donation of 250 mL or more of blood within the last 3 months.
* Condition associated with prolonged bleeding time, including subjects taking anticoagulant medication or antiplatelet therapy.
* Any contraindication to vaccination or vaccine components.
* Immunocompromised persons and subjects who receive treatment with immunosuppressive therapy.
* Previous administration of S. aureus vaccination.
* Receipt of blood products or immunoglobulins within 12 months prior to study
* Participation in another trial (not including observational trials) within the last 30 days.
* Study site personnel or immediate family members (first-degree relatives).
* Women who are pregnant (as determined by urine pregnancy test) or breast-feeding.
* Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
* For subjects aged 65 years or older, a Mini-Mental State Examination (MMSE) score of \<=21.
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery

The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.

Women allocated to either the massage or compression group will be given 10 units of oxytocin intramuscularly immediately after delivery of the shoulder and controlled cord traction will be performed to assist placental delivery. The umbilical cord will be clamped and cut approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and blood clots expelled as quickly as possible after delivery of the placenta.

Eligibility Criteria:
Inclusion Criteria:

* Women giving birth vaginally, aged between 20 and 40 years, with a singleton pregnancy, gestational age of 36 or more weeks, and with fewer than or equal to three previous childbirths.

Exclusion Criteria:

* Exclusion criteria include multiple gestation, fetal malpresentation, the third stage of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis, three or more previous induced abortions, preeclampsia, fetal death, polyhydramnios, hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate infusion, abruptio placentae and having an abdominal wall too thick to palpate the fundus of the uterus or to perform uterine massage or compressions after delivery.
A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family

The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated.

The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.


Eligibility Criteria:
Inclusion Criteria:

* Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
* No limitations will be given regarding the number of family members.

Exclusion Criteria:

* Presence of another household member with ILI during the previous two weeks.
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)

This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome) for up to 208 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Less than 5 years of age at the time of the first study drug infusion
* Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA
* Written informed consent provided by parent or legally authorized representative after the nature of the study has been explained and prior to any research-related procedures.

Exclusion Criteria:

* Previous hematopoietic stem cell transplant (HSCT).
* Previous treatment with BMN 110.
* Known hypersensitivity to any of the components of BMN 110.
* Major surgery within 3 months prior to stuy entry or planned major surgery during the 52-week treatment period.
* Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the Investigator.
* Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.
Platelet Reactivity and MES During CEA

The purpose of this study is to analyze the association between aspirin efficacy and general platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy (CEA).


Eligibility Criteria:
Inclusion Criteria:

* Al patients undergoing elective carotid endarterectomy

Exclusion Criteria:

* Patients requiring a blood transfusion prior to surgery
* Patients with an inappropriate temporal bone window for transcranial Doppler (TCD)
* Patients on vitamin K antagonists or antiplatelet treatment other then aspirin
* Patients with an artificial cardiac valve
Nasal Intubation Using King Vision Video Laryngoscopy

This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group \[n=30\]、 McGrath MAC group \[n=30\] and Macintosh group\[n=30\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* general anesthesia with nasotracheal intubation
* anticipated difficult airway

Exclusion Criteria:

* contraindications to nasal intubation
* Patients with a history of anti-hypertensive drugs