cyrilzakka/clinical-trials huggingface dataset:
Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer

The scope of this study is the methodological development and optimisation of sodium MRI (23Na-MRI) protocols for breast cancer imaging. The study further proposes to utilise biomarkers obtained from 23Na-imaging (cell integrity), FDG-PET (metabolism), multi-parametric MRI (perfusion, vascularity, cellularity, morphology) to generate parameter maps specific for physiological processes in breast cancer.

This is a prospective, non-randomised, exploratory study on ≤20 healthy female volunteers (\>18 years), and ≤45 female patients (\>18 years) diagnosed with primary breast cancer. Healthy volunteers (n≤20) will be scheduled to undergo an 23Na-MR examination. Patients scheduled for primary surgery (n≤30) will undergo a single MR examination, involving 23Na-imaging prior to their planned surgery. Immunohistochemical analysis will be performed on surgical tissue specimens to determine tissue markers of interest for correlation with the imaging findings. Patients undergoing neo-adjuvant therapy (n≤15) will undertake up to two (2) combined PET/MR examinations with FDG (18F-2-fluoro-2-deoxy-D-glucose) and 23Na-MRI. Patient imaging will occur at two time points prior to their planned surgery: (i) baseline (prior to initiation of treatment) and (ii) mid-treatment (after 3-4 cycles of chemotherapy). Histopathological analysis will be performed on pre-treatment biopsies for histological markers of interest for correlation with the imaging findings.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers

* Female, aged 18 years or above
* Participant is willing and able to give informed consent for participation in the study.

Patients

* Female, aged 18 years or above
* Pathologically confirmed primary breast cancer
* Tumour \>1 cm diameter on mammography and/or ultrasound.

Exclusion Criteria for healthy volunteers and patients:

* Pregnant or lactating;
* History of serious breast trauma within past 3 months
* Implants known to be contraindicated at 3T MRI
* Significant or uncontrolled medical problems which according to the opinion of the Principal Investigator render the participant unsuitable for participation in the study
* Underlying conditions, including but not limited to medical or psychiatric conditions, which in the opinion of the Principal Investigator would preclude the participant from adhering to the study protocol or completing the study per protocol
* Lacking the capacity to provide informed consent.

Additional exclusion criteria for patients

* Has undergone chemotherapy or hormonal therapy for breast cancer in the previous 12 months
* Previous surgery or radiotherapy for breast cancer to the ipsilateral breast within the past 4 months
* Previous surgery for benign breast disease within the past 4 months
* History of kidney disease or known allergic reaction to gadolinium contrast agent.
Atrial and Ventricular Wall Stress During Breathing

Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.

With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg raising, and handgrip. Echocardiographic recordings are made before and during each intervention. Participants are otherwise resting in a reclined position.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* known heart or lung disease
The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke

The purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke.

Acupuncture and taping have emerged as treatment alternatives for many diseases with positive and satisfactory results.

Thus, acupuncture seeks to balance all physiological systems, using specific points on the body where needles are inserted.

In turn, the use of taping is associated to various benefits such as improved blood and lymphatic function. In addition, it assists in the correction of muscle function and in the decrease of pain for neurological suppression. The constant afferent mechanical and somatosensory stimuli are perceived in cortical level and may produce motor unit recruitment and contribute to neuroplasticity of the nervous system.

Thus, this research aims to analyze the effects of Acupuncture associated with Functional Taping on patients' upper limb with chronic hemiparesis after Stroke through a prospective, randomized intervention. Seventy-five patients will be evaluated before and after intervention with Acupuncture and / or Function Taping, divided into three groups (Acupuncture, Functional Taping and Acupuncture plus Functional Taping). The evaluation will consist of Isokinetic, Mini-Mental State Examination, Modified Ashworth Scale, Motor Activity Log, Wolf Motor Function Test and Visual Analog Scale of Pain. The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke diagnosis for at least six (06) months, who present hemiparesis in upper limb;
* To accept participate in the study by signing theTerms of Consent;
* Do not have any cognitive impairment.

Exclusion Criteria:

* Do not follow the inclusion criteria;
* To present shoulder subluxation or dislocation, shoulder pain syndrome or amputations (with or without the use of aids);
* To present any allergic reaction due to use of bandage and/or do not adapt to treatment with needles.
Comparison of Different Up-dosing Schedules With Osiris

The purpose of this study is to compare different up-dosing schedules with Osiris.


Eligibility Criteria:
Inclusion Criteria:

* history of grass pollen allergy
* Positive SPT to grass
* Positive IgE to grass

Exclusion Criteria:

* uncontrolled and severe asthma
Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients With COPD

Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative than other traditional indices.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD II-III (FEV1\<80 and \>30%)

Exclusion Criteria:

* Pregnancy
* Lung cancer
* Diabetes mellitus
* Primary exacerbation of COPD
Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders

Emotional disorders such as anxiety and depression are highly prevalent during adolescence and associated with functional impairment that commonly extends into adulthood. In the primary care (PC) setting, these disorders are frequently underdiagnosed and undertreated. Objective: To carry out a prospective, randomized controlled trial (RCT) to test the efficacy of a new transdiagnostic cognitive behavioural group therapy (TD-CBT) protocol for adolescents (age 12 to 18 years) compared to group relaxation therapy (RT). Methods: Two-arm, single-blind, RCT (expected N=160) to compare group TD-CBT for emotional disorders to group RT. The group TD-CBT will be administered in seven sessions (90 min/session) over 12 weeks. Psychological assessments will be carried out at baseline, post-treatment, and at months 3, 6, and 12 after treatment. The assessments will include measures of depression, anxiety, somatization, quality of life, disability, and cognitive-emotional factors. The study will be conducted in two PC centres located in Cantabria, Spain. Discussion: This is the first RCT to evaluate the efficacy of group TD-CBT for emotional disorders in adolescents in the PC setting in Spain. If, as expected, the results confirm the superiority of TD-CBT to conventional RT, the widespread implementation of this new approach-based on scientific evidence obtained in a real-world, primary care setting-could improve treatment outcomes and quality of life in adolescents suffering from anxiety or depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 to 17, inclusive, who present to the PC centre seeking treatment for symptoms of anxiety or depression.
* Scores above the predetermined cut-off points on the GAD-7 (\>= 5) and PHQ-9 (\>= 5).
* Agreement to participate in the study, with written informed consent provided by both patients and parents/guardians.

Exclusion Criteria:

* Presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder, and major depressive disorder (PHQ-9\> 20).
* Presence of severe or recent suicide attempts
* Moderate or severe behaviour disorder that could interfere with the dynamics of the therapy groups.
* Presence of a mental disability (IQ \< 75).
* Be receiving psychological treatment or any type of specialized care related to mental health.
* Receiving any psychopharmacological treatment.
* Parents involved in legal litigation due to separation or divorce.
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Histologically or cytologically confirmed CRC that is metastatic
* Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening
* Evidence of measurable disease as per RECIST, v1.1
* Subject able to receive cetuximab as per approved label with regards to RAS status
* Eastern Cooperative Oncology Group Status (ECOG) 0 or 1
* Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
* Subject able to take oral medications

Exclusion Criteria:

* Prior systemic therapy for metastatic disease
* Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
* Symptomatic brain metastasis or Leptomeningeal disease
* History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
* History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
* Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
* History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
* Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
* Known contraindication to cetuximab administration as per SPC/approved label
Text Messaging for Weight Loss

Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message.

The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP)
* Age ≥ 21 years
* Body mass index (BMI) 25 to 45 kg/m2 and weight ≤ 400 pounds
* Goal of losing weight (not just maintain weight)
* Willing to change diet, physical activity in order to lose weight.
* Currently uses text messaging in English on mobile phone
* Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided)
* Have a scale at home for self-monitoring weight
* Fluent in English (speak, read, write)
* Commit to return for follow-up weight at 6 months regardless of amount of weight lost

Exclusion Criteria:

* Involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months
* Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months
* Any of the following medical conditions which could affect weight or for which weight loss is contraindicated

  * End-stage liver disease
  * End-stage kidney disease
  * Cancer within previous 2 years (except non-melanoma skin cancer)
* Myocardial infarction, stroke, or transient ischemic attack within previous 6 months
* Unstable angina
* Severe arthritis or other medical conditions which would prevent brisk walking
* Schizophrenia
* Hospitalization for psychiatric problems during the prior 12 months.
* Current use or anticipated future use (during 6 month study) of medications that could cause weight loss:

  * phentermine
  * orlistat (prescription Xenical or OTC Alli)
  * topiramate
  * buprioprion
  * exenatide (Byetta)
  * liraglutide (Victoza)
* Prior bariatric surgery or plans for bariatric surgery in next 6 months
* Pregnant or breast feeding within the previous 6 months
* Planning to become pregnant in next 6 months
* Consumes \> 14 alcoholic drinks per week
* Current use of illicit drugs
* Planning to move out of the area in the next 6 months
* Another member of household or a close contact is participating in the study
The Effect of Ylang Ylang Oil and Lemon Oil

This study was conducted as a randomized controlled experimental study.To evaluate the effects of aromatherapy, one of the non-pharmacological pain methods, on labor pain and anxiety in the active phase in primiparous pregnant women.

The main questions it aims to answer are:

Is ylang ylang oil applied as an inhaler effective in reducing labor pain and anxiety? Is lemon oil applied as an inhaler effective in reducing labor pain and anxiety? Participants randomized according to the closed envelope method into the lemon oil group (n=15), ylang ylang oil group (n=15) and control group (n=15). In the active phase (cervical dilatation ≥5), a drop of essential oil was instilled onto square cotton balls to the intervention groups and renewed as one drop every hour until labor occurred. In the control group, 1 drop of saline was dripped onto square cotton balls. Visual pain scale (VAS) and state anxiety ınventory were applied to the intervention groups and control groups before the application. After the application, VAS and state anxiety ınventory were evaluated at 5-7 cm dilatation, and only with VAS at 8-10 cm dilatation. The trait anxiety ınventory was administered to the volunteers after birth.


Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy (37-41 weeks)
* Pregnant women between the ages of 18-35
* had singleton pregnancy with cephalic presentation of the fetus
* Not allergic to ylang ylang oil, flower/lemon or oil or anything
* Absence of any pregnancy complications
* No previous miscarriage, no abortion
* Not having any diagnosed systemic disease
* ≥ 5 cm (cm) (active phase) cervical dilatation
* Pregnant women who do not take any analgesia, anesthesia or anxiolytic drugs
* Spontaneous onset of labor
* Pregnant women who can speak and write Turkish well
* Pregnant woman's consent to participate in the study.

Exclusion Criteria:

* Emergency cesarean section indication
* Use of analgesic, anesthetic and anxiolytic drugs by the pregnant woman
* The pregnant woman's desire to withdraw from the study
Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)

The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.

The primary goal of OSAS therapy is to obtain CPAP adaptation for the highest amount of OSAS patients to reduce the proportion of untreated OSAS in the population. This object is important considering that a longer duration of CPAP treatment is linked with better daytime functioning and metabolic and blood pressure effects of CPAP. The main endpoints will be CPAP usage (defined as the proportion of night with CPAP usage ≥1h); CPAP adherence (defined as the proportion of night with CPAP usage ≥4h); the average nightly usage of CPAP (hour/night); CPAP efficacy (defined as AHI and ESS score). Each measure will be performed after 1 week, 1 month and 6 months.

Eligibility Criteria:
Inclusion Criteria: • Consecutive symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of \>15/h in polysomnography (PSG) or Home Sleep Test (HST) consenting to start long term CPAP treatment.

Exclusion Criteria:

* Age \<18 years
* Unable to communicate in Italian
* Previous usage of CPAP treatment
* Alcohol consumption \> 4 units \>4 times a week
* Acute manifestation of psychiatric diseases
* Life expectancy of \< 6 months for any reason
* Surgical obesity treatment planned within the next 6 months
* Predominantly Central sleep apnea and cheyne stokes respiration
The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs

The study on the relationship among meridian, acupoint and internal

Meridian system is the pathway of transporting qi and blood, and that distributes all the body. Meridian system connects to internal visceral organs interior, and also connects to joints (or acupoint) exterior. The relationship among meridian, acupoints and internal visceral organs is still unclear. Therefore, the purpose of the present study was to investigate the relationship among meridian, acupoints and internal visceral organs. Total 33 subjects randomly finished three sessional studies as follows: 1) sham electroacupuncture (EA) session: the stainless steels acupuncture needles inserted into the subcutaneous layer of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA stimulator, but no electric discharge for 30 min; 2) Zusanli session: the acupuncture needles inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min, and the intensity was visual slightly muscle contraction; 3) Shaohai session: the methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion) . The major outcome measure was the changes of the percentage of gastric slow wave and dysrhythmia in 30 min electrogastrogram recordings, and the changes of cardiac output and stroke volume in 30 min recordings. Secondary outcome measure was the changes of saliva, blood and urine metabolites.

The investigators predict the results of the present study can test and verify meridian theory of traditional Chinese Medicine, meridian system connects internal visceral organ interior, and connects joint (or acupoint) exterior.

Eligibility Criteria:
Inclusion Criteria:

1. Gender：male or female.
2. Age：from 20 years old (inclusive) to 50 years old (inclusive).
3. After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.

Exclusion Criteria:

1. Cancer, congestive hear failured NYHA class\>II, COPD attack.
2. History of esophagus and gastroduodenal surgery、Barrett's esophagus.
3. Can not accept acupuncture points stimulators.
4. Allergic to acupuncture needles.
5. Has a mental illness or is unable to cooperate with the researcher.
Influence of Suture Type on Emergency Midline Laparotomy Closure

There is no clear recommendation in international guidelines regarding the type of suture to be used for closing emergency midline laparotomies. It is recommended to follow the same principles as in elective surgery, thus performing the closure with a continuous suture of slowly absorbable monofilament 2-0 with small-bites technique. Currently, there are several slowly absorbable sutures available on the market, and our center uses two: PDS® and Monomax®. These two sutures are currently used interchangeably at our institution based on the preferences of each surgeon.

Objective: study whether there are differences between these two sutures in the closure of emergency midline laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old, patients undergoing emergency midline laparotomy by the General Surgery Department.

Exclusion Criteria:

* \<18 years old, previous midline laparotomy
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding

Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.


Eligibility Criteria:
Inclusion Criteria:

\*perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea.

Exclusion Criteria:

\*general or local causes of bleeding, drug intake or recent hormonal contraception