cyrilzakka/clinical-trials huggingface dataset:
Validity and Reliability of the Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire in Turkish

The aim of this study is to adapt the questionnaire named "Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire (KMI-PFQ)" into Turkish in healthy women and to introduce it to the literature as a valid and reliable questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-30 years old
* Understanding and speaking Turkish
* Being willing to participate in the study
* Not having any neurological or orthopedic problems
* Not having any pelvic floor pathology diagnosed by a specialist physician

Exclusion Criteria:

* Having any previous or current pelvic floor pathology
* Not understanding or speaking Turkish
The Influence of Obesity on Level of Depression and Cognitive and Executive Functions

The proposed study is a randomized, open, comparative research involving an intervention group and two control groups.

The aims of the study are: 1.To compare levels of depression in female adolescents with obesity and a control group of female adolescents with appropriate weight and height. 2. To investigate whether a decrease in weight due to a short range intervention program provided by dietician for female adolescents with obesity will lead to change in the levels of symptoms of depression and cognitive and executive functions in comparison to a control group of adolescent girls with obesity, matched in age that does not receive such an intervention program.

60 Female adolescents with obesity will be recruited to the study and will be randomized to 1 of two groups- 1. intervention group- participants in this group will attend an intervention program consisting of 12 meetings with dietician and will attend two study visits at the clinic- in the beginning of the study and after three months. 2.Control group- Participants in this group will only come to two study visits at the clinic. In the first two visits they will meet with a dietician and will receive nutrition guidance.

Another 30 girls with appropriate weight will be recruited to second control group- this group will come to two study visits at the clinic- in the beginning of the study and after three months. In the first visit participants will receive nutrition guidance by the dietician.

In the study visits the following procedures will be performed for all study groups: Blood tests, completion of psychological and nutritional questionnaires, completion of computerized tests and measurements of height, weight, fat mass and circumference of hips.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescent girls aged 12-17, who attend the Endocrinology Institute in Schneider Hospital and comply with the research criteria: obesity (BMI above percentile 85) and appropriate weight (BMI between percentiles 5-85).
2. Adolescent level according to Tanner: 4-5.
3. Participants with obesity: BMI above percentile 85 for age group.
4. Participants in control group with appropriate weight: BMI percentile 5-85 for age group.
5. Appropriate height (Percentiles 3-97 according to the CDC curve).
6. Parents' signature on informed consent form.

Exclusion Criteria:

1. Chronic illness or chronic use of medications.
2. Inability to comply with the research conditions.
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer

HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.

At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).

The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.

International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.

To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.

New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* be a female patient
* Patients with histologically proven HER2-positive invasive breast cancer (IHC 3+ or 2+ with positive SISH),
* Neoadjuvant chemotherapy and intra-tumour clips indicated at the multidisciplinary consultation meeting (RCP).
* Signed Informed Consent Form

Exclusion Criteria:

* pregnant or breast-feeding women
* Have had a haematoma requiring level II analgesics at the time of the diagnostic biopsy.
* Known coagulation disorders
* Individual deprived of liberty or placed under the authority of a tutor, or a currator
* Not be affiliated to a social security regimen
Prevention of Type 2 Diabetes Mellitus in Children

This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are:

1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus.
2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children.
3. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.


Eligibility Criteria:
Early adolescent
The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment

The objective of this study is to assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).

Q fever fatigue syndrome (QFS) is one of the most frequent sequelae of Q fever, and constitutes a significant problem in the current outbreak of Q fever. QFS leads to substantial morbidity and has a high socio-economic burden, related to increased use of healthcare facilities and absence from work. It is envisaged that over 750 patients will become chronically fatigued due to Q fever in The Netherlands (20% of 4000 patients from 2007 until now). Although the outbreak appears to diminish, it is expected that Q fever will remain an endemic disease, and therefore this number will continue to grow. A vast medical consumption can be anticipated, stressing the need for an accessible and effective intervention and clear treatment guidelines.

The study will contribute to a better understanding of effective treatment of QFS, providing evidence-based guidelines for general practitioners and medical specialists.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant, non-lactating females who are 18 years or older
* Laboratory-proven acute Q fever since the year 2007 and/or positive serology fitting a past infection with Coxiella burnetii;
* AND being severely fatigued, defined by scoring 35 or higher on the subscale fatigue severity of the CIS;
* AND being fatigued for at least 6 months;
* AND disabled because of the fatigue, defined by scoring 450 or higher on the SIP
* Subjects must sign a written informed consent form.

Exclusion Criteria:

* Fulfilling criteria for chronic Q fever, namely:

  * IFA IgG fase I ≥ 1024, ≥ 3 months after acute Q fever and/or
  * Positive Coxiella burnetii PCR on serum or tissue, 1 month after acute Q fever
* Acute Q fever in the setting of a prosthetic cardiac valve or aneurysm surgery or stenting necessitating prophylactic use of doxycycline;
* Pregnancy or unwillingness to use effective contraceptives during the entire study period;
* Imminent death;
* Inability to give informed consent;
* Allergy or intolerance to doxycycline;
* Somatic or psychiatric illness that could explain the chronic fatigue;
* Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents;
* Receiving antibiotics for more than 4 weeks, potentially active against Coxiella burnetii, for any other reason since Q-fever diagnosis;
* Subjects who are receiving and cannot discontinue barbiturates, phenytoin, or carbamazepine (these drugs may increase the metabolism of doxycycline and therefore reducing half-life of doxycycline);
* Moderate or severe liver disease (AF, ALAT, ASAT \> 3 times the upper limit of normal).
* Current engagement in a legal procedure concerning financial benefits (only current involvement interferes with the effectivity of cognitive behavioral therapy. Once the appeal procedure ends, subjects can be included)
Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent and consent to participate in this study;
2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria:

1. Malignant tumor history within the past 5 years;
2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
3. Histology confirmed not non-small cell lung cancer
4. No matching tissue or blood samplesUnqualified blood samples
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years of age, at the time of signing ICF, inclusive.
* Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD).
* Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age.
* Willing and able to withdraw and refrain from opioids for the course of the study.
* Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study.
* Willing and able to refrain from antidepressants and other excluded medications.
* Capable of reading and understanding English and able to provide written informed consent to participate.
* Willing to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
* If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
* Body mass index (BMI) within the range 17.5 - 35 kg/m\^2 (inclusive).

Exclusion Criteria:

* Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse).
* Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
* Significant (eg, moderate or severe) comorbid traumatic brain injury (TBI) by history.
* Severe depressive symptoms at screening or baseline.
* Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
* Use of antidepressant medication within 2 months of baseline.
* Female participants who are pregnant or lactating.
* History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients in TNX-102 SL or placebo formulations.
* Seizure disorder.
* Current moderate or severe sleep apnea not well controlled by positive airway pressure (PAP) or oral (mouthpiece) devices.
* Has received any other investigational drug within 90 days before Screening or has taken cyclobenzaprine within 21 days of the Randomization visit.
* Previous participation in any other study with TNX-102 SL.
* Family member of investigative staff.
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury

Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an important role in mediating neuroanatomical plasticity and functional recovery following traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma Score and prognosis of such patients with traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffered head trauma and whose highest abbreviated injury score (AIS) was 3 or less (other than head injury)
* Patients who delivered to hospital within 4 h

Exclusion Criteria:

* Patients who suffered open injuries
* Patients who had existing prior neurological disease
* Patients whose serial serum samples could not be obtained
* Patients less than 18 years of age
* Patients who suffered severe life-threatening injury to organs other than the brain
Dietary Therapy in Children With Refractory Epilepsy

In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet \*\* in terms of seizure reduction from baseline seizure frequency at 6 months

Primary objective:

To compare the efficacy of Modified Atkins diet compared to Ketogenic diet \* in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line.

Secondary objective:

Proportion of patients who achieve \> 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-18 years with refractory epilepsy\*
* Willing to come for regular follow up
* No motivational or psychosocial issues in the family which would preclude compliance with the diet

Exclusion Criteria

* Surgically remediable cause for refractory epilepsy
* Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
* Previously received ketogenic diet or modified Atkins diet
* Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness
Patient Characteristics and Tracheobronchial Anatomy

The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge of the tracheobronchial anatomy in order to establish the best choice for the patient. The literature is limited regarding major bronchi dimensions. In addition, the measurement method is not always adequate or properly described and some publications have evaluated only the left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has been little used.

The project is to conduct a prospective study to compare patient characteristics (age, height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if available), and dimensions of the trachea and of the main bronchi from CT scans with 3D reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* patients aged at least 18 years
* undergoing a CT scan

Exclusion Criteria:

* hospitalized patients,
* people benefiting from a legal protection.
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.

Many studies have investigated the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids in addition to the standard treatment for patients with severe asthma attacks.

In this 2x2 factorial design blinded randomized study, no interaction of hypothesized treatments is expected.Investigators hypothesize that two doses of intravenous magnesium sulfate,a high dose followed by a (lower) standard dose, will shorten the time to medical readiness for discharge compared to a single standard dose followed by placebo.The second hypothesis is that nebulized inhaled budesonide will be superior to placebo.

Patient with a severe asthma attack will be admitted to the observation area in the Pediatric Emergency Center and assessed for eligibility for the study by the attending physician, based upon our study inclusion/exclusion criteria.

Eligible patients will be enrolled after obtaining written consent from the parents. Patients will receive routine treatment for a severe asthma attack, such as inhaled bronchodilators, plus intravenous steroids and supplementary oxygen if needed. Standard blood work and chest X-Ray will be obtained and bronchial asthma severity score will be measured at baseline before starting treatment,and then at 4,8,12,24,36,48 hr and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. The patient will be randomized into one of the four study groups and adverse effects of the medications in each group will be monitored and documented carefully.

Eligibility Criteria:
Inclusion Criteria:

1. Children 2-14 years of age.
2. Known to have bronchial asthma.
3. Presenting in severe asthma exacerbation
4. Asthma severity score 8 or higher according to PRAM asthma severity .

Exclusion Criteria:

1. Prematurity \<34 weeks of gestation.
2. Critically ill children requiring immediate intubation or ICU admission.
3. Transfers from other institutions.
4. Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
5. History of neuromuscular disease, cardiac disease, renal disease, liver disease.
6. Underlying chronic lung disease.
7. Radiographic evidence of pneumonia or lung collapse .
8. Hemodynamic instability.
9. Instrumented airway or Tracheotomy.
10. Colostomy or ileostomy.
11. Malabsorption disorder.
12. Known vitamin D deficiency.
13. Receiving Milk of Magnesium for Constipation
14. Chronic diarrhea (duration for 2 weeks)
15. Diuretics use.
16. Immunodeficiency.
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)

Urinary incontinence (UI) is one of the most common side effects of radical prostatectomy (RP) and compromises men's quality of life. The first line treatment for urinary incontinence is the conservative approach of Pelvic Floor Muscle Training (PFMT) but, up to date, there seems to be no statistically significant difference in the effectiveness of several proposed physiotherapy treatments.

Literature highlights the importance of also adding an educational component regarding the intentional contraction of the pelvic floor muscles (a skill termed "the Knack"). Moreover, in some studies, carried out on a sample of women, was introduced the use of virtual reality. This increased the adherence to treatment and showed an improvement in urinary continence. In addition to virtual reality, another intervention methodology used in physiotherapy is the one of Action Observation training (AOT) whose effectiveness has been proven both in sports and rehabilitation.

However, currently the effect of this innovative type of treatment has not yet been studied in men with UI following radical prostatectomy intervention.

The aim of this clinical study is to investigate the effectiveness of using AOT on urinary incontinence in subjects undergoing robotic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone Robot-assisted Laparoscopic Prostatectomy with post-operative IU.
* Objectivity of recruitment and contraction of pelvic floor musculature (PP) at manual perineal testing.

Exclusion Criteria:

* Preoperative incontinence
* Pre-intervention radiotherapy
* Previous urogenital surgery beyond Robot-assisted Laparoscopic Prostatectomy.
* Concomitant presence of neurological, internal or musculoskeletal diseases that may affect functional or motor recovery.
* Less than 5 seconds of endurance in PP contraction