cyrilzakka/clinical-trials huggingface dataset:
Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, \& Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).

There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005).

TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.

Eligibility Criteria:
Inclusion Criteria:

* women
* aged between 18 and 35 years
* anamnestically healthy
* nulliparous and
* a BMI between 18 and 30

Exclusion Criteria:

* latex and nickel allergy
* anamnestically current pregnancy
* menstruation
* urogenital operations
* anal operations
* vaginal infections
A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.


Eligibility Criteria:
Inclusion Criteria:

* Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
* Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).
* Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
* Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
* Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol.

Exclusion Criteria:

* Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder.
* Suspected or previously diagnosed intellectual disability disorder.
* One or more first-degree relatives with diagnosed bipolar I disorder.
* History of seizure disorder (other than febrile seizures).
* History of electroconvulsive therapy at any time during the subject's lifetime.
* Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications.
* Taking any medications that are contraindicated to escitalopram (escitalopram oxalate).
* Inability to speak, read, or understand English well enough to complete the assessments.
* No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
Cognitive Markers in Prodromal MS

The focus of this work is the evaluation of a measure of cognitive functioning- intra-individual variability (IIV) - derived from a computer-based continuous reaction time (RT) task (Cogstate) as an early marker of prodromal MS.

This study is a prospective observational clinical study, where the researchers will recruit adults with early MS (n=60) to complete a cognitive assessment and an optional gait assessment using Runscribe and G-sensor. Thirty-five \[35\] participants will also have a single 60-minute investigational MRI combined with 20 minutes of simultaneous tDCS. The MRI will repeat the protocol from the researchers' current study (ClinicalTrials.gov Identifier: NCT03564496, IRB i18-00548) using simultaneous transcranial direct current stimulation (tDCS) during the imaging acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Ages 23-59 years old (inclusive)
* Prodromal MS (defined by radiologically isolated syndrome ≤ 6 months from first MRI or clinically isolated syndrome ≤ 3 months from first clinical event)

Exclusion Criteria:

* Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score \< 85).
* Presence of severe cognitive impairment (based on SDMT age normative z-score \<-3.0).
* Primary psychiatric disorder that would influence ability to participate.
* Current uncontrolled seizure disorder.
* Current substance abuse disorder.
* History of head trauma in the past year (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator).
* Pregnant or breastfeeding

Additional Exclusion Criteria for tDCS-MRI Participants

* Extreme claustrophobia
* Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
* Treatment for a communicable skin disorder currently or over the past 12 months
* Have any irremovable piercings, metallic based-tattoos, or MRI-contraindicated implants (e.g. pacemakers and defibrillators)
Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.
2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.

This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
2. Eastern Cooperative Oncology Group performance status ≤2 and
3. life expectancy of \>3 months were enrolled.
4. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
5. None was previous exposure to Cetuximab or irinotecan .
6. Patients had to have adequate haematological (absolute neutrophil count \>1.5 × 109/l; platelet count \>100 × 109/l; haemoglobin \>9 g/dl), hepatic \[total bilirubin \<1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase \<2.5 × ULN, or \<5 × ULN in the case of hepatic metastases or \<10 × ULN in the case of osseous metastases; alkaline phosphatase \<2.5 × ULN, or \<5 × ULN or \<10 × ULN in the case of hepatic or osseous metastases, respectively\] and renal function (creatinine clearance ≥60 ml/min)
7. All RAS were wildtype. -

Exclusion Criteria:

1. Pregnant or breast-feeding women;
2. Clinically significant cardiac disease;
3. Lack of physical integrity of the upper gastrointestinal tract;
4. History of other malignancy;
5. Central nervous system metastases. -
A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).

Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).

The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria

  1. Patient identified as a KPC carrier.
  2. Patient capable to understand and sign informed consent
  3. Age \> 18
  4. Patient capable to receive oral medication

Exclusion Criteria:

* Exclusion Criteria:

  1. Patient unable to sign informed consent
  2. Age ≤ 18
  3. Pregnant/lactating female
  4. Patient not expected to survive \> 2 weeks.
  5. Patient unable or not allowed to receive oral medications
  6. A known allergy to study drugs.
Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.

Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject.
* Aged 18 to 75 years
* With a planned surgery:
* Of abdominal location
* Leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products)
* Absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit)
* Followed-up in surgery department
* Written and signed informed consent obtained
* Affiliated to the French Social Security system or equivalent.

Exclusion Criteria:

* Underlying pathology that may interfere with wound healing in the opinion of the Investigator (human immunodeficiency virus \[HIV\], cancer, immunodeficiency disease, generalized infection, systemic disease ...). The presence of low-risk prostate cancer according to the Amico classification (1) (PSA\<10 ng/mL and Gleason's score \< 6 and clinical grade T1c ou T2a) or a grade T1 (a or b) N0M0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria
* Inadequately controlled diabetes (Glycosylated hemoglobin \> 8%)
* Hypo or hyperthyroidism
* Intake of a systemic treatment with glucocorticoids or immunosuppressives
* Known allergy to one of study dressings components
* Participation in a clinical trial in the month prior to his/her inclusion in the study
* Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
Obesity-related Genes in Taiwanese Undergoing Weight Loss

To investigate:

1. Associations between miRNA and insulin signaling-related gene expressions in abdominal adipose tissues in obese subjects.
2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between genders.

Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese male and female subjects to elucidate the possible regulatory role of microRNA in insulin signaling-related gene expression levels and its association with biochemical markers. We hope to find a miRNA that can be used to predict the syndrome associated with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity,BMIs\> 40 kg/m2
* Subjects who underwent bariatric surgery

Exclusion Criteria:

* Obese subjects with complicated metabolic disorders
* Thyroid disease
The Effect of a Descriptive Norm Promoting Vegetable Selection in a Workplace Restaurant Setting: an Observational Study

Encouraging individuals to eat fruit and vegetables is difficult. However, recent evidence suggests that using social-based information might help. For instance, it has been shown that if people think that others are eating lots of fruit and vegetables, that they will consume more food to match the 'norm'.The purpose of this study was to determine whether social norm messages could be used to enhance vegetable purchases in workplace restaurants, in an observational study.

In this study the investigators hypothesised that placing posters containing social norm messages promoting vegetable consumption in three workplace restaurants, would increase the purchase of meals with vegetables, and that this effect would be sustained over time. The investigators recruited three restaurants to this study. For two weeks (Pre-intervention phase) the investigators used till receipts to monitor the number of meals sold with or without vegetables at baseline. For the following two weeks (Intervention phase) the investigators placed social norms posters around the three restaurants, while continuing to collect till receipts. After this, the posters were removed, and receipts were monitored for a final two weeks (Post-intervention).

Eligibility Criteria:
Inclusion Criteria:

* Purchase of a meal at one of the restaurants

Exclusion Criteria:

* None
Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.

With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.

The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.

Eligibility Criteria:
Inclusion Criteria:

* All females, 18 yrs and older, diagnosed with cancer (all types) and their partners
* Have began cancer treatment (surgical treatment, chemotherapy, radiation) - Are in a couple relationship
* Live in Iceland and are able to travel to site of intervention
* Speak and write Icelandic

Exclusion Criteria:

* Single females
* Do not read or write nor speak Icelandic
The Characteristics of Falls and Its Potential Predictors

A prospective study to examine the fall characteristics among elderly faller in Hong Kong and the potential predictors of falls incidence.

This will be a prospective study. One thousand and five hundred older fallers would be recruited. Baseline assessments would be conducted to examine potential fall risk factors and the fall history. The subjects would be followed up for 1 year for fall incidence. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 or older
* able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
* able to walk for ≥ 10 meters
* history of falls in the past 12 months
* living in the community
* able to understand Chinese

Exclusion Criteria:

* blindness
Muscle Strength in Shoulder and Neck Muscles in Tension Type Headache Patients. Effect of Specific Strength Training

Background:

Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance. Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with trapezius myalgia. It is shown that specific strength training leads to prolonged pain relief.

Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients with TTH compared to healthy controls.

Intervention: To investigate the effect of specific strength training on patients with TTH compared with control group, receiving training in ergonomics.

Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and shoulder. Testing conducted by blinded research assistant.

Intervention group: 60 patients with tension headache randomly assigned to the intervention group or control group. Intervention with specific strength training program runs for 10 weeks. The control group will be trained in ergonomics. 3 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* Tension-type headache(TTH), inclusion criteria were age between 18 and 65 years and for patients a diagnosis of TTH ≥8 headache days per month, and ≤3 migraine days per month according to ICHD-II -criteria.

Exclusion Criteria:

* Exclusion criteria were medication overuse headache (ICHD-II), previous whiplash or head trauma, other major physical or neurological diseases, depression, other mental illness, or being unable to understand and speak Danish. The patients were tested for cervicogenic headache according to Jull, et al 2007, and were excluded if the test was positive.
Repositioning Immunotherapy in VetArans With Lung Cancer

This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be more than 18 years of age.
* Patient must have a performance status of 0-1 (ECOG Performance Scale).
* Patient must be a candidate for concurrent chemoradiation.
* Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment
* PD-L1 tumor expression greater than or equal to 1%
* Presence of measurable disease according to RECIST v1.1
* Adequate organ function
* Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity).

Exclusion Criteria:

* Active autoimmune disease that has requires immunosuppressive therapy in the previous year.
* Uncontrolled primary or acquired immunodeficiency (including HIV)
* Baseline corticosteroid usage (\>10 mg prednisone or equivalent daily) aside from supportive medication use.
* Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions.
* Presence of significant comorbidities precluding participation in a clinical study as determined by investigator.
* Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Has known active Hepatitis B or Hepatitis C.
* Has received a live vaccine within 30 days of enrollment.
* Known diagnosis of Interstitial Lung Disease
* Inability to provide informed consent.
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)

This study will 1) Evaluate the prevalence of elevated (conditional or abnormal) transcranial Doppler (TCD) velocities in a cross-sectional analysis of children with Sickle Cell Anemia (SCA) living in Tanzania; 2) Obtain longitudinal data on TCD velocities in this population; and 3) Measure the effects of hydroxyurea therapy on TCD velocities and associated primary stroke risk.

Stroke Prevention with Hydroxyurea Enabled through Research and Education (SPHERE) is a single-center prospective phase 2 pilot study. It will enroll a convenience sample of children with SCA, obtain cross-sectional baseline data at enrolment, and follow them as a prospective cohort for a period of 24 months. The cohort will be divided into two arms based on the initial screening TCD result: 1) those who have a normal (less than 170 cm/sec time averaged mean velocity (TAMV)) initial screening TCD and will be an observation/control cohort; and 2) those who have an elevated initial screening TCD (either conditional (170-199 cm/sec) or abnormal (greater than or equal to 200 cm/sec) TAMV) and will be a treatment cohort that receives open-label hydroxyurea therapy as per the dosing and administration schedule. Those who are found to have a normal TCD at enrolment and are part of the observation/control cohort will undergo repeat TCD 12 months after enrolment. If the TCD at 12 months has changed to an elevated velocity (conditional or abnormal), the study participant can begin study treatment, but will not be included in the primary endpoint analysis. The primary hypothesis is after 12 months of hydroxyurea therapy, children with conditional TCD velocities will achieve a mean decrease of \>15cm/sec from their baseline TCD TAMV.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign informed consent
* Willingness to follow all study procedures
* Available for study visits for the duration of the study and no plans to move away from study center.
* Confirmed diagnosis of Sickle Cell Anemia (SCA) by haemoglobin electrophoresis.
* Able to take oral medication and follow hydroxyurea treatment schedule.

Exclusion Criteria:

There are no permanent exclusion criteria for participants to enroll in the screening TCD portion of SPHERE. Temporary, time-limited exclusion criteria for the screening TCD portion include the following:

* Febrile illness within the past two weeks. (Temporary Exclusion)
* Hospitalized within the past two weeks. (Temporary Exclusion)
* Transfusion within the past two weeks. (Temporary Exclusion)

Patients who enroll in the screening portion, have a conditional or abnormal TCD, and are eligible to start hydroxyurea will be excluded from receiving study treatment if they meet any of the following criteria:

* Abnormal pre-enrolment laboratory values (Temporary Exclusion)
* Known medical condition making participation ill-advised.
* Known allergic reactions to components of hydroxyurea.
* Previous history of stroke.
* Currently pregnant or lactating.