cyrilzakka/clinical-trials huggingface dataset:
TMS in Borderline Personality Disorder Patients

The purpose of this study is to determine the potential effects of repetitive transcranial magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in borderline personality disorder patients. Specially in cognitive flexibility, inhibition control and social cognition.

This is a randomized, parallel group clinical trial to evaluate the efficacy of two protocols of repetitive Transcranial Magnetic Stimulation (rTMS), the application will be over dorsolateral prefrontal cortex (DLPFC) right and left, in patients with borderline personality disorder. 40 ambulatory patients with a borderline personality disorder diagnosis from the National Institute of Psychiatry in México will be included. All Patients will be randomly assigned and will complete a total of 23 sessions rTMS, in any of two groups:

5 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up). The rTMS will be applied over the left DLPFC at 5 Hz, 1500 pulses per session in 100% of Motor threshold

1 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up).

The rTMS will be applied over the right DLPFC at 1 Hz, 900 pulses per session in 100% of Motor threshold All sessions will be applied with a "Dantec" transcranial magnetic stimulator. The affective, borderline and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of the 8-weeks follow up. In same form for neuropsychological evaluations .

Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety, borderline and affective symptom scale scores between treatment groups will be compared using repeated measures ANOVA

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders IV text revision
* Treatment with selective inhibitors of serotonin reuptake
* Mass corporal index more than 19

Exclusion Criteria:

* Suicide risk or suicide attempt recent or actual
* History of epilepsy or seizures
* History of cranial trauma with loss awareness
* Intracranial or intraocular ferromagnetic devices, including skull prosthesis.
* Pregnant womens.
* Neurosurgery, cardiac pacemaker, lefthander
* Patients with psychotic symptoms, bipolar disorder or substance addiction.
The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

This study is planned to compare, in patients sedated, intubated and mechanically ventilated, the efficacy and safety of the Lateral Trendelenburg position in comparison to the Semirecumbent Position to prevent incidence of ventilator-associated pneumonia (VAP).

This study is planned to compare, in patients sedated, intubated or tracheostomized and mechanically ventilated, the efficacy and safety of two body positions in reducing incidence of ventilator-associated pneumonia. The semi-recumbent position prevents gastro-oropharyngeal aspiration of bacteria laden gastric contents and the "gastro-pulmonary" route of colonization. The lateral-Trendelenburg position aims to promote outward drainage of bacteria-laden oropharyngeal secretion, while avoiding bacterial translocation from the oropharynx into the lungs.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients expected to be oro-tracheally intubated for at least 48 hours or longer
3. Enrollment time window within 12 hours following intubation

Exclusion Criteria:

1. Current and past participation in an other intervention trial conflicting with the present study
2. Previous endotracheal intubation longer than 12 hours during the previous 30 days
3. Patients with documented bronchiectasis
4. Cystic fibrosis
5. Witnessed pulmonary aspiration either prior or at intubation
6. Patients with increased intracranial pressure, brain edema; or medical conditions that can worsen with increase in intracranial pressure
7. Patients with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA)
8. Spinal cord injury
9. BMI \> 35, or weight above 300 pound
10. Grade IV Intra-abdominal pressure: IAP \> 25 mmHg or abdominal compartment syndrome , defined as a sustained IAP \> 20 mmHg that is associated with new organ dysfunction / failure
11. Pregnancy
12. Orthopedic problems that will not allow the patient to be kept in one of the study positions
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.

The purpose of this study is as follows:

1. pain : VAS
2. Function : Roland Disability Scale
3. Side effect
4. Validity

Eligibility Criteria:
Inclusion Criteria:

* Having chronic, non-specific, LBP of at least 3 months' duration over 20 years old.
* Back pain must be the chief complaint
* Having normal neurological test
* Having signature voluntarily an IRB-approved consent form at enrollment

Exclusion Criteria:

* Potential spinal disease (e.g. a spinal tumor, infection or fracture etc)
* Other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc)
* Planned or got lumbar surgery
* The prior use of acupuncture within the past 6 months
* Inflammatory arthritis
* The current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants
* The involvement in legal problem related to LBP
* Refusal to be randomized
Transmission Of Respiratory Tract microOrganisms In a School Environment

Through contact with peers in daycare and (primary)school young children play a large role in spreading respiratory pathogens. In this study the investigators will investigate this transmission, the subsequent colonization and infection dynamics, and their association with clinical symptoms and local immune response through dense minimally-invasive sampling. This study will allow us a unique insight into the transmission-, infection-, and colonization-potential of the respiratory pathogens.

Respiratory tract infections impose a large burden of disease upon the world. Pneumonia remains the leading infectious cause of death in children under five worldwide. Known causative agents of pneumonia include, but are not limited to, Spn, Haemophilus influenzae (HI), Moraxella catarrhalis (MC) and viruses such as the Respiratory Syncytial Virus (RSV) and the influenza virus. These microorganisms are regularly found in the upper respiratory tract (URT) without causing severe disease. Colonization of the URT is thought to be important both for immune boosting and to provide competition for other potential harmful colonizers.

This study aims to provide insights into the processes and key host immune and microbiota factors that determine the infection kinetics, transmission and development of immunity during such infections. Furthermore, this study will enable us to closely study the transmission of commonly found microorganisms in an environment that is prone to transmission, the close quarters of school classes in which young children and their teachers spend a large part of their time.

Research within this specific population (risk-group and high transmitting group), young children and their teachers, is warranted. This is due to differences in the pediatric and adult mucosal immune system and infection and transmission dynamics, while animal models not being directly translatable to the human situation.

In this study the investigators will perform dense, longitudinal sampling within groups of closely interacting children and their teachers to study spread and colonization. Furthermore, by determining a range of biomarkers along with profiling the respiratory microbiome the investigators can look for markers predicting colonization and symptomatic infection.

By measuring airobiome through the EDC and air samples collected by a pollensniffer the investigators can measure local exposure to environmental microbes, human pathogens and pollen. This will allow us to compare immune responses and correlate this with clinical symptoms of RTI.

Eligibility Criteria:
There are 2 sets of eligibility criteria, one for participating children and one for participation teachers.

Children:

Inclusion Criteria:

* Within age-limit
* attending primary school

Exclusion Criteria:

* Insufficient proficiency of their parents in Dutch or English language

Teachers:

Inclusion Criteria:

* Adult teacher of participating primary school class

Exclusion Criteria:

* Insufficient proficiency in Dutch or English language
Qualitative Assessment of the Brief Contact Intervention "Stay in Contact" in Suicide Prevention

Background: For 40 years, brief contact interventions (BCIs) have been presented as promising approaches in suicide prevention but patient's experiences of BCIs are less investigated.

Aim: Understand mechanisms of BCIs after suicide attempt, through patient's experience of a French BCI "Stay in contact" and assess its impact on seeking care during suicidal crisis.

Method:This is a single-center, non-interventional, prospective qualitative study using phone call interview on a BCI, 6 months after suicide attempt behavior.

Statistical analysis

Data were analyzed using statistical software (Version 9.4, SAS Institute Inc., Cary, North Carolina, USA). Chi-squared test was used to assess qualitative variables and t-test to evaluate quantitative variables, with p\<.05 considered significant.

The baseline interviews were conducted on the phone, on weekdays, during a mean time of 10 to 15minutes by a trained resident in psychiatry as the only interviewer. The interviewer didn't participate in patient's medical care nor in the follow-up interventions. The interviewer didn't look in patients file before conducted over the phone interviews and had only administrative information on the study subjects: first and last name, age, sex, phone number. The phone call interview wasn't considered as an intervention. Whenever the interviewer judged necessary that a patient needed more intensive treatment, the relevant referral to help was done.

Eligibility Criteria:
Inclusion Criteria:

* be male or female, be aged 18 or older, have a situation permitting follow-up contacts by phone.

Exclusion Criteria:

* be placed under supervision by the law such as guardianship and curatorship, be incarcerated and refusing to participate to the BCI
Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother

Objective: The research was conducted to determine the effect of music and nutrition played together with motivational video on non-stress test (NST) result and mother's anxiety level.

Method: The study was conducted as a randomized controlled clinical trial. The sample of the study consisted of 360 pregnant women, two experimental and one control group (120 pregnant women in each). In the study, pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure. The second experimental group was provided to eat fruit juice and cake before NST, and the video created with a similar content was given about the developments and changes occurring in the mother and fetus during pregnancy, and was watched for about 15-20 minutes during the NST procedure accompanied by music that provided relaxation. The data of the study were collected by using the Participant Presentation Form, NST evaluation form and State Anxiety Inventory.

Non Stress Test (NST) has been used frequently in fetal health assessment in recent years due to its easy application, cheapness, reliability and rapid assessment. False negativity rates of NST also cause an increase in cesarean rates. Studies in recent years show that there are methods and factors that increase fetal movements and shorten NST application time. It was observed that nutrient intake, music playing, fetal acoustic vibration application and halogen light applications before NST increased fetal movements and shortened NST time.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 or over
* Being pregnant more than 32 weeks gestation,
* Having at least one live birth,
* Having had NST before,

Exclusion Criteria:

* Having any risk factor (preeclampsia, IUGG, early membrane rupture, getational diabetes etc.) during pregnancy
* Urinary contraction after NST,
* It is a cardiovascular disease diagnosed in the fetus.
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids

To determine the effects of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes and in urine (60 min). Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.


Eligibility Criteria:
Inclusion Criteria:

* Generally fit and healthy (determined by health screen questionnaire)
* Recreationally active (minimum 3 hours of physical activity per week including walking)

Exclusion Criteria:

* Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes
* Smoking (including vaping)
* BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5
Expanded Breast Cancer Registry and Tissue Repository

The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals are to improve the outcomes and quality of life of patients with breast cancer, and ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an infrastructure that can potentially be adopted as a model for a statewide registry and tissue repository for the discovery of biomarkers for this disease.

The goals of the EBCR are:

1. To register patients diagnosed with breast cancer and information relevant to their diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery, radiation, chemotherapy, hormone therapy, etc), and survivorship (Quallity of Life, etc).
2. To collect relevant demographics including age, menopausal status, race/ethnicity, body mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)
3. To establish a paired tumor tissue and blood sample for each relevant time-point (as defined in the protocol), which will be stored in the Tissue Bank Shared Resource Facility for future hypothesis-driven research.

Institutions and/or physicians are required to report each new diagnosis of breast cancer to the New Mexico Tumor Registry (NMTR). The NMTR is a valuable database that provides information on breast cancer, including trends in incidence and survival. However, relevant information on breast cancer prognosis and treatment is either not routinely collected or not readily available to the NMTR. We propose to establish an Expanded Breast Cancer Registry and Tissue Repository (EBCR) at this institution that could serve as an infrastructure for collection of this information. Furthermore, a tissue bank will be established for collection of paired tissue (tumor, buccal cells and blood sample) from patients diagnosed with breast cancer who consent to providing excess/extra tissue and additional blood for the Tissue Repository. This tissue bank will serve as a repository from which researchers can access tissue samples to conduct laboratory-based studies of genetic determinants of breast cancer risks, prognosis and survival in women with breast cancer seen in this institution.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with breast cancer, regardless of gender, ethnicity/race, stage of disease or treatment, are eligible.
* Patients must be less than or equal to one year from diagnosis of non-metastatic breast cancer OR less than or equal to one year from initiation of treatment for metastatic disease.
* Pathological diagnosis of breast cancer
* Expected availability of clinical follow up data
* Eighteen years old or older
* Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines

Exclusion Criteria:

* Not specified.
Respiratory Training in Hemodialysis Patients

Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and endocrine-metabolic systems. With regard to the musculoskeletal structure, there is progressive muscular loss with consequent increase in muscle weakness, limited resistance, exercise intolerance and fatigue, as well as functional and morphological abnormalities characteristic of uremic myopathy. Respiratory muscles are also affected as a result of uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of respiratory muscle training on muscle strength, functional capacity and quality of life of patients with chronic kidney disease on hemodialysis. Method: This is a prospective, randomized study involving 46 patients followed by the dialysis unit of a university hospital, over 18 years old, of both genders who underwent hemodialysis for more than six months and who signed the informed consent form. Patients will be allocated into two groups: respiratory muscle training with PowerBreath and control. All will be evaluated for demographic data, respiratory muscle strength, lung function, functional capacity and quality of life. The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath. Both groups will be reevaluated after three months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease undergoing hemodialysis for more than 6 months Both genders
* ged 18 years or older
* clinically stable
* who agreed to participate in the study by signing a free informed consent form

Exclusion Criteria:

* Patients with previous or current myoarticular or neurological disease;
* That require some urgent or elective surgical intervention during the protocol;
* Any cardiac decompensation such as arrhythmias, systolic blood pressure greater than 200mmHg or less than 60mmHg, diastolic blood pressure greater than 120mmHg or less than 40mmHg;
* Decompensated diabetes mellitus and acute systemic infection
Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy

The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.

Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1.

Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate.

Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60.

An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years. A female is eligible if she is not pregnant or breastfeeding. WOCBP must use 2 highly effective forms of contraception.
* Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection prior to Day 1.
* Participants with evidence of COVID-19 pneumonia assessed by radiographic imaging (chest x ray or chest CT scan).

Exclusion Criteria:

* Require HFNC, non-invasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.
* Have history of or current thrombosis. Only if current thrombosis is suspected, imaging testing is recommended (e.g. CTPA or per local guidance) to exclude thrombosis.
* Have a personal or first degree family history of blood clotting disorders.
* Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g. azathioprine, cyclosporine).
* Participants with any current malignancy or lymphoproliferative disorders that requires active treatment.
* Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19).
* Severe hepatic impairment, defined as Child-Pugh class C.
* Severe anemia (hemoglobin \< 8 g/dL)
* ANY of the following abnormalities in clinical lab tests at screening, confirmed by a single repeat, if deemed necessary: ALC \< 500 cells/mm3, ANC \< 1000 cells/mm3
* Known allergy to tofacitinib