cyrilzakka/clinical-trials huggingface dataset:
Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity

Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Altered neurophysiological processes in SOR are documented, revealing reduced electroencephalogram at rest and P300 amplitudes, the latter tested through event-related potentials (ERP). Both may explain the failure to regulate incoming sensory stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.

Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction and Goal Attainment Scaling (GAS) scores in adults with SOR.

In this serial experimental research design, 10 individuals with SOR aged 21-45 years will participate. A medical and demographic questionnaire and the Sensory Responsiveness Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks pre-treatment; 2. before the first treatment session; 3. after the last treatment session; and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300 component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power using electroencephalogram resting state, and electronic versions of the Satisfaction with Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a week, will be held at the same time of day.

Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent variables measures change over time.

Eligibility Criteria:
Inclusion Criteria:

1. Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale.
2. free of analgesic medicines for no less than 24 hours before the sessions.
3. independent functioning in the community.
4. fluency in understanding and reading Hebrew

Exclusion Criteria:

1. metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis
2. acute or chronic pain.
3. regular intake of neurological, psychiatric and analgesic medicines.
4. participating in other therapies (i.e., cognitive therapies) at present.
5. substance abuse.
6. pregnancy.
Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS

The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* ii. Hospitalized with COVID-19 pneumonia, based on chest X-ray or CT scan AND iii. Evidence of hyperinflammation: IL-6\>40pg/mL (if available) OR CRP \>2 mg/dL OR ferritin \>2000 ng/mL AND iv. One or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation OR shock requiring vasopressor (without evidence of bacterial / fungal infection) OR need for extracorporeal membrane oxygenation (ECMO) OR severe, refractor ARDS (PaO2/FiO2\<200 mmHg)

Exclusion Criteria:

Known severe allergic reactions to tocilizumab or other monoclonal antibodies

* Active tuberculosis infection based on history
* Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months
* Participating in other drug clinical trials (participation in COVID-19 trials allowed)
* Self-reported pregnant or breastfeeding
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at baseline
* Absolute neutrophil count (ANC) \< 1000/mL at baseline
* Platelet count \< 50,000/mL at baseline
Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP

The purpose of this research is to see the effect of classic constraint-induced movement therapy and its modified form on quality of life of children with hemiplegic cerebral palsy. Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group. Study duration is of 6 months. Sampling technique applied will be purposive non probability sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included. Tools used in the study are Cerebral palsy (quality of life) and Kid Screen 27.

Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP. However conflicting evidence is present on which one of these is more effective and no final conclusion can be made to date. This study intends to add to the literature and contribute in reaching final conclusion about the superiority of either intervention. The purpose of this study was to see the psychosocial effect (quality of life) of CIMT and its modified form on HCP

Eligibility Criteria:
Inclusion Criteria:

* 4 to 12 years CP with unilateral, bilateral or severely asymmetrical impairment Manual Ability Classification System(MACS) I, II or III Wrist extension capacity at least 20°; fingers with 10° of complete flexion Children able to follow Command

Exclusion Criteria:

* Children also having disabilities other than Cerebral palsy Contractures that significantly limit functional arm use. Children with MR
ECA vs E-Document Explanation

This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent forms on their own as a supplement to the normal consent process done in research settings.

In a prior study, the investigators delivered a similar protocol, where subjects were first consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA + RA). Subjects in this protocol struggled with the concept of a "mock" consent process, especially after they had just completed a consent process for the study itself. The current protocol, using deception research methods, aims to provide a more pure assessment of ECA consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent as if it were reality. In the context of a protocol that employs deception methods, participants in the current study would be invited as healthy volunteers, and be randomized to 1 of 2 different consent processes to evaluate the relative benefits of different approaches for informed consent. After the knowledge tests have been completed, subjects will undergo a debriefing where they are made fully aware of the deception and its purpose. At that time, subjects will also be given the opportunity to "opt out" and not have their data included in the study results.

Participants who call in response to the clinic flyers will first confirm eligibility criteria of age (≥21) and language (able to complete a study visit in English). Once eligibility is confirmed, participants will be scheduled to come to BMC for a single study visit that will take approximately 60-90 minutes. Randomization to one study arm or the other will occur when subject arrives for appointment.

The following activities will occur at a single study visit:

1. administer sham consent (via e-consent or ECA per randomization result)
2. knowledge test
3. data collection

   1. socio-demographics
   2. health literacy assessment (REALM)
   3. ECA satisfaction (for ECA arm subjects only)
   4. Emotional connection (adapted PROMIS) (for ECA arm subjects only)
4. Debriefing

   1. Describe true study aims
   2. Opt out option (subject can request that their data not be used)

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* able to come in for a single study visit

Exclusion Criteria:

* Deaf
* Blind
RIRS Versus ESWL for the Treatment of Renal Stones

To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.

European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones \< 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).

Eligibility Criteria:
Inclusion Criteria:

* renal stone measuring 6 to 20 mm
* signing informed consent
* WHO performance status 0-2

Exclusion Criteria:

* Other stone \>5 mm
* concomitant ureteral stones
* BMI \> 35
* severe coagulopathy
* impossibility to sign informed consent
* pregnancy
* age \< 18 years old or \> 85
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.

Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.

Eligibility Criteria:
Inclusion Criteria:

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion Criteria:

* Active infection
* Urethral stricture
Vitamins, Breastmilk HIV Shedding, and Child Health

The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.

The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy

Eligibility Criteria:
This study is analyzing samples previously collected from the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257).

The inclusion criteria in this study was:

* HIV infected women presenting to antenatal care between 12 and 27 weeks of gestation
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

1. History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
2. Subjects with a history of autoimmune disorders.
3. Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy

12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.

Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Diagnosis of spastic Cerebral Palsy
3. Gross Motor Function Classification System level I-III
4. Stable medical background
5. Current medication will remain unchanged for 3 months
6. Provides informed consent
7. can walk at least 10 meters with or without assistive device
8. meets minimum study procedure requirements (elicitation of H-reflex).

Exclusion Criteria:

1. Pregnancy
2. uncontrolled diabetes
3. weak dorsiflexion
4. History of cardiac conditions
5. cognitive deficits that interfere with study procedure and steps for completion
6. Botox within 2 months of the study
7. H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)
8. regular use of electrical stimulation to lower extremity muscles
9. Cochlear or metal implantations on body
10. No history of seizure after age 2 years
11. Current use of antiseizure medicines
12. Any metal or magnetic components in the head (surgical clips, metal work etc.)
13. Implanted device or cardiac pacemakers (applicable for DS8R too)
14. Skin disorders
15. Damaged skin (wounds, broken skin, or recent scar tissue)
16. Allergy to latex (tape)
Efficacy of Preventive Ketamine on Postoperative Pain

* Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
* Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.


Eligibility Criteria:
Inclusion Criteria:

* - Body mass index \> 35 and \< 60 kg/m2
* Either medically free or with well controlled hypertension and/or diabetes.

Exclusion Criteria:

* - Patient's refusal to participate in the study
* BMI \> 60 kg/m2.
* Age less than 21 years.
* Patients with severe systemic disease which is not life-threatening.
* Patients on antipsychotics, antidepressants and/or corticosteroids.
* Patients with history of obstructive sleep apnea.
* Allergic reaction to any of the study medications.
Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care

One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.

In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".

A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:

Two objectives targeting the informal caregivers:

* offer spare time or tutored
* inform, support and accompany

Two objectives targeting the patients:

* encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
* contribute to improve functional cognitive and sensory capacities

The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).


Eligibility Criteria:
Inclusion criteria

* patient affect by Alzheimer disease or related pathology
* patient with an informal caregiver
* patient not using any respite structure
* signed informed consent (patient and informal caregiver)
* affiliate to social security

Exclusion criteria

* patient without informal caregiver
* patient include in another clinical protocol

Exclusion Criteria:

-
Time Restricted Eating on Cancer Risk

Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 and ≤ 67;
* Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing;
* Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;

Exclusion Criteria:

* Tobacco use (current or within last 2 years);
* Active malignancy or history of cancer;
* History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history);
* History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²);
* History of diabetes mellitus:
* History of cardiovascular disease (MI, CHF);
* Current prescription medication use for diabetes;
* Medication affecting glucose metabolism or appetite or immunosuppression;
* Dietary restrictions: currently following vegetarian or vegan dietary pattern;
* Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months;
* Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis);
* History of weight loss \>5% in the last 3 months;
* History of weight loss surgery.
* BMI≥40 kg/m² exclusion;
* After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period.
Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women

The primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.

CHWs identify women in the community in need of breast and/or cervical cancer screening. Based on their screening needs, they invite women to participate in the CLS behavioral intervention. Women are randomized to intervention and usual care comparison (delayed intervention) groups. After women are consented to participate in the study, the study team administers the baseline survey. After the baseline survey is administered, the CLS-adapted intervention (renamed Salud en Mis Manos), is delivered to participants randomized to the intervention group. After the follow-up survey is administered to the participants, women in the comparison group are offered the CLS (SEMM) intervention.

Eligibility Criteria:
Inclusion Criteria:

* women who identify as Hispanic/Latina ancestry or descent and live in the Greater Houston Area in Texas
* no previous diagnosis of breast or cervical cancer

Exclusion Criteria:

* Pregnant women, and women who are adherent to screening guidelines
* prior or current cancer diagnosis