cyrilzakka/clinical-trials huggingface dataset:
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients

This pilot clinical trial studies how well an iPad-based cognitive rehabilitation program works in improving quality of life in patients with grade II-III glioma. An iPad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed WHO grade 2 or 3 gliomas.
* Patients must be \> 18 years old
* Patients must have a life expectancy \> 12 weeks.
* Patients must have a Karnofsky performance status of \> 70.
* This study was designed to include women and minorities, but was not designed to measure differences between them. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
* Patients must speak and be able to read English fluently.
* All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
* Patients may not be known to be HIV-positive. HIV testing is not required for study participation.
* Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
* Patients must be receiving MRI scans at UCSF
* Patients must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 6 months
* Patients must be ≥ 6 months from craniotomy
* Patients must have subjective complaints of cognitive deficits.
* Patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics

Exclusion Criteria:

* Patients who are not able to comply with study and/or follow-up procedures.
* Patients who do not have home access to the Internet.
* Patients who, based on the physician's opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit
Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia

Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients.

This observational study was designed just to visualize the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers.Patients will be followed until Day 29 after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP, D-Dimers or ferritin levels; Bodyweight ≥ 40kg.

Exclusion Criteria:

* Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; Use of tocilizumab within 3 weeks prior; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC \<1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.
Nocturnal Hypertension and Nocturia in African American Men

This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in African American men.

We now went to pursue this correlation by designing a new NIH grant Proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will:

A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.

AIMS AND SIGNIFICANCE OF PILOT DATA

Determine:

1. The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
2. If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
3. The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
4. Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
5. Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.

Purpose:

Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.

Eligibility Criteria:
Inclusion Criteria:

* African American Men
* Age 35 to 79 year-old
* Able to give informed consent
* Pass the home sleep study
* Willing to wear the wrist Actigraphy monitor for 9 days continuously.
* Willing to wear ambulatory blood pressure monitoring (ABPM) for 48 hours twice during the 9 days of the study period.

Exclusion Criteria:

* Diabetes Mellitus
* Taking Prostate medication
* Symptoms of prostate disease or urinary urgency
* Sleep apnea

  1. A neck circumference greater than 17 inches
  2. Using Continuous Positive Airway Pressure (CPAP)
  3. History of a diagnosis of Sleep Apnea
  4. Apnea Hypopnea Index (AHI) \> 15 per hour
The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray

Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.

This study compares the 1-minute waiting time and 3-minute waiting time between the lidocaine spray and the EGD initiation. During the topical anesthesia stage, investigators give local spray with 6 puff on pharynx at the 0 minute in both groups. After the waiting time, EGD is inserted.

The baseline heart rate and blood pressure were recorded before EGD and during the EGD passing through pharynx respectively. After the whole procedure, enrolled patients will fill in the EGD quality questionnaire.

Through this study, investigators can figure out whether 1 minute or 3 minutes may be the optimal waiting time after lidocaine spray.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants included patients aged ≥ 20 years who scheduled EGD from OPD for dyspepsia, peptic ulcer disease, GERD, subepithelial lesion evaluation, and diarrhea

Exclusion Criteria:

* GI bleeding
* endoscopic submucosal dissection due to prolonged scheduled procedure time
* patients from emergency department or ward
Using Vaccum Assisted Closure of Wound Instead of Primary Closure As Prophylactic Way Against Burst Abdomen

A vacuum-assisted closure (VAC) device also known as negative pressure wound therapy (NPWT), is a medical treatment used to promote wound healing, it involves using a specialized device to apply negative pressure (suction) to a wound, which helps to accelerate the healing process.

Benefits :

Improved Healing: By removing excess fluid and reducing edema, the VAC device promotes faster wound healing and tissue repair.

Reduced Risk of Infection: The negative pressure helps to reduce bacterial load and create a more favorable environment for healing.

Enhanced Perfusion: The suction can improve blood flow to the wound area, aiding in the delivery of nutrients and oxygen essential for healing.

Granulation Tissue Formation: The therapy encourages the growth of new tissue (granulation tissue) which fills the wound and supports closure.

Overall, VAC therapy is a valuable tool in modern wound care, particularly for complex or difficult-to-heal wounds. If you or someone you know is considering or using this therapy, it's important to follow the guidance of healthcare professionals to maximize its effectiveness and manage any potential risks.

the study aim to evaluate patients , identify high risk ones , preparing to close wound of laparotomy with vaccum assisted device instead of primary closure with suturing till patient's general condition improve then delayed primary closure and comparing that to high risk patients who close wound primarily with suturing in terms of rate of burst abdomen ...this is a randomized controlled trial

Burst abdomen (abdominal wound dehiscence) is a severe post-operative complication. Incidence as described in literature ranges from 0.4% to 3.5% ... Burst abdomen is defined as post-operative separation of abdominal Musculo-aponeurotic layers, which is recognized within days after surgery and requires some form of intervention. Various risk factors are responsible for wound dehiscence such as emergency surgery, intra-abdominal infection, malnutrition (hypoalbuminemia, anemia), advanced age, systemic diseases (uremia, diabetes mellitus) etc.... Good knowledge of these risk factors is mandatory for prophylaxis... Patient identified as being high risk may benefit from close observation and early intervention

Eligibility Criteria:
Inclusion Criteria:

* intraabdominal sepsis (wbc:\>12000,HR\>90,T\>38,tachypnea and proven infection) Malnutrition including anaemia and hypoproteinemia Chronic diseases including diabetes and uremia Increased intra abdominal pressure including persistent coughing ,diffuse gaseous distention Smoking Previous abdominal surgery Old age Steroid use

operation : Emergency not elective ones Dirty or contaminated Those involving colostomy and ileostomy that is close to wound

Exclusion Criteria:

* Patients having elective surgery Absence of intra abdominal sepsis Negative exploration
A Study of Experimental Medication BMS-986278 Given to Healthy Participants

The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must be in good general health in the opinion of the investigator
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
* Body weight between 55 and 105 kg, inclusive, at screening
* Female participants must have documented proof that they are not of childbearing potential
* Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any major surgery within 6 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion

This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of macular edema
* Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria:

* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
* Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
* Any active ocular infection in either eye
Gestational Diabetes in Uganda and India Improving Screening and Self-management

This trial will evaluate a package of three interconnected educational/behavioural interventions aimed at: a) improving knowledge and skills of GDM guidelines and skills of health providers; b) raising awareness of importance of GDM screening among pregnant women and their families; and c) improving confidence and skills in self-management among those diagnosed with GDM. The interventions will be delivered through the medium of film as they are low-cost and scalable, and are particularly suitable for people who are not very literate, making them ideal for low- and middle-income countries (LMICs).

The research will be carried out in Uganda (Entebbe) and India (Bengaluru). A careful contextual analysis will precede the development of a culturally-tailored film-based intervention for each setting, which will be iteratively refined using qualitative research methods till it is fit for purpose. The effectiveness of the intervention will be evaluated in independent cluster randomised trials, involving \~10,000 pregnant women across 30 maternity units at each site. The films will be made available in the intervention arm facilities: for viewing by doctors and nurses at their meetings, for continual screening in waiting areas of antenatal clinics, and during group education sessions (and personal mobile use) for GDM patients. Where video/projection facilities are unavailable, small low-cost projectors will be made available. Control arms will follow usual care practices.

The principal research question is whether a low-cost educational/behavioural intervention delivered through a package of culturally-tailored films can provide scalable improvements in timely detection and management of GDM. This will be evaluated through assessing three endpoints: a) detection of GDM at 32 weeks of; b) glycaemic control (fasting glucose) in women with GDM at \~34 weeks of pregnancy; and c) adverse perinatal outcomes associated with GDM. Interviews will be conducted with women and health providers to help understand how and why the intervention may be (or may not be) successful. The ultimate aim of the project is to contribute to scientific evidence underpinning the use of films in cost-effectively scaling up behavioural interventions in low literacy settings.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 or over attending for antenatal care at participating health facilities.
* Pregnant women willing and able to give informed consent.

Exclusion Criteria:

* Pregnant women \<18 years
* No informed consent
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VX-670 at different single and multiple doses in participants with DM1.


Eligibility Criteria:
Key Inclusion Criteria:

- Documented clinical diagnosis of DM1 with age of onset greater than (\>) 1 year of age and documented positive genetic test for DM1 in the subject with cytosine thymine guanine (CTG) repeat of at least 100

Key Exclusion Criteria:

- History of any illness or any clinical condition as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Fascia and Fat Tissue Thickness in Healthy Individuals.

Instrument-assisted soft tissue mobilization (IASTM) technique can be used for non-pathological conditions as it has been shown in previous literature to affect flexibility and normal range of motion. The use of instrument-assisted soft tissue mobilization technique has been claimed to be an effective treatment in increasing tissue temperature, reducing adhesion to connective tissue and increasing collagen adaptation and increasing flexibility and normal range of motion. The instrument-assisted soft tissue mobilization technique works on the facial connective tissue in the body. This connective tissue contains "sheaths of collagen, which form the cavities and muscle divisions that mainly cover the organs." In some studies, they stated that instrument-assisted soft tissue mobilization increased perfusion, while in some studies they stated that instrument-assisted soft tissue mobilization increased blood circulation.

The frequency of ultrasonography (USG) examinations for the musculoskeletal system has increased over time with technological developments and USG has entered daily use in the evaluation of various pathological conditions belonging to this system thanks to its comparable results with MR examinations. The unique advantages of USG such as low cost, easy availability, relatively short examination time, and dynamic real-time comparison with the contralateral side have made it easier to use for musculoskeletal examinations.

The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization technique on strength, flexibility, balance, fascia and adipose tissue thickness in healthy individuals.

In the study, iASTM will be applied to healthy individuals and the effect of this technique will be examined. Demographic information of individuals will be recorded; Individuals will be evaluated in detail in terms of muscle strength, flexibility, balance, and fascia and adipose tissue thickness.

The work plan; pre-treatment evaluation, followed by treatment, second evaluation immediately after the end of treatment and control evaluation (third evaluation) 1 hour after the end of treatment. The data collection period is planned as 1,5 year.

Eligibility Criteria:
Inclusion Criteria:

1. Consists of healthy individuals between the ages of 18-35,
2. No history of orthopedic injury (muscle, tendon, joint capsule, ligament damage or peripheral neuropathy) in the lower extremities in the last 1 year,
3. Being able to express himself without cognitive, cognitive and mental problems,
4. Voluntarily agree to participate in the study.

Exclusion Criteria:

1. Injury to any lower extremity between measurements during the treatment process,
2. Having a BMI over 25,
3. Surgery or arthritis in the last 1 year,
4. Not being able or unwilling to do the tests,
5. Not wanting to leave of their own accord.
Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general neurology practices, or other academic or private practice settings) in the United States to assess the psychometric properties of the ARMS questionnaire in approximately 100 adult patients with MS who are experiencing a confirmed relapse, as identified by the investigator or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this study.

The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms affect daily activities and overall function, as well as patient's response to past treatments for previous relapses, as a means of guiding treatment selection. Part 2 is designed to evaluate treatment response in terms of symptom relief and functioning, as well as treatment tolerability. Part 1 of the survey is to be completed when the patient presents with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse of MS. Treatment for relapse will be at the sole discretion of the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent and HIPAA authorization must be obtained from the patient prior to any study-related procedures.
* Patient is ≥ 18 years of age at the time of participation
* Patient has confirmed MS relapse.
* Patient must have been treated with oral or IV corticosteroids for their previous relapse.
* Willingness to comply with all procedures and assessments.

Exclusion Criteria:

* Patient has pseudorelapse.
* Patient was treated with any therapies other than corticosteroids for their previous relapse.
* Any other condition which, in the opinion of the investigator, would not allow proper completion of this study.
Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.

This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.

The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).

The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.

Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-50, who gave birth in a vaginal birth

Exclusion Criteria:

* Sensitivity to Paracetamol or Ibuprofen
* After cesarean section
* Received analgesia prior to study recruitment
* Perineal tears grade 3 \\ 4
* Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
* Women with a diagnosis or medication for anxiety or depression
* Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week