cyrilzakka/clinical-trials huggingface dataset:
Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)

The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee osteoarthritis(OA)


Eligibility Criteria:
Inclusion Criteria:

* have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
* have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
* can speak and read English
* have a device with internet access that can be used for secure video conferencing for real- time remote supervision
* have no plan to change medication regimens for pain throughout the trial
* are able to travel to the coordinating center
* are willing and able to provide written informed consent prior to enrollment

Exclusion Criteria:

* history of brain surgery, brain tumor, seizure,stroke, or intracranial metal implantation
* serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)heart failure, or history of acute myocardial infarction
* alcohol/substance abuse
* cognitive impairment
* pregnancy or lactation
* hospitalization within the preceding year for psychiatric illness
Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)

The investigators are trying to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compare to obtaining renal access at the time of surgery.

We seek to identify whether the placement of a nephrostomy tract prior to surgery versus at the time of PCNL will: 1. decrease blood loss and related complications, and 2. decrease infection-related complications by providing the ability to an accurate collection of urine for culture and initiating appropriate antibiotic treatment prior to definitive stone management. In addition, we seek to determine whether renal puncture under fluoroscopic vs ultrasonic guidance is associated with less blood loss. Although retrospective studies have shown some benefit to placing the nephrostomy tube prior to surgery in terms of decreased blood loss, there are no well-designed, prospective studies comparing the two treatment approaches. We seek to determine which treatment approach is safer, more efficacious, and more cost-effective through a prospective, randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years to 90 years old,
* Patients with stone disease
* Patients who hoose to have PCNL for treatment
* Patients who understand the informed consent

Exclusion Criteria:

* Minors
* Unable to understand the informed consent
* Unwilling to fill out the SF 36 questionnaire
Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care

The registration system will enroll and follow up ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist. The diagnosis of ARDS must be made by an intensivist or chest physician. Including characteristics, co-morbidities, clinical features, laboratory data, organs dysfunction, treatments and outcomes of ARDS patients will be recorded.

Acute respiratory distress syndrome (ARDS) is defined as a syndrome of acute and persistent lung inflammation with increased vascular permeability and characterized by three clinical features: bilateral radiographic infiltrates; a PaO2/FiO2 ratio of 200 mmHg or less, regardless of the level of PEEP and no clinical evidence for an elevated left atrial pressure. If measured, the pulmonary capillary wedge pressure is 18 mmHg or less. In 1994, the American-European Consensus Conference on acute respiratory distress syndrome (ARDS) issued the above definitions that have been widely used by clinicians and researchers (1, 2) When patients with acute respiratory distress syndrome (ARDS), an age-adjusted incidence of 64 per 100,000 person-years and a mortality of 41 percent were detected. Within intensive care units, approximately ten to 15 percent of admitted patients and up to 20 percent of mechanically ventilated patients meet criteria for ARDS (3-6). The mortality rate varies on the basis of the underlying cause, with most patients dying of multi-organ system failure rather than isolated respiratory insufficiency (5, 7). Large trials suggest that the overall mortality of ARDS ranges from 26 to 58 percent (8, 9). The better outcomes always came from tertiary medical centers or big clinical trials, which somewhat might conceal the fact of presence of higher mortality. The mortality rate in our hospital ever reached or even up to 67.2%(10). To improve the quality of care in ARDS patients still has a long way to. We hope to establish a prospective registration system to understand the real status of quality of care first, and then quality improvement interventions will be followed.

Eligibility Criteria:
Inclusion Criteria:

* ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.

Exclusion Criteria:

* NA.
Immune Dysfunction in Allergic Asthma

We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Eligibility Criteria:
Inclusion Criteria:

Mild asthma, adults -

Exclusion Criteria:

children. on inhaled or systemic steroids

-
Methotrexate-associated Anti-TNF Combination Therapy, the Neglected One !

The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). The benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy).

Data on the use of immunosuppressive methotrexate treatment are divergent. Indeed, a previous randomized trial suggested that the combination of anti-TNF alpha including infliximab and methotrexate was no more effective than anti-TNF alpha monotherapy in patients with Crohn's disease. However, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time.

In practice, more and more practitioners are prescribing this combination (antiTNF and MTX) in IBD patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint.

The interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.

Data will be extracted from medical records (age, gender, smoking status, date of diagnosis of chronic inflammatory disease, date of first prescription of antiTNF alpha either infliximab or adalimumab, date of start and end of immunosuppressive azathioprine/6MP and/or metrotrexate, mode of administration of per os or SC/IV treatment, efficacy based on validated clinical scores HBI-PDAI-Mayo, tolerance). A collection will be made on the University Hospital from a computer workstation. An analysis will then be carried out to write the publication secondarily. The data retention period will be one year from November 2019 to November 2020 depending on the duration of this thesis work, which is estimated at one year.

Expected results and prospects : " Methotrexate-associated antiTNF alpha combination therapy is as effective and safe as traditional azathioprine combination therapy in patients with IBD. The positive results may in practice lead to changes in our practices and give first priority to this combination therapy with methotrexate. "

Eligibility Criteria:
Inclusion criteria :

- Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha

Exclusion criteria:

Subject unable to read
Remote Bimanual Virtual Rehabilitation Post CVD

The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);

8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation.

Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Age 48 to 80;
* Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
* English speakers;
* UE unilateral motor involvement (FMA score 10 to 45);
* Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
* Be more than 4 months post casting procedures or Botulinum toxin injections;
* Have cognitive skills to participate (Montreal Cognitive Assessment score 18-30).
* Potential participants will not be excluded due to co-morbidities such as Parkinson, frozen shoulder, or arthritis;
* Have normal cognition or MCI.

Exclusion Criteria:

* Be younger than 48 or older than 80;
* Present with severe visual neglect or legally blind;
* Have severe hearing loss or deafness;
* Present with receptive aphasia or severe expressive aphasia;
* Have uncontrolled hypertension (\>190/100 mmHg);
* Have severe cognitive delay;
* Cannot speak English;
* Have history of violence or drug abuse;
* Participants who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment will be excluded;
* Have severe hand spasticity and/or complete lack of arm movement;
* MoCA scores of 17 and below.
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.


Eligibility Criteria:
Inclusion Criteria:

* OI diagnosis
* increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

Exclusion Criteria:

* Any bisphosphonate use within one year of enrollment
Metabolomic Profile of Vitreoretinal Diseases: an NMR-Based Approach Using Vitreous.

The goal of this observational study was to learn about metabolomics profiles in vitreoretinal diseases by nuclear magnetic resonance (NMR)using vitreous fluid. The main question it aimed to answer was abnormal biomarkers for common retinal diseases such as idiopathic macular hole(IMH), diabetic retinopathy(DR) and retinal detachment(RD). Participants would not be subjected to any intervention and the investigators would only collect preoperative information and remaining vitreous samples. The investigators divided the participants into groups with appropriate disease names based on the disease diagnosis, such as IMH group, DR group, and RD group. The MH group was used as a control group, investigators compared other groups to see the metabolomic abnormalities.

This study aimed to analyze vitreous fluid using NMR to discover potential biomarkers for the prevention, early diagnosis, and treatment of vitreoretinal diseases and to reveal the mechanisms of disease progression. Patients suffering from IMH, DR, RD, idiopathic macular epiretinal membrane (IMM), and retinal vein occlusion (RVO) quiring for pars plana vitrectomy (PPV), who visited Renmin Hospital of Wuhan University, were chosen to participate in this study. Participants were not subjected to any intervention and the investigator only collected preoperative information and remaining vitreous samples. Participants provided preoperative examination information and medical history, and the investigators divided the participants into five groups with corresponding disease names based on the disease diagnosis, including five groups for five diseases: IMH group, DR group, RD group, IMM group, and RVO group. The control group for the diseases was the IMH group, and metabolomic differences were observed. These patients are usually treated with PPV, during PPV typically performed on these patients, vitreous fluid is usually disposed of as waste, and investigators collected 100-250 ul of the fluid for NMR analysis to see metabolomic characterization of these diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmation of IMH diagnosis with concomitant need for PPV surgery;
2. Confirmation of DR diagnosis with concomitant need for PPV surgery;
3. Confirmation of RD diagnosis with concomitant need for PPV surgery;
4. Confirmation of IMM diagnosis with concomitant need for PPV surgery;
5. Confirmation of RVO diagnosis with concomitant need for PPV surgery.

Exclusion Criteria:

1. Diagnosed vitreoretinal disease with no need for PPV surgery;
2. Previous history of PPV surgery;
3. Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;
4. Combination of serious systemic diseases such as hypertension and diabetes mellitus.
Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

* Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
* Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.

Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

Secondary objectives

* Impact of neoadjuvant CT on overall survival
* Impact and differential diagnostic value of linitis
* R0 resection rates
* 3 years recurrence free survival
* Overall 3 years survival
* Prognostic factors
* Prognostic value of the presence of a minority quota of signet ring cell
* Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
* Tolerance of (radio) chemotherapy for ADCI

Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.

Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

For whom the first consultation took place between January 1997 and January 2010

Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach

Planned study period The data will be collected over a period from January 1997 to January 2010.

The objective is to complete the data collection for summer 2010.

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.
* For whom the first consultation took place between January 1997 and January 2010
* As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.

Exclusion Criteria:

* Histological type other than adenocarcinoma
* Other localization than esogastric junction, esophagus or stomach
Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health

The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.

Participants in this study will participate in the following:

1. Provide a milk sample:

   If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon.
2. Answer questions about participant's health:

   Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history.
3. Fill out online questionnaires about participant's eating habits and mood:

   The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods.

   The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether.
4. The investigators will store the participant's sample and information in the Human Milk Biorepository:

   The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them.
5. The investigators will let researchers use the stored materials for approved research studies:

   Researchers can apply to study the samples and information stored in the Human Milk Biorepository.
6. If the participant agrees, the investigators may contact the participant with information about other research studies.

Eligibility Criteria:
Inclusion Criteria:

* Women who are 18 years old or older
* Breastfeeding
* Producing sufficient breast milk to donate an excess to the Biorepository

Exclusion Criteria:

* Women under 18 years old
Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation

california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation, pain, and improving active flexion range (AFLXN) range of motion, and functional recovery after stroke.

All the experimental group participants will receive conventional neuro rehabilitation for 45 minutes along with California tri-pull taping on the subluxed extremity. Lead researcher applied the CTPT method. The tape was applied as following manner.

Before the first intervention day, participants with hair on their shoulder or upper arm were asked to shave the area. Two types of tape was used, a self-adhesive 1.5" cotton undercover tape and a 1" rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape. The first piece (medial) was applied from 1.5" below the deltoid tuberosity running straight up the middle of the arm to 2" above the top of the glenoid fossa between the clavicle and the spine of the scapula. The second piece (posterior) was located from 1.5" below the deltoid tuberosity to 1.5" above the middle of the spine of the scapula. The medial border of this second piece ran along the acromial process. Last, the third piece (anterior) was located from 1.5" below the deltoid tuberosity to run around the front of the humeral head and over the coracoid process, up to 1.5" above the clavicle. The tape will removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient for 6 consecutive weeks.

Following the 6 weeks, each patients of both group was individually re-assessed and evaluated the effect of intervention and parameters were recorded. The recording and measurement obtained before and after intervention was subjected to statistical analysis and the result of that interpreted to obtain the significance of study.

Eligibility Criteria:
Inclusion Criteria:

1. Acute stroke.
2. A minimum of 5 mm (0.2 in) shoulder subluxation in the involved upper extremity.
3. Mini mental status examination (MMSE) score \>23.
4. Age (35-70 yrs.) and of either sex.
5. Brunnstroms stage 1 and 2. -

Exclusion Criteria:

1. Mini mental status examination (MMSE) score \<23.
2. Other musculoskeletal disorder of the affected upper extremity.
3. History of trauma to the affected upper extremity.
4. Hyper or hypo sensitivity disorders.
5. Any skin allergy.
6. Brunnstorm's stage 3 and 4.
7. Individual affected from neurological disorder other than stroke.
8. Un-cooperative patients.
9. Individuals with psychosomatic disorder
Laughter Frequency and Fibromyalgia Symptoms

The purpose of this study is to investigate whether daily laughter frequency is associated with pain intensity and emotional state ratings in individuals who have fibromyalgia syndrome.

Participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider.

Initially, participants will complete a demographics form and two screening assessments. Then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). At the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. They will carry the log with them throughout each day in order to document each instance of laughter.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have fibromyalgia syndrome

Exclusion Criteria:

* None.