cyrilzakka/clinical-trials huggingface dataset:
Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

The objective of the study is to evaluate the efficacy of home High Flow Oxygen for the reduction of severe exacerbation following admission for a severe exacerbation of COPD or death against standard oxygen therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with a diagnosis of COPD defined by GOLD guidelines
2. Admitted in hospital for AECOPD
3. With severe respiratory impairment defined by one of the following criteria (long-term oxygen therapy (LTOT) criteria):

   * Previously established on long-term oxygen therapy according to the following criteria: PaO2 \< 7.3kPa or \<8kPa with polycythemia, pulmonary hypertension or right heart failure on room air in stable condition Or
   * PaO2 \< 7.3kPa or \<8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index admission
4. Patients affiliated or, beneficiary of a social security cover
5. Patient who has read and understood the information letter and signed the consent form
6. For woman of childbearing potential, use of an effective contraception (oestro-progestatives or intra-uterine device or tubal ligation) since at least 1 month and an blood pregnancy test by β-HCG negative at the screening visit, during the duration of the study
7. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

Exclusion Criteria:

1. Age \<18 or \> 85 years
2. Patient treated with chronic NIV with ongoing treatment
3. Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis of OSA will be over-ruled in patient that had a previous overnight polygraphy. For patients who never had an overnight polygraphy, screening for OSA will be made using the STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix 1) is \>3, an Apnea-link recording will be performed. If AHI\>30/h, patient will be excluded.
4. BMI \> 35 kg/m2
5. Patient admitted for an acute COVID-19 infection
6. Hypercapnic respiratory failure justifying NIV defined as

   1. An Arterial Blood Gas (ABG) PaCO2 \> 7 kPa in stable condition within 6 months
   2. Patients with ABG PaCO2 \> 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
7. Pregnancy (blood pregnancy test positive) or lactation ongoing
8. Significant psychiatric disorder or dementia that would prevent adherence to study protocol
9. Tobacco use \< 10 pack-year
10. Expected survival \< 12 months due to any situation other than COPD disease
11. Refusal of high-flow oxygen therapy
12. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
13. Patients already involved in a research protocol that would impact with the outcome measured in the current protocol
ctDNA Methylation Sequencing for Myeloma

1. To carry out research on minimal residual disease (MRD) monitoring in patients with multiple myeloma (MM) based on plasma circulating tumor DNA (ctDNA) methylation sequencing, which aims to explore new MRD detection methods for MM;
2. Carry out ctDNA-based methylation sequencing in newly diagnosed, remission, and, relapsed MM patients, to track the clonal evolution patterns; and explore the in the initial diagnosis-remission-relapse stage of MM, track the clonal evolution characteristics of methylation profiles in MM patients during the disease progression.


Eligibility Criteria:
Inclusion Criteria:

- For myeloma patients: i) Age no less than 18 and no more than 75; ii) Diagnosed with symptomatic multiple myeloma according to IMWG consensus; iii) Provide informed consent in accordance with the declaration of Helsinki.

- For healthy controls: i) Age no less than 18 and no more than 75; ii) Provide informed consent in accordance with the declaration of Helsinki.

Exclusion Criteria:

- For myeloma patients: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.

- For healthy controls: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.
Perioperative Hypothermia: A Multi-center Study of Incidence, Risk Factors and Preventive Measures.

Aims:-

Primary:

To identify the incidence of intra-operative and post-operative hypothermia

Secondary:

To identify factors contributing to peri-operative hypothermia. To identify current anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures by anaesthetists in various hospitals.

To increase awareness of the problem of IPH and guidelines available.

Inadvertent peri-operative hypothermia (IPH) affects patients across all ages, occurring up to 50% in the unwarmed surgical patient. It carries significant morbidity and mortality including increased risk of myocardial infarction, bleeding, and surgical site infection, increased shivering and patient discomfort, as well as increased length of hospital stay. Guidelines have been published by the UK National Institute for Clinical Excellence (NICE) as well as the American Society of Anaesthesiologists. However, the compliance to such guidelines have been poor, and no local guidelines have been developed as yet.

A one month audit was conducted in KKH Department of Paediatric Anaesthesia in 2014 which collected data on the incidence of perioperative hypothermia in patients undergoing general anaesthesia for a variety of surgeries. This preliminary audit demonstrated a 33.7% incidence of hypothermia in PACU among 164 patients.

The investigators wish to carry out a more comprehensive audit to find out the incidence of IPH in both adult and paediatric surgical patients, identify risk factors and assess the current practice to prevent IPH across various healthcare institutions.

The study aims to find out the incidence of IPH, identify the risk factors involved and find out the current preventive measures in various local hospitals; if not already in place, bring awareness to this problem and improve patient outcomes. This is a cross-sectional observational study, aiming to recruit 4000 patients of all ages, across 5 institutions over the course of 6 months.

Patients will receive the current standard of care, as per the anaesthetist in charge, with regards to temperature monitoring, and the use of passive/active warming strategies. The method of temperature monitoring, warming or heat conservation techniques would be recorded and the patient's temperature would be measured at the recovery area post-operatively by the recovery nurse. In addition, patient demographics, surgical time, anaesthetic time, surgical procedure and method of anaesthetic, total fluids given, will also be recorded on a prospectively-designed data collection form.

Eligibility Criteria:
Inclusion Criteria:

* All cases within specified time frame under General anaesthesia (GA), Regional anaesthesia (RA), or combined General and Regional Anaesthesia (GA/RA) not involving the use of extra-corporeal circuits.

Exclusion Criteria:

* Cases done under Monitored Anaesthesia Care (MAC) or that have the use of extracorporeal circuits.

Patients that require direct admission to the intensive care unit (ICU) are also excluded as they do not transit through the recovery area.
Experience of Arab American Women With Breast Cancer: In-depth Interviews

The investigators are conducting a study entitled 'Experience of Arab American Women with Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's experience with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* AMBER participant diagnosed with breast cancer who attended at least 1 support group meeting
* Aged 18 to 85
* Arabic-speaking

Exclusion Criteria:

None
Eating and Physical Activity Patterns of the Population Working in the Uruguayan State Electrical Company.

Stuydy of eatin and physical activity patterns in Uruguayan workers and association with obesity, overweight, and tasks.

A sample of workers from the electrical company will be studies as to eating and physical activity patterns, weight variations, and assigned tasks.

Eligibility Criteria:
Inclusion Criteria:

* It will include all the officials who joined the company from January 1, 2010 to December 31, 2017, of whom they are between 18 and 65 years old, and the total was from 1964.

Exclusion Criteria:

* On the other hand, regarding the officials who meet the inclusion criteria, the following exclusion criteria are established. Therefore, those officials who:

  * Do not have a medical check-up at admission and at least one checkup between one year and two years after entering the company
  * Officials who no longer continue to work at the institution at the date of the study.
  * Participants who do not have weight and height recorded in the medical record
Optimizing Social and Communication Outcomes for Toddlers With Autism

This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

The proposed research tests a theoretically and empirically derived treatment approach aimed at facilitating change in joint attention interactions between caregivers and their toddlers with autism. Young children with autism show impairments in engaging in joint attention skills such as pointing and showing. The importance of joint attention is underscored by data showing that these skills are important to later development of language. Yet these interaction and skills deficits have rarely been the focus of systematic intervention efforts, particularly with caregivers. Moreover, current interventions for young children wiht autism are behavioral in approach, therapist driven, and often exclude the lowest functioning and developmentally youngest children. Thus, targeting these deficits in developmentally young children using familiar caregivers may result in better language outcomes for these children.

The overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused on joint attention intervention with their toddlers versus mothers who receive parent education about autism and child development.

The Primary aims of this research are as follows:

* Aim 1: To determine if caregiver mediated intervention on joint engagement is superior to caregiver education on social communication and language outcomes in children.
* Aim 2: To determine if skill development in the context of caregiver child interaction transfers to interactions with classroom teachers and peers.
* Aim 3: To examine characteristics of families and children that best predict social-communication outcome.

Eligibility Criteria:
Inclusion Criteria:

* Child meets screening criteria for PDD
* Not currently enrolled in a pre-existing intervention program
* Parent is available for intervention
* Child must be ready to start in the Early Childhood Partial Hospitalization Program (ECPHP) at UCLA

Exclusion Criteria:

* Child does not have other sensory or genetic disorders
* Children already on medication on the outset, although we find few toddlers already on medication when they begin treatment. If children begin medication after treatment commences, then we will keep all informatin and data pertaining to possible medication effects and statistically convey medication use if necessary
* Co-morbidity, participant diagnosed with other diseases
* Family/participant unable to follow-up
Postoperative Analgesia Impact of Narcotic Free Anesthesia

The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* 18 to 65 years old
* ASA 1 or 2
* First breast surgery
* Unilateral breast cancer
* Partial mastectomy or radical modified mastectomy ± axillary dissection

Exclusion Criteria:

* Allergy or contrindication to any medication figuring in the protocol or to Aspirin
* Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug
* Narcotic consumption in the past month of 10 mg/day of morphine equivalent
* Chronic pain
* Moderate to severe asthma
* BMI of more than 40
* Diabetes
* Chronic renal or hepatic faiure
* Heart failure
* Anticipated difficult airway
* High grade heart block or bifascicular block
* Mental retardation
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia

Coronary heart disease and stroke are two main causes of human deaths and is directly related to increased levels of plasma lipids.High total cholesterol and low high density lipoprotein cholesterol concentrations are often associated with endothelium dysfunction and inflammation, which can be followed by atherosclerosis.

Rhus coriaria L. (Rhus) with the public name of "Somagh" is a plant species in the anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran, Turkey and Arabic countries).

In a double blind randomized placebo-controlled clinical trial, the investigators want to evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with hyperlipidemia.

Rhus (Somagh) is found in temperate and tropical regions worldwide, often growing in areas of marginal agricultural capacity. Rhus is used as an herbal remedy in traditional medicine because of its assumed analgesic, antidiarrhetic, antiseptic, anorexic and antihypergylcemic properties. The fruits of Rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids such as malice, citric and tartaric acids. Some studies have shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and could be regarded as bioactive compounds with a high potential health-promoting capacity. Phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance the activities of detoxifying enzymes.Moreover, the hypocholesterolemic action of dietary polyphenols has been reported. The hypocholesterolemic effect of Rhus fruit powder and its components have been reported previously in rabbits and mice.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-65 years
* Serum triglyceride \>150mg/dl AND/OR total cholesterol \>= 240mg/dl

Exclusion Criteria:

* Serum triglyceride \> 500 mg/dl
* Serum LDL-cholesterol at level which need drug treatment according to the patient risk categories (NCEP-ATP III)
* Diabetes mellitus
* Hypo. or hyperthyroidism
* Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
* Use of drugs: OCPs, lipid lowering agents, thiazides
* Pregnancy
* Alcoholism
* History of allergic reaction to Somagh
Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff pressure.


Eligibility Criteria:
Inclusion Criteria: :

* Patients intubated in the ICU with a high volume / low pressure PVC-cuffed tracheal tube
* Predicted duration of mechanical ventilation \> or = 48h
* Age \> or = 18 years
* signed informed consent

Exclusion Criteria:

* Contraindication for semirecumbent position
* Contraindication for enteral nutrition
* Pregnancy
* refuse to participate to the study
Interpersonal Psychotherapy Online Training Study

Interpersonal psychotherapy (IPT) is an evidence-based therapy for the treatment of eating disorders (including binge eating disorder, bulimia nervosa, and disordered eating not meeting full diagnostic criteria). On a basic level, IPT is a time-limited treatment that helps the client understand the relationship between symptoms and social interactions. Traditional training methods require substantial cost, time, and resources, making evidence-based treatments difficult to disseminate. As such, college clinicians are not typically trained in IPT delivery, which prevents their clients from reaping the potential benefits of treatment. This study will attempt to show how technology can overcome such barriers to training dissemination.

The purpose of this study is to see if online training in IPT is as effective as in-person training. To find out, the following procedures will occur: First, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the "gold standard" training (the group receiving in-person training in an associated, IRB-approved study, # 201111113).


Eligibility Criteria:
THERAPISTS:

Inclusion criteria:

* Therapist must be a staff member at the counseling center and have a patient case-load large enough to be able to complete data collection at the different time points (\>8 hours/week)
* Staff member is expected to continue working at the counseling center for several years • Postdocs who anticipate to be at their center for at least one year are eligible

Exclusion criteria:

* Therapists from all universities affiliated with the NIH-funded trial (IRB# 201111113)
* Therapists working less than 8 hours/week
* Therapists who are anticipating leaving employment at the recruited counseling center within the time frame of the study including, but not limited to trainees and interns
* Therapists for whom their administrative duties preclude seeing a sufficient number of clients to be able to complete data collection at the different study time points
* Therapists who do not see students seeking treatment for eating disorders
* Individuals who are non-degreed trainees (i.e., psychology interns)

STUDENTS:

Inclusion criteria:

* Student patients of therapists who seek counseling services at their respective schools
* Students exhibiting symptoms of an eating disorder

Exclusion criteria:

• Students exhibiting symptoms of anorexia nervosa
Plantar Fasciitis, Operation or Conservative Treatment

The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.

Plantars fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development ( Orthosis and glucocorticoid injections are 2 widely used treatments and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain.

Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects .

However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment.

The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.

Eligibility Criteria:
Inclusion Criteria:

* pain at the medial attachment of fascia plantaris
* first step pain in the morning
* symptoms for at least 3 months
* ultrasound scanning at the first visit shows thickness of the proximal fascia above 4 mm
* patient can read and understand danish

Exclusion Criteria:

* known arthritis inflammatory bowl disease, psoriasis or clinical signs of any of these.
* leg ulcerations
* long lasting oedema of the leg and foot
* palpatory decreased puls in the foot
* diabetes
* reduced sensibility in the foot
* infections in the foot
* daily use of pain killers
* pregnancy or planning to become pregnant
* earlier operations on the foot, that is judged to complicate training.
* patients assessed not to be able to participate in the training for other reasons
* Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months
Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.

At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).


Eligibility Criteria:
Inclusion Criteria:

* Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
* Age: no limit

Exclusion Criteria:

* Stage IV breast cancers