cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders

The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients at Newbridge House
* Aged 11-18
* Primary diagnosis of any form of eating disorder
* Females

Exclusion Criteria:

* Previously received NEAT group at Newbridge House
* Aged under 10 years
* Severe learning disability
* Inpatients without compulsive exercise behaviours
* Day patients
* Co-morbid psychosis
* Males
Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).

Women with antiphospholipid syndrome (APS) have live birth rates as low as 10% in pregnancies without pharmacological treatment. Low dose aspirin (LDA) ,unfractionated heparin(UFH) , Low molecular weight heparin (LMWH) , prednisone, and intravenous immunoglobulin (IVIG) have been used either alone or in combination in order to improve the live birth rate in APS positive women with recurrent miscarriage. A Cochrane review of 13 randomized or quasi-randomized, controlled trials of various management options of pregnant women with a history of pregnancy loss and APL, revealed that combined UFH and aspirin was the treatment of choice which reduced pregnancy loss by 54% .

During the past decade , low molecular weight heparins were widely used in the prophylaxis and treatment of patients with venous or arterial thrombosis ,with an efficacy and safety superior or at least equivalent to that of UFH .Although recent studies reported the use of LMWH in the management of patients recurrent pregnancy loss secondary to antiphospholipid syndrome resulted in encouraging results . It is not clear whether the efficacy and safety of LMWH is equivalent to that of UFH .

Although LMWH is more expensive than UFH . LMWH has longer half life , greater bioavailability , more stable dose-response relationship than UFH and therefore can be administered once daily. Furthermore, LMWH requires less frequent monitoring than UFH and and has less adverse effect on bone mineral density and platelet count .These advantages make LMWH more attractive for the patients and physicians than UFH .

There are only two studies which compared the efficacy of LMWH plus LDA with that of UFH plus LDA in the management of pregnant women with recurrent pregnancy loss secondary to APS. In addition ,no randomized controlled study has yet compared the efficacy of LMWH plus LDA with UFH plus LDA.

The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a minimum of three consecutive pregnancy losses before 10 weeks gestation
* Positive lupus anticoagulant and/or anticardiolipin antibodies (IgG and IgM) on at least two occasions twelve weeks apart .
* Age between 19 - 37 years,
* Body mass index between 19-30

Exclusion Criteria:

* Parental chromosomal abnormalities
* Uterine abnormalities
* Luteal phase defect
* Systemic lupus erythematosus
* Previous thromboembolism
* Sensitivity to aspirin.
Assessment of Knee Arthrosis After Bariatric Surgery

Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Knee MRI is not currently part of the investigations preceding bariatric surgery.

Assessment of knee arthrosis in severely obese patients after bariatric surgery.

Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* bariatric surgery
* IMC \>= 35

Exclusion Criteria:

* those of bariatric surgery
* contra-indication to MRI
* pregnancy
Endostar for Locally Recurrent Nasopharyngeal Carcinoma

The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.

The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
2. No evidence of distant metastasis
3. More than 1 year from the end of the first course of radiotherapy
4. Male, or female not in the phase of lactating or pregnancy
5. ECOG 0-2
6. Aged 18-70 years old
7. WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
8. Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
9. Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence
2. Evidence of distant metastasis
3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
4. Severe, active co-morbidity
5. Prior anti-tumor treatment after diagnosis of local recurrence
6. MRI was not performed 3 months after the first course of radiotherapy
7. Abnormal function of heart, brain and lungs, etc
8. Lactation or pregnancy
9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Respiratory Emissions in Healthy Participants

This is an randomised cross over trial in healthy participants measuring respiratory emissions during different respiratory activities.


Eligibility Criteria:
Inclusion Criteria:

* Adults, over the age of 18 and able to give informed consent
* Symptom free from any respiratory illness in the last 48 hours

Exclusion Criteria:

* Pregnant (where the participant feels that their pregnancy will make participation uncomfortable)
* Inability to give consent
* Current respiratory disease. Participants with well controlled asthma will be included (defined as asthma that the participant self-rates their asthma as being under control and that does not limit exercise, work)
Evaluation of an Artificial Intelligence-Assisted, Image-Based Dietary Assessment Tool in the Framingham Heart Study

Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Further utilizing food recognition technologies to capture real-time food intake may aid in overcoming limitations of existing methods. Keenoa, an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data.

Primarily, the investigators will assess acceptability and usability of Keenoa compared with the traditional, web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in the Framingham Heart Study Third Generation-based cohorts at examination 4. The investigators will also determine the proportion of participants who complete all three days of dietary assessment, either through Keenoa or ASA24. Further, the investigators will relate dietary determinants of glycemic variability (e.g., percent carbohydrate, fiber intake, etc.), obtained from each dietary assessment tool, to the continuous glucose monitor (CGM)-derived outcomes.

With a randomized block design, this study will take place as part of the Framingham Heart Study (FHS) glucose study (R01 DK129305). Currently participants from the Third Generation-based cohorts are asked at their fourth examination to wear Dexcom G6 Pro continuous glucose monitor on either their arm or abdomen for a duration of at least 4 days. During this time, participants are asked to complete 3 consecutive days of dietary record through ASA24. For this trial, the investigators will randomize the dietary assessment tool weekly between ASA24 and Keenoa, therefore, depending on the week of administration, participants will be randomized to either a 3 days dietary record via ASA24 or a 3-day dietary record through Keenoa. This trial will last a total of 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* FHS participants from the Gen 3 cohort who will attend the Exam 4 cycle

Exclusion Criteria:

* Participants with cognitive impairment which may prevent them from being able to complete diet records and follow instructions for continuous glucose monitor device wear.
Yoga Impact in Fibromyalgia, Primary Health Care

This study aims to evaluate the effectiveness of a complementary therapy using Yoga within the scope of First Health Care in Portugal, in pain control, quality of life and well-being of the patients with Fibromyalgia. It also, pretends to assess the viability and to identify the barriers to this sort of therapy in the context of Primary Health Care.

Fibromyalgia is a chronic and debilitating pain syndrome characterized by widespread and persistent pain, also affecting sleep quality and cognitive function. It is estimated to affect 3.6% of the population; however, since it is a condition that is often underdiagnosed, the actual numbers may be higher. It is also an incurable disease, so treatment is based on symptom management through pharmacological therapy, which is not always effective. Due to the inadequacy of pharmacological therapy, there is a need for complementary therapies, and despite the limited number of studies conducted in this area, some therapies based on meditative movement (notably yoga) are beginning to emerge, with beneficial effects reported on pain management and quality of life in these patients. Therefore, this study aims to investigate the benefits and feasibility of this type of intervention at the Primary Health Care level.

Eligibility Criteria:
Inclusion Criteria:

* Users of the Family Health Unit diagnosed with Fibromyalgia;
* With cognitive capacity to answer the questionnaire;
* With physical capacity to take part in Yoga classes.

Exclusion Criteria:

* people under 18 years old.
Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.

Back pain is a common and expensive medical condition. Although rarely life-threatening, back disorders are a major cause of pain, disability, and social cost affecting the quality of life in most patients. Although primary care providers routinely treat back pain, little is known about how often primary care providers manage occupation-related symptoms and how outcomes compare with other treatment modalities. Treatment outcomes utilizing a non-operative treatment paradigm have not been adequately studied. This paradigm consists of treating patients sequentially with analgesics, physical therapy, use of back supports, caudal epidural steroid injections, or surgical referral. The use of spinal supports as a complimentary treatment along with physical therapy and posture education is promising.

Eligibility Criteria:
Inclusion Criteria:

* Patients must present with clinical symptoms of low back pain and evaluated by the study physician
* Visual Analog Score (VAS) for Pain \>6 in response to the following question: Circle one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain you experienced in last week."
* Patients must have x-ray and or an MRI film for diagnostic evaluation based on physician judgment.
* Age \>18; both male and female
* Pain duration \>3 months

Exclusion Criteria:

* Prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment
* Moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture
* Patients with diagnosed lumbar canal stenosis
* Serious concomitant medical illness (i.e., heart disease)
* Obese patients (twice the width of the Moller Orthopedic Back Support)
* Patients with moderate to severe scoliosis
* Past or present existence of a movement disorder, e.g., Parkinsonism, or any neurological disease that might affect ambulation and or postural changes History of osteoporosis
* Severe psychiatric disorder
* Prior spine surgery
* Multiple vertebral compression fractures with kyphosis
* Past or present workmen's compensation claim, SSI disability, or ongoing litigation
Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

To minimize multiple manipulations and to decrease the economical burden; here, we describe how to utilize the patient's own dislocated intraocular lens to re-fixate with the sclera.

When a scleral fixated intraocular lens (IOL) is displaced; routinely it is extracted and exchanged with another IOL and re-fixated to the sclera or another modality can be used. Both can carry many complications due to multiple manipulations. Nevertheless, suture and/or haptic end exposure is another expected future complication, which can range from foreign body sensation to endophthalmitis.

Here, the investigators utilized the same participant's IOL with minimum manipulations and the haptic ends buried inside scleral pockets to prevent future exposure and complications. The pocket entry is sutured with 8/0 vicryl, which is absorbable, to overcome complications.

Eligibility Criteria:
Inclusion Criteria:

* Dislocated primary scleral fixed IOL

Exclusion Criteria:

* Iris claw IOL
* Anterior chamber IOL
Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population

The purpose of this research study is to see whether a tele-health intervention can improve health, functioning status, emotional status, quality of life, and patient satisfaction for patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this intervention.


Eligibility Criteria:
Inclusion Criteria:

* equal to or greater than 18 years old
* 1 + past CHF diagnosis in LSU database, with history of CHF diagnosis extending back for 12 months
* LSU primary care or chronic disease clinic patient for equal or greater than 6 months.
* On CHF medication for equal to or greater than 6 months
* Have had a past echocardiogram
* Mental competency to consent and participate (determined by clinical judgment and chart abstraction)
* Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
* Currently-working conventional telephone line at primary residence
* Grounded electrical power supply at primary residence
* Anticipation of remaining in the LSU HCSD patient population for the next year
* Not on home oxygen therapy
* No planned surgery within the next six months
* Living at home (not institutionalized)
* No history of major organ transplant
* No diagnosis of metastatic or inoperable cancer
* Not under treatment for cancer
* Not under treatment for end-stage renal disease or end-stage liver disease
* 1 + emergency department visit or inpatient stay in past 12 months

Exclusion Criteria:

* Are on home oxygen
* Have a planned surgery within the next 6 months
* Have a history of major organ transplant
* Have a diagnosis of metastatic or inoperable cancer
* Are under treatment for cancer
* Are under treatment for end-stage renal disease or end-stage liver disease
* Have HIV/AIDS
* Have a cognitive condition, such as Alzheimer's or dementia that would make it difficult for you to understand how to use the tele-health device.
Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons

The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.

The investigators study is being conducted to evaluate and compare the seroresponses of the novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1 vaccination as part of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1 vaccination among HIV patients. Finally, the investigators will collect data on influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and influenza isolates causing ILI events will be genetically characterized.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Receiving the novel H1N1 vaccine (killed formulation) as part of routine clinical care
* A military beneficiary who expects to remain in the local area for the next 6 months

Exclusion Criteria:

* Healthcare worker who is involved in direct patient care
* Acute febrile illnesses within 30 days prior to H1N1 vaccination (e.g., pneumonia, influenza, ILI)
* Diabetes type 1 or type 2
* Systemic steroid or immunosuppressive medication use within 4 weeks of vaccination
* Active diagnoses of a cancer (non-melanoma skin cancer allowed).
* History of organ transplant
* Chronic active hepatitis B or C
* Active illicit drug use or alcohol abuse
* Blood transfusion within the last year
* Allergy to eggs
* Previous significant adverse reaction (e.g., anaphylaxis) to the seasonal influenza vaccination
* History of serious reactions to any prior vaccination (e.g., Guillain Barre Syndrome (GBS)).
* Received another vaccination in the last 4 weeks (receipt of seasonal influenza vaccination is allowed)
* Among females of childbearing potential, pregnant or within 6 weeks of being postpartum
* History of ILI which was confirmed as an H1N1 infection
An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

The aim of this study is to evaluate the efficacy of romiplostim administered at every other week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks after weekly doses of romiplostim.

Regarding the determination of appropriate dose, it is well known that romiplostim resulted in dose-dependent increases in platelet counts, but required dose for raising platelet count is variable between individuals according to each patient's ability to eliminate serum romiplostim. Because of this variability, after administration of initial 1mcg/kg of romiplostim, dose adjustment is recommended based on the platelet response to given dose of romiplostim. However, the optimal dose interval of romiplostim has rarely been studied. In pivotal studies, romiplostim was administered on a weekly schedule, and based on these studies, one dose at every week is being widely used. In one study in which ITP patients received weekly subcutaneous doses of romiplostim at a range from 3 to 15mcg/kg, half life of romiplostim was estimated from 1 to 34 days, suggesting that lengthening the interval between doses more than a week can be potentially possible in some patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has an ability to provide written informed consent prior to participating to the study
2. Subject is male or female ≥ 18 years of age
3. Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines.
4. Subject received at least 1 prior therapy for ITP including corticosteroids, immunoglobulin, or splenectomy, but had an insufficient response to any of these treatment (PLT count should be \< 30x109/L before romiplostim initiation.)
5. If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period

Exclusion Criteria:

1. Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
2. Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks
3. Subject has a known hypersensitivity to any recombinant E coli-derived product
4. Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
5. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
6. Subject is pregnant or breast feeding
An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea

This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia.
* Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
* If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

* Subject is pregnant, lactating or is planning to become pregnant during the study.
* Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
* Subject has used systemic immunosuppressants within 30 days prior to study start.
* Subject has used systemic retinoids within 6 months prior to study start.
* Subject has used any topical rosacea therapy within 14 days prior to study start.
* Subject has had laser or light therapy on the face within 3 months of study start.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
* Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study start (except subjects on stable dose for greater than 3 months).
* Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment by an ophthalmologist.
* Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.