cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active Rheumatoid Arthritis
* Inadequate response to anti-TNF
* Eligible for MabThera/Rituxan therapy according to physician's decision

Exclusion Criteria:

* According to Summary of Product Characteristics
Effect of Nutritional Efforts on Discharged Elderly Patients

The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise.

At the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge.

They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality.

If there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment.

The control group receives standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
* Age: 50+
* At admission, found in nutritional risk score ≥3 according to NRS-2002.
* On special food concept, Herlev's Glories during hospitalization
* Discharged to own home in a municipality in Planområde Midt (Ballerup, Herlev, Lyngby-Tårbæk, Gentofte, Gladsaxe, Rødovre, Egedal, Rudersdal, Furesø).
* Can read, hear and understand Danish
* Cognitive able to participate in the study, based on whether they are informed in time, place and own data.

Exclusion Criteria:

* Food allergy or intolerance
* Planned weight loss or following a special diet
* Receives enteral or parenteral nutrition
* Patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet
* Patients who does not want a food package or goodiebag
* Patients who are permanently bedridden
* Patients who are discharged to nursing homes or rehabilitation
* Patients in isolation
* Late palliative patients
* Terminal patients
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.


Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥ 18 and ≤ 65 years at the time of enrollment
2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS), myelofibrosis, or chronic myeloid leukemia
3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
4. Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
5. Estimated glomerular filtration rate (eGFR) \> 50 mL/minute
6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
8. Total bilirubin \< 1.5 times upper limit of normal (ULN) (\< 3 times if attributed to Gilbert's syndrome) and ALT/AST \< 3 times ULN

Key Exclusion Criteria:

1. Prior allogeneic HCT
2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
3. Planned donor lymphocyte infusion (DLI)
4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
5. Karnofsky performance score \< 70% (Appendix 12.7)
6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \> 4 (Appendix 12.8)
7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
8. Seropositive for HIV-1 or -2, HTLV-1 or -2
9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
11. History of idiopathic or secondary myelofibrosis
12. Women who are pregnant or breastfeeding
Comparison Between Isotretinoin, Silymarin and Both in the Treatment of Acne Vulgaris

This study aims to compare the effects of isotretinoin and silymarin or both in treatment of acne and their effects on the level of IGF-1, SAA1 and malondialdehyde (MDA) in acne patients.

Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. The pathogenesis of acne is multifactorial. Traditionally, four distinct processes were believed to play critical roles: increased sebum production, alteration of keratinization processes leading to comedone formation, follicular colonization by Propionibacterium acnes (P.acnes) and inflammatory mediators around pilosebaceous unit.

Orally administered isotretinoin is currently the only agent that can affect all four main factors implicated in acne.

Serum insulin-like growth factor -1(IGF)-1 is a polypeptide hormone that has effects on sebocyte differentiation and proliferation. It leads to lipogenesis, and synthesis of inflammatory cytokines. IGF-1 also stimulates androgen synthesis leading to overproduction of sebum.

Propionibacterium acnes can increase the release of serum amyloid A1 (SAA1) .There is significant elevation of SAA1 in patients with acne, with a positive correlation with its severity.

Oxidative stress plays a role in the pathogenesis of acne in part due to the generation of reactive oxygen species (ROS) in response to infection by the bacterium Propionibacterium acnes, which colonizes the skin and grows in plugged hair follicles, thus attracting inflammatory cells, mainly neutrophils. These in turn secrete inflammatory mediators and generate ROS, which augments the inflammatory response and tissue damage.

Silymarin, the main active component of milk thistle consists of a mixture of flavonolignans and flavonoid taxifolin. Silymarin acts as a hepatoprotective, anticancer, anti-inflammatory and immunomodulatory agent.

Silymarin acts as a free radical scavenger, stabilizes the plasma membrane and reduces the production of inflammatory mediators produced by P. acnes, and scavenges the released free radicals.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 years or more. Patient with moderate or severe acne. Not receiving acne treatment in the last month.

Exclusion Criteria:

* Pregnancy or lactation. Patients with known hypersensitivity to isotretinoin or silymarin. Patients with depression, liver diseases or high cholesterol. Patients with acromegaly. Patients with chronic inflammatory, infective or neoplastic disorders.
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Eligibility Criteria:
Inclusion Criteria:

* Meet legal criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Efficacy of the Memory Motivation (MEMO) Web Application Training

Memory, attentional, and behavioural symptoms are the clinical hallmarks of Neurocognitive disorders (NCD) such as Alzheimer's disease and related disorders. The World Health Organisation (WHO) guidelines for risk reduction of cognitive decline and dementia indicate that Cognitive training may be offered to older adults with normal cognition and with mild cognitive impairment to reduce the risk of cognitive decline and/or dementia. The use of Information and Communication Technologies (ICT) in the health domain is progressively expanding. The Alzheimer Innovation Association have developed MeMo (Memory Motivation) a free web application that can be used at home by patients.

The objective of the present study was to assess the effectiveness of employing the MeMo platform on cognitive performance in patients suffering from NCD.

The objective of this study is to evaluate the effectiveness of the MeMo cognitive training exercise platform in patients suffering from neurocognitive disorders. These exercises ,have been developed by the association Innovation Alzheimer and the CoBTeK research team, located with the Nice memory Center at the Institut Claude Pompidou. MeMo can be used freely at home by patients. More specifically, it is a randomized controlled study that aims to compare the evolution of activities cognition and behavior between patients not using these exercises, and patients using these exercises for 12 weeks, 4 sessions per week.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient consulting the Memory center
* older than 60 years old
* Mini Mental State examination score (MMSE) between 16 and 28 / 30
* met the DSM 5 diagnoses of mild neurocognitive disorders (mild NCD) or major neurocognitive disorders (Major NCD).

Exclusion Criteria:

* Patients not able to read and write French
* presence of a hearing or major visual impairment
* a history of premorbid mental retardation
* had already used the MeMo application
* were presently involved in structured memory training activities.
Eating Disorders and Autism Spectrum Disorders

This is an observational study where patients with eating disorders (ED) are compared with healthy controls without eating disorder (HC) regarding eating disorders features and autism spectrum features. Also patients will be reassessed after 5 years.

The first author who suggested that eating disorders (EAD) and autism spectrum disorders (ASD) share common features was Christopher Gilberg in 1980. Currently it is known that patients with ED have social impairment, which is also a risk marker to develop ED, eating disturbances are overrepresented in ASD, ED and ASD have common behavioural features such as rigidity, perfectionism, and harm avoidance; and common cognitive profiles such as inflexibility, high attention to detail, high scores in systemizing profiles and poor results in advanced theory of mind tests. This relationship is also supported by similar neural phenotypes such as atypical structure and function in social brain regions found in both disorders.

The aim of the present study is to explore the relationship between ED and ASD traits in a sample of Spanish participants diagnosed with AN, bulimia nervosa (BN), binge-eating disorder (BED) and other eating disorders (OED). Specifically, the investigators aim to explore possible differences within the different ED and its particular transdiagnostic features in association with autistic traits.

The sample will consist of 90 patients with ED and 45 healthy controls (HC) without any current or lifetime history of mental disorder, both groups will be compared regarding ED and ASD features. Also patients will be reassessed in a 5 year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Being Diagnosed with ED

Exclusion Criteria:

* language or intellectual impairment
Scapular Mobilization Versus Capsular Stretch

The goal of this study is to compare the effect of scapular mobilization versus posterior capsular stretch on pain, function, range of motion, and posterior capsular tension in patient with frozen shoulder

Frozen shoulder is a musculoskeletal condition that is commonly encountered in physical therapy practice. It is characterized by a painful, gradual loss of both active and passive glenohumeral motion resulting from progressive fibrosis and ultimate contracture of the glenohumeral joint capsule. Frozen shoulder affects about 2% of the general population, with a higher prevalence in people between their 40s and 60s. Frozen shoulder occurs more in diabetic patient.

The traditional principles of treatment of frozen shoulder are to relieve pain, maintain range of motion, and ultimately to restore function. The physiotherapy treatment of frozen shoulder consists of different modalities such as Transcutaneous Electrical Nerve Stimulation (TENS), Interferential Therapy (IFT), Ultrasound, Short Wave Diathermy (SWD) etc., and the physical therapy exercises such as stretching, Codman exercise can be used.

Scapular-mobility exercises, or scapular-mobilization (SM) techniques is widely used in the management of musculoskeletal disorders of the shoulder. Scapular mobilization can cause pain reduction with improvement in the shoulder range of motion. Scapular mobilization can reduce the disability in patients with shoulder dysfunction.

Posterior capsular stretch is applied along with mobilization which causes significant improvement in increasing range of motion and functional disability. Capsular stretching showed a more significant reduction in pain when compared to general exercises.

Therefore, what are the possible effect of scapular mobilization versus posterior capsular stretch in treating patients with frozen shoulder?

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged from 40-65 years old.
* Diabetic and non-diabetic patients' diagnosis of stage 3 frozen shoulder (frozen phase) by an orthopedist.
* The presence of pain and limited movement in the shoulder for at least 2 months.
* Passive joint movements are limited when compared with the normal side.
* Unilateral involvement.

Exclusion Criteria:

* Recent joint infection or surgery.
* History of shoulder subluxation, dislocation, or ligamentous injury.
* Shoulder arthroplasty.
* Shoulder and cervical pathology.
* Recent trauma.
* Neurological disorders with muscle weakness in the shoulder joint.
* Infection, pregnancy, carcinoma patients, severe cardiac or psychiatric conditions.
* Previous shoulder surgeries to the affected shoulder.
* Previous manipulations under anesthesia of the affected shoulder.
* Radiological evidence for glenohumeral joint arthritis.
A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis

The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.

MS-CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with Multiple Sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. It consists of a simple tool used by the patient to improve mood reporting. This then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. This dashboard launches straight from the patient's electronic health record (EHR). MS-CATCH was designed using extensive human-centered design in all phases of development, and HIPAA compliant REDCap for electronic data capture. While the tool requires institutional approvals to launch within the UCSF EHR, the design elements could be readily repurposed using these technologies to support other institutions' requirements. Each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the COM-B (Capability, Opportunity, and Motivation to change Behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18
* Ages 18 to 80
* PHQ-9 score of 5-19
* Any MS therapy, or no treatment
* California resident to enable clinical telemedicine visits if warranted during the study visit

Exclusion Criteria:

* Cognitive dexterity or visual impairment (typically defined as corrected acuity less than 20/70) that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to adhere to the study protocol
* Inability to provide informed consent
* Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder
* Substance abuse that in the treating neurologist's perspective could influence the patient's safety on study or adherence to study protocol
* Another co-morbid CNS diagnosis eg. TBI
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)

A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* HIV positive
* No active heart disease

Exclusion Criteria:

* Pregnant or breast feeding
* Unwilling to use birth control or abstinence to prevent pregnancy
* Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
* Plan to receive NNRTIs while in the study
* Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
* Alcohol or substance abuse
* Hepatitis
Way to Be Active III (Framing Incentives)

Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18.
2. Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

1. A score of "high" on the International Physical Activity Questionnaire (IPAQ) activity level scale
2. BMI less than 27
3. Pregnant or lactating
4. Participation in another physical activity study
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years at time of randomization
* Informed consent
* Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
* Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg

Exclusion Criteria:

* An estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
* Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg or DBP \< 85 mmHg
* Symptomatic(secondary) hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Individual is pregnant, nursing or planning to be pregnant
* Severe hepatic dysfunction
* Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)