cyrilzakka/clinical-trials huggingface dataset:
Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups

Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.

According to the Haute Autorité de Santé (HAS), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. In addition, a significant decrease in satisfaction with meals was observed with increasing level of dependence.

The objective of the study is to evaluate the feasibility of implementing the finger food in care settings that could have a positive impact on the nutritional status of elderly people living in EHPAD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
* Presenting at least one of the following 3 criteria:

  * Unintentional weight loss ≥ 5% in 1 month
  * Involuntary weight loss ≥ 10% in 6 months or compared to the usual weight or compared to the weight at entry to the EHPAD
  * Confirmed sarcopenia:

    * Male (at least one of the 2 criteria):

      * Dynamometer (kg): \< 27 AND calf circumference (cm): \< 31
      * Impedancemetry: appendicular muscle mass index \< 20 kg OR appendicular muscle mass index \< 7 kg/m²
    * Woman (at least one of the 2 criteria):

      * Dynamometer (kg): \< 16 AND calf circumference (cm): \< 31
      * Impedancemetry: appendicular muscle mass index \< 15 kg OR appendicular muscle mass index \< 5.5 kg/m²
* Loss of autonomy according to the Tully scale \< 12/18 with a score of 2 or 3 on the item "Able to bite, chew, swallow without making false routes"
* Person having given free, informed and express consent
* Person having an affiliation to a social security scheme

Exclusion Criteria:

* Protected person: safeguard of justice
* Swallowing disorder having a contra-indication to the texture of hand-eating meals.
* Lack of motor skills in both hands
* Specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition
* Wearer of a pacemaker
Effect of Dairy Fat on Plasma Phytanic Acid in Human

The aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.


Eligibility Criteria:
Inclusion Criteria:

* sign written consent
* Age: 20-42
* BMI: 20-30
* increased risk of developing MS
* refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

* poor compliance
* if they suffering from any chronic or long lasting illness
* abuse of alcohol or medicine
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling.

The study will look at data from a large, US-based group of RA patients who have taken the below medicines:

* Tofacitinib
* Abatacept
* Tocilizumab or sarilumab

The study will compare clinical disease activity scores of patients on the different medicines taken. The study will also decide whether some patient traits or disease factors play a role in how medicines may improve disease activity.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years on the cohort entry date.
2. Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:

   1. At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist;
   2. At least one inpatient visit with a RA diagnosis code;
   3. At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or
   4. At least one outpatient record with an RA diagnosis and a prescription or fill for a disease modifying anti-rheumatic drug (DMARD) from a specified list and does not have any of the non-RA conditions for which those drugs may also be prescribed.
3. Initiation of specified biologic or targeted synthetic molecule DMARDs of interest for treatment of RA (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, tocilizumab, or sarilumab).
4. At least 180 days of baseline data available prior to and including the cohort entry date.
5. At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).

Exclusion Criteria:

1. Patients diagnosed with concomitant indications for tofacitinib \[psoriatic arthritis (PsA), UC, and polyarticular course juvenile idiopathic arthritis (pcJIA)\] at any time prior to cohort entry date, determined by at least two (2) diagnosis codes at least 30 days apart and prior to baseline.
2. Patients with \>1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.
Microwave Ablation in Mild Axillary Hidradenitis Suppurativa

With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease of the hair follicle, and is predominantly located in the axillary, inguinal and anogenital regions. Current treatment options for HS include systemic oral antibiotics, anti-TNFα, and surgery, which are used to treat the consequences rather than treating the primary pathogenesis of HS. With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles, eccrine and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years of age) male or female patients with mild HS and able to participate, willing to give written informed consent and to comply with the study restrictions;
* Minimum of 3 AN-count located in each axilla;
* Maximum of 5 AN-count located in each axilla.

Exclusion Criteria:

* Patients with \>1 abscesses or draining fistulas per axillary region;
* AN-count ≥ 5 in other regions than the axillary area;
* Any current and / or recurrent clinically significant skin condition in the treatment area other than HS;
* Surgical scars covering more than 25% of each individual axillary area;
* Open surgical wound(s) in the axillary areas prior to randomization;
* Use of anti-inflammatory or immunomodulatory medication (intralesional corticosteroids, oral antibiotics, biologics, prednisone) within 2 weeks prior to randomization;
* Contraindication for miraDry therapy;
* Heart pacemakers and other electronic device implants;
* Supplemental oxygen;
* Resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine;
* Previous use of miraDry therapy or MWA in the axillary area;
* Previous use of successful laser or light therapy for hair removal in the axillary area;
* Use of botulinum toxin injections 6 months prior to randomization;
* Use of aluminiumhydroxychloride 1 month prior to randomization;
* Pregnant or lactating women at randomization.
Randomised Controlled Trial for the selfBACK Project

The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.

The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain.

The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.

The weekly plan includes three categories of content;

1. information/education
2. recommended daily number of steps
3. recommended strength and flexibility exercises

Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
* LBP of any duration
* Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
* Age: ≥18 years
* Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
* Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

Exclusion Criteria:

* Not interested,
* Unable to speak, read or understand the national language (Danish/ Norwegian),
* Cognitive impairments or learning disabilities limiting participation,
* Mental or physical illness or condition limiting participation,
* Inability to take part in exercise/physical activity,
* Fibromyalgia (diagnosed by a health care professional),
* Pregnancy,
* Previous back surgery
* Ongoing participation in other research trials for LBP management.
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS)

Ankylosing spondylitis (AS) is a chronic, progressive inflammatory rheumatic disease involving primarily the sacroiliac joints and the axial skeleton. The main clinical features are back pain and progressive stiffness of the spine. Oligoarthritis of the hips and shoulders, enthesopathy, and anterior uveitis are common, and involvement of the heart and lungs is rare. The current understanding of the pathogenesis of this disorder is limited.It mainly about to hereditary susceptibility (eg hla-b27),infection and autoimmunity.

Although traditional drugs, such as Nonsteroidal antiinflammatory drugs (NSAIDs) disease-modifying antirheumatic drugs (DMARDs such as MTX,SASP OR thalidomide) and steroids have been used in the treatment of AS, however, many studies have indicated that the overall response to these drugs is not satisfied. Addition, the severe side effects of these drugs have also been observed. The management of AS patients therefore remains unsatisfactory and targeted therapies are needed. Human MSCs isolated from human umbilical cord/placenta have been shown to have immunoregulatory, immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplantation in the AS patients.

This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant +DMARDs therapy (experimental group) or DMARDs therapy (control group). Patients will undergo MSC transplant at the start of the study on Day 0. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age 18\~60 years old with plan to infuse MSCs.
2. Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria
3. Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted
4. Patients must have an ECOG 0\~2.
5. No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/L.
6. No severe infection.
7. Each patient must sign written informed consent.

Exclusion Criteria:

1. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)
2. Psychiatric condition that would limit informed consent.
3. HIV, hepatitis B or C, tuberculosis, other infections
4. Positive Pregnancy Test or lactation
5. Patient has enrolled another clinical trial study within last 4 weeks.
6. Contraindications to MSC
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

No data to be entered.

Eligibility Criteria:
Inclusion Criteria

1. Signed Informed Consent Form, prior to screening evaluations
2. In good physical and mental health
3. Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion Criteria

1. Any clinically significant systemic disease
2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
3. History of recurrent miscarriage
4. Undiagnosed vaginal bleeding
Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

This study is an early Phase II double-blind, pilot randomized controlled clinical trial. The study team will use a permuted block randomization design stratified by a Posttraumatic Stress Disorder (PTSD) severity median score on the PTSD Checklist (PCL-5) derived from a recently completed STRONG STAR repository. Participants will be up to 24 individuals with PTSD to investigate the safety, feasibility, and PTSD symptom change associated with CBD 250mg taken twice a day for 18 days (n=up to 12) vs. placebo (n=up to12) in combination with a standard of care, 10-sessions massed PE psychotherapy administered over 2 weeks. Aims 2 and 3 will evaluate biochemical and physiological outcomes associated with the brain endocannabinoid (eCB) and PTSD that may be affected by CBD. Permuted block randomization is advantageous in small clinical trials to ensure equal allocation of participants in each condition. Participant randomization will be subdivided into randomized blocks of four, two patients in each block will be assigned to CBD and two will be assigned to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the age of 18 to 65 years old at time of screening.
2. Able to write, read, and speak English
3. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
4. Stable medication regimen for at least four weeks prior to the onset of study participation.

Exclusion Criteria:

1. History of opiate, cocaine, methamphetamine, benzodiazepine, or cannabis abuse as determined by the National Institute of Drug Abuse Quick Screen (NIDA-Q).
2. Currently using opiates, cocaine, methamphetamines, benzodiazepines, or cannabis as evidenced by a positive urine drug screen prior to enrollment.
3. Currently pregnant as determined by a positive urine pregnancy test prior to enrollment.
4. Current clinically significant alcohol abuse in the past two weeks on the Quick Drinking Screen (QDS).
5. Currently breastfeeding.
6. Ongoing illness or physical health problem(s) that may be exacerbated by CBD (e.g., history of liver problems)
7. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to cannabinoids.
8. Concomitant medications with possible CBD-drug interactions
9. Alanine transaminase (ALT) or Aspartate transaminase (AST) enzyme levels 3x normal limits.
10. Concurrent engagement in trauma-related psychotherapy for PTSD.
11. Current or past DSM-5 diagnosis of psychotic disorder or bipolar disorder as determined on the Mini International Neuropsychiatric Interview (MINI 7.0).
12. Suicide attempt in the last year and/or suicide risk requiring immediate intervention or requiring a higher level of care than can be provided by the study treatment as determined by the Self-Injurious Thoughts and Behaviors Interview (SIT-BI).
13. Allergy to sesame seed oil.
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)

This prospective cohort study will provide information about:

Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time.

The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility Criteria:
Inclusion Criteria:

* All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018

Exclusion Criteria:

- For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded
Study Using the CervicalStim Device Following Cervical Fusion

This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.

The purpose of this post market prospective study is to examine the effect of the adjunctive use of the Orthofix CervicalStim device on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. High risk subjects are those who are having a multi-level (2 or more) cervical fusion, who are smokers, who are diabetic or those who are osteoporotic. Because this is a post market prospective study, subjects who are enrolled in this study will be identified by the Investigator as needing cervical fusion surgery and asked to participate in a study looking at the efficacy of cervical fusion with adjunctive use of the CervicalStim bone growth simulator. The type of cervical fusion surgery performed is up to the Investigator; the subjects in the study must be agreeable to using the bone growth stimulator for 6 months post-surgery. The subjects will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 years of age at the time of Informed Consent.
2. Requires a cervical fusion surgery within 30 days of Informed Consent signing.

   a. Surgical approach is at the physician's discretion.
3. Subject has one or more high risk factors:

   1. Is currently using nicotine
   2. multi-level cervical fusion surgery planned
   3. Prior failed fusion at any cervical level
   4. Subject reported diabetes
   5. Subject reported osteoporosis
4. Body mass index ≤ 45 kg/m2 at the time of consent.
5. Must have reliable access to an iPhone or an iPad with Wi-Fi access for downloading the free device-specific app (iPhone 5S or higher, iPad, iPad Pro, iPad mini or iTouch using iOS v.9.3 or later).

   a. When the android version of the mobile app for the CervicalStim device becomes available (estimated to be Dec. 2017), subjects who have reliable access to devices using android operating systems will be eligible for study inclusion.
6. Able and willing to complete electronic questionnaires and able to read and understand study instructions in English.
7. Able and willing to comply with the study plan and able to understand and sign the study-specific Informed Consent Form (ICF).

Exclusion Criteria:

1. Current alcoholism and/or any known current addiction to pain medications.
2. Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
3. Any clinically significant finding that places the subject at health risk, impacts the study, or affects completion of the study, in the opinion of the Investigator.
4. Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator.
5. Subject is a prisoner.
Physiotherapy Efficiency on Child Asthma

The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.


Eligibility Criteria:
Inclusion Criteria:

* child (6 to 17 years old)
* hospitalized in pediatric unit for asthma crisis

Exclusion Criteria:

* patient who can't participate because of his healthcare (resuscitation...)
* impossibility to measure Peak Expiratory Flow (PEF)
Psychological Ressources, Anxiodepressive Symptoms, Well-being and Therapeutical Observance in Parkinson's Disease

Anxiodepressive symptoms are frequently observed in Parkinson's disease patients. These non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance.

The objective of this study is to determine if psychological ressources are associated to anxiodepressive symptoms, to parkinson well-being and therapeutical observance. It will be interesting to determine if the presence of some - or multiple- psychological ressources could prevent patients from anxiety, depression, impaired well-being and impaired observance.

This study will analyse retrospectively psychological scalescompleted by 30 parkinson's disease patients through previous psychological interviews. The scales investigate anxiety, depression, well-being, psychological ressources, and therapeutical observance.

The results will highlight the importance of working on psychological ressources with Parkinson's disease patients through psychotherapy, in order to improve their well-being, positive emotions and maybe contribute to better therapeutical observance.

The scales used are :

* The SPANE
* The PAS
* The LOT-R
* The SCS
* The brief BDI
* The SSAM
* The HAD
* The MAAS
* An observance scale

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Parkinson's disease

Exclusion Criteria:

* Patients with any other parkinsonian syndrome