cyrilzakka/clinical-trials huggingface dataset:
Sitting Balance in Lower Limb Amputees

The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

Postural stability is important for amputees to perform daily life activities and participate in social activities. The aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. A force platform was used to measure the postural stability of individuals. The sitting limits of stability of the participants were recorded in cm. Amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. Congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. Our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.

Eligibility Criteria:
Inclusion Criteria for amputee:

* Unilateral transfemoral amputation
* Using their prosthesis for at least 6 months

Exclusion Criteria:

* congenital amputee
* Bilateral lower extremity amputation
* Central or peripheral vestibular disorders
Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease

The goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.

This is a Phase 2b, multicenter, randomized, double-masked, active-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Provide written informed consent.
* Be willing and able to comply with all study procedures.
* Have a history of dry eye disease for at least 6 months prior to Visit 1.

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at Visit 1 or Visit 2.
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.

  * Additional inclusion/exclusion criteria apply.
Combating Diagnostic Wandering and Impasse for Cystic Fibrosis

After cystic fibrosis (CF) neonatal screening, some children remain with a not concluded diagnosis. In France, the medical follow-up is not standardized, some of them may be lost of follow-up. The aim of the study is to identify children at risk of developing CF. Other children carry mutation at risk of CFTR related disorder (CFTR-RD) but remain asymptomatic during childhood. The aim of the study is to evaluate those children by microbiology, respiratory function test and lung imaging tests to reclassify them in the CFTR spectrum.

Cystic fibrosis (CF) is a life-limiting genetic disorder related to the mutation of the CF Transmembrane Conductance Regulator (CFTR) gene. Cystic fibrosis neonatal screening in France has been generalized in 2002. Patients with hypertrypsinemia and two CF mutations are diagnosed CF and followed in CF center with standards of care.

But some children with hypertrypsinemia may have an intermediate chloride sweat test and only one CFTR mutation, or a negative sweat test and two CFTR mutations at least one of which is of unknown pathogenicity.

Some other patients may present with two CFTR-RD mutations and may unravel a monosymptomatic disease in adulthood (CFTR-related disorder) such as congenital bilateral absence of vas deferens (CBAVD), acute recurrent or chronic pancreatitis, disseminated bronchiectasis, chronic rhinosinusitis...We have very few data about age of onset, type of symptoms, and infraclinical disease.

Patients will be identified according to neonatal screening data and genetic database, and will undergo clinical evaluation, pancreatic and lung disease evaluation to reclassify them in the CFTR spectrum.

Eligibility Criteria:
Inclusion Criteria:

* undiagnosed patients with hypertrypsinemia at CF neonatal screening and :

  1. either an intermediate chloride sweat test (30-59 mmol/L) and at most one CFTR mutation
  2. or negative chloride sweat test (\< 30 mmol/L) and two CFTR mutations one of wich is of unknown significance (VUS)
* patients with two CFTR mutations at least one of which is of Varying Clinical Consequence according to "CFTR2" database or "CFTR-RD" according to "CFTR-France" database.

Exclusion Criteria:

* CF patients with 2 CF causing mutations
Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments

This blinded randomized comparative trial aims to determine the effectiveness of a customized Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in: a) reducing pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in pregnant women with PGP, c) improving quality of life for pregnant women with PGP d) cost effectiveness.

Pelvic girdle pain (PGP) occurs in an estimated 70% of pregnant women, of whom 25% have severe pain and 8% significant disability. Current methods of management, such as the use of rigid pelvic belts, are limited in their effectiveness. The Dynamic Elastomeric Fabric Orthoses (DEFO) has recently proven beneficial in managing PGP in athletes. There is a need to explore the potential use of DEFO for managing PGP during pregnancy. The primary aim of the study is to compare the effectiveness of a DEFO to a rigid 'off the shelf' pelvic support belt in terms of its effectiveness in reducing PGP during pregnancy. The secondary aims of the study are to compare the effectiveness of the DEFO to the rigid 'off the shelf' pelvic support belt in (a) optimizing activity levels in pregnant women with PGP, (b)improving quality of life for pregnant women with PGP. The relative cost effectiveness of these two interventions will also be compared.

Eligibility Criteria:
Inclusion Criteria:

women 20-36 weeks pregnant, who:

* report intermittent PGP (commenced or aggravated during pregnancy) which causes walking and/or stair climbing to be bothersome and
* are positive on at least 3 out of 7 pain provocation tests

Exclusion Criteria:

* recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory, infective, traumatic, neoplastic, degenerative or metabolic, i.e. trauma, unexplained weight loss, history of cancer, steroid use, drug abuse, HIV infection, immunosuppressed state, neurological symptoms/signs such as: bowel, bladder, sensory, motor, reflex involvement (cauda equina, lumbar disk lesion, spinal stenosis,)
* fever
* systemically unwell
* obstetric complications
* pain that does not improve with rest/severe disabling pain
* history of chronic back or pelvic pain requiring surgery
* focal inflammatory signs/tenderness of spine (spondylolisthesis)
* known skin allergy to lycra
* \>36 weeks pregnant (production of customized DEFO will take approximately 1 week)
HOPE Intervention for COVID-19

The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19.

The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19. Participants in the intervention group will be assigned to peer leaders trained in the HOPE intervention methods.

Eligibility Criteria:
Inclusion Criteria:

1. 18-30 years old
2. English speakers only
3. U.S. Resident
4. Part of phase 1a or 1b of COVID-19 vaccine rollout (Healthcare personnel, education, and frontline essential workers, verified through LinkedIn profile)
5. Uses social media and/or online communities greater than twice per week
6. Has, or is willing to accept a friend request and group invite from our Facebook social media page
7. Have not received a COVID-19 vaccine and do not have medical conditions or other circumstances preventing them from receiving one

Exclusion Criteria:

-
Bringing Life to Those Near Death

The purpose of this study is to assess whether virtual reality technology can reduce anxiety, depression, and emotional distress screening scores in palliative care patients.


Eligibility Criteria:
Inclusion Criteria;

* A terminal or end-stage condition with an expected prognosis of a year or less.
* An established palliative care patient.
* English-speaking.
* Able to wear virtual reality equipment (goggles, etc.).
* Subject or Caregiver able to provide consent.

Exclusion Criteria:

* Younger than 18 years of age.
* Lack of a prognosis of approximately 1 year or less.
Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices

The aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and increase early exclusive breastfeeding in research areas of rural Bangladesh.

Suboptimal early infant feeding practices are the norm in Bangladesh, and contribute to its poor infant health and nutrition. However, the modern health services are unable to help because approximately 85% of births take place at home. The Government has begun the huge process of training the informal community traditional birth attendants (TBAs) who, along with community volunteers (CVs), deliver the majority of babies, especially in the rural areas. The proposed operations research will take place in one of the poorest rural districts. It will compare the cost effectiveness of practical training of these relatively uneducated community members, with or without supportive supervision in improving early infant feeding practices, using a cluster-randomized study design. The practices to be measured before and after on probability samples include: 1) delayed cord clamping, 2) early skin to skin contact and 3) newborn-led initiation of breastfeeding within one hour of birth, 4) avoidance of the traditional prelacteal feeds, and 5) exclusive breastfeeding, at least for the early months. Costs will be carefully monitored so as to compare the cost per behavior improved per infant.

Eligibility Criteria:
Inclusion Criteria:

* Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester

Exclusion Criteria:

* First trimester women and lactating women of children ages 6 to 23 months.
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia

The primary objective of this study is to evaluate the safety and tolerability of CY6463 when administered to participants with stable schizophrenia who are on a stable antipsychotic medication regimen


Eligibility Criteria:
INCLUSION CRITERIA:

1. Provides written informed consent to participate in this study
2. Body mass index is between 18 to 40 kg/m2
3. Fluent English speaker
4. Diagnosed with schizophrenia at least 1 year ago
5. Psychiatrically stable schizophrenia with no more than moderate symptomatology
6. On a stable atypical antipsychotic regimen
7. Agrees to use effective contraception throughout the study and for at least 3 months afterward
8. Agrees to avoid using tobacco/nicotine and caffeine for several hours at a time
9. Agrees to not participate in another study of a drug or device while in this study

EXCLUSION CRITERIA:

1. Was in another study of a drug in the past 2 months
2. Fails a drug/alcohol screen, including amphetamines, barbiturates, cocaine, marijuana, methadone, methamphetamine, 3,4 methylenedioxymethamphetamine (MDMA), phencyclidine, or nonprescribed benzodiazepines or opiates
3. Has had a recent heavy smoking habit (\>40 cigarettes/2 packs/day) or recently had nicotine replacement therapy
4. Has significant heart disease
5. Has hemophilia or any other bleeding/platelet dysfunction condition
6. Has hepatitis or HIV

Additional inclusion and exclusion criteria apply, per protocol.
Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization

The aim of this study is to evaluate the optimization of local anesthetic effect with duplex ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or therapeutic interventional procedures.

In total, 200 patients scheduled for various diagnostic or therapeutic interventional radiology procedures requiring femoral artery puncture, will be randomized in two groups after informed consent. Patients will be randomized to undergo groin local anesthesia with the proposed method of duplex ultrasound guided injection of lidocaine versus standard injection of lidocaine with manual palpation (control group).

The protocol includes the registration of patients' demographics (age, gender, risk factors for peripheral arterial disease), arterial morphological characteristics (calcifications and presence of atheromatous disease), as well as technical details of the procedure (total puncture duration, sheath size, antegrade/retrograde puncture, etc.)

Primary study endpoint will be peri-procedural pain that will be assessed with the use of a visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary study endpoints will evaluate procedural safety and complications during the immediate post-procedural period (up to 7 days).


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for diagnostic intra-arterial procedures
* Patient scheduled for therapeutic intra-arterial procedures
* At least 1 palpable femoral artery
* Patient informed consent

Exclusion Criteria:

* Allergic reaction to iodine contrast media
* Allergic reaction to lidocaine
* Bilateral obstruction of femoral arteries
* Impaired or lost vision
Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease

De Quervain disease is characterized by an adductor pollicis longus and extensor pollicis brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial styloid. This pathology is recognized as a musculoskeletal disorder of the upper limb triggering functional deficits resulting to possible modifications in the professional activity, sources of absenteeism, thus constituting an economic cost for society. At the etiological level, this pathology also affects young mothers (it's called "mother's wrist" or mommy thumb"), mobile phone users ("textonite", "Blackberryte") or video game players ("Nintendoite").

Currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or corticosteroid infiltration. Howewer, these therapies have undesirable effects. The interest of this study is therefore to propose another therapy based on aromatherapy gel.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 18 to 75,
* Patient with unilateral De Quervain's tenosynovitis,
* Patient cared in the Hand Surgery Department, SOS Mains Emergency Department or Rheumatology Department of Strasbourg University Hospitals,
* Patient informed of the results of the prior medical examination,
* Informed consent signed by the patient,
* Patient affiliated to a health insurance social protection scheme or beneficiary,
* For a woman of childbearing potential, negative urine pregnancy test at the inclusion visit and maintenance of effective contraception throughout the study.

Exclusion Criteria:

* Pregnant or breastfeeding patient,
* Patient allergic to a component of the gel with essential oils, Dicloflenac®, NSAIDs, or one of the excipients
* Patient treated with oral non-steroidal anti-inflammatory drugs
* Patient with ongoing treatment with another ointment at the treatment application site (radial edge of the wrist)
* Patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected lesion, burn or wound,
* Patient with atopic skin disease,
* Patient with epilepsy or with a history of epilepsy,
* Patient with a history of homolateral De Quervain's tenosynovitis, or having already had corticosteroid infiltrations in the 6 months before his inclusion on the ipsilateral side of the pathology,
* Patient with associated tendinopathies in the elbow or forearm region,
* Impossibility of giving the patient information (patient in an emergency situation, patient with difficulties of understandin, agitation of the patient),
* Patient under legal protection, under guardianship or curatorship.
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis

This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
* Hemodialysis for greater than or equal to (\>=) 8 weeks
* Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \>= 8 weeks before screening and with no weekly dose change \>= 25 percent (%) (increase or decrease) during the 2 weeks of screening

Exclusion Criteria:

* Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
* Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
* Active malignant disease
* Pure red cell aplasia (PRCA) or history of PRCA
* Pregnant or lactating females
* Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment
The COVID-ICU Healthcare Professional Study

The project is a longitudinal cohort study based on an electronic questionnaire on views and experiences of COVID-ICU Health care professionals during the pandemic. In addition, a few of the informants participating in the cohort study will be asked to participate in focus groups to get a deeper understanding of the experiences of Health care professionals. Leaders at the randomized hospitals will be asked to participate in individualized interviews.

Health Care professionals in intensive care units (ICU) are working front-line with coronavirus disease (COVID-19) patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in need of intensive care treatment.

Data collected will identify the health care professionals' (nurses, medical doctors, leaders) views and experiences from the planning period of COVID-19 ICU units until a follow-up at 12 months.Themes to be covered in the survey are organization, information, communication across disciplines, education, practical implementation, use of personal protective equipment, daily working conditions and psychosocial aspects. The Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD"-Services for Sensitive data web-based solution "Nettskjema" will be used combined for consent form and data collection from the survey. It is within the scope of the study to perform sub analysis on background variables as profession related to daily working experiences on COVID-ICU and psychosocial aspects.

A few of the informants (medical doctors, nurses, leaders) participating in the cohort study will randomly (computerized) be asked to participate in focus groups to get a deeper understanding of the experiences of the health care professionals during the pandemic and after the pandemic when they are back to a normal working condition. Leaders at the randomized hospitals will be asked to participate in individualized interviews. Data from the focus group interviews and individual interviews will be taped on a recorder approved by data protection officer at Oslo University Hospital and then stored at a secured computerized research place at Oslo University Hospital.

The gained knowledge from both the survey, the focus group interviews and individual interviews in this study may guide hospital directors and the government in follow up of health care professionals and to prepare for a later pandemic.

Eligibility Criteria:
Inclusion Criteria:

All health care professionals (nurses, medical doctors, leaders) working in all COVID-ICUs in Norway will be invited to participate in this project.

Exclusion Criteria:

No exclusion criteria