cyrilzakka/clinical-trials huggingface dataset:
Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects

In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.

Owing to the high prevalence of disability in stroke older adults, walking capacity and participation can be severely affected. According to the International Classification of Functioning, Disability and Health 2001, participation involves functioning in life. In Rehabilitation Medicine, there has been a growing concern about it as a way to assess success of treatment. However, appraisal of participation in stroke research is scarce.

In all stages after a stroke, Physiotherapy interventions in favor of intensive high repetitive task-oriented and task-specific training have obtained benefits on trained actions and activities. But, the effect of this type of treatment on the impact the disease has on patient´s participation is under investigated.

The aim of this study was to determine which kind of physiotherapy task-oriented training program could better improve participation in chronic stroke subjects: an upper limb strength training program (ULST) or a combined cardiovascular/task-oriented interval training (IT) program.

Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.

A randomized single-blind controlled trial was carried out. Fourteen subjects with chronic hemiplegia resulting from stroke (onset \>6m) were recruited. All participants were fully informed about the experimental procedures and the aim of the study. Written informed consent was signed by each subject prior to participate. Approval from the ethics committee of the University of Valencia was obtained for the study.

Subjects were randomly allocated to an ULST program with elastic bands (n=7) or to a cardiovascular/task-oriented IT program (n=7), focused on walking capacity. In the ULST group, a nine 5-minute station circuit session was designed. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. The IT program consisted of a set of 8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. Duration of both programmes was 3 months (3 sessions/week).

Participation was assessed by the Stroke Impact Scale (SIS-16) and the Frenchay Activities Index (FAI), before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* More than 6 months after first stroke

Exclusion Criteria:

* Functional disability not related to the aftermath of stroke
* Participate in other rehabilitation programs
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction.

Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years.
* Informed written and verbal consent

Exclusion Criteria:

* Operation by different indication such as

  * Fracture
  * Ganglion
  * Tumors
  * Osteophytes
  * Rheumatoid Arthritis
  * Persistent medial artery
  * Metabolic causes
* Alcoholism
* Hyperthyroidism
* Myxedema

  * Hereditary Cardiac Amyloidosis
  * Known WT ATTR
  * AL Amyloidosis
  * Myelomatosis
  * MGUS and Morbus Waldenström
WAKIX® (Pitolisant) Pregnancy Registry

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman of any age
* Consent to participate
* Authorization for her HCP(s) to provide data to the registry
* For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)
* For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy

Exclusion Criterion:

• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)
Radiesse® Safety Study For the Treatment of Hands

The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.

This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B).

Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.

Eligibility Criteria:
Inclusion Criteria:

1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
2. Is at least 22 years of age.
3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.

Exclusion Criteria:

1. Was a participant in the Radiesse hands pre-market clinical study
2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
3. Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
Managed Access Programs for INC424, Ruxolitinib

The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib

CINC424A2405 - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGHVD).

Eligibility Criteria:
Inclusion criteria

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.
Diabetes Electronic Prompt for Improved Care Coordination and Treatment in the ED

The goal of this clinical trial is to improve the processes of Type 2 Diabetes (T2D) care coordination and treatment in the emergency department (ED) by utilizing clinical decision support mechanisms in the electronic health record (EHR). The main question is whether electronic prompts triggered by hyperglycemia and elevated A1c results in providers providing earlier treatments and faster time to subsequent primary care appointment and greater reduction in hemoglobin A1c (HA1c).

ED clinicians will receive alerts called Our Practice Advisories (OPA's) through the EPIC EHR. The 1st OPA triggers when a random point-of-care (POC) glucose is ≥250 mg/dL, prompting a suggested additional HA1c order. A 2nd OPA triggers if the resulting HA1c is ≥10%, prompting consideration of further care coordination in the Observation Unit. Investigators will compare the outcomes between the two groups: hyperglycemia electronic prompt alerts vs no alerts.

Type 2 Diabetes (T2D) is a growing public health crisis with rates of diabetes steadily increasing over the last 10 years. The ED is commonly the first point of contact for individuals who present with symptoms of hyperglycemia, often with very severe (HbA1C \> 10%) underlying diabetes. However, there is currently no national guideline or clinical policy for the ED management of patients who are not in diabetic ketoacidosis (DKA) or in a hyperglycemia hyperosmolar state (HHS). The investigators hypothesize that there are two subgroups who may benefit from greater care coordination initiated from the ED: patients who are newly-diagnosed with severe T2D and patients whom T2D is poorly-controlled despite medication adherence. This study designs electronic prompt practice advisories that nudge ED providers towards more aggressive treatment pathways. It is currently unknown whether alert tools can improve the delivery and coordination of care of patients with severe T2D presenting to the ED.

Eligibility Criteria:
Inclusion Criteria:

Moderate hyperglycemia, (glucose ≥250 mg/dL)

* Patients who arrive in the emergency department
* Not pregnant or peri-partum
* Not SARS-COV-2 PCR positive in past 7 days

Exclusion Criteria:

* Diabetic ketoacidosis (pH \< 7.20, HCO3 \< 15, AG \> 25)
* Diabetic foot ulcer or skin complications
* Hyperglycemic hyperosmolar state with neurologic impairment
* Patients who leave against medical advice (AMA), elope from the ED, or are transferred to another facility
Ultrasound Description of the Sciatic Nerve

Sciatic nerve blocks are frequently used for anesthesia or analgesia for surgery of the lower legs. Currently, if ultrasound is used to find the sciatic nerve, the leg must be raised to locate the nerve with the ultrasound probe on the back of the thigh. In pediatric surgery, the patients are anesthetized (asleep) before the block is given. It is difficult for one person to administer the sciatic nerve block using this method. We would like to identify the sciatic nerve using ultrasound on the side of the thigh and its location to the adjacent structures.

The sciatic nerve block is frequently used for anesthesia or analgesia for surgery of the lower extremities. Ultrasound-guided sciatic nerve blocks performed at the lateral mid-femoral level have been successfully described with subjects in the supine position and the lower limb elevated in order to accommodate the ultrasound probe against the posterior aspect of the thigh. In the pediatric setting in which nerve blocks are commonly performed with the patient anesthetized rather than awake, we find this technique to be unwieldy as a single-operator technique. Using a more ergonomic approach that has not been previously described, we plan to identify and describe the sciatic nerve with the ultrasound positioned against the lateral aspect of the thigh. We hope to describe the appearance of the sciatic nerve and its location in relation to adjacent anatomic structures using this modified approach.

This a prospective cross-sectional study of 40 pediatric subjects 11-17 years of age. Three ultrasound images of the sciatic nerve will be obtained via the lateral mid-thigh approach in 40 pediatric patients scheduled to undergo sciatic nerve block - the first image prior to placement of the block, the second after the nerve is located by the stimulating needle and the third after the injection of local anesthetic.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 11 to 17 years old.
2. Patients undergoing lower extremity surgery who are scheduled to have a sciatic nerve block as part of the anesthetic.
3. Parental/guardian permission (verbal consent) and child assent. Note: if you record ANY PHI, you will need to obtain written consent since HIPAA requires written authorization for use of PHI.

Exclusion Criteria:

None
Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats

Premature infants (infants born \<37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. The safe transport of these premature infants is an important concern. Sub-optimal positioning in car seats can lead to breathing problems in premature infants. With the help of electrical impedance tomography, the investigators want to assess the changes in lung volume during the transition from a supine to a semi-upright position in the car seat.

Hypothesis The investigators hypothesise that there is a decrease in the end-expiratory lung volume (EELV) of preterm infants transferred from supine to car seat position. They expect that the curved, semi-upright built of a standard car seat negatively impacts lung aeration and ventilation of preterm infants, which may result in cardiorespiratory events. They also hypothesise that EELV will normalise following the repositioning of the infant back to the supine position.

Primary objective The primary objective of this study is to assess lung volume changes during the transition from a supine to a semi-upright position in a car seat in preterm infants.

Study procedures As soon as all inclusion criteria are met, the study intervention is initiated. For the baseline measurement, the child is placed in supine position on a flat surface. The EIT belt is attached at nipple level around the infant's thorax during the last nursing care before the start of the intervention. Continuous measurement is conducted for 30 minutes.

Subsequently, the child, with the EIT belt securely in place, is repositioned from a supine to a semi-upright position in a car seat, where another 30-minute measurement is taken. A third measurement will be conducted after the infant is returned to the standard supine position in his/her cot. Manipulations during the measurement periods will be kept to a minimum to avoid disruptions or artefacts in the data recordings. EIT data will be obtained for a total of 90 minutes (plus a maximum of 10 minutes for repositioning).

Subgroup analyses will be performed for the primary outcome:

* Preterm infants ≥ 32 versus \< 32 weeks at birth
* Infants with a weight ≥ 2 kg versus \< 2 kg at the time of the study
* Car seat positioning: nursing staff versus parents

Eligibility Criteria:
Inclusion Criteria:

* Gestational age up to 36 6/7 weeks at birth and/or birthweight \< 2.5 kg
* Preterm born infants fulfilling all criteria for discharge from the NICU
* Discharge home planned within 48 hours
* Written informed consent by one or both parents or legal guardians as documented by signature.

Exclusion Criteria:

* Severe malformation adversely affecting lung aeration or malformations limiting life expectancy.
* Inability of the parents to understand the study procedures due to cognitive or linguistic reasons.
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses

ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.

Patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up will be included.

These patients will be followed up during 30 months (2.5 years) (if no relapse occurred before) with ctDNA detection performed at each hospital visit. At each visit, clinical, biological (squamous cell carcinoma (SCC) serum marker will be done systematically) and radiological/pathology (if any) results will be prospectively collected in the study.

For the patients who have a relapse or new HPV-induced invasive cancer before 30 months, the follow-up will be discontinued at the date of the relapse.

For the patients who will have completed their follow-up for the study (2.5 years) with no relapse or new HPV-induced invasive cancer, they will be followed up for 6 months (+ 14 days), to collect any late relapse (if any). None specific study procedure will be performed during this period.

Eligibility Criteria:
Inclusion Criteria:

1. 1) Patient curatively treated within the past 3 years for:

   * a HPV-induced stage Ib3, Ic, II or III cervix cancer
   * a HPV-induced stage II or III anal canal, vagina, vulva or penis cancer
2. Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams).
3. Age ≥ 18 years
4. Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available.
5. Patient who a follow-up visit is scheduled in the including center at least twice a year.
6. Patient being affiliated to the French social security.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patient presenting with active invasive tumor masses (e.g. stage IV cancer).
2. Patient deprived from ability to decide on her own or placed under the authority of a tutor.
3. Patient unable to have a regular follow up for geographical, social or psychological reasons.
Impact of MOHO on Therapists Working With Clients in Cancer Population

The purpose of this study is to examine the impact of an introduction to the occupation-based theory (MOHO) on the clinical reasoning of therapists working with cancer clients.

The study will occur at MDACC, a comprehensive cancer center in the Texas Medical Center (TMC) in Houston. The center is the largest freestanding comprehensive cancer center in the world. The facility provides inpatient and outpatient services and supports research and education.

The facility has more than 50 buildings in the greater Houston area and in central Texas. The setting for this study will be the rehabilitation services area on the main campus in the TMC.

There are private offices, conference rooms and treatment areas where video chats and monthly meetings will occur.

The study is projected to occur over a one year period. Sessions will be videotaped (video chats - initial and follow ups and monthly group meetings) for further review. Analysis of the tapes will provide data for further research and education presentations. Sessions will also be audiotaped and transcribed for further review and data analysis purposes. Neither the videotapes nor audiotapes will be shared with anyone at the facility or any uninvolved parties. Audiotapes and videotapes will be stored in locked file cabinets and password protected computers will be used to view and analyze the audio and video tapes. Only the research team will have access to the stored data locked in the file cabinet.

Eligibility Criteria:
Inclusion Criteria:

No training in MOHO constructs,English speaking.

Exclusion Criteria:

Training in using MOHO concepts in practice, highly skilled in use of MOHO, and non-English speaking. If a therapist is skilled and knowledgeable of the constructs of MOHO, there will be no way to determine if introduction of the model has impacted a therapist's clinical reasoning. All the materials used for the study will be in English and analysis of data will be conducted by English speaking individuals, therefore the study participants must speak English.
Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease

it is a prospective, randomized, double-blinded, crossover study on the use of an association of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected by symptomatic supraventricular ectopic beats without structural heart disease.

The study will evaluate the reduction of the number of supraventricular ectopic beats and symptoms related.

24 subjects without structural heart disease with a minimum of 300 supraventricular ectopic beats in 24 hours will be enrolled in the two participating centers and randomized to the treatment or to the placebo for 4 weeks. At the end of the first treatment period, a 24 hours Holter ECG will be performed. After 1 week of wash-out therapy, subjects will be crossed over to the other treatment for 4 weeks. Another 24 hours Holter ECG will be performed at the end of the study. During the baseline visit and during each follow up visit, symptom score and quality of life questionnaires will be completed by the subjects.

Eligibility Criteria:
Inclusion Criteria:

* age: 18 to 80 years
* symptomatic supraventricular ectopic beats (at least 300 in 24 hours recording)
* no structural heart disease evaluated with ecg, echocardiography, stress test and chest x-ray.
* no antiarrhythmic drug in use.

Exclusion Criteria:

* acute systemic illness
* preexcitation
* 3 or more consecutive ectopic beats
* vascular disease
* diabetes
* asthma
* soy allergy.