cyrilzakka/clinical-trials huggingface dataset:
Prosthetic Use, Mobility and Daily Functioning

The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.

Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life.

Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited.

There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility.

The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.

Eligibility Criteria:
Inclusion criteria for experienced users of prosthesis - intervention group:

* Unilaterally amputated (above the ankle joint / under the hip joint)
* Minimum 12 months since amputation
* Have a well-adapted prosthesis before baseline measurements
* Not attended an organized, regular training program for the last 6 months
* Uses the prosthesis on a daily basis
* Participation approved by physician

Inclusion Criteria for experienced users of prosthesis - control group:

* Unilaterally amputated (above the ankle joint / under the hip joint)
* Minimum 12 months since amputation
* Have a well-adapted prosthesis before baseline measurements
* Daily use of the prosthesis
* Not attended an organized, regular training program in the last 6 months
* No participation in regular and systematic training between pre- and post-testing

Inclusion Criteria for new users of prosthesis:

* Unilaterally amputated (above the ankle joint / under the hip joint)
* No prior record of use of prosthesis
* Participation approved by physician

Exclusion Criteria:

* Bilaterally amputated over ankle joint
* Lack of understanding of Norwegian language (oral, written)
* Neurological disorders affecting gait function
* Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function
* Other issues that complicate participation in a rehabilitation intervention
Mobile Health Technology-Enabled AFib Management

The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or older at time of consent
2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
3. BMI (Body Mass Index) ≥ 27.0

Exclusion Criteria:

1. Permanent Afib (decision has been made not to attempt sinus rhythm)
2. Severe valvular disease
3. Moderate mitral valve stenosis
4. Prior cardiac surgery
5. Presence of implanted cardiac device
6. History of cardiac arrest
7. Left ventricular ejection fraction (LVEF) ≤ 35%
8. Life expectancy \< 1 year
9. Non-English speaking
10. Treating clinician deems unsafe for exercise
11. Any other reason that makes patient unsuitable for study at the discretion of the PI
A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.

The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.

APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Type 1 or Type 2
* Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
* HbA1c less than or equal to 12 %
* Single full thickness DFU on the plantar aspect of toes or foot
* Ankle Brachial Index greater than or equal to 0.7

Exclusion Criteria:

* Infection of the ulcer
* Active Charcot's disease
* wound involves deeper tissues including bone or tendon
* Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
Flexibility of Cognition And Persistent Pain

This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests.

Postoperative pain is a normal, physiologic, protective response to tissue injury that routinely resolves after healing of the surgical site. However, in some patients, pain persists long after surgery. PPSP is a diagnosis of exclusion that has most consistently been defined as pain that (1) developed after a surgical procedure, (2) is not residual from a preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to other causes. One suggested risk factor for PPSP is poorer performance on tests of cognitive flexibility. Two common tests of cognitive flexibility are the Trail Making Tests (TMT) A and B and the Color Word Matching Stroop Test (CWMST).

Three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy will be enrolled. During preoperative evaluation, participants will complete the TMT and CWMST. Subjects will be followed prospectively and will complete surveys at one month, six months, and one year postoperatively to assess PPSP prevalence and intensity.

Eligibility Criteria:
Total Knee Arthroplasty (TKA) patients

- Inclusion criteria: Adults age 18 to 85 undergoing unilateral TKA for osteoarthritis English as primary language

- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Surgical indication for condition other than osteoarthritis (i.e. rheumatoid arthritis, spondylarthropathy) Prior knee surgery

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Thoracotomy/mastectomy patients

- Inclusion criteria: Females age 18 to 85 undergoing mastectomy for breast cancer OR Adults age 18 to 85 undergoing unilateral open thoracotomy or video-assisted thoracoscopic surgery (VATS) for any non-cardiac etiology English as primary language

- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Plan for breast reconstruction Prior breast/thoracic surgery
Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)

The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in humans induced by tonic heat stimulation. It has been shown in animal studies with rats that HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat stimulation in healthy subjects and promote future research and understanding of the anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary hyperalgesia after HBO.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yr Approved physical health examination Healthy Male

Exclusion Criteria:

* Arterial hypertension Chronic pain Claustrophobic tendency History of substance abuse Impaired cognitive abilities Inability to participate in quantitative sensory testing Incomplete understanding of Danish Neurological deficits Previous barotrauma or pneumothorax Previous head trauma Unable to equilibrate pressure in middle ear and/or sinuses
Slippers to Reduce Transfer From Floors to Surfaces

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Subjects are randomized to wear slippers versus standard care and cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces, personal items, bedding, socks or feet, and hands of patients.

The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Hospitalized patients are enrolled and randomized to wear slippers any time they are out of bed versus standard care. Bacteriophage MS2 is inoculated onto a site on the floor between the patient bed and the bathroom. Cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces (bed rail, bedside table, telephone, call button), personal items, bedding, socks or feet, and hands of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of 18 years of age or older
* Ambulatory
* Able to demonstrate an understanding of study procedures

Exclusion Criteria:

* Unable or unwilling to fulfill study requirements.
* Expected length of stay less than 48 hours
* Any patient deemed not suitable for study participation at the discretion of the study investigator
Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

The study is being conducted to compare the effect of standard treatment (target LDL-C level: \<120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: \<70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.


Eligibility Criteria:
Inclusion Criteria:

Patients meeting the following inclusion criteria will be included in the study:

1. Patients giving voluntary written consent to participate in the study
2. Male or female patients 50 years of age or older (at informed consent)
3. Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
4. Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
5. Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
6. Patients with two or more of the following risk factors

   * Male
   * 65 years of age or older
   * Smoker
   * L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
   * Left ventricular hypertrophy
   * First- or second-degree family history of MACE
   * Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (\<60 mL/min/1.73 m2)

Exclusion Criteria:

Patients meeting the following criteria will be excluded from the study:

1. Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
2. Patients judged to have familial hypercholesterolemia
3. Patients with a serum triglyceride level of ≥400 mg/dL
4. Patients with a history of myocardial infarction
5. Patients with a history of coronary revascularization (PCI or CABG)
6. Patients with a history of treatment of unstable angina
7. Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
8. Heart failure patients
9. Patients with a history of hypersensitivity to statins
10. Patients with a history of drug-induced myopathy
11. Patients with poorly controlled arrhythmia
12. Patients with severe liver or kidney disease
13. Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
14. Patients who are or may be pregnant
15. Patients judged by the investigators to be ineligible for participation in the study for any other reason
Tongue Muscular Assessment in Healthy Children

This study aims to obtain normative values for tongue motor functions in healthy children.

Since the tongue is a complex structure consisting of a continuous array of muscle fibers with varying orientation, tongue motor functions (strength, endurance) are likely to differ according to a protrusion (pulling out the tongue), elevation (lifting the tongue to the roof of the mouth) or swallowing movement.

There are currently no normative data for the motor functions of the tongue in children. After their parents fulfilled the Pediatric Sleep Questionnaire, each included children will undergo an anthropometric and a tongue motor functions assessment.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 4 and 17

Exclusion Criteria:

* Eating disorder
* Dysphagia
* Cardiorespiratory disorder
* Neurological disorder (including neuromuscular disorders)
* Previous or ongoing obstructive sleep apnea-hypopnea syndrome
* Previous or ongoing cancer of the head or neck
* Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
* Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
* Previous or ongoing orthodontic treatment (e.g. braces)
* More than 33% of positive answers to the Pediatric Sleep Questionnaire (8/22)
Use of 3D Printing High-fidelity Craniofacial Manikin to Teach Noninvasive Positive Pressure Ventilation

The aim of this study is to enhance the learning efficiency and ability of problem-solving for student of Department of Respiratory Therapy with the innovative 3D printing high-fidelity manikin.

Background :

Noninvasive positive pressure ventilation plays an important role in treatment of respiratory failure. Respiratory Therapists should be familiar with operating ventilator, choosing the adequate interface, and putting the interface on patients' face correctly. Simulation-based clinical training was limited because of lack of the high-fidelity manikins or simulators. To enhance the simulation-based clinical training, the investigators develop 3D printing models and applied into the medical school and hospital training.

Study Design :

The first part is a laboratory in-vitro experiment; the second part is a randomized controlled trial of medical education study.

Methods :

The 3D scanning and 3D printing technology will be using to create the high-fidelity manikin with an upper and lower airway tract. The 3D printing material will be choosing to be able to close real human organ especially considering the soft biological tissue. The present study will be divided into two parts. The first part is a laboratory in-vitro experiment, which aims to verified the function of the high-fidelity manikin; the second part is a medical education study.

Effect :

The investigators expect the use of 3D high-fidelity model in training students of Department of Respiratory Therapy will enhance the learning efficiency and ability of problem-solving.

The experience and outcome of the study will further extent to medical school and hospital training.

Key words:

3D printing; medical education model; high-fidelity simulation; respiratory care.

Eligibility Criteria:
Inclusion Criteria:

* Student of Fu Jen Catholic University

Exclusion Criteria:

* Refused to participate in the study
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.


Eligibility Criteria:
Inclusion Criteria:

* Have documented diagnosis of GD.
* Have a TSH value \< 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
* Meet one of the following at the Screening Visit:

  * Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:

    * Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
    * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
  * Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:

    * Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.
    * Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
    * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

* Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
* Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value \< lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.
* Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit.
* Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.
* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.

Additional exclusion criteria are defined in the protocol.
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.

This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Stop H2 blockers 72 hrs prior to starting study
* Stop PPI - 3 weeks prior to staring study
* Heartburn 3+ times a week
* Insomnia 3+ times a week for 3 months
* Erosive esophagitis or Abnormal pH test

Exclusion Criteria:

* On PPI or H2 blocker \& not willing to get off
* Normal EGD (upper endoscopy) w/ normal pH test
* Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C\&D) LA=Los Angeles criteria. Grades include A-D
* Previous gastrointestinal Surgery
* HX of Diabetes/neuropathy
* HX of seizures
* Known psychological abnormalities(depression,anxiety...)
* Clinically Significant Underlying co morbidity
* Narcotic medications(pain meds)
* Regularly taking sleeping medications (2 week wash-out allowed)
* Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.
QOL and Sarcopenia in Patients With Ascites

Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies.

Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites.

Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.

Patients with refractory ascites defined as requiring \>1 paracentesis within a 6 week period will be prospectively enrolled. The Patient-Reported Outcomes Measurement Information System (PROMIS-10) and ascites-specific (Ascites Q and Edmonton Symptom Assessment System: Ascites Modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. Sarcopenia will be assessed by muscle area measurement from a single CT image at the L4 level at baseline, 2- and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/=18
2. Eastern Cooperative Oncology Group (ECOG) performance score \< 3
3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
4. Capable of giving informed consent

Exclusion Criteria:

1. Life expectancy less than 3 months
2. Unable to participate in neuropsychological tests/questionnaires
3. Pregnant or nursing women. .
Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .

Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .

Eligibility Criteria:
Inclusion Criteria:

* Second pregnancy after previous unexplained fetal death
* Singleton pregnancy
* No any medical disorders during pregnancy like diabetes or Systemic Lupus Erythematosus
* Normally located placenta
* No congenital fetal anomalies
* Patient accept to participate

Exclusion Criteria:

* Confirmed thrombophilia
* Twin pregnancies
* Refused to participate