cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.

The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks.

Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24.

Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).

Eligibility Criteria:
Inclusion Criteria:

* Patient who undergo modified Lapidus arthrodesis operation and associated with:
* Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) \[23,24\].
* Willingness and ability to participate in the trial
* Signed Informed Consent

Exclusion Criteria:

* Diabetes mellitus
* Rheumatoid arthritis
* Previous foot surgery
* Classic Lapidus surgery
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
* Inability or contraindications to undergo the investigated intervention
* Pregnant women
Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients

Social isolation among elderly people is a frequent and major determinant for health.

The risk of premature death is 2 to 5 time higher for socially isolated people, similarly for morbidity, duration of healing and complications rate.

Denutrition is also frequent for elderly people with potentially serious consequences. Vitamin deficiency, especially in B9 and B12 vitamins, are often associated with denutrition among elderly people.

Folic acid (vitamin B9) is not influenced by inflammation and folic acid income are necessarily exogene. Vitamin B9 is provided by fresh fruits and vegetables, and giblets.

The investigators observed a high prevalence in folic acid deficiency for socially isolated elderly patients. The investigators made the hypothesis that a folic acid defiency is associated with social isolation for elderly people.

The primary purpose is the study of the association between folic acid deficiency (measured by dosing of plasma concentration of vitamin B9) and social isolation evaluated by Lubben Social Network Scale in 6 questions.

The secondary purposes are the study of the correlation between folic acid deficiency and social conditions, nutritional status, biological data, poly pharmacy, cognitive functions, dependency and length of stay at hospital.


Eligibility Criteria:
Inclusion criteria :

* Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
* Age \> 75 years
* Patient has given his consent

Exclusion criteria :

* Digestive malabsorption disorder : gastrectomy, extended intestinal resection, Crohn disease, celiac disease, parenteral nutrition
* Chronic alcoholism
* Treatment with sulfamids, methotrexate, anti epileptic treatment (hydantoin)
* Hemodialysis
* Patients under protection measure (curatorship, guardianship, judicial protection)
* Patient refuses to participate
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
2. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
4. Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
5. Be in general good health.
6. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month before screening.
2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
3. Have a significant risk of suicidal or violent behavior.
4. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
5. Have a known history of neuroleptic malignant syndrome.
6. Have a known history of long QT syndrome or cardiac arrhythmia.
7. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
8. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
9. Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
10. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
11. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
12. Are currently pregnant or breastfeeding.
13. Have HIV or hepatitis B.
Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.

Cross-sectional evaluation of two groups of patients:

* patients receiving currently available drugs, in order to determine the changes in fat accumulation by successive dual X-ray absorptiometry (DXA) determinations
* patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance (insulin resistance or diabetes), fat accumulation (waist circumference) and hypertriglyceridemia.

The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Older than 18 years
* Receiving first or second antiretroviral regimen or
* Previous evaluation and classification of lipodystrophy syndrome

Exclusion Criteria:

* Pregnancy
* Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids or hormones before inclusion
* Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)
Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients

Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.

All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in the ICU were eligible for this study
Effect of the Hockey Slideboard Training Combined With Blood Flow Restriction (BFR) in the Rehabilitation Following Anterior Cruciate Ligament Surgical Reconstruction (ACL-R)

ACL injuries represent a major health and economic burden. The overall incidence of ACL injuries has increased and is likely to continue to increase, in part due to increased sports participation.

In the acute post-surgical phase there is a period of physiologic recovery from the surgical injury and subsequent relative muscle disuse that is associated with atrophy loss of strength and anterior knee pain. Therefore, improvement of muscle function is a priority in the rehabilitation and reathletization process.

To achieve significant muscle hypertrophy as well as a possible subsequent increase in strength, it is widely accepted that resistance exercises with relevant load (\~70% of the one repetition maximum - 1RM) are necessary; however, in patients undergoing anterior cruciate ligament reconstruction (ACL-R), exercises with high loads are considered unsafe in the early stages and could increase the risk of re-injury.

BFR training is an established muscle training and rehabilitation technique in which the blood supply to and from the muscles involved in the exercise is restricted using an external device.

Although the physiological mechanisms related to this intervention are not yet well understood, it is thought that in BFR training, despite the low level of mechanical tension, the main driver of myocellular hypertrophy could be metabolic stress that is realized by local accumulation of metabolites. Thus, it seems that hypertrophic adaptations can be induced with much lower exercise intensities using BFR. In fact, when combined with low-load resistance training (e.g., 20% 1RM), training with BFR has shown positive results in increasing muscle volume and strength after ACL-R in complete safety comparable to standard training without BFR.

It has also already been demonstrated how incorporating the use of the hockey slideboard into the rehabilitation procedure following ACL-R gives benefits in terms of strength recovery of the extensor muscles of the operated limb with the same safety profiles as standard rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* having undergone ACL-R following a unilateral rupture, with reconstructive surgical technique by bone-patellar tendon-bone autograft (BPTB) or semitendinosus-gracilis autograft (STG)
* ACL-R including associated meniscal lesions treated with selective meniscectomy and/or non-complex meniscal suture

Exclusion Criteria:

* not having undergone ACL-R following a unilateral rupture, with reconstructive surgical technique by bone-patellar tendon-bone autograft (BPTB) or semitendinosus-gracilis autograft (STG)
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury

The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).

Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.

In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic SCI with tetraplegia.
* Male or female.
* 18-65 yrs old.
* At least 1 yr post-SCI.
* Tolerate sitting upright at for at least one hour.
* Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested.
* Motor grade \>1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested.
* Cognitively and behaviorally capable of complying with the regimen.

Exclusion Criteria:

* Fracture of the treated limb resulting in loss of range of motion
* Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)
* DVT of the treated extremity
* Peripheral nerve injury of the treated extremity
* Osteo- or rheumatoid-arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM
* Skin condition not tolerant of device
* Progressive neurodegenerative disorder
* Botox treatment of the treated extremity in the prior 5 month
* Chronic ITB therapy
* Uncontrolled seizure disorder
* Uncontrolled high blood pressure/angina
* Pain in affected limb or exercise intolerance
The Hopkins Rehabilitation Engagement Rating Scale

Objective: To verify the reliability and validity of the Turkish versions of the Hopkins Rehabilitation Engagement Rating Scale (HRERS) for knee arthroplasty.

Methods: A total of 51 consecutive participants, inpatients of an orthopedic clinic at the university hospital, were recruited between 2021-2022 June. Cronbach's alpha coefficient was used to assess internal consistency. By evaluating the scores of 51 retested patients one week later, the test-retest reliability was determined using the intraclass correlation coefficient (ICC). Pearson's correlation coefficient was used to assess the construct validity.

First of all, permission was obtained from Kortte et al., one of the developers of Hopkins Rehabilitation Engagement Rating Scale (HRERS), to have a Turkish version of HRERS via e-mail before starting the research study. The translation and the cultural adaptation of the Turkish version of the HRERS were accomplished in line with the stages outlined by Beaton et al.. Two independent native Turkish translators performed forward translation. One was a physiotherapist to ensure clinical consistency, and the other was a translator with no medical or clinical background to reveal vague concepts in the original questionnaire. A single consequent Turkish translation was formed from the combination of the two translations The Turkish scale was translated back into English by two English-native speakers who speak Turkish fluently, and the English version of the scale was compared to the original. A group of experts authorized the final version of the document in Turkish, which was backward translation. Translators reviewed the translations and compared certain inconsistencies.

Before the formal questionnaire, the pre-final Turkish version of the questionnaire was used for a pilot test. The Turkish translation was primarily applied to five participants for the detection of unintelligible questions or words. Turkish translation was applied to five participants in order to determine the questions or words that were not understood. We asked the participants the following questions: "Is there a question you don't understand?" "Are there any words you don't like?" Since the participants did not have any problems, no changes were made to the questionnaire, and the final Turkish version of the HRERS (HRERS-T) was provided.

Eligibility Criteria:
Inclusion Criteria:

* Providing hospitalization and rehabilitation follow-up due to knee or hip arthroplasty by Süleyman Demirel University Hospital, Department of Orthopedics and Traumatology,
* Volunteering to participate in the study,
* It means getting a score of 24 or above when the Standardized Mini Mental Test Score is applied.

Exclusion Criteria:

* Having serious vision and hearing loss,
* Having an orthopedic, vestibular, neurological or mental problem such as upper and lower extremity pathology that may prevent or limit the application of the test protocol,
* Having a diagnosis of postural hypotension,
* Lack of cooperation,
* Being in the recovery period of an acute disease was determined as an exclusion criterion.
Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime

The current ongoing war in Israel, which began in October 2023 with a risk for spreading regionally across the Middle East, has presented a significant challenge to many patients, affecting also those receiving active oncology treatment. The present study examines a unique setting of care involving a diverse population of patients, including those receiving oncology treatment, from a widely diverse social, cultural and religious, background. Patients are offered integrative medicine treatments for 3 weeks with the goal of addressing war-related physical, emotional, and other quality of life-related concerns. After signing the informed consent form, patients will be randomly allocated to one of the two study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation modalities with acupuncture (Group B). The response to the study intervention for quality of life-related concerns will be re-assessed immediately; at 24-48 hours; and after 3 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) to determine the impact of the intervention on their QoL and concerns.

Integrative medicine is increasingly being included in supportive and palliative care, primarily in oncology settings. The current military conflict in Israel has led to a surge in cases of emotional and physical distress, overwhelming the health profession throughout the country.

Study objectives and purpose: The primary study objective is to improve patients\&#39; QoL-related concerns including those affected by the military conflict.

Study design and setting: The study is taken place within a prospective randomized controlled methodology.

Study population: Patients of either gender, hospitalized for various indications (oncology or not) or undergoing out-patient oncology treatment, age ≥ 18 years.

Allocation to study arms and groups: Participants will be randomly assigned using the "Research Randomizer" online tool (https://www.randomizer.org/) to one of the following study groups:

* Single-modality integrative medicine, receiving acupressure/relaxation only (Group A)
* Multi-modality integrative medicine receiving acupressure/relaxation with acupuncture (Group B) In both study groups, the interviews will address quality of life-related concerns, including war-related concerns. Reassessment of these concerns will be conducted immediately post-treatment, 24-hour post treatment and following 3 weeks. patients in both groups will be offered weekly integrative medicine treatments during the 3 weeks following the first treatment .

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer, age ≥ 18 years who are either hospitalized or undergoing oncology treatment in an outpatient care setting; or hospitalized for any other diagnosis
* Patients expressing quality of life related concerns affected directly or indirectly to the war and related security status.

Exclusion Criteria:

Inability to read and provide informed consent
Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum radiation emitter for adhesive capsulitis.

Adhesive capsulitis (also termed frozen shoulder, stiff painful shoulder, or periarthritis) is a common cause of shoulder pain estimated to affect 2-5% of the general population.

The disorder is characterized by spontaneous onset of shoulder pain and progressive global stiffness of the glenohumeral joint accompanied by significant disability. Most studies have suggested a self-limiting condition lasting an average of two to three years, although significant numbers of people have residual clinically detectable restriction of movement beyond three years, and smaller numbers have residual disability.

Many interventions have been advocated for the treatment of adhesive capsulitis, although only limited data from randomised controlled trials are available. In addition, there are not enough data to either support or refute the efficacy of any of the commonly used interventions for this condition, including non-steroidal anti-inflammatory drugs, corticosteroid injections, and physiotherapy. Oral steroids were first advocated in the 1950s, with claims that they expedited recovery and reduced the need for manipulation under anaesthesia. However, these medications are associated with many adverse reactions.

The aims of this study are to determine whether three weeks' treatment with quantum spectrum radiation emitter in patients with adhesive capsulitis is effective for improving pain, function, and range of motion.

Eligibility Criteria:
Inclusion Criteria:

* ability to provide written informed consent
* over 18 years old
* with pain and stiffness in one shoulder predominantly for three weeks or more
* restriction of passive motion in at least one shoulder by more than 30˚ in two or more planes of movement, measured at the time of the onset of pain with a gravity inclinometer.

Exclusion Criteria:

* hypertensive patients
* patients with cardiac arrhythmias
* patients with epilepsy
* patients with pacemakers, hearing aids or other electronic components
* pregnant patients
* patients with radiological evidence of osteoarthritis of the shoulder or fracture;calcification about the shoulder joint;reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive"drop arm sign", a high riding humerus visible on X ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound)
* patients likely not to comply with follow up (for example, living too far away to attend for follow-up assessment, or indicating they would be unable or unwilling to attend for outcome assessment)
* patients without written informed consent.