cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Web-based Treatment for Depression in Patients With Neurologic Disorders

200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are recruited via the multiple sclerosis clinics of the University Medical Center Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the online program deprexis or to a wait-list control condition. All participants receive free-of-charge online access to deprexis either immediately or with a six month delay.

At three time points (1. prior to intervention, 2. after completion of the intervention nine weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous online survey, which was implemented using the software package OPST®.

The survey consists of different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome (IIT analysis for pre versus post). It is assumed that the severity of depressive symptoms will improve to a significantly greater extent in the deprexis than in the wait-list control condition in the course of nine weeks and will be maintained in a six month follow-up.

Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented) or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and emotion-focus interventions. The ten modules are framed by one introductory and one summary module. Communication is carried out online via simulated dialogues. Patients have to respond to narrative text messages from the virtual therapists in multiple-choice response fashion, enabling them to express doubt, to affirm a particular message or to request more information. Text messages are aided with drawings, photographs and animations. The program is adaptive and selects exercises and contents on the basis of the subject's response. The modules are sequential and each module refers and builds upon previous one. Modules can (and should be) repeated within the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* presence of a confirmed diagnosis of multiple sclerosis or epilepsy
* self-reported urge to be treated for depressive symptoms (no externally confirmed diagnosis necessary)
* informed consent (provided online in line with regulations by the Hamburg Department of Data Security)

Exclusion Criteria:

* unable to provide informed consent
* diagnosis of bipolar or schizophrenia spectrum disorders
* substantial neurocognitive impairment (e.g. dementia)
* acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and phone numbers.
Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called "New Onset Diabetes After Transplant" or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations.

Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).

Eligibility Criteria:
Inclusion Criteria:

1. Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
4. Ability to read consent form and give consent in English.

Exclusion Criteria:

1. Use of insulin or non-insulin hypoglycemic medication before transplantation
2. Cystic fibrosis patients
3. Age \< 18 years of age
4. Pregnancy
5. Non-English speaking subjects
Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon

This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age. Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause these infections as prevalent in Lebanon.

This study will be performed at six large hospitals in Lebanon in the three largest cities Beirut, Tripoli, and Saida. The study will enroll children younger than 5 years of age who are admitted to the hospital because of gastroenteritis. Enrollment will continue for a period of two years at each hospital. Inclusion criteria are age \< 5 years, with gastroenteritis as the main reason for admission to the hospital or for a stay in the Emergency Department longer than 12 hours. Exclusion criteria include onset of symptoms beyond 12 hours of admission (health-care associated infection). For all enrolled subjects, data will be collected about severity of illness, outcome, and history of vaccination. Stool samples will be collected for genotyping of rotavirus.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 5 years
* Gastroenteritis as admitting diagnosis
* Informed consent
* Parents willing and able to cooperate

Exclusion Criteria:

* Age \> 5 years
* Onset of gastroenteritis beyond 12 hours of admission
Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study

* The objective of the research is to do translation and to culturally familiarize the COPENHAGEN Neck Functional Disability Scale into the Urdu language.
* To investigate if the COPENHAGEN Neck Functional Disability Scale is reliable and validate in the Pakistani population with Chronic Neck pain.
* To check the correlation with Neck Disability Index, Neck Pain and Disability Scale.

The English version of the COPENHAGEN Neck Functional Disability Scale will be translated into Urdu and culturally adapted, as per a previous recommendation. The COPENHAGEN Neck Functional Disability Scale will be given to participants who have consented, and would be chosen based on convenience sampling and inclusion and exclusion criteria. The inter-observer and intra-observer reliability of the COPENHAGEN Neck Functional Disability Scale, Neck Pain and Disability Scale , and Neck Disability Index will be evaluated in this study. On the same day, the questionnaire will be filled out created two times. An Inter - observer assessment will be done with 2 hour break between distributions of questionnaires. The initial observer then will gather a third assessment over one-week period. For data entry and analysis, Statistical Package of Social Sciences Version 23 will be utilized. Internal consistency will be checked using the Cronbach alpha value, and test retest reliability will be assessed using the Intra-class coefficient.

Eligibility Criteria:
Inclusion Criteria:

* From 20 years Old to 60 Years Old
* Participants with chronic Neck pain
* The patient having minimum cervical ROM and pain.
* Patient not taking medicine.
* No intervention between the test-retest assessments.

Exclusion Criteria:

To complete the forms because of a psychological Impairment, history or presence of;

* Rheumatic diseases, severe articulation inflammation, and cardiac disease.
* History of previous cervical or thoracic spine injury
* Any systematic disease with an unstable spine
* Illiteracy or lack of understanding of Urdu Language
* The presence of neurologic or musculoskeletal disorders other than the Neck Condition.
Family Inclusive Early Brain Stimulation

Social interaction (in the form of serve and return exchanges) between child and parent are crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan countries are ill-equipped to maximize the benefits from this interaction. The investigators approach builds on the traditional outlook that "it takes a village to raise a child" i.e., not only the parents but other extended family members play a role as caregivers to young children. The investigators intention is to use the existing post-natal/child welfare clinics to deliver an intervention, which uses culturally acceptable videos and active skills building, to deliver health messages and practical skills to women, with the intention that they will subsequently engage and teach their partners and other caregivers about early brain stimulation and child development.

A two arm cluster randomized control design will be used to select a total of about 400 participants each of the control and intervention groups. The participants will be drawn from primary health care (PHC) centres offering immunization services in Ibadan. In the intervention group, mothers will be trained on early brain stimulation using group video sessions followed by individualised question and answer sessions. These sessions will take place at 6 week and 10 week post natal immunisation visits. The control arm will receive the standard of care - routine immunization care- group health talks.

The child's development will be assessed using the Survey of Wellbeing of Young Children (SWYC) instrument.

Outcome variables will include changes in self-reported early child brain stimulation behaviour and increase in the awareness of parents and significant others on the social and emotional difficulties of children.

Eligibility Criteria:
Inclusion Criteria:

* All mothers with live children aged 1-6 weeks

Exclusion Criteria:

* Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
* Mothers who are unable to communicate to provide information
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.

This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥18 years and ≤ 89 years of age.
* Subject must be able to speak and read English.
* Subject must have both legs fully intact (cannot be an amputee) with normal function.
* Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).
* Subject legs must fit into the provided knee length compression sleeves (\<32").
* Subject must give written informed consent.

Exclusion Criteria:

* Subject is currently pregnant or breastfeeding.
* Subject has a positive COVID history within the previous 6 months.
* Subject presents with

  * - local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound
  * - arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response
  * - edema of legs or pulmonary edema from congestive heart failure
  * - deformity of the leg
  * - current Deep Vein Thrombosis as identified during baseline clinical screening
  * - recent or old Deep Vein Thrombosis as identified during baseline clinical screening
  * - reflux in the superficial or deep veins
  * - history of DVT/PE
  * - known May-Thurner Syndrome
* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
Safety and Feasibility of the EyeControl Device

The EyeControl device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.This study is aimed to demonstrate the safety and feasibility of the EyeControl device in healthy volunteers, and ALS patients in early stages.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 to 65 years old
2. Subject with understandable speaking communication
3. Subject fluent in Hebrew (speech and writing skills)

   Additional inclusion criteria for Stage 2 of the study:
4. Subjects with early stage ALS diagnosis - whose speech capability is unaffected

Exclusion Criteria:

1. Subjects with glasses or contact lenses
2. Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes
3. Medical history of epilepsy
4. Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol
5. Pregnant or lactating women
Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients

The aim of this study was to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.

Hyperchloremic acidosis is frequent in critically ill patients. Renal tubular acidosis (RTA) may contribute to acidemia in the state of hyperchloremic acidosis, but the prevalence of RTA has never been studied in critically ill patients. Therefore, we aimed to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.

This prospective, observational trial was conducted in a medical ICU of a university hospital. 100 consecutive critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria were included.

Base excess subset calculation based on a physical-chemical approach on the first seven days after ICU admission was used to compare the effects of free water, chloride, albumin, and unmeasured anions on the standard base excess. Calculation of the urine osmolal gap (UOG) - as an approximate measure of the unmeasured urine cation ammonium - served as determinate between renal and extra-renal bicarbonate loss in the state of hyperchloremic acidosis.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the medical ICU of the Div. of Gastroenterology \& Hepatology of the Medical University of vienna
* age ≥18
* expectancy to stay in the ICU ≥24hours
* clinical necessity for a urinary catheter

Exclusion Criteria:

* anuria
Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy

RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.

PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it works compared with sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.

OBJECTIVES:

Primary

* To compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy (BMAB) treated with magnetic acupressure at bilateral large intestine 4 (LI 4) points vs sham acupressure at bilateral proximal fourth interosseus space of the hand.

Secondary

* To compare the duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMABs.

OUTLINE: Patients are stratified according to the number of prior bone marrow aspirations and biopsies (BMAB) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs BMAB). Patients are randomized to one of two treatment arms.

* Arm I (acupressure): Patients receive acupressure at bilateral large intestine 4 (LI 4) points using Haci Magnetic Acupressure Suction Cups (MASC) during BMAB.
* Arm II (sham acupressure): Patients receive acupressure at bilateral proximal fourth interosseus space of the hand using the same size MASC as in arm I during BMAB.

Patients in both arms also receive analgesic and anxiolytic medications as determined by the acupressure operator and physician.

Patients complete a questionnaire before and after BMAB to assess pain experienced before and during BMAB and their attitude towards the procedure.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Scheduled to undergo a routine bone marrow aspiration with or without biopsy

  * No requirement for conscious sedation during the procedure

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior acupuncture or acupressure
* No prior participation in this study
High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with adhesive capsulitis

Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation.

In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder.

High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics:

Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz\~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool.

Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50\~100mT.

Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
2. The symptoms endure for a duration exceeding 3 months.
3. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.

Exclusion Criteria:

1. Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
2. Presence of systemic rheumatic disease.
3. Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
4. Acute compression of cervical nerve root.
5. Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
6. Recent receipt of shoulder injections for treatment within the last 3 months.
7. Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.
8. Expectant or breastfeeding women.
9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring insulin supplementation.
Physiotherapy in Stress Urinary Incontinence

The goal of this randomized controlled trial is to evaluate and compare the effects of functional magnetic stimulation and pelvic floor muscle training on pelvic floor muscle function, urinary incontinence symptoms and quality of life in women with stress urinary incontinence. The main questions it aims to answer are:

* What is the effect of functional magnetic stimulation on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence?
* What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence?
* Which intervention is more effective - functional magnetic stimulation or pelvic floor muscle training program?

Participants will be evaluated before and after the intervention with the following methods:

* International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF);
* Incontinence Impact Questionnaire-Short Form (IIQ-7);
* Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.

The study was performed in the period of 07/21/2021-30/10/2021. The study included 48 women 29-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave birth and signed the consent form. Women complaining of vaginismus, suffering from urinary tract infection, cancer, epilepsy or skin conditions with implanted pacemakers, metal implants and pregnant women were excluded from the study. Study participants were randomly divided into two groups: the I group (n=24), in which participants underwent functional magnetic stimulation (FMS) and the II group (n=24) in which subjects received pelvic floor muscle training (PFMT) program. Participants were evaluated before the intervention and repeated after 6 weeks. Subjects responded to a general questionnaire before the intervention, before and after the intervention, the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess the symptoms of urinary incontinence and their impact on quality of life. Pelvic floor muscle strength and endurance were assessed with a "Pelvexiser" perineometer. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.

Eligibility Criteria:
Inclusion Criteria:

* complains of stress incontinence for at least 4 weeks;
* women who have given birth.

Exclusion Criteria:

* pregnancy;
* vaginism;
* urinal infection;
* oncological disorders;
* epilepsy;
* skin problems;
* if they had an implanted heart pacemaker, metal implants.