cyrilzakka/clinical-trials huggingface dataset:
Combined Effect of Underwater Ultrasound

This randomised controlled trial aims to investigate the effects of underwater ultrasound therapy and customised foot insoles in RA patients. The study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. The research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of RA patients.

Rheumatoid arthritis (RA) is a chronic inflammatory disease that can cause pain, swelling, limitation of movement and deformities in the joints (Cabrera-Sánchez et al. 2024)(Cabrera-Sánchez et al. 2024). Foot and ankle involvement is quite common in RA patients and this may adversely affect the daily living activities of patients. In addition to pharmacological approaches, physical therapy methods and the use of biomechanical supports are also important in the treatment of RA.

Ultrasound is a physical therapy method used to reduce pain and inflammation and accelerate tissue healing (Király et al. 2021). Underwater ultrasound applications may be more effective in superficial areas and may reduce the risk of damage to sensitive tissues around the joint. On the other hand, customised foot insoles (orthotics) are frequently used to correct foot deformities, eliminate biomechanical imbalances and reduce pain (Gaino et al. 2021).

This randomised controlled trial aims to examine the effects of underwater ultrasound therapy and customised foot insoles in RA patients. The study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. The research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of RA patients.

Eligibility Criteria:
Inclusion Criteria:

* - ACR/EULAR 2010 diagnostic criteria with foot involvement and having a disease duration of less than two years were enrolled in the study over a period of three months.
* with foot involvement diagnosed by a rheumatologist.

Exclusion Criteria:

* - Degenerative diseases and anatomical abnormalities were excluded
* if they presented in an acute symptomatic flare or they needed to use walking assistance
* neurological problems, malignant process, cognitive deterioration, pregnancy, previous foot surgery and the presence of a foot wound
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.

  4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.

  5.Written informed consent signed by the patients or representatives

Exclusion Criteria:

* 1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level \> 2.5 mg/dL. Expected survival time of less than 24 months
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome.


Eligibility Criteria:
Inclusion Criteria:

1. All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
2. We define high-risk fractures as those that are either:

   * Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
   * Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
   * Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed
3. Requiring incision for fixation or debridement of 3 cm or greater.
4. Patients 18 years of age or older

Exclusion Criteria:

1. The study injury is already infected at time of study enrollment.
2. Patient is unable to receive incisional NPWT for any reason.
3. Patients who have already had definitive fixation prior to enrollment in the study.
4. Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
5. The study injury is a Gustilo Type IIIB or IIIC open fracture.
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)


Eligibility Criteria:
Inclusion criteria:

* Patient must be able to provide an informed consent
* Patient older than 18 years' old
* Patient with suspected diagnosis of HIT, need 2 of the following:

have a fall in platelet count of \> 30% from a baseline prior to heparin/LMWH Platelet factor 4 (PF4) ELISA positive Develop skin lesions secondary to subcutaneous heparin With T score more than 4 For those less than 4 we will use serotonin release assay-SRA

* Patient received the bridging therapy of non-heparin anticoagulant
* Patient is receiving the standard of care treatment for HIT
* Patient is willing to be followed up for by one of the physicians listed in the delegation log
* The Primary physician responsible for the patient is agreeing for the patient to participate
* Patients are not involved in a clinical trial for HIT management

Exclusion Criteria:

* Patient is unable to sign an informed consent
* Patient doesn't have a confirmed diagnosis of HIT
* Patient Does not have Pulmonary embolus
* Patient does is not on Warfarin for other indications
* Patient is a known case of hypercoagulable disorder
* Patient is not willing to come back for follow up
* Patient is critically ill or has a life expectancy of less than 3 months
* Pregnancy that is in First trimester.
* Multi-system organ failure or estimated survival of less than 30 days
* Uncontrolled hypertension defined as a blood pressure \>180/110 mm Hg
Incentive Disbursement Pattern

This study will be a three-arm randomized, controlled trial that the investigators will run in 2014 with approximately 4,000 users of an app called Achievemint. AchieveMint rewards users with points (which can be redeemed for prizes) for every step they take. The investigators will be testing three different point-based programs designed to encourage users to build exercise habits over the course of a month: stable incentives, increasing incentives, and decreasing incentives. After the investigators' month-long intervention period, the investigators will observe users' step counts during a month-long follow-up period to test which of the investigators' habit-building programs leaves users with the best exercise habits (or the highest step counts) after they conclude.

The time frame of observation will be 8 months.

Past research has shown that paying people to exercise repeatedly can create exercise habits that last long after cash incentives are removed (Charness and Gneezy, 2009; Acland and Levy, 2013). the investigators' research will examine what kind of incentive programs build long-lasting habits most effectively. Specifically, the investigators will compare the long-term effects (based on step counts in the one month after the conclusion of the investigators' intervention) of three different interventions: (1) incentives for taking steps that remain stable over the course of a month (stable incentives); (2) incentives (of equal net value) for taking steps that start low and grow larger over the course of the month (increasing incentives); and (3) incentives (of equal net value) for taking steps that start high and decrease over the course of the month (decreasing incentives). For example, during the month-long intervention, users in group (1) will receive 6x their usual points every day for each step they take; users in group (2) will receive 2x the usual points for several days, then 3x the usual points, and so on up to 10x the usual number of points; finally, group (3) will have the same incentive schedule as group (2) but in reverse - starting with a 10x multiplier and declining. The question is this: Is it better to ease people into exercise when trying to help them form a lasting habit, to start them off intensively and then ease up the pressure, or to maintain steady, constant incentives to exercise? By examining the steps taken by members of the investigators' three experimental groups in the month following the investigators' intervention, the investigators will be able to assess whether increasing, decreasing, or stable incentives are ideal for creating lasting habits after incentives are removed. The anticipated output of this project is a published research paper.

The time frame of observation will be 8 months.

Eligibility Criteria:
Inclusion Criteria:

* all users of the Achievemint app will be eligible for inclusion

Exclusion Criteria:

* all users of the Achievemint app who are in the top 30 percentiles of activity levels will be excluded.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory women between the ages of 40 and 64 years, inclusive
* postmenopausal, defined as amenorrheic for at least 24 months
* clinically acceptable physical exam
* clinical laboratory tests (complete blood count \[CBC\], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (AST) and alkaline phosphatase (ALT), which must be \< 1.25 times the upper limit of normal, or gamma-glutamyl transpeptidase (GGT), which must be \< 1.5 times the upper limit of normal
* normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals)
* body mass index between 17 and 27
* willing to sign an approved informed consent form before any study-specific assessments and oral consultations are performed

Exclusion Criteria:

* administration of medications within 6 months before investigational product administration that are known to effect bone metabolism, including but not limited to the following: calcitonin, parathyroid hormone (or any derivative), supplemental vitamin D (\> 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics
* administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis
* diagnosed with any condition that affects bone metabolism
* greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities
* routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of investigational product administration
* known sensitivity to any drugs
* positive test results for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus antigen/antibody, syphilis
* receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product
* donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200 mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening
* subject had previously entered this study
* any other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent
Evaluation of the Treatment Approach ROBIN

The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at Clinical High Risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at CHR state and even ﬁrst-episode psychosis is limited. To fill this gap, the clinicians from the early intervention center in Zurich have developed the treatment approach "Robin" (standardized manual and smartphone App) for adolescents with high risk for developing a psychotic disorder. The treatment approach is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. The evaluation aims firstly to compare the efficacy of "Robin" in 30 CHR adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. Primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy and quality of life. For the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with CHR for psychosis, aged 14-18, will be recruited over three years. At-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group.


Eligibility Criteria:
Inclusion Criteria:

* 1) At least two self-experienced and self-reported cognitive basic symptoms as assessed by the children-youth version of the Schizophrenia Proneness Interview Child and Youth Version (SPI-CY)
* and/or 2) at least one attenuated psychotic symptom for psychosis assessed by the Structured Interview for Prodromal Syndromes (SIPS)

Exclusion Criteria:

* a diagnosis of a psychotic disorder
* current substance or alcohol dependence
* insufficient German or English language ability
* low intellectual abilities with IQ \<75
Can CCTA Technicians Provide Accurate Interpretation of Findings in Patients Presenting to the ED in After Hours?

Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice in chest pain patients with low to intermediate probability of coronary artery disease (CAD). Qualified CCTA readers may not be available around the clock in most centers, limiting the use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide initial accurate diagnosis to guide initial management and triage of such patients


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for elective CCTA to assess coronary artery disease

Exclusion Criteria:

* Patients with previous coronary revascularization procedures (PCI or CABG).
Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values and placental transfusion. The most effective way to manage umbilical cord in in 'two-step' delivery remains to be established.

Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by 'two-step' delivery. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).

Eligibility Criteria:
Inclusion Criteria:

Vaginal delivery Gestational age \>37 weeks Natural process of labor

Exclusion Criteria:

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
P4ACE Trial for Persons With Chronic Knee Pain

The goal of this single-blind, cross-over clinical trial is to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). In this cross-over trial, participants will perform two types of walking on a treadmill. Intermittent walking will involve 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. Continuous walking will involve resting for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes.

The study objectives are to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). The investigators hypothesize that continuous walking will result in greater increases in clinical pain and mechanistic pain sensitivity than intermittent walking. Physical activity (PA) has been recommended as the first-line management strategy for people with chronic knee pain. Walking is an accessible, low-cost, joint-friendly form of PA and is widely advocated for older adults with knee complaints. However, movement-evoked pain is a commonly cited barrier for PA engagement. On one hand, a bout of PA may produce short-term analgesia and reduce pain. On the other hand, excessive or prolonged PA may exacerbate symptoms and lead to avoidance/fear of subsequent PA. Besides the total PA volume, how it is accumulated could also impact joint health. It is biomechanically plausible that shorter and frequent activities are more beneficial to articular tissues than longer and infrequent activities. Compared to intermittent loading, prolonged continuous loading had a detrimental effect on the biomechanical functions of articular cartilage in a bovine model. Findings of this study will provide insight on the relations between patterns of PA and pain profiles.

Eligibility Criteria:
Inclusion Criteria:

* men or women aged 45-75 years
* BMI ≤ 35 kg/m2
* frequent movement-related knee pain (knee pain on more than half the days of the past month)
* no morning stiffness or morning stiffness lasting \< 30-min
* self-reported unilateral or bilateral knee pain of ≥ 3 and ≤ 7 on a 0-10 numeric pain rating scale (NPRS)
* knee pain duration ≥ 12 months
* physically able to walk unassisted on a treadmill at ≥ 4 km/hour for 30 minutes
* own a smart phone
* willing and able to wear an activity monitor and answer electronic survey questions delivered via a smart phone over a 10-day period.

Exclusion Criteria:

* intra-articular steroid injections in the previous 3 months
* intra-articular hyaluronic acid injection in the previous 6 months
* any arthroscopic or surgical knee procedures (e.g., partial meniscectomy) in the past 12 months
* lumbar radiculopathy
* neurological, vestibular, or visual dysfunction affecting walking balance and mobility
* plan for total knee arthroplasty in the next 12 months
Physiology of GIP(1-30)NH2 in Humans

Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. The objective of this study is to investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose, bone markers (CTX and P1NP) will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men of Northern European descent
* BMI: 19-25 kg/m2
* Stable body weight (±5%) in the last three months

Exclusion Criteria:

* Treatment with medication or dietary supplements that cannot be paused for 12 hours
* More than 14 units of alcohol per week or abuse of narcotics
* Established liver disease and/or plasma alanine aminotransferase (ALT) ≥3 × normal value and/or INR outside the normal range
* Renal impairment (eGFR \<60 ml/min/1.73 m2)
* Severe arteriosclerotic heart disease or severe heart failure (NYHA group III or IV)
* Low blood count (haemoglobin \<8.3 mol/l)
* Special diet or planned body weight change before the trial period
* First-degree relatives with diabetes
* Participation in other clinical experiments with medication
* Any disease/condition that the investigators estimate disturbing for the participation in the experiment