cyrilzakka/clinical-trials huggingface dataset:
PRCT: Ligament Reconstruction & Tendon Interposition With a Joint Spacer for Trapeziometacarpal OA

The purpose of this study is to compare the effectiveness of two types of operative treatment in terms of resolving symptoms, improving function and also with respect to x-ray outcomes.

The hypothesis is that insertion of a spacer will provide similar symptomatic relief, but improved long term gains in key and tripod pinch strength when compared to LRTI.

Trapeziometacarpal (TMC) arthritis is a common condition, which occurs when the cartilage (tissue) covering the bones at the joint at the base of the thumb wear away. This condition occurs in 10% of women and 1% of men.

There is controversy regarding the best treatment of this condition and many surgical techniques are in common use.

One of these involves removing the wrist bone (trapezium) at the base of the thumb and, using a tendon from the forearm, reconstructing an important ligament, which contributes to the stability of the thumb. This is known as a Ligament Reconstruction and Tendon Interposition (LRTI).

A newer type of operation involves the insertion of a Ascension PyroDisk which is made from a thick pyrocarbon layer encasing a graphite core with a small amount of tungsten. These materials have been shown to be safe when implanted in the body. The PyroDisk is a disk shaped design which has a curved surface designed to fit between the bony surfaces of the trapezium and the metacarpal, reducing pain and allowing for full movement of the joint. It contains a hole in the center through which a strip of tendon can be passed and helps hold the disk in place.

This research study is designed to determine the effectiveness of the Ascension PyroDisk spacer when compared to the LRTI procedure described above. The effectiveness of both of these procedures will be determined by comparing range of motion, grip and pinch strength, x-rays, function and return to work. It is important to compare both procedures, as it is not known which procedure is the most effective.

Eligibility Criteria:
Inclusion Criteria:

* isolated trapeziometacarpal osteoarthritis
* duration of symptoms of at least six months
* failure to respond to non-operative management
* age 50 or older
* less than 30 degrees of ipsilateral MCP hyperextension
* British Columbian resident living in the Lower Mainland and available for protocol follow-up

Exclusion Criteria:

* previous surgery for TMC arthritis
* other significant ipsilateral wrist or hand pathology
* a history of inflammatory arthropathy
* a requirement for concommitant surgery for another condition
* any previous hand or wrist fracture
Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position

The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants who are born at ≤ 35 weeks of GA

Exclusion Criteria:

* Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
* Grade IV intraventricular hemorrhage
* Ventilator-dependence beyond 60 days of life
* Inability to orally feed prior to discharge
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.

The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years

Eligibility Criteria:
Inclusion Criteria:

* Age: 9 to 26 years of age
* Gender: Female
* All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
* Current SLEDAI score ≤ 6
* Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment

Exclusion Criteria:

* Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
* Current SLEDAI score \> 6
* Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
* Previous administration of any HPV vaccine
Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.

The period of about a month after the discharge of acute heart failure patients is defined as a transition time. During this period, the patient has a high mortality rate and a readmission rate because the patient is not stabilized. In the United States and Europe, the readmission rate is more than 25% within 30 days, and the mortality rate within 30 days after discharge is three times that of patients with chronic heart failure.

The TRANS-HF is a prospective, randomized, multi-center, controlled study, which enrolls patients with acute heart failure with reduced ejection fraction.

The objective of TRANS-HF is to improve GAI at six months through three interventions: pre-discharge checklist, heart failure education, and telephone monitoring before the first outpatient visit.


Eligibility Criteria:
All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous

Inclusion Criteria:

1. Symptoms of heart failure
2. Signs of heart failure
3. Lung congestion in Chest-X-ray
4. Objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels
5. Left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. Patients younger than 19 years old
2. Patients who do no consent
Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants

This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 30.0 kg/m\^2, inclusive
* Body weight ≤102 kg
* Willing to consume a high-fat breakfast, including pork
* Adheres to the contraception requirements of the protocol
* Additional criteria apply.

Exclusion Criteria:

* Received any investigational drug or device in a clinical research study within 90 days
* Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
* History of any drug or alcohol abuse in the past 2 years; a confirmed positive drugs of abuse test result
* Regular alcohol consumption; a confirmed positive alcohol breath test at screening
* Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes and nicotine replacement products in the last 6 months
* Female of childbearing potential, pregnant, or breastfeeding
* Male participant with pregnant or lactating partners
* Clinically significant abnormal clinical chemistry, hematology or urinalysis result
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV)
* Active renal and/or hepatic disease
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological or psychiatric disorder
* Any form of cancer in the 5 years (exceptions apply)
* History of adrenal insufficiency
* Have a condition that could be aggravated by glucocorticoid antagonism
* Donation or loss of greater than 400 mL of blood or plasma within the previous 3 months
* Currently using glucocorticoids or have a history of systemic glucocorticoid use in the last 12 months or 3 months for inhaled products
* Additional criteria apply.
Real World Data on Vedolizumab Concentration and Outcomes in Inflammatory Bowel Disease (IBD) Patients Switching From Intravenous (IV) to Subcutaneous (SC) Vedolizumab in University Hospital Center Osijek

Inflammatory bowel disease consists of ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world data on vedolizumab serum concentration and treatment outcomes in cohort of patients treated at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. Study will be recruiting patients who switched from intravenous to subcutaneous vedolizumab according to routine clinical practice.

This is a non-interventional, prospective study of participants with IBD who switched from intravenous to subcutaneous vedolizumab in the real world setting.

The study will enroll approximately 30 participants. The data will be collected at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. All the participants will be assigned to a single observational cohort. All procedures (e.g., blood draw for serum trough concentration of vedolizumab, stool collection for fecal calprotectin or colonoscopy) will be done for routine clinical care. Data will be collected at baseline and at 6-12 months after switch from intravenous to subcutaneous vedolizumab. At baseline, data on age, gender, body mass, diagnosis, time from diagnosis, prior and concomitant therapy for IBD, comorbidities, time from switch from vedolizumab IV to vedolizumab SC, and vedolizumab serum trough concentration during vedolizumab IV therapy, will be collected. At control visit, data on concomitant therapy, adverse events, hospitalization, surgery and vedolizumab serum trough concentration during vedolizumab SC therapy, will be collected. For evaluation of disease remission at baseline and at control visit, Harvey-Bradshaw index (HBI) for Crohn's disease and Partial Mayo score (PMS) for ulcerative colitis (HBI \<5 or PMS \<2); or value of fecal calprotectin (\<150 µ/g); or Simple Endoscopic Score for Crohn's disease (SES-CD) and Mayo endoscopic subscore (MES) for ulcerative colitis (SES-CD \<3 or MES \<2), will be used.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older
2. Diagnosis of IBD (UC or CD)
3. Signed informed consent
4. Switched to or planning to switch from vedolizumab IV to vedolizumab SC
5. Disease remission at the time of switch (according to clinical, laboratory or endoscopic parameters)

Exclusion Criteria:

1. Corticosteroid therapy at time of switch from vedolizumab IV to vedolizumab SC
Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity"

The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS) and/or nutritional on body composition and functional tasks in elderly females with sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy based on a high protein supplement.


Eligibility Criteria:
Inclusion Criteria:

* community dwelling
* Sarcopenic Obesity

Exclusion Criteria:

* exercising more than 60 min/week
* more than 4 weeks absent during the interventional period,
* injuries (i.e. hip TotalEndoProsthesis (TEP), abdomen/groin hernia) or diseases (i.e. epilepsy, cardiac arrhythmia) that prevent WB-EMS intervention
* medication and/or diseases affecting our primary endpoints.
Anal Fistula Plug for High-type Anal Fistulae

The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients.

An anal fistula is an abnormal communication between the anal or rectal lumen and the perianal skin. Anal fistulae are described according to the level at which they transgress the anal sphincter. If the internal opening begins above the anal sphincter then the fistula is described as 'high'. Traditional surgery for high-type anal fistulae often requires staged operations with fistulotomy and seton insertion. The surgery usually results in large and deep wounds which can take months to heal. Moreover, risk of faecal incontinence is inevitable because part of the anal sphincter is divided during the surgery.

The Surgisis® anal fistula plug is a minimally invasive and sphincter-preserving alternative to traditional fistula surgery. It is a newly developed biomaterial made from complex collagen obtained from pigs - animals that have a collagen structure almost identical to that of human tissue. During manufacturing of the plug, living cells are removed by special processes to help ensure that no transmittable diseases are present in the tissue. The plug is a conical device and is placed by drawing it through the fistula tract and suturing it in place. As pig collagen is so similar to human collagen, the plug, once implanted, incorporates naturally over time into the human tissue (human cells and tissues will 'grow' into the plug), thus facilitating the closure of the fistula. Preliminary clinical data from USA showed a high fistula closure rate of 87%. The anal fistula plug can also avoid protracted postoperative wound care and minimise the risk of faecal incontinence.

We would like to carry out a pilot study, the aim of which is to evaluate the efficacy and safety of this new anal fistula plug in the management of high-type anal fistulae. This is believed to be the first study of its kind in Hong Kong.

Patients with high-type anal fistulae confirmed by MRI will be recruited into this study. Patients with previous history of fistula surgery, patients with Crohn's disease, and patients with known allergy to porcine material will be excluded. EUA + anal fistula plug will be performed. Outcome measures include fistula healing rate, recurrence rate, and morbidity. Follow-up MRI will be arranged at 3 months and 6 months after the operation to objectively evaluate the healing of the fistulae.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high-type anal fistulae confirmed by MRI
* Informed consent available

Exclusion Criteria:

* Patients with previous fistula surgery
* Patients with Crohn's disease
* Patients allergic to porcine material
The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes

Many volunteers visiting seniors make socially-based "friendly visits". This study investigated the efficacy of volunteers making visits focused on stimulating cognition. Participants were randomly assigned to either a "friendly visit" control group or a cognitive stimulation group. Seniors receiving stimulation visits made statistically significant improvement in memory abilities.

Older adults who maintain their cognitive skills and abilities are able to live more independently than those whose skills have deteriorated. The costs (money, time, personnel) associated with providing cognitive stimulation programs to residents in long-term care homes often prohibit the delivery of these programs. The present study explored the efficacy of using volunteers to administer a stimulation program in two long-term care homes. The program focused on stimulating reasoning, attention, and memory abilities using uncomplicated, pen-and-paper exercises. Thirty-six resident participants and 16 volunteer participants were randomly assigned to one of two parallel groups, either the control or stimulation group.

For eight weeks, three times each week, control group participants met for standard "friendly visits" (casual conversation between a resident and volunteer) and stimulation group participants met to work through a variety of exercises meant to stimulate the cognitive abilities of residents. Results were analyzed using a 2-way ANOVA and indicated statistically significant Group x Time interactions for Verbal Memory (F(1, 33) = 7.92, p = .008), Non-Verbal Memory (F(1, 33) = 6.8, p = .014), Learning (F(1, 33) = 5.27, p = .028), and Verbal Fluency (F (1, 33) = 5.56, p = .024).

Volunteers completed a post-study questionnaire which indicated that the volunteers in the stimulation group found their skills-based interactions more stimulating for residents. Given this showing of improved resident abilities, it is reasonable to assert that the study does demonstrate that a volunteer-administered, cognitive stimulation program can provide measurable gains in the cognitive abilities of older adults. Further studies concerning the role of volunteers in the maintenance of the cognitive abilities of older adults are recommended.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and over
* living in a long-term care home
* normal or corrected visual and auditory acuity
* English proficiency
* not currently using de-stabilizing, psychotropic medication known to impair cognition
* ability and willingness to actively listen to and accurately follow 2-step instructions for at least 20 consecutive minutes
A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir

In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.

This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus \> 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* out patient
* documented HIV-1 infection
* first line treatment failure:

  * after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors
  * two measurements of plasma HIV RNA levels \> 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification
* satisfactory compliance (\>80%) to 1st line antiretroviral treatment
* signed informed consent
* agreement for contraception for women of childbearing age

Exclusion Criteria:

* HIV-2 infection or HIV-1/HIV-2 coinfection
* uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB
* first line antiretroviral treatment with a protease inhibitor or tenofovir
* ongoing treatment with rifampicin
* severe hepatic insufficiency (PT \< 50%)
* ALT \< 3 times the upper limit of normal
* creatinine clearance calculated by Cockcroft's formula \< 50 mL/min
* Hb \<=8 g/dL; platelets \< 50,000 cells/mm3; neutrophils \< 500 cells/mm3
* pregnancy and lactation
Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis

In this study, we investigated the clinical variability in paroxysmal sympathetic hyperactivity in patients with acute brain injury and examined the prognostic value of the Paroxysmal Sympathetic Hyperactivity Assessment Measure (PSH-AM) in relation to Doppler ultrasound assessment of volume status, right heart function, and pulmonary edema. Thirty patients with ABI were prospectively enrolled. A correlation analysis between the PSH-AM score and related clinical indicators was performed using Pearson's or Spearman's correlation coefficient. Receiver operating characteristic curves were used to assess the prediction of the 6-month Glasgow Outcome Scale Extended score for neurorehabilitation prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Only adult patients (\>18 years of age) were included. The other inclusion criteria were 1) definite cerebrovascular accident or craniocerebral injury (a clear change in consciousness or suggestive imaging); 2) the ability to undergo ultrasound to obtain information on volume status and cardiac and pulmonary monitoring; and 3) fulfilment of the measurement conditions.

Exclusion Criteria:

* The exclusion criteria were 1) a history of cardiovascular disease, such as coronary artery disease, heart failure, or atrial fibrillation; 2) presence of severe valvular disease or an EF of \<30%; 3) chronic lung disease; 4) chronic liver failure or renal insufficiency; 5) comorbid malignant neoplasm or acute/chronic infectious disease prior to craniocerebral injury; 6) pregnancy or breastfeeding; 7) history of psychiatric disorders; 8) history of drug abuse or alcohol misuse; 9) history of β-blocker use; 10) comorbid spinal cord injury; 11) death or discharge from hospital within 5 days of hospitalization.
The Effect of Ketanserin on the Microcirculation in Sepsis

This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

This is a pilot study, including 10 ICU patients with severe sepsis with MFI \< 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI \< 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* severe sepsis and MFI \< 2,5 after resuscitation

Exclusion Criteria:

* age \< 18 year old
* pregnant
* participation other trials prolonged Qt interval