cyrilzakka/clinical-trials huggingface dataset:
The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients

It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined.

Cancer is a disease that requires a long-term struggle with the psychosocial and economic burden it creates on the individual, family and society, bringing with it many health problems. Although chemotherapy treatment is the main treatment method for patients, it can cause some changes in the individual's appearance while treating cancer and many symptoms such as nausea, vomiting, diarrhea, alopecia, and constipation after treatment. At the same time, patients may feel tired, sleepy and depressed after treatment. However, cancer patients and their families experiencing some unknown diagnosis and treatment processes related to cancer also cause them to be unhappy as a result of experiencing some physical, social, emotional and spiritual problems during the treatment.

It is reported in the literature that pet therapy or animal-assisted treatments reduce disease-related symptoms and make patients happy. Pet therapy is an auxiliary non-pharmacological form of treatment that heals physiological and psychological diseases through interactions between animals and humans that meet certain criteria, and stimulates and activates the body mechanisms required for the development of the individual's health behaviors. In the literature, pet therapy studies with oncology patients are quite limited. Therefore, this study was conducted to examine the effects of live cat and robotic cat therapies on the symptoms and happiness levels experienced by oncology patients after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for admission to the study are 18≤ of age,
* Agreeing to participate in the research,
* Being conscious of receiving outpatient chemotherapy treatment for 3≤ months, and being able to communicate.
* The criteria included no impairment in mental and cognitive functions of patients/relatives in the live group,
* Patients in the live cat group not having any animal allergies, and the cat group having a cat.

Exclusion Criteria:

* Not agreeing to participate in the research,
* Being under 18 years of age,
* Having known psychological disorders, having a visual, hearing, or speech disability, and having an animal allergy.
* Also excluded are having a surgical wound (suture, drainage, etc.), neutropenia or severe infection (by resistant bacteria), fever, diarrhea, respiratory symptoms or vomiting during the week before the start of the study.
Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19

This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19
* SpO2 between 92 and 96% with low-flow oxygen therapy (\< 15 L/min).

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other chronic respiratory disease
* Confusion
* Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial.

The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or "PTX-022".


Eligibility Criteria:
Key Inclusion Criteria:

* Completed the PALV-05 (VAPAUS) study
* Agree to contraceptive use

Key Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)
* Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study
* Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study
The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde Cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent PEP and hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given common treatment, the other uses somatostatin in the base of common treatment.

A prospective, multi-center, investigator sponsored, randomized controlled trial, 15 sites join in in China, 908 subjects will be enrolled.

A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.

Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age \> 18 years.
* Normal amylase level before undergoing ERCP.
* Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

* Pregnancy or history of allergy to somatostatin.
* Renal insufficiency (Scr\>177umol/L).
* Acute myocardial infarction within 3 months of the procedure.
* History of subtotal gastrectomy (Billroth II Method).
* Symptom of shock before undergoing ERCP, such as hypotension (systolic blood pressure \< 90mmHg) or tachycardia (HR \> 120 bpm).
* Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent .
* Patients involved in other study within 60 days.
* Patients unfitted for the study by investigators.
* All contraindications to Stilamin.
Prosthetic Pelvic Organ Prolapse Repair

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.

It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

Eligibility Criteria:
Inclusion Criteria:

* Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
* Patient must have provided written informed consent form prior to enrolment
* Patient must be insured

Exclusion Criteria:

* Previous of surgery for prolapse
* Unfavourable conditions to one or other of the 2 evaluated procedure
* Pelvic malignancy in the course of evolution
* Contraindication to the use of mesh
* Women not reading French
* Patients haven't have a social insurance
* Pregnancy or desire for future pregnancy
* To be under guardianship or deprived of liberty
* Simultaneous participation in another biomedical research
Impact of Specialist Led Integrated Care in COPD

This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices.

This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. It will be run from the Heart of England NHS Foundation Trust, which will provide the specialist input and oversight, and up to 40 practices across the Eastern Birmingham Health Organisation with approximately 2200 patients with COPD confirmed by their current medical practitioner. Each practice will be randomised to either the intervention or control group. The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. Treatment will be at the discretion of the clinician and is not specified in the trial protocol. The investigators anticipate that the treatment recommendations in the intervention arm may include referral to pulmonary rehabilitation and reduction in the use of inhaled corticosteroids, which are prescribed at high rates in our locality. The control group will be seen by the usual staff at their practice. These patients will not be seen by the trial team and their data will be extracted remotely using electronic systems.

The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices. Secondary outcomes will include: referral to secondary care, unscheduled healthcare consultations (ED attendance, hospital admissions), COPD exacerbations, healthcare costs, medications prescribed, biochemical markers of disease, radiological investigations, lung function tests measured when clinically indicated, and death within 12 month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Practices will be eligible for inclusion if they give consent to data collection and are part of the EBHO.
* Patients from the practices will be eligible if they are coded to have COPD within the GP record. In addition patients who are not coded to have COPD in the GP record, but who have a hospital admission with a primary diagnosis of COPD within the enrolment period for practices (first 3 months) will be eligible.

Exclusion Criteria:

• Patients will only be excluded if they are proven not to have COPD at specialist assessment, or during the follow up period, as determined by changes in medical coding within the GP record. If patients are assessed by the specialist and the diagnosis is not felt to be robust, enrolment will be suspended until this matter can be clarified by use of post bronchodilator spirometry and/or other required parts of their clinical care.
Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- \<--\> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.

In this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Invasive monitoring of blood pressure
* Non opposition to the research
* Admission to the intensive care unit
* Need of intermittent hemodialysis

Exclusion Criteria:

* Sodium bicarbonate infusion
* Pregnancy or breastfeeding
* Juridical protection
Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis

Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and 20% of these patients will face a recurrent event after the usual three to six-month course of anticoagulant treatment. To date, most patients are given prolonged anticoagulant treatment. However, anticoagulant treatment are associated with a major risk of bleeding (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.

Over the past few years, microparticles (MPs) which are small vesicles originating from the budding of cellular membranes have emerged as important biological entities regulating hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and tissue factor (TF). All data obtained in mouse models support a role of MPs in venous thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs vectorize molecules which are not only procoagulant but also profibrinolytic. The net result depends on a balance between both activities (the coagulo-lytic balance). This balance is can be measured by two complimentary assays on MPs.

We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of VTE recurrence after stopping the anticoagulant treatment.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with a VTE history with at least 3 months of anticoagulant treatment.

Exclusion Criteria:

-
4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia

The recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. Since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological tests for this purpose. Patients, who were scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests before (T1), 15 minutes after the surgery (T2) and on discharge from the recovery room (T3). The tests used were Wechsler memory scale (test 1, working memory capacity), d2 - test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was used in healthy female volunteers, all test results were compared at the different time points.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients scheduled for ambulatory gynaecologic surgery
* age of 18 to 60 years
* a physical status I-II according to American Society of Anesthesiologists (ASA) classification
* fluency in German language and the ability to perform all tests

Exclusion Criteria:

* chronic consume of analgesics, psychotropic drugs, sedatives or alcohol
* if the ambulatory surgery lasted more than 60 minutes
* if the schema of standardised general anaesthesia was changed
* if the ambulatory setting was changed and the patients unexpectedly remained over night in the hospital.
A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2

The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts in psoriasis subjects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with plaque psoriasis at least 6 months prior to Screening, if suitable for systemic treatment or phototherapy, and if have a stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before the first dose). Subjects with psoriatic arthritis may be included if they have not received systemic treatment within the last 12 months and their disease is stable
* Subjects must use adequate contraceptive measures from the Screening Visit until 4 weeks after final administration of the investigational product
* Subject that has a maximum body weight of 243 pounds (110 kg)

Exclusion Criteria:

* Subjects with psoriatic arthritis that have received systemic treatment within the last 12 months.
* Subjects will not be eligible if they have current forms of psoriasis other than chronic plaque-type (e.g. erythrodermic, guttate, or pustular)
* Subject that has a current drug-induced psoriasis form (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Subject that has a history of recurrent or medically important infections, a clinically significant candida infection or clinically significant skin infection with Staphylococcus aureus requiring systemic treatment in the last 12 months prior to the first administration of study drug
* Subject that smokes more than 15 cigarettes, or equivalent in tobacco, per day Subject with a history of suicide attempt or suicidal behavior
* Any live vaccination within 3 months prior to Screening
* Subject that is pregnant, intends to become pregnant during the course of the study, or is lactating
Development of a Computerized Adaptive Test (CAT) for Evaluation of Sleep, Fatigue and Quality of Life in Patients With Chronic Pain

The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System


Eligibility Criteria:
Inclusion Criteria:

be able to read Portuguese be able to write Portuguese being in treatment for chronic pain

Exclusion Criteria:

hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests
Cellular and Tissue Based Therapy Registry

The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.

The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide comparative effectiveness data for patients with chronic wounds and ulcers and to understand whether clinical practice guidelines are followed in the use of these products. These products are referred to by a variety of names of which are inaccurate reflections of their structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered tissues," "biological dressings"). The preferred term is cellular and/or tissue based products (CTPs). CTPs are utilized for their biological influence on the healing process by stimulating or supporting healing. They may or may not be incorporated into regenerating tissue. Both tissue derived and biosynthetic products may be made with or without dead cells and biomaterials made of living cells may be comprised of autologous cells (cultured and not cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The diversity of products and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of CTPs in wound healing.

Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The CTPR is a subset of the USWR data. All patient data from all participating outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS and other initiatives. Data used for effectiveness research is HIPAA de-identified. These data are derived from structured language entries directly transmitted from electronic health records which also link to billing and charge documents once practitioners sign and lock charts, confirming the veracity of data entries.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving cellular and tissue based products

Exclusion Criteria:

* none
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6


Eligibility Criteria:
Inclusion Criteria:

* The subject presents with duration of chronic low back pain of \> 3 months requiring regular use of analgesics (\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used

Exclusion Criteria:

* The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)