cyrilzakka/clinical-trials huggingface dataset:
Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively

Patients with bilateral end-stage knee osteoarthritis will be included in the current study. Bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. We will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. The patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (Knee Society Scores and Knee Injury and Osteoarthritis Outcome Score), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of bilateral primary knee osteoarthritis Age 55 to 85 years Must be able to walk without support

Exclusion Criteria:

Rheumatological joint diseases Previous knee surgery Neuromuscular diseases Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.
Physical Activity in University Students Around COVID-19 Confinement

The period of confinement due to COVID-19 may lead to reduced physical activity levels with negative consequences for health and quality of life in the short and long term, in case the sedentary habits are maintained over time. It is therefore essential to know the physical activity and health habits of university students during the confinement, as it could help in the design of effective strategies for the post-confinement period, as well as for any similar future situations. The general objective of the study is to know how university students have adapted their physical activity and health habits to the situation of confinement generated by COVID-19, as well as to identify the determining factors and the possible consequences. It is expected that there will be modifications in the patterns of physical activity in this situation, which could vary based on sociodemographic and economic determinants, and could affect parameters of health and quality of life. A survey will be sent to all students by email through the corresponding vice-rectorates of the sixteen participating universities (https://covid19.ehu.es/). The survey will be completed "online" anonymously. Among those participants who wish to keep participating in the study, a follow-up will be carried out one month and one year after the end of the confinement period. In this case, those subjects must indicate their willingness to keep participating and provide a contact email. The follow-up period will allow to know how physical activity and health habits are modified in the long term.


Eligibility Criteria:
Inclusion Criteria:

* University students of any degree (bachellor's degree, master's degree, doctorate degree or any other University studies

Exclusion Criteria:

-
Gilead Sustained Virologic Response (SVR) Registry

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.


Eligibility Criteria:
Key Inclusion Criteria:

* Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
* Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
* Provide written, informed consent
* Be willing and able to comply with the visit schedule and protocol-mandated procedures

Key Exclusion Criteria:

* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
* History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery

Currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after Cochlear implantation. The literature on this subject is contradictory, and very limited. The aim is to assess the impact of postoperative antibiotic treatment on post-operative infection rate, and thereby discuss if postoperative antibiotic treatment has any benefits in the preventing treatment against infectious complication.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing cochlear implantation at this facility from 2010 to 2022

Exclusion Criteria:

* none
Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study

The purpose of the present study is to evaluate cardiotoxicity during re-challenge of a different modality of fluoropyrimidine (primary end-point S-1 and secondary any other fluoropyrimidine) after having perceived cardiotoxicity with a fluoropyrimidine based regimen previously. The patient population is being treated for solid tumors.

Fluoropyrimidine chemotherapy agents, such as 5-fluorouracil and capecitabine, are occasionally associated with cardiotoxicity that may manifest as chest pain, ECG alterations, cardiac arrhythmia, and rarely myocardial infarction and sudden death. Clinical fluoropyrimidine cardiotoxicity is infrequent (1-8% of patients), but subclinical toxicity may be much more common (up to one third of patients). The underlying mechanisms are not well understood, but they may include abnormal coronary artery contractility or spasm, and myocardial toxicity. Cardiotoxicity may be less frequent with S-1 (a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1) as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking.

Anecdotal evidence suggests that patients who have cardiotoxicity on other fluoropyrimidines may be successfully treated with S-1. The purpose of this retrospective study is to compare different 5-fluorouracil-based dosing modalities and S-1, and compare cardiotoxicity during these treatments.

The patient population was treated for solid tumors with a 5-fluorouracil based regimen and had a cardiac event grade 1-4. All patients were re-challenged with a different fluoropyrimidine or S-1 and assessed for cardiotoxicity during re-challenge.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor
* Cardiotoxicity grade 1-4 during fluoropyrimidine-based treatment
* Re-challenge with a different fluoropyrimidine-based therapy

Exclusion Criteria:

• Participation in a trial with experimental drugs
Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

Pain after laparoscopic cholecystectomy (LC) is a common complaint that prolongs hospital stay and thus increases morbidity. There are three primary sources of pain after LC, incision site, local and systemic effects of pneumoperitoneum, and post cholecystectomy wound to the liver. External oblique intercostal plane block (EOIPB) has recently been described as a novel block for upper abdomen surgery. the probable mechanism of the block with the dyeing of both the anterior and lateral branches of the intercostal nerves T7-T10. This block also provides a dermatomal sensory block at the T6-T10 level in the anterior axillary region and the T6-T9 level in the midline.

EOIPB has the benefit of being performed with the patient supine when compared with QLB and ESPB. It also has an advantage over SIPB in that it produces greater analgesia throughout the midline of the abdomen. The hypothesis of this randomized study is that patients who will undergo EOIPB will have lower opioid consumption in the postoperative period than patients who receive routine multimodal analgesia alone. The study aims to assess pain control in the immediate postoperative period by assessment of Numerical Rating scale (NRS), time for the first analgesic request as well as total morphine intake in the first 24 hours after surgery.

Study design:

This is a prospective, randomized double blinded control study which will be conducted in department of anesthesia and surgical Intensive care unit at Theodor Bilharz Research Institute after approval by research ethics committee and patient informed consent. 50 patients will be enrolled in the study and divided into two groups either (EOIPB group (E) or Control group (C). Randomization will be done by allocation 1:1 of scheduled cases per day.

Sample size: 38 patients

Eligibility Criteria:
Inclusion Criteria:

1. ASA 1-2.
2. Patients undergoing elective laparoscopic cholecystectomy with estimated pneumoperitoneum time of 60 to 90 min.-

Exclusion Criteria:

1. Coagulation disorders.
2. Liver/ kidney disease
3. Previous abdominal surgery
4. Infection in the block site
5. Chronic opioid use
6. Local anesthetic (LA) allergy,
7. Pregnancy, or BMI ≥35 kg/m2
8. Duration of surgery (≥ 2.5 h due to surgical complications), -
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus

A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).


Eligibility Criteria:
Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC or stage III not eligible for curative intent treatment
* Intended to receive palliative radiotherapy to the thorax, to a dose of 30Gy in 10 fractions or 20Gy in 5 fractions. In either treatment arm at least 5cm of the esophagus should be in the intended treatment field.
* Willingness and ability to provide informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* Age 18 years or older
* Prior or planned systemic therapy (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist, provided that no systemic treatment is given within 2 weeks prior to RT, concurrent with RT or within a 2-week period post RT.
* Concurrent palliative RT to other metastatic sites is permissible
* Life expectancy \> 3 months

Exclusion Criteria:

* Prior thoracic RT
* Serious medical comorbidities precluding RT
* Pregnant or lactating women
* Inability to attend the full course of RT or planned follow-up visits
* Planned concurrent palliative RT to the stomach and/or liver
* Congenital abnormalities of the esophagus or severe disorders of the esophagus (e.g. achalasia)
Food Effect Study For Apixaban Commercial Image Tablets

To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* History or evidence of abnormal bleeding or coagulation disorder (eg, easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery) and/or having a first degree relative under 50 years of age with a history of abnormal bleeding or coagulation disorder
Study of Chemoimmunotherapy for High-Risk Neuroblastoma

The purpose of this study is to find out whether an experimental drug called Hu3F8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF. The investigators want to find out if this combination is safe and what effect it has on the participant and the disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
* High-risk NB as defined as any of the following:

  * Stage 4 with MYCN amplification (any age)
  * Stage 4 without MYCN amplification (\>1.5 years of age)
  * Stage 3 with MYCN amplification (unresectable; any age)
  * Stage 4S with MYCN amplification (any age)
* Patients fulfill one of the following criteria:

  1. Have evidence of soft tissue disease OR
  2. If they only have osteomedullary disease at protocol enrollment, they should have:

     * Had previously received Hu3F8+GMCSF therapy AND have had less than a complete response to it OR
     * Had progressed progressive disease after their most recent anti-neuroblastoma therapeutic regimen
* Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy.
* Prior treatment with murine and hu3F8 is allowed.
* Prior treatment with irinotecan or temozolomide is permitted.
* Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody positivity is allowed.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Patients with CR/VGPR disease
* Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 except for hearing loss, alopecia, anorexia, nausea, and hypomagnesemia from TPN, which may be grade 3
* ANC \< 500/uL
* Platelet count \<30K/uL
* History of allergy to mouse proteins
* Active life-threatening infection
* Inability to comply with protocol requirements
* Women who are pregnant or breast-feeding
Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy

The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed.


Eligibility Criteria:
Inclusion Criteria:

* smoker over 18 years old
* consent to participate
* presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.

Exclusion Criteria:

* cognitive impairment
* drug uses
* pregnancy or lactation.
Biology and Experience of Eating in Women With Obesity

The purpose of this study is to understand how the opioid system is involved in eating behavior.

Obesity is associated with greater risk for cardiovascular disease (CVD), stroke, diabetes, and mortality, and is a heterogeneous condition with various causes and thus a diversity of intervention targets. Compulsive overeating afflicts 30% of people seeking obesity treatment and increases risk for CVD factors. This trial involves two participant visits to test whether opioid blockade (Day 1 or 2, depending on randomization), compared to placebo (Day 1 or 2, depending on randomization), will elicit common symptoms of opioid withdrawal, including nausea. Participants will receive each condition on separate days.

Eligibility Criteria:
Inclusion Criteria:

* Obese, as defined by BMI greater than or equal to 30
* Self-reported binge eating as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), in the last 4 weeks
* If sexually active with men, must agree to use birth control until the final study visit is complete (e.g., barrier methods, oral contraceptive)
* Subject must be able to complete written informed consent procedures and be able to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant or breastfeeding
* Severe hypotension (\< 90/60 mmHg)
* Recent or current use of vasoconstrictor or vasodilator medication
* Current or history of diabetes
* Allergies to any ingredients in naloxone hydrochloride
* History of or current alcoholism or drug dependence
* Bulimia Nervosa as defined in DSM 5
* Current or past use of opiate-containing medications in the last 30 days
* Plan to use opiate-containing medications during study participation period
* Medical conditions that are contraindicated with intranasal procedures: Nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage caused by the use of substances (e.g., cocaine)
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

The purpose of this study is:

1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
2. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).


Eligibility Criteria:
Inclusion Criteria:

* AJCC 1-3 staged gastrointestinal cancer patient
* patient undergoing radiotherapy as treatment
* age 20 yr and higher
* ECOG 0-2

Exclusion Criteria:

* age \< 20
* ECOG 3-4
* patient experiencing nausea or vomiting prior to accrual
* patient under antiemetic medication
* patient under steroid medication (topical or inhalant steroid application are exceptional)
* patient under opioid medication
EBIS: The Eindhoven Breech Intervention Study

The purpose of this study is to evaluate whether successful external cephalic version is associated with maternal thyroid function and mood state in pregnant women with breech presentation at term.

The relationship between successful external cephalic version and neonatal thyroid function will also be investigated.

A possible beneficial effect of successful external cephalic version on the development of congenital hip dysplasia will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* Gestation of 35 weeks or more
* Appropriate knowledge of the Dutch language
* Fetus in any of the 4 types of breech presentation: frank breech, complete breech, incomplete breech or footling presentation

Exclusion Criteria:

* Previous caesarean section
* Indication for caesarean delivery irrespective of presentation
* Previous abruptio placenta
* Multiple pregnancy
* Ruptured membranes
* Non-reassuring fetal monitoring tests results
* Hyperextended fetal head
* Significant uterine or fetal anomaly
* Use of thyroid medication
* Maternal autoimmune disease (such as insulin-dependant diabetes mellitus)
* Intra-uterine growth retardation
* Oligohydramnios
* HIV-positive women
Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit

Sepsis is common and is associated with significant mortality, morbidity and health-care costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. Because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.

Recently, a number of studies have shown the utility of procalcitonin (PCT) measurements in reducing the duration of antibiotic treatment in patients with respiratory tract infections presenting to the primary care setting or the emergency department. However, it remains unclear if a similar strategy can be effectively and safely implemented in the critical care setting. We attempt to address the controversy on this issue, by collecting, analyzing and interpreting the currently available relevant evidence. To this end, a systematic review and meta-analysis of the randomized controlled trials reporting on the outcomes of critically ill septic patients managed with or without a procalcitonin-based algorithm will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Randomized controlled trials (RCTs) that report on the outcomes of critically ill patients managed with a procalcitonin-guided algorithm versus routine practice.
* Participants of any age with proven or suspected sepsis will be considered. - As routine practice, the investigators will consider the institution and discontinuation of antibiotics by the attending physicians with the aid of clinical signs, symptoms, microbiological data, well established laboratory parameters (i.e., white blood cell count) and widely accepted guidelines but without the knowledge of PCT values. The investigators will set no limitations regarding the time, country or language of publications. The investigators will search for trials conducted in critically ill neonates and children.

Exclusion Criteria:

* The investigators will exclude studies that are not RCTs and studies performed outside the ICU, namely in the primary care setting, the emergency department or the clinic.