cyrilzakka/clinical-trials huggingface dataset:
Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation

A total Achilles tendon rupture is a common injury most often occuring in people aged between 30 and 50 years. The injury is more common amongst men than women (ratio 3:1) and typically occur during sports activities involving excentric and/or plyometric muscle work in plantar flexion of the foot (e.g., jumping, sprinting, change of directions).

Overall, there is no significant difference in treatment outcomes between surgical and non-surgical treatment besides a slightly greater risk of adverse events in surgical treatment and a small increased risk of re-rupture in non-surgical treatment. Several studies have investigated the importance of rehabilitation protocols without outcome differences between groups comparing more or less aggressive strategies.

Achilles tendon rupture often leads to significant limitations in functional level. Some of the most common used outcome measures for functional status are the heel rise tests evaluating endurance and maximum heel rise height. Studies using these tests often shows substantial deficits several years after the injury.

The purpose of this study is to investigate factors associated with functional status after rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patient has an acute achilles tendon rupture (treated within 14 days after injury).
* Adult patients aged of 18 years or older.
* Patients has given informed consent to participate in the study.

Exclusion Criteria:

* Patients with bilateral achilles tendon rupture
* Patients with re-rupture of previous achilles tendon rupture
The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia

The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

Background: The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity.

Methods : A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

Eligibility Criteria:
Inclusion Criteria:

* Patients had undergone primary unilateral total knee replacement surgery
* Patients hospitalized for at least seven days were enrolled in this study.

Exclusion Criteria:

* Medically stable patients who used glucocorticoids or strong analgesic drugs
* Patients had post-traumatic OA, rheumatoid arthritis (RA), psoriatic arthritis, cognitive, hearing and visual problems Patients were diagnosed chronic pain condition were excluded from the study.
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.

Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.

Eligibility Criteria:
Inclusion Criteria:

* Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month
* Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days
* English or Spanish speaking
* Planning to continue implant use for six months
* Access to a cell phone that can accept and send text messages

Exclusion Criteria:

* Postpartum within six months
* Post-abortion within six weeks
* Pregnant
* Breast-feeding
* Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
* Bleeding dyscrasia
* Anticoagulation use
* Active cervicitis
* Allergy to tamoxifen
* History of venous thromboembolism
* Current or past breast or uterine malignancy
* Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Cochlear implant candidate in one or two ears per current FDA indications
2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
4. 18 years of age or older at the time of enrollment
5. Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.

4. History of temporal bone fracture that involves the cochlea/internal auditory canal.

5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).

6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.

7. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.

8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.

9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.

10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan

In Pakistan, due to the lack of a National based cancer registry exact number of CRC cases is unknown. However, minimal data that is present in literature shows an increase in CRC cases with a concerning increase in incidence in younger age groups11. This makes it pertinent to understand current pattern of CRC and its risk factors from a local perspective. This will direct future strategies in an attempt to reduce the incidence and mortality associated with CRC in our general population.


Eligibility Criteria:
Inclusion Criteria:

* Individuals visiting SIUT as attendants to the patients visiting outpatient department or admitted in hospital.

Exclusion Criteria:

* Attendants / whose patients visit GI, colon and oncology OPD outpatient department or admitted in GI wards.
Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis

Impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in MS. However, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the EDSS and the MSFC.

The primary aim of this study is to investigate, whether in MS patients contrast acuity and sensitivity change over a period of two years.

Secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course)
* Written Informed Consent

Exclusion Criteria:

* Relapse within the last 30 Days
* Significant Cognitive Impairment
* Severely Decreased Visual Acuity
* Preexisting Severe Retinal Pathology
GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial

The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols
* Other Types of Leukemia (NK Cell Lymphoma/Leukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols
* Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols
* Age minimum 18 yrs
Prospective Post-market Clinical Follow-up Study of the HBS 2 Resorb Mg in Patients With Intra- and Extraarticular Fractures, Pseudarthroses and Arthrodesis of Small Bones and Bone Fragments.

This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years and older
* Patient is undergoing surgery with HBS 2 Resorb Mg
* Written informed consent obtained for the treatment
* Treatment of intra-articular and extra articular fractures and pseudarthroses of small bones and bone fragments as well as arthrodeses in the treatment of:
* Scaphoid fractures and scaphoid pseudarthroses
* Proximal radius head fractures
* Fractures of the radial styloid process
* Fractures of the ulnar styloid process
* Metacarpal fractures
* Metatarsal fractures

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Persons who are legally detained in an official institution
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
* Skeletally immature
* Intraoperative decision to use implants other than the device under investigation
Fast Track Appendectomy for Suppurative Appendicitis

The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 5-18
* Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
* Intraoperative findings of suppurative appendicitis

Exclusion Criteria:

* Pregnancy
* Complex medical history not appropriate for same day discharge
Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information

The aim of this study is to evaluate the effect of incorporation of outcome information in the Intensive Care Unit (ICU) decision-making process on patient and family reported outcomes and experiences of patients, relatives and ICU clinicians in a randomized clinical trial design in the Jeroen Bosch Ziekenhuis and Radboudumc in the Netherlands.

Background Due to advances in critical care medicine, more patients survive their critical illness. However, many Intensive Care Unit (ICU) survivors suffer from physical, cognitive and/or mental problems impacting patients' quality of life (QoL). Because of a lack of long-term outcome information, ICU physicians make decisions regarding ICU treatment based on their clinical experience and intuition. Moreover, patients and relatives are often not involved in the decision-making process.

To improve the ICU decision-making process and to make it more substantiated, the use of patient-reported outcome measures (PROMs) is of utmost importance. Therefore, the Radboudumc, in collaboration with six regional hospitals, including Jeroen Bosch Ziekenhuis (JBZ), set up a large-scale prospective cohort study, MONITOR-IC (www.monitor-ic.nl), to study long-term outcomes of ICU survivors', their QoL and their needs.

This research sets out to evaluate the effect of incorporation of outcome information in the ICU decision-making process on patient and family reported outcomes and experiences of patients, relatives and ICU clinicians in a randomized clinical trial design in the Jeroen Bosch Ziekenhuis and Radboudumc in the Netherlands.

Methods A prediction model for long-term QoL was previously developed using physiological, pathological, drug and treatment data from patients' electronic health record combined with PROMs from one centre of the MONITOR-IC. It was externally validated with the data of six other centres and an E-health tool was developed, incorporating this prediction model. For this research, the E-health tool will be incorporated in family meetings.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU for 12 hours or more
* Patients (or their legal representative) provide written informed consent

Exclusion Criteria:

* Patients admitted to the ICU due to a COVID-19 infection
* Moribund patients
Ceramic Tooth Restorations - a Comparison Study

This randomized clinical study aims to compare success and survival of two different ceramic tooth restoration materials. The hypothesis for the study is that fluoride treated zirconia will retain as good as lithium disilicate reinforced glass ceramic when cemented by the same resin cement.

One group of patients will receive a restoration in fluoride treated zirconia, the other group will receive a restoration in reinforced glass ceramic. All restorations will be cemented in the same manner. At 3, 6, 12 and 24 months the participants will be examined.

A randomized controlled clinical study that aims to compare success and survival of potassium hydrogen difluoride (KHF2) etched zirconium dioxide and lithium disilicate reinforced glass ceramic cemented to molars/premolares using dual cure resin cement.

The null hypothesis for the study is that zirconium dioxide and lithium disilicate reinforced glass ceramic will retain equally good tooth substance when cemented with resin cement.

Participants are recruited from the student clinic at Faculty of Dentistry, University of Oslo. Patients who fulfill the inclusion criteria 1) age above 18, 2) require restoration on premolar/molar and 3) are able to come to treatment and recall, are informed about the study and invited to participate. Consent to participation are signed by the patient. At any time and for any reason participants can withdraw from the study.

Personal information will be registered in Service for Sensitive Data, which is a platform to collect, store, analyze and share sensitive data. An encoded research file will be kept separate from the patient journal.The content of this file will be patient journal number and classification of the restoration on a four level scale (Californian Dental Association - CDA) for each recall.

A randomizing tool will be used to decide which ceramic restoration each participant will receive. Treatment will be performed by one clinician. The tooth preparation will be with little retention, and preferably supragingival. For cementing the restorations a standardized protocol for a dual cure resin cement will be used.

Participants only have to pay for the dental technician expenses and will be the same amount regardless of type of ceramic.

Each participant will be examined at 3, 6, 12 and 24 months by a clinician different from the one who performed the treatment. The 4 level CDA classification will be used to characterise each restoration.

Each of the two treatment groups will consist of 20 participants. Significant results will be achieved with the approximate distribution across categories: Category 1: 19,9 %, category 2: 79,4 %, category 3: 4,6 %, category 4: 2,5 %

Eligibility Criteria:
Inclusion Criteria:

18 years or older In the need of treatment on molars or premolars Lives near by Oslo

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Exclusion Criteria:

The patients that does not fulfill the inclusion criteria

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A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes

The purpose of this study are to determine whether a test dose program for taxanes will reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether a test dose program for taxanes will result in cost reduction due to decreased drug wastage.

Patients will be randomized on to one of two arms:

1. Test dose arm 1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
2. Non test dose arm The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.

Eligibility Criteria:
Inclusion Criteria:

* Patient must sign informed consent
* Patient must be greater than 18 years of age
* Patient must be receiving his/her first dose of either Taxol or Taxotere
* Patient must have received routine premedications for hypersensitivity reactions
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human

The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic need for bilateral extraction of lower first premolars

Exclusion Criteria:

* Alcoholism, smoking, drug use and abuse of drugs; Systemic diseases: uncontrolled diabetes, blood dyscrasias, kidney or heart failure and osteoporosis; clinical or radiographic signs of pathological processes in the bone;