cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures

The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF

Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.

As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.

In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

Eligibility Criteria:
Inclusion Criteria:

* Closed ankle fractures (44A, 44B, 44C)
* Ages of 18-65
* Men or women, including pregnant women
* Willing to consent

Exclusion Criteria:

* Open fractures
* Other lower extremity injuries/conditions that affects functional outcomes
* Problems maintaining follow up (homeless, not willing to return for follow up)
* Prisoners
* Unable to consent
Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,

Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.

The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Referred to the 3 DAN centers with maternal seroconversion to CMV during their pregnancy, confirmed, with or without confirmed prenatal transmission.
* Presence of ultrasound signs without criteria of seriousness if the materno-fetal infection is proven.
* Support between January 1, 2008 and December 31, 2020.
* No opposition from patient

Exclusion Criteria:

* Reversed or anteconceptional CMV seroconversion
* Concomitant infection with another infectious agent and suspected cross-reaction
* Multiple pregnancy
* Ultrasound and / or MRI severity criteria
* Medical termination of pregnancy
* Fetal death in utero
* Birth \<32 weeks and / or birth weight \<1500 grams (birth criteria in maternity level IIA)
* Intercurrent event that may be the cause of an abnormality in psychomotor development
* Patients protected by justice
Breath Metabolomics of Placebo Effects, a Pilot Study

This study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.

Interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as Cold Pressure Test (CPT). CPT reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.To this end, probands will be continuously connected to a Heartrate \& Blood Pressure Monitor. First, baseline exhalation will be assessed. Then, the CPT is performed according to the 'CPT Guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (NaCl nasal spray). After 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). The process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adult volunteers
* German speaking, or good knowledge of the German language
* Able to understand the study
* Able to give informed consent

Exclusion criteria:

* Regularly taking medication potentially interfering with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers)
* Current pregnancy
* Daily smokers (as per WHO definition: A daily smoker is someone who smokes any tobacco product at least once a day.)
* Neuropathy
* Chronic pain
* Neuromuscular or psychiatric disease
* Known or suspected heart, kidney or liver disease
* Hypertension (Systolic (mmHg) \>130, Diastolic (mmHg) \>80)
* History of fainting or seizures
* History of Frostbite
* Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment.
Clinical Assessment of Sports Exertion

The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion. The CASE is highly sport-specific as it tests multiple body positions that mimic requirements typical of individual and contact sports activities including soccer, gymnastics, cheerleading, swimming, and basketball. It was developed by clinicians at the Baylor Scott and White Sports Concussion Program in an effort to identify specific system impairments in athletes who were unable to successfully demonstrate readiness for return to play protocols. Like the other published forms of concussion exertion testing described above, the CASE is a provocative exercise test that may also prove to be useful in making informed return-to-play decisions based upon the athlete's symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* 10-22 years of age who have participated in organized sport activities within the past 12 months
* Diagnosed with a concussion according to international concussion in sport group criteria
* Asymptomatic at rest and must be cleared from return-to-play by a qualified healthcare professional no later than 30 days following clearance

Exclusion Criteria:

* Orthopedic or neurologic, or other limitations
* History of seizures
* Previous or current diagnoses for cardiopulmonary conditions
* Medical diagnosis of diabetes and/or currently on medications for diabetes (e.g., insulin)
* Uncontrolled asthma
* Pregnancy
* Currently experiencing symptoms of COVID-19 or \< 7 days since last symptoms
* History of moderate or severe traumatic brain injury defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less
* Symptom score \>1 point on initial PCSS intake
* A current diagnosis of and treatment with medication for attention-deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions
* Limited English proficiency
* Currently taking prescription medication for concussion related impairments
* Anticoagulant or antiplatelet use
* History of a medical condition that mimics the signs and symptoms of prolonged concussion symptoms (eg, history of chronic headaches, active migraines, cardiovascular conditions)
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System

The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.

Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)

Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.

Eligibility Criteria:
Inclusion Criteria:

1. an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy
2. patients who are agree with the study enrollment

Exclusion Criteria:

1. an age under 20 or over 80 years
2. severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems)
3. a lack of consent to participate in the study
4. the inability to include a patient in clinical trials according to the regulations or laws in Korea
5. the inability to complete regular follow-up visits (e.g., immigration)
6. the use of modified radical neck dissection due to lateral neck node metastasis
7. prior thyroid surgery or cervical irradiation
8. active enrollment in another clinical trial
9. the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time)
10. the desire to undergo endoscopic or robot-assisted thyroidectomy
A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Advanced Kaposi's sarcoma.

Prior Medication:

Allowed:

* Prior intralesional vinblastine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Acute intercurrent infection other than genital herpes.
* Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
* Symptomatic peripheral neuropathy.
* Any condition that compromises ability to give informed consent or complete the study.

Concurrent Medication:

Excluded:

* Concurrent ganciclovir.

Patients with the following prior conditions are excluded:

* Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
* History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.

Prior Medication:

Excluded:

* Prior systemic chemotherapy.
* Intralesional therapies within 7 days prior to study entry.
* Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
* Interferon preparations (alpha or beta) within 28 days prior to study entry.

Prior Treatment:

Excluded within 7 days prior to study entry:

* Radiation.
* Local therapies (e.g., cryotherapy).
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement

This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.

The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.

After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old,
* Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP \> 50%),
* Patient who agrees to participate in the evaluation and who has signed the inform consent,
* Patient covered by social security system.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Patient unable to tolerate CT contrast agent
* Patient already participating in another clinical study
* Pregnant or breast-feeding woman.
Polyunsaturated Fatty Acids Supplementation and Blood Metabolome

Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* good health,
* proper body weight
* not meeting the needs for polyunsaturated fatty acids

Exclusion Criteria:

* increased body weight,
* limited communication to an extent that makes it impossible to carry out a food interview,
* eating disorders (according to food history),
* metabolic diseases,
* pregnancy,
* lactation,
* taking drugs that influence the metabolism of lipids or carbohydrates
Corneal Thinning During Topical Bevacizumab Therapy

The purpose of this study is to determine whether topical bevacizumab is safe or not when used in corneal neovascularization for long term period.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of corneal neovascularization
* must be able to apply eyedrop

Exclusion Criteria:

* have active keratitis
Translation of Quebec Back Pain Disability Scale Into Local Languages of Pakistan.

The aim of the present study is to translate the Quebec Back Pain Disability Scale into Pashto, Punjabi, Sindhi and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from low back pain. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.

The Quebec Back Pain Disability Scale is a first-hand measure of functional disability for patients with back pain. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its major aim is to be a responsive measure of functional disability in back pain. Quebec back pain disability Questionnaire has unique strong characteristics that are quite feasibly used and have good identification properties regarding Low Back Pain. There is extensive usage, applicability, and validity of QBPDS in research and clinical practice. Along with these factors the capability of the QBPDS to identify significant fluctuations in patient's condition, makes its use evidently advocated.

Quebec Pain disability scale, originally a French scale has been translated and validated into a few languages before. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and to study effects of treatments in low back pain patients. Along with helping in appraisals of outcomes amongst various populations. So, to gather the best outcomes of this questionnaire in Pakistan region it is imperative to translate it into Pashto, Punjabi, Sindhi and Balochi hence the local languages.

Eligibility Criteria:
Inclusion Criteria:

* Patients both male and female having age group equal or \>18,
* should be able to read the questionnaire that is in their native language(Punjabi, Sindhi, Balochi and Pashto) and
* diagnosed with nonspecific low back pain for more than 3 months.

Exclusion Criteria:

* Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently,
* any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
* Any issues in understanding or expressing the native language (Punjabi, Pashto, Balochi or Sindhi) will be excluded.
An Enhanced Artificial Intelligence Breast MRI Interpretation System

Interpretation of breast MR images is a very time-consuming process and places a great burden on breast radiologists. This project aims to develop a technical solution that addresses this healthcare challenge by developing a system that is able to automatically interpret breast MR images in order to aid the radiologist in their diagnosis.

Breast cancer is the most common type of cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2015. In the UK, one in five cases of breast cancer results in a fatality. The IntelliScan project aims to develop a technological solution that addresses a significant healthcare challenge. IntelliScan will develop a software system that will be able to interpret breast MR images automatically in order to identify potential breast cancers.

Regular MRI screening of the breast is offered to women from the age of 20, who are at higher risk of developing breast cancer. MR image sequences provide a large amount of information to the radiologist and the interpretation of images is a manual process, which is very time consuming. The high number of women eligible for MRI screening combined with the amount of data provided by MRI scans places a great burden on healthcare systems. Therefore, automatisation of this process would greatly relieve this burden and also has the potential to provide more accurate diagnoses.

In this first study, the system's user interface as well as the algorithm will be developed using existing MRI scans. Existing MRI scans with known breast anomalies will be used to develop the decision-making basis for the algorithm. The system will then be tested using existing MRI scans without information about possible anomalies and results will be compared to results from the software system currently in use. In addition, the user-friendliness of the system's user interface will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Breast MRI scans
* MRI examinations undertaken at partner NHS Trust in the UK
* MRI examinations undertaken on the MRI system currently installed at partner NHS Trust site (since 2008)

Exclusion Criteria:

* Incomplete breast MRI datasets
* Breast MRI without lesions
* Breast lesion on MRI not biopsied
Scoliosis Shared Decision Making

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

For patients and parents who are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options. This video will then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). Investigators will follow the patient's electronic medical records for 2 years after their decision of treatment option. No outcome forms will be specifically collected as part of the study, as outcomes forms are currently being collected clinically on all scoliosis patients.

Based off of the initial video recordings, the first visual prototype of the shared decision making tool for scoliosis has been developed. This prototype of the shared decision making tool will be now be used to help test it's efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Scoliosis curve \>40 degrees, \< 65 degrees
* Risser score \> 2
* Age \> 13 years

Exclusion Criteria:

* Risser score of 0 or 1
* Non-ambulatory scoliosis patients
* Ages 12 year and under
Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model

Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.

There is an intense communication inside the follicular structure. Bidirectional information between the oocyte and the granulosa cells is needed for a normal follicular development and oocyte competence.

There are conflicting results on the effect of pre-incubation time in ICSI.

It is not clear the proper time to denudate the oocyte from the somatic cells prior to ICSI, and some authors describe a negative impact of the premature cummulus removal on the ICSI results.

The aim of this study is to investigate wheter a preincubation time between oocyte retireval and injection has any effect on the ICSI ( intracytoplasmatic sperm injection) results .

Eligibility Criteria:
Inclusion Criteria:

* Oocytes retrieved from healthy donors, younger than 32 years old , with proven maternity(preference), who meet the admission criteria of ovodonation program:
* The oocytes included will be the product of antagonist stimulation protocol and with Gnrh agonists trigger. (see annex)
* Healthy women under 50 years of age , who meet the criteria as receptors into the ovodonation program.
* Oocytes retrieved after 36.5 h + -1 h of administration of triptorelin acetate.
* Only mature oocytes, in stage MII, will be included and injected.
* Use of fresh or thawed semen for the ICSI.

Exclusion Criteria:

* Cases of severe male factor such as azoospermia or severe oligo-astheno-teratospermia( alone or combinated)
* Sperm samples from surgical procedures (biopsy / testicular or epididymal puncture)
* Donors with a polycystic ovarian profile, according to The Androgen Excess and PCOS Society (AES), 2006.
* Thawed donated oocytes
* Oocytes from patients who have previously donated within a period of less than three months.
* Donors whith poor response (oocyte retrieved less than \< 4 oocytes).
* Suspicion or signs of Endometriosis in donor patient.