cyrilzakka/clinical-trials huggingface dataset:
Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up

A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.

Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength).

Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359

Eligibility Criteria:
Inclusion Criteria:

DS center

* acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees.
* Age 20-70

SÖS center

* Age 50-74 for women and 60-74 for men
* injury only after fall from a standing height
* wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening
* good knowledge of written and spoken swedish
* fracture diagnosed within 72 hours from injury
* patient resident within the catchment area of SÖS center

Exclusion Criteria:

DS center:

* no previous fracture of either wrist
* ipsilateral acute fracture of the upper extremity
* medicated with warfarin
* unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems)
* open fracture
* fracture that was not amenable by both methods (distal fragment to small or to comminuted)

SÖS center:

* former disability of either wrist
* other concomitant injuries
* rheumatoid arthritis or other severe joint disorder
* Dementia or pfeiffer score under 5 points
* drug abuse, alcohol abuse or psychiatric disorder
* dependency in activity of daily living
* medical condition contradicting general anesthesia
Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.


Eligibility Criteria:
Inclusion Criteria:

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
* Understands and is willing to comply with all study procedures and restrictions.
* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
* Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis.
* Retreatment cases due to an endodontic failure.
* Single or bi-radicular teeth.

Exclusion Criteria:

* General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
* Specific: root resorption, root fractures, impossibility of restoration and cases were primary or secondary root canal treatment is not the treatment of choice.
Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.


Eligibility Criteria:
Inclusion Criteria:

* Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.

Exclusion Criteria:

* Children who had lost medical record.
Deep rTMS in Parkinson Disease Pain Syndromes

Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease
* Signed term of informed consent
* Parkinsson disease related pain

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or lacting women
* Moderate or severe cognitive impairment
Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia

Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. Herein, the investigators describe the protocol to verify three novel X-ray indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios, as the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.

Acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation.

Current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior X-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. The commonly used measurement indicators include centre-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index (AHI). Moreover, some differences exist in the measurement results between male and female patients. Acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. It is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and Sharp angle.

Eligibility Criteria:
Inclusion Criteria:

* No experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery;
* No marked pelvic tilt;
* No hip dislocation;
* No obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis;
* No significant lesions in the pelvis or proximal femur;
* Aged over 16 years;
* Provision of written informed consent.

Exclusion Criteria:

* Those with advanced osteoarthritis;
* Those with osteoarthritis secondary to acetabular dysplasia;
* Those with ankylosing spondylitis involving the hip joint;
* Those with rheumatoid arthritis;
* Those with inflammatory inflammation of the hip joint;
* Those with tumor lesions in the hip joint.
STI Knowledge and HPV Vaccine Acceptance in Bamako, Mali in 2012

Although screening for pre-cancerous cervical lesions and human papilloma virus (HPV) vaccination are accepted and effective means to prevent cervical cancer, women in Mali have limited access to these interventions. In addition, cervical cancer prevention by HPV vaccination has been controversial in some settings. To reduce cervical cancer prevalence and increase HPV vaccine uptake, it is important to understand the level of knowledge about cervical cancer screening and practices related to vaccination in at-risk populations. In this study, the level of knowledge about HPV and cervical cancer and attitudes towards vaccination were assessed among 301 participants (male and female, adults and adolescents) in a house-to-house survey in two urban neighborhoods in Bamako, Mali. The survey was combined with a brief educational session on HPV. Prior to the education session, overall knowledge of HPV infection and cervical cancer was very low: only 8% knew that HPV is a sexually transmitted infection (STI). Less than 20% of women had ever consulted a gynecologist and less than 3% had ever had cervical cancer screening. After hearing a description of HPV vaccine, more than 80% would accept HPV vaccination; fathers and husbands were identified as primary decisions makers and local clinics or the home as preferred sites for vaccination. This study provides information on STI knowledge and vaccine acceptance in Bamako, Mali in 2012, prior to the introduction of HPV vaccination.


Eligibility Criteria:
Inclusion Criteria:

* 12-17 years of age, with guardian consent
* 18 years or older
* Male or Female
* Living in Mèkin-Sikoro and Djikoroni

Exclusion Criteria:

* 12-17 years of age, without guardian consent
* \<12 years of age
* Living outside Mèkin-Sikoro and Djikoroni
Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.


Eligibility Criteria:
Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
SFA TReatment and vAscular Functions

Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis.

The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4, or 5
* Planed peripheral intervention TASC A-C
* Subject must be between 40 and 85 years old
* Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
* Guidewire must cross lesion(s) within the true lumen, without a relevant sub-intimal course
* Vessel diameter ≥3.0 mm and ≤6.0 mm
* Willing to comply with the specified follow-up evaluation
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Lesions TASC D
* Angiographic evidence of thrombus within target vessel
* Thrombolysis within 72 hours prior to the index procedure
* Aneurysm in the femoral artery or popliteal artery
* Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
* Unstable angina pectoris at the time of the enrollment
* Recent myocardial infarction or stroke \< 30 days prior to the index procedure
* Life expectancy less than 12 months
* Septicemia at the time of enrollment
* Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
* Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
* Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock

The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.


Eligibility Criteria:
Inclusion Criteria:• Written informed consent by patient or relative

* Time in ICU \< 48 hours
* Septic shock
* Pulmonary artery catheter and radial arterial catheter
* Age 18 - 75 years
* Sinus rhythm
* Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study
* Mechanical ventilation with sedation
* Pwcp \<18 mmHg

Exclusion Criteria:

* Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
* Contraindication to fluid challenge
* Contraindication to TEE
* Previous heart failure, heart valve stenosis of insufficiency
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 or over
* Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
* Has completed Study FE200486 CS07
* Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Suicidality and Suicide Attempt Among HIV Patients on Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

The purpose of this study was to compare the frequency of suicidality and suicide attempt among HIV patients starting treatment with Efavirenz and with patients starting treatment with other HIV medications.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* At least 6 months of enrollment before first prescription
* Antiretroviral naive

Exclusion Criteria:

* No diagnosis of HIV on patient record
* Age \< 12 years
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

This single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (SC) administration to healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male subjects, aged 20-45 years inclusive at the time of screening
* Chinese subjects must have Chinese parents and grandparents, all of whom were born in China
* A body mass index (BMI) between 19 and 24 kilograms per height in meters squared (kg/m\^2), inclusive
* Able to participate and willing to give written informed consent and to comply with the study requirements

Exclusion Criteria:

* Any history or presence of a clinically significant disorder, or any other condition or disease which in the judgement of the investigator would place the subject at undue risk; interfere with absorption, distribution, metabolism, and excretion of emicizumab; or interfere with the ability of the subject to complete the study
* Major illness within 1 month prior to dosing, and/or any condition which could relapse during or immediately after the study
* Use of any prescribed or over-the-counter (OTC) medication or herbal medicine taken within 14 days prior to dosing or within 5 times the elimination half-life of the medication prior to dosing (whichever is longer), with some exceptions
* Any significant donation/loss of blood or plasma (greater than 450 milliliters) within the 3 months prior to dosing
* Regular smoker with consumption of more than 10 cigarettes per day or the equivalent amount of tobacco
* Participation within a clinical study with an investigational drug or device within the last 3 months prior to dosing
* Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to foods or environmental agents
* Previous or concomitant thromboembolic disease such as deep vein thrombosis (DVT) or signs of thromboembolic disease, or family history of thromboembolic disorder such as serious DVT
* At high risk for thrombotic microangiopathy (e.g., have a previous medical or family history of thrombotic microangiopathy), in the investigator's judgment
* Previous or concomitant autoimmune or connective tissue disease
* History of tuberculosis or active tuberculosis with positive test result at screening
* Any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation
The Effect of Liposome Vitamin C on the Absorption and Metabolism of the Human Body.

To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine.

we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start. The subjects were informed to consume one sachet vitamin C without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1, 2, 3, 4, and 8 hours after taking test sample.

Eligibility Criteria:
Inclusion Criteria:

1. Adults between 20-60 years old,
2. No heart, liver, kidney, endocrine and major organic diseases

Exclusion Criteria:

1. Renal insufficiency and dialysis
2. Cancer
3. Underweight (BMI≦17) or obese (BMI≧27),
4. Take chronic disease drugs,
5. Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg,
6. Too high fasting blood glucose ≧ 100 mg/dL,
7. Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL,
8. Have a history of vitamin C allergy,
9. People with mental illness,
10. Pregnant or breastfeeding women,
11. Hematosis,
12. Kidney stones,
13. Long-term vitamin C supplements (at least 200 mg per day for more than one month)
Probiotic Supplementation on Weight Loss

The investigators are trying to better understand how bariatric surgery leads to weight loss, and the role of bacteria that live in the gut in making this happen.

The investigators are interested in seeing how a probiotic, which is a dietary supplement containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial population and what effect it has on weight loss and loss of fat. Before undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be asked to provide a stool sample to assess the make-up of their gut bacterial population. They will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount of fat present inside the body.

After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be given either a probiotic supplement or dummy pill (placebo) for 3 months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and stool sample will be repeated at the end of the 3 month period and analyzed for changes.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects who are \> 18 and \< 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
2. Will also meet one of the National Institute of Health's criteria for bariatric surgery, i.e. body mass index (BMI) \> 40 kg/m2 or BMI \> 35 kg/m2 with significant weight-related comorbidities.
3. Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.

Exclusion Criteria:

1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.
2. Patients with allergy to antibiotics precluding the use of standard peri-operative antibiotics (cefazolin and metronidazole) will be excluded.
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom

The purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients

The sample calculation was performed based on the previous pilot study, in which 10 subjects were included. Through this study, a statistically significant effect on the variables analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the clinical trial is 20 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Must be signed the informed consent.
* Bilateral carpal tunnel syndrome: clinic and electromiography positive.
* Aged between 18 and 65 years

Exclusion Criteria:

* Patients undergoing surgical intervention of carpal tunnel syndrome in one of two hands
* Unilateral carpal tunnel syndrome
* Patients with chronic pain and / or previous injury (wrist tumor, lymphedema ...) in either hand
* Patients with systemic diseases (diabetes, thyroid ...)
* Patients with pharmacological treatment to take analgesia for any other chronic pathologies
* Subjects who have suffered from a neurological disease that affects the musculoskeletal system
* Mental illness that prevents the compression and / or realization of the study
* Patients with tattoos, scars and / or marks on any of the hands or distal forearm area
* Pregnant women and minors