cyrilzakka/clinical-trials huggingface dataset:
Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up

The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?

Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.

Eligibility Criteria:
Inclusion Criteria:

* End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Genetics of Obesity in Chinese Youngs

The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese subjects,providing a convincing argument for further treatment of obesity and metabolic syndrome.

Obesity has become a major worldwide challenge to public health, owing to an interaction between the obesogenic environment and a strong genetic contribution.Previous studies found that genetic factors determine 40%-70% of obese phenotype.Under such circumstances, the screening of obesity susceptibility gene is particularly important for society or family to take measures to prevent obesity.

Recent extensive genome-wide association studies(GWASs) have identified numerous single nucleotide polymorphisms associated with obesity,but these loci together account for only a small fraction of the known heritable component.Two studies in 2010 Nature,for the first time, put rare copy number variation (CNV)in association with severe early-onset obesity.Their significance lie not only in the discovery of the pathogenic genes of severe early-onset obesity but,more importantly,in providing new strategies for finding out genes that cause complex diseases.

Obese patients and healthy lean controls proved by a series of blood biochemical examinations will be enrolled in this study.The present study intends to use the techniques such as enzyme-linked immunosorbent assay, real-time fluorescence quantitative PCR,gene chip,construction of viral vectors,transfection, taking advantage of the established database,by means of serum assays and functional tests, associate copy number variation with obesity phenotype to explain the root cause of obesity.Meanwhile biomarkers, gut flora and genetic risk factors will be evaluated in the study subjects.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI)≥ 30kg/m2
* predominantly east China to minimize population stratification
* willing and able to provide informed consent

Exclusion Criteria:

* pregnancy/lactation
* Cushing syndrome
* Hypothyroidism
* obesity caused by pituitary and hypothalamic lesions
* drug related obesity
* history of major psychiatric illness
Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping

This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.

Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

1. either male or female, older than 18 (include 18).
2. tumors oppress or be in close proximity to one or more of major hepatic veins.
3. the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
4. preoperative liver function assessment: Child-Pugh classification is A or B.
5. preoperative laboratory test: blood platlet count \> 100×10\^9/l, prothrombin activity \> 60%.
6. liver cirrhosis.

Exclusion Criteria:

1. contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
2. extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
3. hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
4. regular hepatectomy.
5. tumors located in the left lateral lobe of liver.
6. previous hepatectomy.
7. pregnancy or lactation.
8. refusal to participate this trial.
Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

The aim of this observational study was to investigate the long-term effects of patients receiving interventional transcutaneous electrode-pulsed radiofrequency therapy versus calcium channel blockers for the treatment of childhood migraine pain. The main question to be answered was.

Which of the long-term effects of interventional transcutaneous pulsed radiofrequency versus calcium channel blockers for the treatment of childhood migraine pain is more effective? Participants who have started both treatments will answer questions about their headaches in an online survey for 3 months as part of their regular medical care.

There are two groups in the trial. One group will receive transcutaneous pulsed radiofrequency treatment for a total of 3 weekly sessions. The other group will receive 1x 5 mg flunarizine active ingredient. Both groups will consist of 30 patients. All patients will be followed from the start of treatment and will be assessed at month 1 and month 3 using the paediatric migraine disability index, headache diaries and visual pain scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine according to ICHD-3 Migraine criteria
* Being between the ages of 8-18
* Having 4 or more migraine attacks per month

Exclusion Criteria:

* Other primary or secondary headache diagnosis
* Patient could not be reached during follow-up
The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP .

Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy . the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders

• Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP.

Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy. the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders The recent entry of Helicobacter pylori to the growing list of etiologies of itp has stirred much interest. . The relationship between H pylori infection and immune thrombocytopenia (ITP) is less clear .

However, among patients with H.pylori-associated ITP, a significant percentage achieve lasting remission after eradication of H.pylori .

H.pylori can be readily detected by non invasive methods, the C-urea breath test and antigen detection in stools are considered to be the most accurate, with both sensitivity and specificity in the range of 90% to 95% .

Eligibility Criteria:
Inclusion Criteria:

1.Patients diagnosed ITP and failed on steroid therapy.

Exclusion Criteria:

1. Patients with systemic lupus erythromatous
2. Drug administration
3. Hepatitis c infection
Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation

Posttraumatic stress disorder (PTSD) is a highly debilitating disease with response rates to pharmacological treatment rarely exceeding 60%. Preliminary attempts have been made to use repetitive transcranial magnetic stimulation (rTMS) as a non-pharmacological treatment alternative, but thus far rTMS approaches have demonstrated only modest efficacy. A major factor contributing to these limited effects stems from the depth penetration of TMS, which is not sufficient to directly modulate deep subcortical structures, such as the amygdala, that are affected in PTSD. Moreover, while rTMS effects have been shown to be state-dependent, (i.e. vary substantially according to the neural state during stimulation), this important factor is rarely considered during the clinical application of rTMS. The current study addresses both of these limitations to improve the therapeutic efficacy of rTMS for PTSD. Here we will develop a protocol to test if connectivity-based rTMS is able to modulate amygdala activity through the functional connections with medial prefrontal cortex, taking advantage of state-dependency to enhance rTMS effects by actively engaging the amygdala through a fear perception task. BOLD activation in the amygdala and its connectivity with the frontal cortex will constitute the primary outcomes to test rTMS efficacy. Heart rate variability and skin galvanic responses, acquired during the presentation of fearful faces, will be used as continuous moderators of task engagement during rTMS. If successful, this study will pave the way for a large-scale study to investigate whether state-dependent, connectivity-based rTMS of the amygdala can improve rTMS efficacy as a clinical treatment for PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Age Restrictions: Young Group (from 18 to 35 years old)
* Use of effective method of birth control for women of childbearing capacity.
* Willing to provide informed consent.

Exclusion Criteria:

* Current or recent (within the past 6 months) history of substance abuse or dependence.
* Current serious medical illness.
* History of seizure, epilepsy, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Inability or unwilling to give informed consent.
* Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV).
* Clinically defined neurological disorder.
* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or currently taking medication that lowers the seizure threshold.
* Claustrophobia (MRI scanner).
* Pregnancy.
CPAP In-home Assessment USA

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Aged 22 and over
* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria:

* Contraindicated for PAP (CPAP or AutoCPAP) therapy
* Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
* Has obesity hypoventilation syndrome or congestive heart failure
* Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
* Has implanted electronic medical devices (e.g cardiac pacemakers)
* Pregnant or think they may be pregnant
* Not fluent in spoken and written English.
Stories to Educate Patients With Ankle, Foot, and Knee Injuries

Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. On discharge, patients will receive the current fact-based sheet or that plus a narrative explaining the work-up and treatment of these injuries. Outcomes will be assessed by a survey measuring patient satisfaction and understanding.


Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic knee, ankle or foot injury presenting to ED
* No indication for X-ray by Ottawa Rules criteria
* ED provider planning to discharge patient

Exclusion Criteria:

* X-ray obtained
* Need for X-ray by established Ottawa Rules criteria
* Children
* Pregnant women
* Patient to be admitted to the hospital
* Patient non-English speaking or illiterate
Computer-based Cognitive Training for Individuals With Parkinson's Disease

Computer-Based Cognitive Training for Individuals with Parkinson's Disease" is a 3-arm randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control (AC) training program to evaluate the feasibility of empirically supported computer-based cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased interventions to target non-motor symptoms associated with PD.

Patients meeting criteria for MCI will be initially randomized to one of the 3 conditions. Participants will complete cognitive training exercises on their home or clinic-provided computers for 60 minutes per day, 5 days per week. Compliance and performance will be monitored on a weekly basis and at completion of the study. Outcome measures will be collected one week before initiation of the intervention and within one week completion of the intervention. Neuropsychological functioning, including tests of processing speed, attention, and executive functioning, will serve as primary outcome measures. Patient reported outcomes, including measures of overall QOL and disease-specific QOL, and support-person reported outcomes (if applicable), including measures of overall QOL and caregiver burden, will be secondary outcome measures. This pilot study promises to evaluate computer-based cognitive training in a novel population and expand access to cognitive rehabilitation services, and is designed to improve cognitive functioning and QOL among a wide range of individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

* Participants eligible for this study must speak English and have a confirmed medical diagnosis of Parkinson's disease and meet established criteria for MCI in PD (Litvan et al., 2012), defined as individuals with performances of approximately -1 to -2 standard deviations below the mean on at least two tests within five cognitive domains assessed in their clinical neuropsychological evaluations.

Exclusion Criteria:

* Exclusion criteria include diagnosis of PD dementia based on Movement Disorder Society Task Force criteria (Emre et al., 2007) and other PD-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing (Litvan et al., 2012).
Study of Ocular Penetration of Topically Administered Fluoroquinolones

This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a visually significant cataract and are planning to have cataract surgery.
* Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.

Exclusion Criteria:

* Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
* Subjects who signs of ocular infection or active inflammation in the study eye.
* Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
* Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
* Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.
* Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.
* Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
Effect of Wearing Face Masks on Salivary Parameters and Halitosis

During the current COVID-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. Patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks.

Scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. Studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion).

Therefore, the present study aims at measuring the effect of wearing different face masks on salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity) and halitosis (volatile sulphur compounds).


Eligibility Criteria:
Inclusion Criteria:

* Oral healthy adult volunteers who are able to give written consent

Exclusion Criteria:

* Non-fulfillment of the inclusion criteria
* Denied access to the University Medical Center Goettingen at the Corona screening
* Exemption from wearing a face mask for medical reasons
* Medical reasons hindering participants from refraining eating and drinking prior (except for water) or during the visits
* Hyposalivation / xerostomia (unstimulated saliva \< 0.3 mL/min, stimulated saliva \< 0.7 mL/min)
* Refusal to use fluoridated toothpastes
* Smoking
Fecal Biomarker Study for Patients With Ulcerative Colitis

The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for this biomarker study;
* Be enrolled in Study 2007021 (QDIEM).

Exclusion Criteria:

* Meet the QDIEM Protocol 2007021 for Exclusion Criteria
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
3. No previous systemic treatment for MCL.
4. ECOG physical strength score is 0-2.
5. Expected survival time \>6 months.
6. Voluntary written informed consent prior to screening.

Exclusion Criteria:

1. Uncontrolled or significant cardiovascular diseases
2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.