cyrilzakka/clinical-trials huggingface dataset:
Computer-guided Versus Conventional Eminectomy

Temporomandibular joint (TMJ) dislocation represents a non-self-limiting condylar hypermobility due to its displacement from the glenoid fossa, most commonly in an anteromedial non-functional positional stuck.

The pathogenesis of (TMJ) dislocation is multifactorial, as the topography of the bony eminence, ligamentous and capsular laxity, muscular hyperaction or discoordination, as well as the presence of occlusal disturbance, would all contribute to its incidence, with a typical presentation of pain, open mouth, and masticatory muscle spasms

The surgical treatment modalities of the recurrent anteromedial condylar dislocation are directed to ligamentous, musculature, and bony alteration. Since it was first described by Myrhaug in 1951, Eminectomy has been recognized as the gold standard and the salvage surgical intervention for the management of recurrent condylar dislocation by the unrestricted free posterior translation of the mandibular condyle after the elimination of the bony interference by the excision of the obstructing eminence. However, the procedure carries out the potential risks of dislocation recurrence as the attention is usually directed to the excision of the lateral aspect of the bony eminence rather than its anteromedial extension and the anterior portion of the glenoid fossa or the invasion of the middle cranial fossa as a result of excessive unplanned bone removal, fracture propagation due to improper surgical technique, or eminence pneumatization

The current study designates a randomized controlled clinical trial that compares an eminectomy-based computer-guided digital workflow versus a free-hand conventional eminectomy for the treatment of patients with bilateral recurrent (TMJ) dislocation concerning the recurrence rate as a primary outcome and the Maximum interincisal opening (MIO) as a secondary outcome, stating a null hypothesis that the digital workflow is indifferent to the conventional technique regarding recurrence rate and (MIO). Furthermore, the study assesses the accuracy of the innovative digital workflow within the computer-based eminectomy group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an age range of 18-60 years with no sex predilection, with bilateral recurrent episodes of condylar dislocation of a minimum of three per month with previously failed conservative management.
2. Proper general health and medically classified as ASA I or ASA II.

Exclusion Criteria:

1. The patients with unilateral condylar dislocation, facial nerve motor functional affection, and those with the radiographic interpretation of pneumatized articular eminence or zygomatic arch.
2. ASA III medically classified patients and those with a history of previous (TMJ) surgery.
Smoking Cessation Program in the Preadmission Clinic

Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates

Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.


Eligibility Criteria:
Inclusion Criteria:

* Patients who smoke more than 10 cigarettes per day for more than 1 year
* And had no period of smoking abstinence longer than 3 months in the past year.
* Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients \> 18 years of age

Exclusion Criteria:

* Patients unwilling or unable to give informed consent
* Patients who are pregnant and breast feeding
* Patients with any psychiatric disorder
* Patients who used nicotine replacement / bupropion within previous 3 months
* Cardiovascular disease within the past 6 months
* Any serious or unstable disease within the past 6 months
* Drug or alcohol abuse within the past year.
Magnesium Sulfate in Pregnancy and Postpartum

There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery. Termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know the minimum effective dose.The investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours.

The definitive treatment known for pre-eclampsia is the interruption of pregnancy. While the definitive treatment is the pregnancy interruption, management includes other measures that have proven effective, including the administration of antihypertensive drugs for severe hypertension and that the use of anticonvulsant such as the magnesium sulfate.

There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe / serious disorder. Unfortunately these studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. That is, if the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of anticonvulsant drugs after birth. Obvious post delivery management sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown if the administration of magnesium sulfate for a minimum period not yet determined before birth and delivery requires even keep the drug after discontinuation.

For all these reasons the investigators propose the following: A randomized trial where all those patients who received magnesium sulfate for less that 8 hours before birth will be randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-Continue magnesium sulfate for 6 hours postpartum.

Eligibility Criteria:
Inclusion Criteria:

Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.

Exclusion Criteria:

* Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.
Nutritional Approach in Adults Followed up in Spanish Hospitals for Heart Failure (BOCADOS-IC)

This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure.

Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years with malnutrition (MNA-SF score ≤ 11) with chronic ambulatory heart failure (HF).

Exclusion Criteria:

* Admission for heart failure (HF) in the last month,
* Chronic renal failure on dialysis.
* Patients already on nutritional treatment.
* Concomitant diseases which, apart from the HF itself, could lead to a life expectancy of less than 1 year,
* Patients included in other clinical trials.
* Patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose.
* Patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute HF,
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.


Eligibility Criteria:
Inclusion Criteria:

* Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
* Pregnancy complicated by high glucose levels starting November 2011

Exclusion Criteria:

* Recognized DM prior to pregnancy
* Uncontrolled hypertension during pregnancy
* Severe active thyroid disease during pregnancy
* Severe diseases of the cardio-pulmonary system
* Diagnosis of a severe psychiatric disorder
* Diagnosis of cancer
* Conditions that lead to diet changes
* Addiction to alcohol or illegal drugs
* Current corticosteroid medicine use
Immunogenicity and Safety Study of Serum-Free Avonex

To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.
* Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.
* Must be able to understand and comply with the protocol.

Exclusion Criteria:

* Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.
* History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.
* Abnormal screening or baseline blood tests determined to be clinically significant by the investigator
* History of a seizure within 3 months prior to Day 1.
* History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
* Known allergy to natural rubber latex.

Other inclusion and exclusion criteria apply as per protocol
Preterm Birth Cohort Study in Guangzhou

The Preterm Birth Cohort Study in Guangzhou (PBCSG) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

Preterm birth has become the leading cause of neonatal death and the second leading cause of death among children under five years of age. Preterm childrens are more susceptible to adverse health problems including brain injury and neurodevelopment delay, and are at risk of chronic diseases which could impair the health status and life quality later in life. However, the causes of preterm birth is still not clear, and there are no effective prediction and preventive strategies. The Preterm Birth Cohort Study in Guangzhou (PBCSG) will collect the epidemiological,clinical information and biological specimens including maternal blood,cord blood, placenta, children's blood and stool samples of preterm childrens and their mothers. More importantly, childrens' health status, physical and neurodevelopment will be followed up to late childhood and adolescence. The preterm birth cohort would help to explore the mechanism of preterm birth and to examine the short- and long-term influence of preterm birth on physical health and neurodevelopment of childrens.

Eligibility Criteria:
Inclusion Criteria:

1. Born before 37 weeks of gestation
2. Born in Guangzhou Women and Children's Medical Center
3. Intended to remain in Guangzhou for more than 3 years

Exclusion Criteria:

1. Multiple birth
2. Stillbirth
3. With major congenital abnormalities
Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD

Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover, airway bacterial colonization linked to an increased susceptibility is observed in COPD patients. Effective Th17 immune response is needed to develop a good response against bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22 response to bacteria in COPD leading to airway bacterial colonization and infection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed COPD according GOLD guidelines
* Current or ex-smoker (at least 10 pack-years)
* Hospitalized for COPD exacerbation

Exclusion Criteria:

* Asthma or Cystic fibrosis
* No other chronic lung disease
* Solid Tumor unhealed or not considered in remission
* Inhaled drug consumption
* Women of childbearing potential without effective contraception
* Pregnant or breastfeeding women
* Incapable of consent
* Lack of social security coverage
Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction

To recover lower-limb motor function is a primary goal for rehabilitation after anterior cruciate ligament (ACL) reconstruction. Although quantitative testing and questionnaire evaluation provide a lot of valuable information, while functional magnetic resonance imaging (fMRI) provides a powerful method to assess functional connectivity (FC) involved in motor function recovery before and after receiving a novel combined rehabilitation training. However, our understanding of the FC changes during early rehabilitation after ACL reconstruction is partial and incomplete.

ACL has become one of the most common and easily damaged knee ligaments in sports and military training affecting young and active people. The extensive interest in ACL ruptures is related to the subsequent articular degeneration and severe dysfunction, resulting in skeletal muscle functional limitations not only in athletics but also in daily living. Thus, restoring lower limb motor function and stability has become the primary goal after ACL reconstruction (ACLR). Moreover, the newest study has indicated that increased neural activity may reflect central neuroplastic strategies to preserve motor functionality after ACLR\[1\]. Postsurgical rehabilitation guidelines for the orthopedic clinician recommended a common treatments for ACLR patients\[2\]; however, because of long time consuming and poor compliance, which are difficult to get patient recognition, it is very urgent to find a safe, effective and easy conduct and alternative therapy. Transcranial direct-current stimulation (tDCS) is a non-invasive technique of brain stimulation that has potential for clinical utility in neurorehabilitation, and could improve the lower excitability, muscle strength and dynamic balance by acting on the primary motor cortex\[3\]. For another, motor imagery based brain-computer interface (MI-BCI) based neuro rehabilitation paradigms have emerged as a novel iatrotechnics on motor function and brain function recovery\[4\]. However, it is little explored whether the clinical application of MI-BCI therapy combined with tDCS could be effective for early rehabilitation after ACLR patients. This case report would explore the efficacy and neuromechanism for the ACLR patient treated with MI-BCI training combined with tDCS. BOLD-fMRI was performed before and after four weeks' treatment.

Eligibility Criteria:
Inclusion Criteria:

* Duration of anterior cruciate ligament injury: 3-12 months
* Must bet acceptted anterior cruciate ligament reconstruction

Exclusion Criteria:

* The affected limb has severe ligament and meniscus damage
* Contralateral lower extremity sports injury
* Other medical conditions, such as severe disc herniation, are not eligible for the test
Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors.

II. Determine the toxicity and safety profile of this regimen in these patients.

III. Determine the pharmacokinetic profile of this regimen in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists
* Previously untreated disease allowed
* No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis)
* No CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
* No prior thrombotic events

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No clinically significant cardiac disease
* No prior deep venous thrombus
* No prior arterial vascular event
* No prior myocardial infarction
* No unstable angina
* No prior transient ischemic attack or cerebrovascular accident
* No cardiac arrhythmias that could be related to cardiac ischemia

Pulmonary:

* No clinically significant pulmonary disease
* No history of pulmonary embolism

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No severe malnutrition or intractable emesis
* No chronic diarrheal disease within the past 6 months

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* No more than 1 prior chemotherapy regimen
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* Prior gemcitabine or flavopiridol allowed
* No other concurrent chemotherapy

Radiotherapy:

* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 50% of bone marrow
* No concurrent radiotherapy
A Randomized Control Trial: Returning to Run After Injury

The purpose of this study is to examine the effectiveness of telehealth via video feedback to transition rear foot strike runners to non-heel strike runner following a lower extremity injury. Telehealth re-education gait training is much cheaper than in-clinic retraining sessions with a medical provider and could be much more widely used by both consumers and researchers as a training aid, a way to help alter running form, prevent running injuries and be used as a tool for use in the rehabilitation of running related injuries.

A convenience sample of 30 runners from the United States Military Academy (USMA) at West Point, New York (NY) who are recovering from a lower-extremity injury and are interested in participating in a return to run program. Acceptable lower-extremity injuries can include stress fractures proximal to the ankle, anterior chronic exertional compartment syndrome (CECS), patella-femoral pain syndrome, osteoarthritis of the lower-extremity, iliotibial band syndrome, chronic lower-extremity pain and or any participant that may benefit from the following; shorter stride, increased step rate, reduced knee loading, and reduced ground reaction force average vertical loading rates (AVLR). All participants will be screened via questionnaire and physical assessment for inclusion / exclusion from the study. Upon enrollment runners will be randomized into two groups. Regardless of group, all runners will have their running form and foot strike pattern analyzed using an instrumented treadmill and high-speed motion capture initially and at week 10. Kinetic and kinematic data including AVLR, impulse, foot strike pattern (FSP), contact time, step length, and step rate will be recorded at these time points. Additionally, all runners will receive the same graduated return to run intervals and 4-week home exercise program. Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Pain free walking 2 miles in 35 minutes
2. Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry
3. 20 unassisted single leg heel raises
4. Recovering from a lower-extremity injury

Exclusion Criteria:

1. History of previous stress fracture / fracture of the foot
2. Participant who already uses a non-rearfoot strike running pattern
3. Participant is pregnant
Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality

This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.

This study used a single subject design to test the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime quality for children with developmental disabilities. Baseline data was collected during the time that participants spent on the wait list for treatment. Treatment data was collected each week during treatment session. This protocol produced a significant change in both the number of foods the children in the study ate as well as the parents perception of mealtime quality.

Eligibility Criteria:
Inclusion Criteria:

* Children who accepted less than 15 foods as part of their regular diet
* Children who refused whole food groups

Exclusion Criteria:

* Children with life threatening food selectivity per parent report and physician referral information