cyrilzakka/clinical-trials huggingface dataset:
Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method

The definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.

DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.

The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)


Eligibility Criteria:
Inclusion Criteria:

* Adult person
* Affiliated or beneficiary of a statutory social insurance scheme
* Free ans informed consent
* Following foot surgery like DMMO only or DMMO and hallux valgus

Exclusion Criteria:

* Minor or legally protect adult
* Amputation disturbing the natural course of the step
* Osteoarticular diseases/sequelae affecting walking and/or balance
* Neuromuscular diseases/sequelae affecting walking and/or balance
* Vestibular disorders affecting balance
* Patients requiring a walking aid (e.g., walker)
* Pregnant woman
* Patient with dementia who are unable to follow verbal instructions
DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.

Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Patients with end-stage renal disease hemodialysis for at least 3 months

Exclusion Criteria:

* Non-cooperation
* Active cancer
* Hospitalization during the course of the study
The National Diabetes Prevention Program in Rural Communities

The purpose of this pilot trial is to compare feasibility and effectiveness of remote delivery (social media or video conferencing) of the National Diabetes Prevention Program (N-DPP) to adults in rural communities. The research team will train a Kansas State Research and Extension staff to deliver the video conferencing arm while a research team member will lead the social media arm.

This pilot trial will compare the feasibility and effectiveness of DPP delivered through Facebook (DPP-FB) or group format delivered remotely by Zoom (DPP-R) in adults in rural communities. Both interventions will recruit through the Corporative Extension Service (CES), which serves as the community outreach arm of all land grant universities through over 2,900 offices across the U.S. The Kansas State Research and Extension (KSRE) (Kansas version of CES), is well positioned, but underutilized for the delivery of DPP in rural areas. Delivery of DPP by a well-recognized entity, such as the KSRE, may improve the probability of dissemination and long-term program sustainability. Two CES offices serving rural counties in Kansas will be randomized (1:1) to the DPP-FB or DPP-R arms. Our research team will train one professional staff from KSRE (with backgrounds in nutrition programming and family consumer science) to deliver the DPP-R intervention. A research team member will deliver the DPP-FB intervention. This project will address the following aims:

Primary aim: Compare weight and MVPA between DPP-FB and DPP-R across 6 mos. The investigators expect greater weight loss and MVPA in the DPP-R arm compared with the DPP-FB arm.

Secondary aim: Compare the feasibility of DPP-FB and DPP-R across 6 mos. based on participant retention and program attendance. The investigators expect greater participant retention and program attendance in the DPP-R arm compared with the DPP-FB arm.

Eligibility Criteria:
Inclusion Criteria:

1. Prediabetes as defined as A1C = 5.7-6.4%, fasting glucose = 100-125 mg/dl, (confirmed from physician/medical record in the previous year), history of gestation diabetes mellitus OR a positive result based on the CDC- DPP screener
2. Age ≥18 yrs.
3. Willing to commit to participate on a weekly basis for the 6 month intervention
4. Living in the county of a rural KSRE local unit. Rural counties will be defined using the American Community Survey definition which categorizes a county as rural if the population is \< 65,000
5. Internet access and capability to use Zoom
6. Clearance from primary care physician

Exclusion Criteria:

1. Diagnosis of Type 2 diabetes
2. Unable to participate in physical activity.
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol

Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Eligibility Criteria:
Inclusion Criteria:

* orotracheal intubation
* surgery of the ear
* written consent
* ASA I-III

Exclusion Criteria:

* preexisting pathologies of the vocal cords
* obesity
* difficult airway
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?

the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients between 18-60 years old
* patients with BMI \> 40
* patients undergoing Laparoscopic Sleeve Gastrectomy

Exclusion Criteria:

* patients with Chronic obstructive pulmonary disease (COPD), Asthma,
* patients with uncompensated heart failure
* Uncompensated diabetes mellitus
* Patients Who have orthopedic problems that effects the exercise test
Ultrasound-guided Biofeedback for Transversus Abdominus Re-education in Non-specific Low Back Pain Patients

As rehabilitative ultrasound imaging (RUSI) for monitoring and re-educating deep trunk muscles is becoming more and more popular in current musculoskeletal rehabilitation and research, the purpose of this pilot study was to explore the effects of applying ultrasound-guided imaging as a means of feedback for the activation/contraction of the deep transervsus abdominis muscle of the trunk during an exercise programme in people with non-specific low back pain (NSLBP). The outcome mesures being explored were pain intensity (primary outcome) through Numeric Pain Rating Scale (NPRS), functional, muscular and psychosocial parameters.

Background: It is believed that ultrasound-guided imaging of activation/contraction of the deep abdominal muscles (such as transervsus abdominis) is useful for assisting deep muscle re-education, which is often dysfunctional in non-specific low back pain (NSLBP). Thus, this pilot study aimed to evaluate the use of real-time ultrasound (US) as a feedback device for transverse abdominis (TrA) activation/contraction during an exercise program in chronic NSLBP patients.

Methods: Chronic NSLBP patients are recruited and randomly assigned to an US-guided or control group. The same motor control-based exercise program is applied to both groups. All patients would receive physiotherapy twice per week for 7 weeks. Outcome measures, tested at baseline and post-intervention, include Numeric Pain Rating Scale (NPRS), TrA activation level (measured through a pressure biofeedback unit-based developed protocol), seven established motor control tests, Roland-Morris Disability Questionnaire (RMDQ) and Hospital Anxiety and Depression Scale (HADS). Analysis of variance utilizing a two-way mixed ANOVA model for dependent measures of two factors (treatment group and time point of measurement) of which only one is repeated (time point of measurement) is performed to determine between- and within-group differences before and after treatment. Additionally, independent samples' t-test and paired samples' t-test are used for differences between and within groups, respectively, as well as χ2 tests for differences on the motor control tests and the TrA activation level procedure across the groups.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18-60 years-old
* suffered from NSLBP lasting longer than 12 weeks, producing moderate or severe disability

Exclusion Criteria:

* people with previous spinal surgery
* people suffering from systemic diseases
* pregnant women
Vitamin D Improves Clinical Manifestations in Asthmatic Children

Objectives: Evaluation of the effect of vitamin D supplemental therapy (VDST) on clinical manifestation of bronchial asthma (BA) as judged by The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and estimated serum levels of immunoglobulin E (IgE).

Patients \& Methods: scores of ISAAC questionnaire and blood samples were obtained for estimation of serum IgE and 25-hydroxy VD (25-HVD) at booking time (T1) of 102 BA patients. VDST was provided as 2000 IU daily for 3 and 6 months for patients had moderate and mild HVD, respectively. At the end of 12-m after start of VDST (T2), ISAAC questionnaire and serum levels of 25-HVD and IgE were re-evaluated and the percentage of change was calculated.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the age group of 6-14 years, free of exclusion criteria and complaining of chest wheezes were included in the study.

Exclusion Criteria:

* Presence of acute asthmatic attack, current or recurrent chest infection, allergic dermatological disorders, chronic rhino-sinusitis, deviated nasal septum, other nasal or palatal congenital anomalies, history of chronic exposure to allergens, or living in areas characterized by air pollution, being passive smokers since birth, presence of autoimmune disorders, serum 25-HVD \>50 nmol/L and presence of clinically evident HVD.
Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.

This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;
* Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;
* Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial.

Exclusion Criteria:

* Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans

The objective of this study is to determine whether providing Medicare beneficiaries with a web-based patient-centered decision tool to help them choose among prescription medication coverage plans improves outcomes for patients including a greater likelihood of changing a plan, better coverage for prescribed drugs, less decisional conflict when choosing plans, and greater satisfaction with the choice process relative to current practice.

In this study, the investigators tested the effectiveness of two versions of a web-based tool (called CHOICE) to help people choose among Medicare Part D plans (Treatments A and B) relative to standard care (Control). Both treatment arms incorporated simplified design and automated importation of an individual's prescription drugs relative to standard care. The treatment arms varied based on whether they provided expert guidance on recommended plans. In the control arm, study participants were directed to the existing, publicly available Medicare.gov website and received instructions on how to download their drugs from the Palo Alto Medical Foundation (PAMF) patient-facing online personal health portal (myhealthonline). The study sample included PAMF patients who were enrolled in Part D plans (not Medicare Advantage) during the 2016 enrollment period. Prior to the 2017 open enrollment period (October 15 to December 7, 2016), we invited a subset of PAMF patients not covered by either MediCal or a Medicare Advantage plan, aged 66-85, residing in 4 counties served by PAMF, and with at least one active medication order to participate in a study examining the effectiveness of decision tools that provide personalized information on the financial implications of enrolling in different Part D plans. The primary study outcomes included 1) Plan switching, 2) Decisional conflict 3) Satisfaction with the choice process, and 4) Change in generosity of coverage of prescription drugs. The investigators measured the primary study outcomes using a combination of administrative data and a post open enrollment survey. The investigators also collected information on individual characteristics at the time of enrollment in the study and implemented a survey examining use of the intervention tool to assess patient experience at the time of use.

Eligibility Criteria:
Inclusion Criteria:

* The study population included Medicare beneficiaries who received care from the Palo Alto Medical Foundation, a large multi-specialty group in the San Francisco Bay Area ages 66-85, one per household enrolled in a Medicare Part D plan in 2016.

Exclusion Criteria:

* Enrolled in a Medicare Advantage Plan and/or MediCal
Evaluation of Toothpaste on Dental Plaque

The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.

The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 9-12 years
* The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
* Absence of orthodontic appliances/brackets
* No physical limitations
* No previous trauma history
* It was determined as the absence of soft-hard tissue pathology.

Exclusion Criteria:

* Patients not between 9-12 years
* The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
* Presence of orthodontic appliances/brackets
* Physical limitations
* Previous trauma history
* It was determined as the presence of soft-hard tissue pathology.
Brief Therapies for Problem Gambling Substance Abusers

This project evaluates the efficacy of brief interventions for individuals seeking treatment for substance use disorders who also have gambling problems. In total, 220 problem gambling substance abusers will be randomized to one of three conditions: (a) a control condition consisting of 10 minutes of psychoeducation about gambling, (b) 10 minutes of brief advice about problem gambling and how to reduce it, or (c) four session of motivational and cognitive-behavioral therapy. Gambling, substance use and psychosocial problems will be assessed using standardized instruments at pre-treatment, month 2, 5, 8, 12, 16, 20 and 24-month follow-up evaluations.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* current (past-year) DSM-IV criteria for alcohol, cocaine, opioid or marijuana abuse or dependence
* score \>3 on the past-two month SOGS
* report an average of \>2 gambling days per month for the past 2 months; (e) spent an average of \>$50/month on gambling in the past 2 months
* English speaking
* sign informed consent.

Exclusion Criteria:

* have uncontrolled major psychiatric disorders other than substance use that require inpatient hospitalization (e.g., active bipolar disorder, psychosis, suicidality)
* desire specific gambling treatment or are currently receiving treatment for gambling
* have severe cognitive impairment
* read below 5th grade level
* plan to relocate \>100 miles or are likely to be incarcerated
Health Communication in Families

There are two goals of this research study. First, we hope to develop a plan to guide family discussions that can help parents diagnosed with lung cancer talk about cancer risk with their adult children. Second, we want to understand how families talk about cancer prevention.

In large part due to the advent of genetic testing, families have recently become a more central focus in cancer prevention. Given the high concordance of health behaviors within families (Kristeller et al., 1996), there is interest in developing family-wide behavior change interventions to reduce cancer risk. A cancer diagnosis represents a "teachable moment," in which a diagnosis may prompt health behavior change. Although this phenomenon has been observed among cancer survivors, it has not been examined among a patient's family members. Several critical questions exist about how families understand and communicate with regard to cancer risk information and what family processes facilitate or impede health behavior change. There is very little existent research in the area of cancer prevention among family members of cancer patients. Results in this area could help us develop interventions for family members who are motivated to make health behavior changes, and to inform and guide others who may not be motivated at the time their family member is diagnosed. Most importantly, the results could also help us intervene with family members of those who have been diagnosed with cancers where genetic and lifestyle components are important in the etiology of the illness, such as lung cancer and melanoma, and thus first-degree family members would benefit from strong messages to adopt healthy lifestyles. The research will rely on qualitative data collection and analysis. We will conduct qualitative interviews with 20 pairs of melanoma patients and one adult son or daughter, and 20 pairs of lung cancer patients and one adult child/sibling/or spouse. More specifically, for each pair of participants (i.e., the patient and his/her family member) we will conduct three interviews: an individual interview with the patient, an individual interview with the family member, and a joint interview where we will talk to the patient and family member at the same time. We will analyze interview data with a qualitative data computer analysis program, and identify themes and conclusions representing the core ideas in our data.

Eligibility Criteria:
Inclusion Criteria:

* Lung cancer patients must have a history of smoking.
* Family members of lung cancer patients must be active smokers in order to participate in the study.
* All participants must be more than 18 years of age and be fluent in English.
* Patients must have received a diagnosis of either lung cancer or melanoma within the past 3 to 18 months.
Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events

Homocysteine recently gained access to the category of risk factor for the development of atherosclerotic cardiovascular disease in the general population. Chronic renal failure patients, even before being introduced to dialysis therapy have almost universal elevation of serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular disease that we might now speculate, with a contribution of potentially toxic levels of the aminoacid homocysteine.

We conducted a double blind , randomized, placebo controlled trial, for two years, enroling, simultaneously, 186 end-stage kidney disease patients of any cause, older than 18 years of age, stable on hemodialysis, assigned to receive either oral folic acid 10 mg three times a week on post dialysis sessions, under nurse supervision or an identical appearing placebo for the entire lenght of the study, from april 2003 to march 2005.

The two groups had similar baseline clinical and laboratory characteristics. There was no loss of follow-up. At admission, homocysteine serum levels were above 13,9 umol/L in 96.7% (median 25.0, range 9.3-104.0)with only five cases in the normal levels; homocysteine remained elevated at 6, 12 and 24 months on those receiving placebo; folate treatment significantly decreased total homocysteine levels to a median value of 10.5 umol/L (2.8 - 20.3)which remained at this level for the entire study time (P\<0.001); every one was alive and tested at six months, sixty eight were either transplanted(15)or died (53) from cardiovascular disease(seventeen in the folic acid group and twenty one in the placebo (P\>0.05)or other causes(15), after being included in the study. Intima-media wall thickness blinded measured at the common carotid artery decreased from 1.94+-0,59 mm to 1.67+-0.38 (P\<0.001) with folate therapy and became thicker, from 1.86+-0.41 to 2.11+-0.48 mm in the placebo group.

In conclusion, folate treatment for two years was not effective on modifying cardiovascular death and non fatal cardiovascular events of this sample population with chronic uremia; however, the ultrasonographic evaluation of the common carotid arteries intima-media wall thickness at entry and twenty four months later unequivocally showed a significant thickness decrease with supervised folate intake.

Earlier prescription of folic acid might benefit patients with chronic renal failure,preventing cardiovascular deterioration

Eligibility Criteria:
Inclusion Criteria:

* Patients stable on hemodialysis for 4 months or more
* Eighteen years of age or older

Exclusion Criteria:

* Potential kidney transplant from a living donor in the near future
* Severe cardiovascular disease
* Cancer and active inflammation