cyrilzakka/clinical-trials huggingface dataset:
Comparing Efficacy of Bone Marrow Aspirate Concentrate (BMAC) Combined With Allograft in Treatment of Calcaneus Fractures

The purpose of this study is to evaluate the efficacy of BMAC when used in conjunction with viable allograft bone for treating displaced intra-articular calcaneal fractures, in terms of rate of allograft incorporation into the host tissue, bone healing, and functional outcome.

The study group will consist of patients with intra-articular calcaneal fractures admitted to our academic level I trauma center that underwent open reduction internal fixation. Inclusion criteria will be patients with a closed displaced intra-articular fracture Sanders type III without any evidence of neurovascular injury. Patients will be randomly divided into three groups according to the plan of management: autograft alone, viable allograft combined with BMAC, or viable allograft alone. Radiographic imaging and three-dimensional standing computed tomography will be used to assess the articular surface, Bohler's angle, the crucial angle of Gissane, and the height, width and length of the calcaneus. The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hind-foot scoring system and visual analog scale (VAS) will be used to post-operative evaluation of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Closed displaced intra-articular fracture without any evidence of nerve or blood vessel injury, the fractures belonged to Sanders type III according to Sanders classification and amenable to open reduction internal fixation
* Life expectancy of at least 1 year
* Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
* Adequate soft tissue coverage at the fracture site through primary closure.
* Unilateral or bilateral calcaneal fractures.

Exclusion Criteria:

* Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period
* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study.
* Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 10%)
* A current endocrine or metabolic disorder known to affect osteogenesis
* Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy.
* Inadequate neurovascular status in the involved limb that may jeopardize healing.
* Patients who have a preexisting calcaneus deformity that cannot accommodate a reduction or a previous history of osteomyelitis in the index limb.
* Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.
Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching

This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on pain sensitivity control and color change after home tooth whitening. It also evaluated the influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of patient satisfaction after bleaching treatment.


Eligibility Criteria:
Inclusion Criteria:

* individuals aged 18 to 29 years of both sexes with chroma greater than A2 in the upper incisors and canines, in the Vita Classical color scale;
* absence of active caries lesions
* patients who had never undergone bleaching therapy;
* good oral hygiene and no hypersensitivity to tactile and evaporative stimuli through the Visual Analog Pain Scale;

Exclusion Criteria:

* patients undergoing fixed orthodontic treatment;
* patients with darkened non-vital teeth and/or with extensive restorations in molars;
* presence of cracks or fractures;
* patients allergic to the product, with the presence of gastroesophageal disorders and with dentinal exposure in anterior and/or posterior teeth.
Study of Ocean Rowing Muscle Metabolism. 1. What Effect Does Rowing 3000 Miles Across Atlantic Ocean Have on Calf Muscle Size? 2. In the Catabolic State of Extreme Endurance, is Muscle Loss Uniform or Can the Human Body Select Depending on Load and Nutrient Availability?

Little is known on the human adaptation to extreme endurance and with the increasing popularity in long duration events we seek to provide insight into the physiological and metabolic adaptation processes of ocean rowing.

Rowing 12-18 hours a day will illicit a high energy expenditure and anecdotally people have lost large amounts of body weight and variable amounts of muscle mass, particularly in the lower limbs. This may provide insights and a potential new model to to study muscle unloading.

Previous research has investigated factors determining muscle loss through bed rest and limb immobilisation. These methods are limited in that some do not include inflammation or changes in nutrition, which have been shown to be key drivers of muscle loss. These studies aim to investigate a potentially new model of muscle unloading.

Ocean rowing is an ultra-endurance sport where people spend 35-90 days at sea. Usually rowing for a minimum of 12 hours a day, in a 2-hour on/off shift pattern with daily food rations. Rowers lose body and muscle mass. There is likely to be low-grade inflammation, nutritional deficit, fatigue and rowers do not stand up for the entire crossing. Part 1 aims to quantify this muscle loss by inviting rowers in the annual 3000 mile Talisker Whisky Atlantic Challenge 2020 to take part. While part 2 aims to continue the work by measuring upper and core muscles as well as lower limb muscles from the first study with the aim of understanding how the body allocates resources in a hypocaloric, high energy expenditure environment.

Muscle mass of the lower limbs of the rowers will be measured with ultrasound, as well as body mass, body composition, energy expenditure and nutritional intake, the week before the race and immediately after arrival in Antigua. As well as adding novel insights to the knowledge base around factors affecting ultra endurance performance, the results will then be used to inform future intervention studies aimed at preventing muscle loss.

Eligibility Criteria:
Inclusion Criteria:

- Taking part in the Talisker Whisky Atlantic Challenge 2020 and 2021

Exclusion Criteria:

- lower limb amputee musculoskeletal, metabolic, neurological disease pacemaker fitted
Home-Based Interventions for Adolescents With Type 1 Diabetes

Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.

The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.

The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.

Eligibility Criteria:
Inclusion Criteria:

* a current hemoglobin A1c(HbA1c) of \>9.0%
* an average HbA1c of \>9.0% during the past year
* reside in the metro Detroit tri-county area
* diagnosed with Type 1 diabetes for at least one year
* aged 10-17
* patient of Children's Hospital of Michigan Diabetes Clinic

Exclusion Criteria:

* severe mental impairment/thought disorder
* Active suicidality
* Active homicidality
* Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients

The aim of the following study is to evaluate the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Patients who agree to participate to the study will use 2 different toothpaste Sensodyne Repair and Protect and Parodontax, which will used with split mouth design. The following indices will be measured: BEWE, Bleeding Index, Gingival Index, Plaque Index, Dental sensitivity test- Schiff, Pain Intensity Index- VAS and PPD.

Informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. To the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. The method used in the study is "Split-Mouth" design, in which contralateral teeth with MIH will used for control group. For the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. The toothpaste used for the study consist in 2 different types: Sensodyne Repair\&Protect (used for the Trial group) and Parodontax Complete Protection (used for the control group).

The 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. The products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing.

At each meeting will be taken all the indices and the timing is: T0- study begin, T1- after 1 month, T2-after 3 months, T3- after 6 months, T4- after 9 months, T5- after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-MIH) on contralateral permanent teeth
* Patients with mild or moderate MIH
* Good general health (absence of particular systemic pathologies)

Exclusion Criteria:

* Patients undergoing orthodontic therapy
* Patients taking drugs
* Patients with severe MIH (tooth surface with defect \&gt; 2/3, post-eruptive enamel breakage)
Fidgety Movements in Cystic Fibrosis

Very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. It has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak General Movements (GMs) repertoire.

It has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. There is no research done with GMs assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research.

Having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. For this reasons, in the study the investigators aimed to investigate the characteristics of GMs in the "Fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the GMs characteristics and the features of the disease.

The hypotheses the investigators have set for this study are listed below;

Ho: Spontaneous movements of the "Fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants.

H1: Spontaneous movements of "Fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with cystic fibrosis
* Being between the postterm 3rd and 5th months

Exclusion Criteria:

* Having congenital anomalies,
* Having an ongoing infection,
* Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
* Fidgety movements evaluation results; being abnormal (AF), sporadic (F +/-) or non-F (F-)
* Baby's family does not want to be involved in the work
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy

This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.

PRIMARY OBJECTIVES:

* Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).
* Identify any synchrony in EMG and EEG for PFM activity.
* Identify any relationship between EEG activity and UDS findings.

SECONDARY OBJECTIVES:

I. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.

EXPLORATORY OBJECTIVE:

I. Examine feasibility of replacing EMG with EEG monitoring for muscle activity.

OUTLINE:

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG and UDS, respectively, before surgery, 6 weeks after surgery, 3,months after surgery and 6 months after surgery.. Patients complete questionnaires over 5-10 minutes about urinary function.

Eligibility Criteria:
Inclusion Criteria:

* Adults who had or are undergoing robot-assisted radical prostatectomy (RARP)
* Must be continent preoperatively
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
Stereotactic Radiotherapy for Renal Cancers

Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Initially developed in small-sized (\<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery.

Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In Cleveland (USA) two phase I studies are already underway.

The investigators propose to develop a phase I study for tumors of less than 4 cm. As found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control.

The primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:

* Step 1: 4 x 8 Gy.
* Step 2: 5 x 8 Gy.
* Step 3: 4 x 10 Gy.
* Step 4: 4 x 12 Gy.

The patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 75 years with an operable renal tumor or patient with inoperable renal tumor irrespective of age, or patient with metastatic renal tumor and indication for nephrectomy.
* Histologically-confirmed Renal carcinoma less than or equal to 4 cm
* Tumor that is visible and measureable on abdominal scanner and/or MRI (Magnetic Resonance Imaging)
* Karnofsky performance status ≥ 60%

Exclusion Criteria:

* Patient with only one kidney and renal cancer
* Patient not able to cooperate during treatment
* Previous history of abdominal radiation therapy
* Tumor having infiltrated the renal pelvis
* Polycystic kidney disease
* Previous history of intestinal inflammatory disease such as ulcerative colitis or Crohn's disease
* Renal insufficiency (creatinine clearance \<30 ml/mm evaluated by DTPA (diethylenetriamine pentaacetic acid ) scintigraphy)
* Uncontrolled hypertension (SBP(systolic blood pressure) above 160 mmHg DBP(diastolic blood pressure) above 100 mmHg with antihypertensive treatment)
* Non primary lesions (benign lesions such as angiomyolipoma, renal metastases,...)
* Antineoplastic and/or antiangiogenic treatment in the month preceding radiotherapy
* Progressive cancer other than renal cancer at time of inclusion with the exception of in situ cervical carcinomas, basal cell carcinoma of the skin, and non-metastatic prostate cancer controlled without hormone therapy
* Participation in another ongoing study that may interfere with the present study
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.


Eligibility Criteria:
Inclusion Criteria

1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment
2. Available for the entire study period

Exclusion Criteria

1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
2. A previous anaphylactic reaction to any vaccine or vaccine-related component
3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.


Eligibility Criteria:
Inclusion Criteria:

* All heart valve diseases needing heart valve surgery.

Exclusion Criteria:

* All four limbs existed ischemic condition
The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly

The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

The prognosis of pancreatic cancer is extremely unpleasant, which can be characterized with a 5-year survival rate of only about 6%. The disease usually pertaining no symptoms at the early phase, this might be one of the causes why it is discovered at a relatively late, inoperable stage - in most of the cases. The success of reducing the high mortality rate of pancreatic cancer could depend on the significant development of early diagnosis and also prevention programs. As the lifetime prevalence of pancreatic cancer is only 1.39%, screening through the whole population would be extremely expensive and difficult to manage. It would be recommended for all the individuals at high risk for pancreatic cancer to be examined. Patients newly diagnosed with diabetes have an approximately 8-fold risk for developing this type of cancer, compared to the average population. In addition to this age is also known as an independent risk factor for the pancreatic cancer. Recently there has been a biomarker panel identified, which may distinguish between pancreatic cancer and chronic pancreatitis in patients, with high sensitivity and specificity. The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes mellitus using a specific biomarker panel. Only patients with type 2 diabetes are meant to be included. Diabetes is classified by determining C-peptide levels, representing the endogenous insulin synthesis, also detecting glutamic acid decarboxylase (GADA) antibodies, the autoantibody against the pancreatic islet cells. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Eligibility Criteria:
Inclusion Criteria:

* patients over 60 years of age
* diabetes diagnosed within six months (newly diagnosed)
* signed written informed consent

Exclusion Criteria:

* continous alcohol abuse
* chronic pancreatitis
* previous pancreas operation/pancreatectomy
* pregnancy
* present malignant disease