cyrilzakka/clinical-trials huggingface dataset:
Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)

The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. The secondary objective of this study is to determine if several salient features identified in the US scan can be used to predict target motion identified in the MR scan.

The goal of radiotherapy treatment of cancer is to cure or locally control the disease while minimizing complications to healthy tissue. Given the complexity of tumor and normal tissue response to radiation, precise and accurate delivery of absorbed dose distributions, within known tolerances, is necessary to achieve the maximum therapeutic ratio. The complex treatment process of radiotherapy introduces geometrical uncertainties including respiratory induced tumor motion. The goal of this research is to develop and validate a novel image-guidance technique to directly track tumor motion using a 4-dimensional (4D) planar ultrasound (US) transducer during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition. The image sets will be rapidly matched using advanced image and signal processing algorithms, allowing the display of virtual MR images of the tumor/organ motion in real-time from an ultrasound acquisition.

Eligibility Criteria:
Inclusion Criteria (Healthy Volunteers):

* Must be eighteen (18) years of age or older.
* Must be able to provide informed consent.

Inclusion Criteria (Patients):

* Patients diagnosed with malignancies of the liver.

Exclusion Criteria (All):

* Under the age of eighteen (18) years.
* BMI exceeds the size of the bore of the MRI scanner.
* Unable or unwilling to provide informed consent.
* Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.
* Women who are pregnant, suspect they might be pregnant or breastfeeding.
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

The purpose of this study is to evaluate the esthetic performance of resin infiltration technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth

The teeth that meet the inclusion criteria will be cleaned from debris and clinical intra-oral photos of the lesions will be taken before and after the treatment. Resin infiltration technique will be performed according to manufacturer's instructions under rubber-dam isolation. Intra-oral photos will be taken directly after infiltration (1 day), and 1 week and 6 months later.

The system of the Commission Internationale de l'Eclairage (CIE) involving 3 color parameters: lightness (L), red/ green chromaticity (a), and yellow/blue chromaticity (b), will be used to assess the extent and durability of color and lightness changes between lesion and sound enamel areas before and after resin infiltration. The extent of assimilation and durability of effect will be assessed by comparing CIE L\*a\*b data collected before infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later.

The color assessments were standardized using a spectrophotometer (SpectroShade, Italy). Lesion areas will be measured for each time point by using an image analysis toolkit (ImageJ, National Institutes of Health, Bethesda, Md.).

Multifactorial analysis of variance with repeated measures will be used for statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parents of patients who accept to participate and sign the informed consent.
* At least one non-cavitated anterior teeth with a superficial discoloration on enamel due to demineralization or hypo mineralization
* Fully erupted anterior teeth with closed apices.

Exclusion Criteria:

* Patients and parents of patients who accept to participate.
* Teeth having absence of active cavitated-caries lesions, root canal treatment or restorations
* Teeth with ICDAS code 3 lesions (localized enamel breakdown due to caries with no visible dentin)
* Teeth that have a previously esthetic procedure (e.g. bleaching)
* Patients who are not in cooperation with the procedure.
* Fully erupted teeth with open apices
Use of Stem Cells in Diabetes Mellitus Type 1

Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.

Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.

The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.

These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Patients with Type 1 Diabetes Mellitus.
2. Age from 18 years to 35 years either gender.
3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml
5. No clinical evidence of renal, retinal, vascular or skin complications
6. Body Mass Index not exceeding 30
7. Any HbA1c
8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
9. Informed Consent by patient

Exclusion Criteria:

1. Age less than 18 years and more than 35 years
2. Pregnancy
3. Married women or women expected to be married within the study period
4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
5. Diabetic coma or pre-coma current or recent within the last 2 months
6. C-Peptide less than 0.5 ng/ml
7. Disease duration more than 3 yrs.
8. Complication mentioned in 5 above in inclusion
9. Non-consenting patient or withdrawal of consent.
10. Bleeding disorders
Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

The study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or AVM-related intracranial hemorrhage

The study is a prospective description and evaluation of an approved and unchanged clinical management, evaluating already used different diagnosis methods to assess brain perfusion in patients with atraumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage.

Eligibility Criteria:
i. Inclusion Criteria

1. Age ≥ 18 years
2. Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed)
3. In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible
4. No contra-indication to perfusion imaging
5. Subject or legal representative is able and willing to give informed consent.

ii. Exclusion Criteria

1. Traumatic intracranial hemorrhage
2. Contra-indication to imaging or patient's refusal.
A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
* BMI \<40 kg/m squared
* HbA1c greater than or equal to 7% and less than or equal to 11.5%
* Serum creatinine less than 2 for males and less than 1.8 for females
* Acceptable pulmonary function

Exclusion Criteria:

* Significant hepatic disease
* Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes
Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation

This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for Haematologic Malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Recipient must

  1. Be between the ages of 16 and 65 years old
  2. Have one of the following hematologic malignancies:

     * Acute myeloid leukemia (de novo, secondary or therapy related) in untreated 1st relapse or in remission or with evidence of molecular relapse but blasts less than 5%
     * Chronic myeloid leukemia in chronic or accelerated phase (de novo or therapy related)
     * Myelodysplasia (de novo or therapy related)
     * Other hematologic malignancy (de novo or therapy related) including but not limited to: ALL (CR 1, CR2 or CR3), CLL, non-Hodgkin's lymphoma, Hodgkin's lymphoma
  3. Must be receiving a myeloablative conditioning regimen of busulfan and cyclophosphamide or TBI and cyclophosphamide or other myeloablative regimen approved by the Clinical Study Chair. (Regimens containing ATG are not allowed.)
  4. Have an HLA-identical sibling donor
  5. Meet the transplant centre's criteria for myeloablative allogeneic transplantation\*
  6. Have an ECOG performance status of 0, 1 or 2
  7. Have given signed informed consent

Donor must

1. Be 18 years of age or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.)
2. Be able to undergo general anesthesia and BM harvest or peripheral blood collection as per assessment by a transplant physician. (If an anesthetist assesses a donor after randomization and determines the donor should not undergo general anesthesia, then the donor and recipient will be withdrawn from the study.)
3. Be a sibling of the recipient
4. Be a 6/6 HLA match of the recipient. HLA typing is by serologic or DNA methodology for A and B and by DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
5. Have given signed informed consent

Exclusion Criteria

Recipient

1. The recipient is HIV antibody positive

Donor

1. The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection
2. The donor is pregnant or breastfeeding at the time of progenitor cell collection
3. The donor has a history of malignant disease within the last 5 years or current malignancy other than non-melanomatous in situ skin carcinoma or cervical carcinoma in situ
4. The donor is HIV antibody positive
5. The donor has a known sensitivity to E. coli-derived products
6. The donor and recipient are identical twins
Substrate Oxidation Does Not Affect Short Term Food Intake in Healthy Boys and Men

The purpose of this study is to investigate the effect of substrate oxidation, expressed by RER, on food intake regulation and net energy balance.

The relationship between substrate oxidation as measured by respiratory exchange ratio (RER) and food intake is undefined. This study is examining the effects of three modulators of substrate oxidation (RER), a glucose preload, exercise and age food intake regulation and net energy balance in normal-weight boys (9-12 y) and men (20-30 y).

Subjects (15 boys, 15 men) were measured in random order with treatments of beverages of either water or glucose followed by either moderate exercise or rest for 40 min. Measures included RER via indirect calorimetry, energy expenditure, subjective appetite, food intake measured at an ad libitum pizza meal and net energy balance as the sum of the calories of the glucose preload + calories from the pizza lunch minus energy expended at exercise or rest.

Eligibility Criteria:
Inclusion Criteria:

* Born at full term
* Men Age:20-29 years/BMI: 20-25
* Boys Age 9-11/BMI percentile: 15th to 85th:

Exclusion Criteria:

* Smokers
* Dieters
* Individuals with lactose intolerance, allergies to milk and dairy products
* Individuals with gastrointestinal problems
* Individuals with diabetes or other metabolic diseases
* Individuals scoring ≥ 11 on an Eating Habit Questionnaire
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome

The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) - insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of Noonan syndrome
2. Height less than the 3rd percentile for age and sex (height SDS \< -1.88)
3. Basal IGF-I less than the mean for age and sex (IGF-I SDS \< 0)
4. Chronological age greater than 2 years
5. Bone age ≤ 11 years for boys, and ≤ 10 years for girls
6. Pre-pubertal
7. Documented pre-treatment height velocity less than the mean for age and sex

Exclusion Criteria:

1. Clinically significant diseases
2. Chronic illnesses
3. Prior treatment with rhIGF-1
Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients

This is a multicentre study examining the effectiveness of angiotension converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis (CAPD) patients.

RRF has been shown to decline progressively with time on dialysis in both CAPD and hemodialysis. Although RRF is an important determinant of mortality and morbidity in peritoneal dialysis (PD) patients, few studies have addressed therapeutic approaches for preserving RRF after the initiation of dialysis therapy. Blockade of the renin-angiotensin system by ACEI or ARB is a well-established approach for renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials showed that an ACEI, ramipril, and ARB, valsartan , were effective in the preservation of RRF of CAPD patients. However it is important to point out that the evidence cited has limitations. First, the trial only involved patients from one university teaching hospital. Second, transport characteristics, were not assessed before the start of the study. Third, the trial was too small to detect potentially important differences in health care use and survival between groups. Therefore, whether both ACEI and ARB preserve RRF, improve clinical outcomes and decrease health care use and costs should be tested in much longer and larger studies involving multiple sites. In order to confirm these findings, here the investigators will perform prospective, randomized, open-label and multiple center study to address long-term effects of ACEI, ARB and combination of both therapy on RRF in Patients on CAPD.

Eligibility Criteria:
Inclusion Criteria:

* All patients received CAPD more than 1 months
* Subjects of either sex, 20-75 years old
* Residual GFR of 3mL/min per 1.73 m2 or more
* With hypertension
* No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 1 month
* Provision of written informed consent by subject or guardian

Exclusion Criteria:

* Underlying medical conditions, such as congestive heart failure, or therapy with an ACE inhibitor or ARB
* Peritonitis or volume overload within the preceding 1 month
* Myocardial infarction within the preceding 6 months
* Clinically significant valvular disease
* Malignant hypertension
* History of hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months
* Any condition that may have precluded a patient from remaining in the study, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder
* History of allergy or intolerance to an ACE inhibitor or ARB
* Participation in another clinic trial within 2 weeks prior to screening
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life

Project summary

Rationale

Many NICU's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. The researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. The researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization.

Objectives

The investigators plan to conduct an intervention study in premature infants receiving probiotics (\< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. The main outcome will be bacterial concentration in the stomach after one week of life.

Methods

The study is a prospective, randomized controlled trial in preterm infants. Infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. The intervention will last one week. The infants will be followed until discharge. The investigators plan to include 11 infants in each group.

Primary outcome

Concentration of bacteria in gastric aspirates on day seven.


Eligibility Criteria:
Inclusion Criteria:

* Under 32 weeks GA at birth
* Admission time considered to be more than seven days
* Signed informed consent within 48 hours after birth

Exclusion Criteria:

* Transfer to another hospital within seven days
* Major gastrointestinal malformations
* No tube feeding within first 48 h of birth
Effects of PIR and PFS on Pain, ROM, and Disabilty in Tight Hamstring Syndrome

This randomized clinical trial aims to compare the effects of post-isometric relaxation (PIR) and post-facilitation stretch (PFS) on pain, range of motion, and disability in individuals with tight hamstring syndrome. Conducted at Riphah Rehabilitation Clinic, Lahore, participants aged 18-35 years with posterior thigh pain will be divided into two groups. Both groups will receive hot pack therapy and core strengthening exercises, with Group A receiving PIR and Group B receiving PFS. Outcomes will be assessed at baseline and after 4 weeks using NPRS, a disability questionnaire, and a goniometer, with data analyzed using SPSS version 25.

Both PIR and PFS are subtypes of Muscle Energy Techniques (MET) that have shown potential in improving muscle flexibility and reducing discomfort. This study aims to address the impacts of PIR and PFS on pain, ROM, and disability in patients with tight hamstrings syndrome, providing valuable insights for clinical practice and enhancing the understanding of effective interventions for this common musculoskeletal issue.

The current literature on stretching techniques for musculoskeletal conditions reveals several gaps specifically relevant to the effects of Post Isometric Relaxation (PIR) and Post Facilitation Stretch (PFS) on tight hamstrings syndrome. Despite the high incidence of hamstring tightness and its association with conditions such as nonspecific low back pain, there is limited research directly comparing the effects of Post Isometric Relaxation (PIR) and Post Facilitation Stretch (PFS) on this condition. While studies have explored various stretching methods such as Muscle Energy Technique (MET), static stretching, and myofascial release, there is a notable lack of direct comparative research between PIR and PFS in patients with tight hamstrings. Additionally, existing studies had often focused on immediate or short-term outcomes, with limited investigation into the long-term effects of these techniques on pain, range of motion (ROM), and disability.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age between 18 to 35 years(45)
* Bilateral hamstring muscle tightness
* Individuals having lack of Active knee extension more than 20 degrees(46)

Exclusion Criteria:

* Low back pain radiating to the back of thigh
* History of fracture, dislocation of hip(47)
* Acute or chronic hamstring injury
* Any neurological disease(48)
* Congenital deformity of the lower limb
* Inflammatory condition that affects motion
* A history of a cervical whiplash injury(45)
Assessment of Fetal Position in Active Labor

Vaginal exams are used routinely in labor to assess cervical dilation and position of the baby (facing anterior, facing to the right or left side, facing towards maternal spine). This technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help confirm or correct the vaginal assessment by obstetricians, but has not been used to assess the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians in training. The investigators plan to use ultrasound assessment to determine if this education is effective in increasing accuracy in the resident population.

Residents will be informed of the study through an education session (as a group) and then be consented individually. Each resident will complete 15 baseline exams, 20 exams with immediate ultrasound confirmation, and 15 exams for post-test baseline. Exams will take place periodically throughout the year. Both 3rd and 4th year residents will be assessed during the same time period by the MFM fellows. Ultrasounds will follow the vaginal exam as closely as possible to prepare for delivery. A picture of the fetal position (with no name or MRN) for documentation to be taken during the SOC ultrasound and kept in the research chart for the resident.

In training feedback is not always standard. This teaching tool, consistent and standard feedback with regard to the correlation between vaginal exam and ultrasound, would allow the resident to learn to assess fetal position more accurately.

Information from the maternal chart (history and delivery information) will be collected as de identified. Data will be recorded on the data collection sheet which is labeled with a code number linking the resident participant only.

Data collected from the residents will be assigned a random Code numbers used to link the subject to their data.

Code and identifiers will be kept separate. Paper copies will be kept in a locked cabinet, in a locked office, in a locked suite.

Eligibility Criteria:
Inclusion Criteria:

* Physicians in obstetrics training -

Exclusion Criteria:

* Physicians outside of obstetrics training.