cyrilzakka/clinical-trials huggingface dataset:
Lactobacillus Reuteri for the Treatment of Infantile Colic:

Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as \>3 hours of crying on \>3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported.

Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.

Eligible infants will be randomly assigned to receive either L. reuteri 108 CFU per day or placebo. Both the active treatment and placebo will be taken orally, 1 times daily, for 21 days.

All infants are eligible for screening. If a patient appears to meet the criteria for enrollment and express interest in the study, cow's milk elimination diet will be prescribed for 1 week to a breastfeeding mother (and to an infant, in case of formula fed infants). Care givers will be asked to record for 1 week symptoms of colic. Children fulfilling inclusion criteria will be asked to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Full-term infants age \<5 months
* Infantile colic (\>3 hours of crying on \>3 days in the week) within 7 days prior to enrollment
* Exclusive or predominant (\>50%) breastfeeding
* Informed consent

Exclusion Criteria:

* Acute or chronic illness
* Gastrointestinal disorders
* Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.
Monopolar and Bipolar in Esophageal ESD

The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.

Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.

Traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation induced by large amounts of energy. Almost all patients with 60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions, since it avoids the need for morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome and scar formation, by using significantly less energy. This bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.

Our tertiary referral center Baylor St Luke's Medical Center is a center of excellence for ESD procedure and the investigators have previously reported our Esophageal ESD experience using the monopolar current knife. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal dissection.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old
* Patient is capable of providing informed consent
* Patient is referred for ESD procedure of an esophageal neoplastic lesion

Exclusion Criteria:

* Patient is \< 18 years old
* Patient refused and/or unable to provide consent
* Patient is a pregnant woman
* Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique
Accuracy of Photogrammetric Three-Dimensional Facial Models Reconstruction Compared With Direct Anthropometry

Accuracy of Two Different Photogrammetric Software for Three Dimensional Facial Model Reconstructions Compared with Direct Facial Anthropometry.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 or older

Exclusion Criteria:

* Presence of:

  1. Extensive facial hair (beards).
  2. Significant facial defects.
  3. Surgical scars.
  4. Neuromuscular disorders that may hinder stability of head during image acquisition.
  5. Accessories that could interfere with image acquisition.
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 to 49 years of age inclusive
2. Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).
3. Male or female

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.
2. A history of significant hypersensitivity, intolerance, or allergy to any drug compound
3. History of alcohol or other substance abuse
Maximizing Patient Goal Attainment

To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Individuals 21 years of age or older
* New patients or existing patients with a new problem that are scheduled to see an orthopaedic surgeon in the Hip and Knee Arthroplasty service for a knee consult.

Exclusion Criteria:

* Individuals who are unable to consent or complete surveys without assistance
* Non-English speaking
* Patients who are less than 12 months from surgery on the knee they are being evaluated for, less than 6 months from surgery on the spine, or less than 3 months from another knee/hip surgery
Observational Study of Iron Overload in Stem Cell Transplantation

Recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. However, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. Therefore, the investigators are conducting a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.

As above.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histologically confirmed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS)
* Planned allogeneic stem cell transplantation with myeloablative conditioning regimen (regardless of stem cell source or donor HLA match)
* Patients will be eligible even if they have had prior stem cell transplantation (autologous or allogeneic)

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI):

  * Patients with cardiac pacemakers, implanted cardiac defibrillator (ICD), cardiac electrodes, pacing wires, internal electrodes, cochlear, otologic or other ear implants, metallic fragments or foreign body, metallic prosthesis. Patients with surgical staples should not be imaged until 7 days post-op unless approved by a radiologist;
  * Severe claustrophobia
  * Note: a history of allergic reaction to gadolinium is not a contraindication to enrollment, as contrast will not be used.
* Inability to provide informed consent
Inspiratory Muscle Training in Patients With End-stage Renal Disease

Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy. The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory muscle strength, with positive effects on functional capacity and quality of life of kidney patients, however, the effects of IMT were not addressed in the specific variables of the respiratory system and to date there are no studies on the use of daily training in this population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage renal disease patients. Methods: A randomized controlled clinical trial to be developed in Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE) during the period from November 2015 to December 2016. The sample is composed of 24 individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months and provide inspiratory muscle weakness. Patients will be divided into two groups, the training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham group will be subjected to the same procedure (duration and frequency), but without load. Participants will be assessed before and after intervention through a global assessment form, questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.


Eligibility Criteria:
Inclusion Criteria:

* Have a chronic kidney disease
* Hemodialysis for a minimum period of twelve months
* Inspiratory muscle weakness, with MIP \<80cmH2O for men and \<60cmH2O for women

Exclusion Criteria:

* Neurological deficit
* Chronic lung disease
* Severe heart disease (unstable angina and acute myocardial infarction)
* Decompensated diabetes
* Infectious disease
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer

The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥45 years old
2. Receiving breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy
3. Negative surgical margins
4. Tumor staging： A. patients without neoadjuvant chemotherapy: pT1-2N1M0, axillary lymph node dissection with 1-3 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) B. patients without neoadjuvant chemotherapy: pT1-2N1M0, sentinel lymph node biopsy with 1-2 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) C. patients with neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0, requiring positive clinical lymph nodes with pathological confirmation, receiving ≥6 cycles of neoadjuvant chemotherapy, and ≥3 sentinel lymph nodes detected for those with simple sentinel lymph node biopsy
5. Signed informed consent

Exclusion Criteria:

1. Distant metastases
2. Metastasis to ipsilateral internal breast, supraclavicular or subclavicular lymph nodes
3. Previous radiotherapy to the chest
4. Bilateral breast cancer
5. Pregnancy, breastfeeding
6. Previous or concurrent other malignancy with tumor-free survival \<5 years (but excluding skin cancer with non-malignant melanoma, papillary/follicular thyroid cancer, cervical carcinoma in situ)
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT

This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.

Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.

Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 7 years and 18 years
* Diagnosis of cerebral palsy with hemiplegia
* Upper limb spasticity ≥ 1
* IQ ≥ 50

Exclusion Criteria:

* Any contra-indications to rTMS
* Severe spasticity (score of 4 or more in Ashworth scale)
* Uncontrollable epilepsy
* History of Botulinum toxin A injection in previous 6 months
* Upper limb casting in previous 6 months
Once Weekly Parathyroid Hormone for Osteoporosis

Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis. This study will evaluate the safety and effectiveness of PTH when given once a week.

In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. The most common form of osteoporosis is postmenopausal osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter.

PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must be self-injected, is very expensive, and has been associated with worrisome side effects. The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis. A once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of PTH. A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis.

Women will be randomized to receive either PTH or placebo. Women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium and vitamin D supplements daily. Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. Bone mineral density will be measured at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Bone mineral density scan with a T-score between -1 and -2
* Willing to self-administer injections
* Postmenopausal

Exclusion Criteria:

* Medications to treat osteoporosis, including: hormone replacement therapy for more than one month in the 6 months prior to study, or for more than 12 months in the 2 years prior to study; alendronate, risedronate, or etidronate for more than 1 year anytime prior to study; calcitonin in the 3 months prior to study; taken raloxifene or tamoxifen in the last 6 months or for more than 1 year in the 2 years prior to study; fluoride for more than 1 month in the 5 years prior to study
* Bone fracture since menopause
* Femoral neck T-score below -2 AND lumbar spine T-score below -2.5 OR femoral neck T-score below -2.5 AND T-scores of both total hip and lumbar spine below -2
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.

With 2.1 million new breast cancer (BRC) cases each year globally, BRC is one of the biggest health challenges today. Available anticancer therapies have limited efficacy and are coupled with toxic side effects. Nutritional intervention can ameliorate undesirable effects, reduce exhaustion, psychological harm, and costs spent on treating these side effects. The proposed project AID aims to improve clinical outcome, quality of life (QoL) and survival rate in BRC patients on adjuvant endocrine therapy with aromatase inhibitors (AI) by nutritional interventions. In a three-arm randomised controlled nutritional trial involving 90 BRC patients who will receive either supplement or placebo pills (control group), or an anti-inflammatory diet for 4 months, along with the AI therapy, changes in nutritional status, QoL, biochemical and clinical parameters will be measured in comparison among three groups. The second goal is to establish cause-and-effect relationships among the clinical outcomes, nutritional status and biochemical parameters related to cancer, including inflammatory and redox status, plasma lipidome and polymorphism of fatty acid desaturase (FADS) genes. Introducing an effective nutritional intervention in BRC patients as an integral part of the multimodal therapeutic approach is the goal of this project.

Eligibility Criteria:
Inclusion Criteria:

* Age: 45 to 70 years
* Postmenopausal women
* Histologically confirmed BRC, stage I to IIIa
* ER positive /HER2 negative
* Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months
* Body mass index from 20 to 34.9 kg/m 2
* Able to understand the requirements of the study and provide written information consent

Exclusion Criteria:

* Metastatic or locally advanced disease
* HER2-positive tumors
* Presence of other malignant or serious chronic diseases
* Active infections
* Previous stroke or heart attack,
* Rheumatoid arthritis and other types of autoimmune diseases
* Presence of a significant neurological deficit
* Dementia
* Allergy to the ingredients of the dietary preparation or to fish, fish oil and nuts fruits.
* Allergies to evening primrose oil or other oils containing gamma-linolenic acid (borage, black currant)
* Use of lipid-lowering drugs (statins, Normolip)
* Current use of warfarin or other anticoagulants
* Corticosteroid therapy for the last month
* Use of dietary supplements based on fish oil, evening primrose, and flaxseed oils, omega 3-6-9 fatty acids, multivitamins with added omega-3 of fatty acids 3 months before the start of the study