cyrilzakka/clinical-trials huggingface dataset:
Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of 2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both physical and psychological domains, interfering with self-esteem and mental well-being. Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be a stressful intervention for patients and their caregivers.

Postoperative pain is the major concern for patients undergoing orthopedic surgery. Significant postoperative pain also adversely affects other outcomes by hindering the healing process and delaying rehabilitation with loss of movement and walking. After arthrodesis the pain reported by the patients is significant.

Various strategies have been explored for acute pain management in patients undergoing surgery for scoliosis, with a focus on the first days post surgery. The link between breathing, lumbar spine function and pain perception is an aspect that has always been studied. The diaphragm plays an important role in spinal control and in the management of pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce significant and clinically relevant improvements in the treatment of pathologies of the spine and especially in the management of painful symptoms.

A systematic review highlights how pain is able to influence the flow, frequency and volume of the respiratory act. At the same time, a regulation of breathing can be an useful tool in the control of painful symptoms.

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe tool that can be introduced for the control of painful symptoms.

The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative phase in patients undergoing arthrodesis surgery for adolescent idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled.

Exclusion Criteria:

* Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.

Primary Objective(s):

Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.

Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible
* ECOG performance status 0 or 1
* Male or female ≥ 18 years of age

Exclusion Criteria:

* Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma
* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.
* Subjects with resectable disease or suitable for definitive chemoradiation
* Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
* Tumors of squamous cell histology
* Known central nervous system metastases
* Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization
* Serious or non-healing wound
Evaluation of Hepatic Fibrosis on Multiparametric MRI

As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.


Eligibility Criteria:
Inclusion Criteria:

* chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
* Or transplant recipient for viral hepatitis and on anti-viral agent medication
* AND scheduled for liver resection, biopsy or transient elastography
* AND signed informed consent

Exclusion Criteria:

* younger than 18 years
* any contra-indication for contrast-enhanced MRI
* pregnant or nursing women
* biliary obstruction
* unable or unwilling to give informed consent
Prognostic Value of Progesterone on Oocyte Retrieval Day for In Vitro Fertilization Outcome

This observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.

There has been evidence, that increased serum levels of progesterone on triggering day are associated with a decreased probability of pregnancy after IVF.

There is no study that investigate assocation between serum progesterone levels on the day of oocyte pick-up and IVF outcomes. This study will be the first in this case.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years
* Basal FSH \< 12 IU/L
* Basal P \< 1.6 ng/mL

Exclusion Criteria:

* Women with polycystic ovaries syndrome (PCOS)
* Women with Stage III-IV Endometriosis
* Women with a pathological condition of the adrenal glands
Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients

Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.


Eligibility Criteria:
Inclusion Criteria:

* The study includes all patients aged equal to or over twenty who had trauma.

Exclusion Criteria:

* Patients with burns.
* Patients with hangings.
* Patients with drowning.
* Patients with with unavailable laboratory data.
Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia

The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.

The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patient age: \> 18 years
* Ability to provide written, informed consent

Exclusion Criteria:

* Pregnancy or planning a pregnancy
* History of nasal, esophageal \& gastric surgery
* History of recurrent epistaxis or nasal trauma
* Subjects with a history of unresolved drug or alcohol dependency
* Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
* Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
* Inability to provide written informed consent
* Inability to discontinue drugs such as Plavix
* Advanced chronic liver disease
* Severe uncontrolled coagulopathy
* Active cancer in any organ over the past 3 years.
Mini Distractor in Vertically Deficient Bone

ADO is a bone regeneration technique, introduced by Chin and Toth in 1996 based in a biological process used for regenerate and consolidate bone between two bone segments obtained after osteotomy.These segments have been gradually separated by the process of distraction. ADO can be performed both horizontally (AHDO) and vertically (AVDO).

Distraction osteogenesis (DO) can be used to regenerate missing hard and soft tissue, Distraction osteogenesis relies on the body's ability to generate bone as two segments of bone are "distracted" apart. The osteotomies are created and the distraction device is placed. Typically, there is a latency phase of one week were a ﬁbrovascular bridge is formed in the osteotomy site. This provides a template to generate new bone as the segments are distracted apart during the activation phase. Once the desired distraction has occurred, the device is left in place for a period of time. Once consolidation (typically 2 to 6 months) has occurred, the distraction device can be removed and implants can be placed. Chiapasco compared GBR to DO and found that both are equally effective in alveolar bone augmentation for implant placement and further stated that the long-term prognosis of vertical bone gain in DO is more predictable.

Eligibility Criteria:
Inclusion Criteria:

* Acquired alveolar defects (Post extraction, Traumatic avulsion of teeth, Periodontal disease, After tumor resection), congenital alveolar defects, vertically deficient edentulous ridge in maxillary or mandibular anterior region with
* Allen Type A moderate vertical ridge deficiency (3-6mm)

Exclusion Criteria

* Medically compromised patients
* Subjects who underwent radiotherapy or chemotherapy
* Smokers and
* Radiographic presence of less than 5mm of anterior maxillary and mandibular bone height
Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair

Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.

Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.

Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.

Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.

Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.

Eligibility Criteria:
Inclusion Criteria:

* Two valve repair / replacements
* Age above 18
* Informed consent

Exclusion Criteria:

* pulmonary hypertension
* insulin-dependent diabetes mellitus
* severe atherosclerosis of femoral arteries
* severe respiratory failure
* pregnancy
Improving Person Centered Care for Abortion Clients in India

The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion.

This study evaluates whether providing pharmacists with additional information about medication abortion can improve abortion person-centered care for women accessing MA at these sites.

Eligibility Criteria:
Inclusion Criteria:

* Pharmacist providing medication abortion within Lucknow, Kanpur, Unnao
* Agreed to participate

Exclusion Criteria:

* Pharmacists not providing medication abortion within Lucknow, Kanpur, Unnao
* Did not agree to participate
Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia.

Dysgeusia, characterized by altered taste, is a common side effect of radiation used in oropharyngeal cancer treatment. Radiation affects taste buds, leading to issues like loss of appetite, malnutrition, dependence on feeding tubes, dysphagia, and impacts social and overall quality of life. Patients often report bitter, metallic or no taste with food after radiation. Miracle berries, known for interacting with sweet taste receptors, could potentially transform acidic tastes into sweet ones.

The aim is to explore mBerry's potential in alleviating dysgeusia, aiding patients in achieving better nutritional status and quality of life.This study includes the use of mBerry tablets, which contain protein within the miracle berry called miraculin, for the treatment of radiation-induced dysgeusia. mBerry is not approved by the Food and Drug Administration (FDA) for the treatment of radiation-induced dysgeusia. It is being used as part of this research study to find out if mBerry tablets improve taste outcomes among head and neck cancer patients after radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer
* Receiving primary or adjuvant radiation therapy

Exclusion Criteria:

* Received a total glossectomy or total laryngectomy.
* Patients with allergies to peanut, latex, peach, or soy will be excluded as they are at increased risk of allergy to mBerry.
* Diagnosis of diabetes as well as prediabetic patients and those that are taking Metformin.
Prevalence of Iodine Deficiency in Remote Communities of Haiti

Haiti is one of the few remaining countries that is at risk of iodine deficiency disorders. In the 2018 survey, iodized salt was found in \<20% of households and iodine excretion from non-pregnant and pregnant women suggested inadequate intakes, with those in remote inland settings most at risk.

The Haiti Salt Program (HSP) was established in 2006 at the University of Notre Dame, US (UND). Using a self-sustaining business model that protects the livelihoods of all who work within it, the HSP has a goal of supplying fortified salt to combat IDD and lymphatic filariasis. HSP purchases salt from local small producers for processing in a local factory equipped with robust, standardized and controlled facilities that iodizes the salt under correct conditions, ready for fair resale to the consumer. The salt is currently distributed in the West Department, though a country-wide roll-out is envisaged. This initiative has the potential to accelerate optimization of population iodine intake across Haiti and through IDD prevention, positively contributing to the development of the country.

Data on iodine status and intake of native iodine-rich foods, iodized salt and other iodine-fortified foods e.g., bouillon cubes in Haiti, are sparse, particularly from rural and remote locations. An update on the situation in such remote areas in Haiti is trequired, to inform and leverage the development and implementation of iodized salt policy in the region.

The specific objective of this study is to assess the iodine status of two representative population subgroups, namely school-age children and women of reproductive age, in a remote region of the Central Plateau of Haiti. We hypothesize that the mUIC will indicate population iodine insufficiency in both of these population groups.


Eligibility Criteria:
We will recruit school age children (male and female, aged 9-13 years) and women of reproductive age (aged 18-44 years).

The inclusion criteria for all subjects will be:

1. residence within the study area for ≥12 months;
2. general good health as assessed by no reported treatment for chronic disease;
3. no known history of goiter or other thyroid disease;
4. no exposure to iodine containing contrast agent or medication within the last year;
5. Women of reproductive age should not currently be pregnant or be breastfeeding, assessed by asking the women.
Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration.

As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years old
2. Able and willing to sign informed consent
3. For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
4. For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date
5. For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC

Exclusion Criteria:

1. Decompensated cirrhosis (Child-Pugh B or C)
2. Pregnant or breastfeeding women
3. For community linkage arm: Prior treatment with a direct acting antiviral regimen
4. For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir
5. Poor venous access not allowing screening laboratory collection
6. Have any condition that the investigator considers a contraindication to study participation
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease

The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone

To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone

Eligibility Criteria:
Inclusion Criteria:

* Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
* Active posterior uveitis and/or retinal vasculitis

Exclusion Criteria:

* Visual acuity inferior to 1/10 on Snellen chart
* Being under cytotoxic drugs or having received them in the past 2 months
* Not being able to follow the one year treatment and the regular follow ups
Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis

Endometriosis is a chronic inflammatory disease affecting approximately 10-15% of reproductive age women, and, in recent years, an association between this pathology and dysbiosis, either involving the gut or the genital microbiota, has been hypothesized.

Therefore, the aim of the study is to investigate the etiopathogenetic role of cervico-vaginal microbiota, and its relationship to the gut microbiota, in women with endometriosis. Furthermore, the effects of a multi-strain oral probiotic formulation will be evaluated on the composition of the genital microbiota in healthy women and patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 40 years old;
* clinical diagnosis of endometriosis via gynecological examination and transvaginal ultrasound (TVUS);
* genital healthy condition as confirmed via gynecological examination.

Exclusion Criteria:

* pre-menarche or menopause status;
* diabetes, neoplastic diseases, urinary or genital infections in the past 6 months
* bowel and/or liver disorders;
* current treatment with oral contraceptive or progestins, prokinetics, antacids or proton pump in-hibitors;
* sexual activity in the week before sampling;
* recent or current antibiotic treatment (oral or topical);
* the use of probiotics and/or prebiotics for three months before the enrolment.