cyrilzakka/clinical-trials huggingface dataset:
The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption

Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Willing to consume the supplements provided throughout the duration of the study

Exclusion Criteria:

* History of diabetes, prediabetes or impaired glucose tolerance.
* Existing, UNTREATED, thyroid condition.
* Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
* Acute disease at the time of enrollment.
* Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
* History of active UNTREATED gastrointestinal disorders or diseases including:

  i. Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation
* Suspected state of immunosuppression or immunodeficiency including HIV.
* History of bariatric surgery.
* Pregnant or lactating women.
Sterile Inflammation and Molecular Aberrations in MDS

The objective of this study is the description of the possible association between genetic mutation/aberration profiles, inflammatory tonus and clinical phenotype based on PROMs and HRQoL. Apart from gaining a better understanding of the causal correlation between genetics, sterile inflammatory processes and QoL (e.g. fatigue) in MDS, this study is supposed to identify potential novel biomarkers and, ultimately, therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients \> 18 years
* MDS, MDS/MPN diagnosis based on current WHO classification. CCUS and CHIP defined by Valent (Valent, Oncotarget, 2018) and by Stauder (Stauder, Blood, 2018)
* Signed and dated declaration of consent by the patient according to ICH-GCP Guidelines

Exclusion Criteria:

* Any other illness, whether physical or mental, or any laboratory abnormalities which prevent a declaration of consent by the patient
* Patients with an acute and/or uncontrolled infection, including patients that are afebrile under treatment with antibiotic/antifungal/antiviral prophylactic medication
* Any pre-existing autoimmune disease requiring a systemic immunosuppression
* Steroid therapy (\>10mg Prednison/day or equivalent), regardless of its necessity up to 4 weeks before inclusion in the study
* Anamnestic and/or current therapy with hypomethylating agents (HMA) or immunomodulatory imide drugs (IMiDs)
* Status post allogenic stem cell transplantation
* Previous or ongoing chemotherapy
* Pregnancy or breastfeeding period
Protective Brace to Prevent Hand and Arm Injuries

When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

Workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of occupational MSDs. The National Institute for Occupational Safety and Health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. Most currently available braces do not adequately address these NIOSH requirements. This study will evaluate the efficacy of a brace with piezoelectric damping material.

Participants in the study will be fitted with a brace on each hand. One brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. Participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. The tests will take approximately 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Normal hand anatomy and full range of motion

Exclusion Criteria:

* History of significant hand or wrist arthritis
* Open wounds
* Prior hand or wrist surgery
* Neuropathies
* Skin hypersensitivity
* Contact dermatitis
* Reflex sympathetic dystrophy
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A

The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.

Previously treated pediatric participants will be treated with a prophylactic regimen of rFVIIIFc. PK analysis of pre-study factor VIII (FVIII) and rFVIIIFc will be performed in a sub-group of the study participants prior to commencement of prophylactic treatment. After these PK results are available, remaining participants have the option of proceeding directly to prophylactic treatment. After completing the end of study assessments, eligible participants would be able to continue treatment in Study 8HA01EXT.

Eligibility Criteria:
Key Inclusion Criteria:

* Severe hemophilia A defined as \<1 IU/dL (\<1%) endogenous FVIII
* Male \<12 years of age and weight ≥13 kg
* History of at least 50 documented prior exposure days to FVIII
* No current, or history of, inhibitor development to FVIII

Key Exclusion Criteria:

* Other coagulation disorders in addition to Hemophilia A
* History of anaphylaxis associated with any FVIII or IV immunoglobulin administration

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Urinary Creatinin/Protein Ratio in Preterms

From the first days of life, the newborn presents a "physiological" proteinuria explained by the coexistence of a glomerular and tubular immaturity, all the more marked as the gestational age (GA) is weak. In the child term, proteinuria decreases the first month and its persistence is the marker of kidney damage. The persistence of proteinuria in preterm infants is also considered a marker of renal impairment; however, neither the "physiological" values nor the pattern of urinary excretion of proteins in the first month of life are known.

The proteinuria / creatininuria ratio is a validated indicator of proteinuria, as it is correlated with 24-hour urine proteinuria.


Eligibility Criteria:
Inclusion Criteria:

* Premature gestational age at birth superior or equal to 32 week of amenorrhea hospitalized in the intensive care unit or neonatal intensive care unit of the University Hospital of Reunion, southern site, Saint Pierre, in the first 24 hours of life
* Informed consent form Legal representant

Exclusion Criteria:

* Renal malformation known in antenatal
Exercise and PTSD in Older Veterans

The purpose of this study is to examine whether posttraumatic stress disorder (PTSD) symptoms impact adherence to a 12-week physical activity program and whether exercise can help improve PTSD symptoms and health outcomes in older Veterans. Veterans over the age of 60 with PTSD were be recruited to participate in a 12-week physical activity program consisting of aerobic and strengthening activities. 54 participants were randomized to an intervention arm (n=36) or usual care wait-list control (n=18).

There is substantial evidence that physical inactivity contributes to poorer physical health outcomes in older adults. There is a paucity of work examining physical activity in Veterans with PTSD. Consequently, the efficacy of exercise as a beneficial adjunctive therapy in the treatment for PTSD symptoms and related health sequelae has not been established. Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Summary: This pilot trial will extend the investigators' understanding of the physical and psychological benefits of physical activity in Veterans with PTSD. The results from this study will be used to be used to develop a larger, randomized controlled exercise trial for Veterans with PTSD. Once new, effective exercise therapies for Veterans with PTSD are established, we can augment traditional PTSD therapy with exercise therapy to promote the prevention and treatment of chronic diseases common in this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for current PTSD,
* live within 50 miles of Durham VA Medical Center (VAMC) and have reliable transportation,
* registered for care at the Durham VAMC,
* independently mobile (assistive devices acceptable),
* speak and write fluent conversational English

Exclusion Criteria:

* Active substance dependence other than nicotine,
* cognitive impairment, uncontrolled psychotic symptoms,
* clinical history of cardiovascular disease (CVD) occurring within the past 3 months,
* uncontrolled hypertension,
* renal disease or currently receiving dialysis,
* psychotropic medication initiated within 6 weeks prior to enrollment
* proliferative retinopathy
The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy

This study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* currently pregnant and primiparous
* able to provide informed consent
* able to have internet access
* have a confirmed diagnosis of epilepsy based on EEG or clinical evidence

Exclusion Criteria:

* need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician
* prior involvement in the Lullaby Project
Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.

Objective of the study:

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma

Study design:

Pilot study to determine safety and feasibility

Study population:

Patients with locally advanced pancreatic carcinoma, without distant metastasis

Intervention:

Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis.

Primary study outcome:

The main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation.

Secondary study outcome:

Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
* Not eligible for operation with curative intent
* \>18 years
* Written informed consent

Exclusion Criteria:

* WHO performance status 3-4
* Expected life span \<3 months
* Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
* Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU
Etiology and Treatment of Neonatal Seizure

Genetic diagnosis for neonates suffering from epilepsy has important implications for treatment, prognosis, and development of precision medicine strategies. Investigator performed exome sequencing (ES) or targeted sequencing on neonates with seizure onset within the first month of life. Investigator subgrouped our patients based on the onset age of seizure into neonatal and before 1 year (1-12 months), to compare the clinical and genetic features and treatment strategies.

Seizure is one of the most common neurological conditions in neonates, and has substantial impact on patients'quality of life and social integration. Epileptic encephalopathy is characterized by refractory seizures, cognitive dysfunction, and poor prognosis. Despite the recent progress in technology, molecular diagnosis of neonates suffering from possible epileptic seizures can be challenging, due to genetic and phenotypic heterogeneities. A large number of specific pathogenic variations have been related to various forms of epilepsies. Next-generation sequencing (NGS) has significantly improved the molecular diagnosis for rare diseases. NGS focusing on genes known to be associated with human diseases is a practical approach as a first-tier assessment for patients with heterogeneous genetic background. In addition, currently medical therapy for seizure is not based on the etiology, but the clinical manifestations, and the main purpose is not to rescue the underlying diseases process, but just to reduce the likelihood of seizures occurrence. In this study, Investigator performed NGS on neonates with seizure onset before 1 year of age, to detect and quantify genetic variants, and assess existing therapeutic effects. Our findings will have important implications for the development of precision medicine strategies.

Eligibility Criteria:
Inclusion Criteria:

* severe seizures in neonates or generalized epilepsy or intractable epilepsy in infancy with generalized tonic-clonic seizures,
* seizures onset before 1 year of age,
* epileptic syndromes/epileptic-encephalopathies with unknown etiology.

Exclusion Criteria:

* Patients were excluded if they had traumas, central nervous system infections, hypoxic-ischemic encephalopathy, vascular events, systemic infections, and diagnosed metabolic disorders, and pathogenic copy-number variants were identified using array-based comparative genomic hybridization (CGH).
Curve Correction of Early Onset Scoliosis by Mehta Serial Casts

Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis

Early Onset Scoliosis refers to various types of Scoliosis with onset before 10 years of age .In addition to spinal Deformity Progressive Scoliosis will also affect the development of thoracic cage and lungs . So Early correction is important .

Curve correction can done by operative and nonoperative techniques . Our Study include the curve correction by Mehta Serial Casts which not need for blood transfusion and has a good role in stop progression and delay the need for surgery .

Eligibility Criteria:
Inclusion Criteria:

* All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .

Exclusion Criteria:

* Cases with previous spine surgery and those whose guardians refuse to participate in the study .
Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients

This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients.

Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. Two groups will be formed, the easy airway group and the difficult airway group. The main aim is to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion. Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim. At the end of the study, determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.

Eligibility Criteria:
Inclusion Criteria: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study.

-

Exclusion Criteria:

* Patients under 18 year-old
* Patients who do not require nasogastric tube insertion
* Patients with anatomical changes in the head and neck region
* Patients without an informed consent form
ECMO Braile Biomédica® in COVID-19 Patients

Retrospective data collection to evaluate the gas transfer capacity of the Braile Biomédica® OxyPrime® ECMO BRCoating® Membrane Oxygenator in COVID-19 patients during the pandemic.

Multicenter, retrospective, non-comparative, non-randomized study to assess the clinical performance of the OxyPrime® ECMO BRCoating® Membrane Oxygenator in adult patients with COVID-19

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator, from March 2020 to July 2022, following the Instructions for Use (IFU) of the products.

Exclusion Criteria:

* Patients without a diagnosis of COVID-19
Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient.

The therapeutic support and monitoring are standard.

Eligibility Criteria:
Inclusion Criteria:

1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient

Exclusion Criteria:

1. - Metastatic disease
2. - Patient having another severe disease or uncontrolled which could jeopardize the trial participation
3. - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons
A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening
* Body mass index (BMI) within the range 18 to 30 kilogram/meter\^2 (kg/m\^2) (inclusive)
* A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile
* A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention
* A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention

Exclusion Criteria:

* History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate \[eGFR\] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin)
* Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection