cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression

Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can cause significant deterioration in function and quality of life (QoL). The goal of treatment is to improve functional status and symptoms, but the optimal treatment regimen for these patients has not been thoroughly established. Many patients with SCC present with uncontrolled systemic disease and poor performance status, and are not eligible for standard surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone, however recent trials suggest that less than 70% of patients are ambulatory, that the re-establishment of ambulation in non-ambulatory patients is poor, and the duration of improvement is guarded with radiotherapy alone.

Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to treat spinal metastasis has demonstrated superior results in pain control, tumour response and durability. SBRT requires time for careful planning, and many patients with neurologic symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is still unclear in this patient population, although it seems to be a potential alternative to surgical decompression in patient not suitable for surgery. The investigators propose a feasibility study to investigate the potential benefits of dose escalation with a sequential SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior outcomes with SBRT. The investigators also aim to characterize the effect on motor function and ambulation, pain and QoL. This study could stimulate further multi-center randomized trials in this area, improve motor function and patient-reported QoL, and contribute to improving oncology care in Canada in a meaningful way.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of metastatic malignancy (radiologic or pathologic)
2. Evidence of disease in vertebral body with epidural component such that Bilsky radiologic score is 1c-2 on MRI (abuts spinal cord without cord compression (1c), or spinal cord compression but with visible CSF (2)
3. Motor function (MF) of 3 or greater

Exclusion Criteria:

1. Surgical candidate
2. Instability of vertebral bodies with or without bony retropulsion requiring surgical intervention or hardware placement
3. Previous radiotherapy course to same region of spine with overlapping fields (prior to phase I course) at discretion of treating radiation oncologist
4. No CT or MRI within previous 3 months
5. Life expectancy estimated \<3 months
6. Performance status KPS\<40
7. On active chemotherapy or targeted therapy or immunotherapy (must be stopped for at least one week prior to and following)
8. Pregnant or lactating
9. Contraindications to radiotherapy (eg. active autoimmune disease requiring medication)
10. Inability to lie flat comfortably for at least 20 minutes
11. Age \< 18
The China Laparoscopic Right Hemicolectomy SNAPSHOT

The main objective is to explore the current practice of right hemicolectomy for colon cancer located in the ascending colon and hepatic flexure in selected Chinese high quality and high volume centres. This study will identify a potential area to improve the level of standard care and serve as a reference cohort to which planned standardization and addition of innovative aspects can be compared to


Eligibility Criteria:
Inclusion Criteria:

* Segmental right sided hemicolectomy (including extended)
* Cancer stage 1-3 (CT-staged)
* No prior abdominal surgery

Exclusion Criteria:

* Stage cT4b, perforated disease
* Acute obstruction
* Emergency surgery
* Right hemicolectomy or ileocaecal resection as part of a large procedure such as subtotal colectomy or panproctocolectomy
* Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

1. age between 20 to 65 years
2. Receiving caesarean delivery
3. Receiving spinal and/or epidural anesthesia

Exclusion Criteria:

1. Clinical diagnosis of pre-existing gastrointestinal disorders
2. .Clinical diagnosis of an intraoperative blood loss exceeding 1000 ml during cesarean delivery
3. Clinical diagnosis of existing chronic medical disorders
4. .History of major abdominal surgery
5. Clinical diagnosis of any acute complications resulting from cesarean delivery
Feel Breathe, Restriction Device Ventilatory Nasal

It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with the aim of increase nasal airflow resistance, therefore the objective was to examine the effects of FeelBreathe with lung ventilation and gas exchange during exercise.

Background: Different devices are currently used to train inspiratory muscles, thus showing an increase in the physical performance. It is a control trial to investigate the effects of a new restriction and filtering device ventilatory nasal flow (FeelBreathe).

Methods: A total of 27 trained male caucasian subjects (age: 32.5 ± 7.23 years) were recruited from different sports clubs. Measurement of maximum static inspiratory pressure were taken before exercise testing and an incremental test in cycle ergometer to volitional fatigue for the determination of gas exchange data. Each subject performed three identical submaximal exercises at 50% of ventilatory thresholds under different breathing conditions: 1) oronasal breathing 2) nasal breathing and 3) nasal breathing with Feel Breathe, Restriction and Filtering Device Ventilatory Nasal Flow.

Discussion: Researchers try to find if the new device called FeelBreathe causes changes in the lung ventilation and gas exchange during exercise. If the results show altered breathing pattern and cardiometabolic variables, FeelBreathe could be used to training respiratory muscles.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25-35 years.
* trained male caucasian cyclists
* Non-smokers
* Each subject completed an approved informed consent form and detailed health questionnaire before testing.

Exclusion Criteria:

* Smokers.
* Presence of diseases during the test period. In particular, they had no current symptoms of nasal disease, snoring, asthma or allergic rhinitis.
* Unwillingness to complete the study requirements.
The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes

It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time


Eligibility Criteria:
Inclusion Criteria:

* Being a physically disabled athlete
* Preparation for the Paralympic Games
* Volunteering to participate in the study

Exclusion Criteria:

* Serious psychiatric illness
* Regular use of sedatives or neuropsychiatric drugs
* presence of active alcohol or drug addiction
* Presence of a systemic or neurological problem that develops independent of disability pathology.
FSHD Molecular Characterization

To characterize the clinical and molecular phenotype of FSHD.

The purpose of this study is to validate alterations in therapeutically relevant biomarkers in muscle tissue from FSHD patients. These biomarkers are responsive to the upregulation of the DUX4 gene and protein, which is the fundamental molecular defect in FSHD. In anticipation of a future clinical trial, the Investigators intend to assess the correlation between the expression of these relevant biomarkers and clinical functional measures. The Investigators will also explore the utility of muscle MRI in identifying regions of muscle suitable for sampling for relevant biomarkers, as MRI-related signal changes have been proposed as an anatomic marker of early FSHD pathology.

Eligibility Criteria:
Inclusion Criteria:

* 13 years or older
* Genetically proven FSHD1 or FSHD2 as determined by the investigators

Exclusion Criteria:

* Inability to complete an MRI scan (Adults only).
* Other medical or cognitive issues that, in the opinion of the examiner, preclude accurate functional assessment.
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

This research is being done to understand more about a sexually transmitted virus called Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.

This study evaluates oral HPV infection and risk factors in people with head and neck cancer and their partners or spouses. The study focuses on oropharyngeal cancer patients and includes patients with HPV-associated and HPV-unassociated disease. A comparison group of people without cancer (controls) are also being enrolled. Couples are followed longitudinally and there is a repository of study samples. It is hoped that this research will help us understand risk factors for oral HPV infection, persistence and transmission as well as researching biomarkers for HPV-associated oral cancer and survival.

The study is led by Dr Amber D'Souza (Johns Hopkins) and laboratory testing for the study is performed in the laboratory of study co-investigator Dr Maura Gillison (Ohio University). The study biorepository is led by Dr karen Anderson (Arizona State). Participants are being enrolled at four sites across the United States including: Mt Sinai (site PI Dr Marshall Posner), Johns Hopkins (site PI Dr Sara Pai), Dana Farber Cancer Institute (site PI Dr Robert Haddad) and Oregon Health and Science University (site PI Dr Neil Gross).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and incident oropharyngeal cancer

Exclusion Criteria:

* Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent
* Cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)
Pituitary Function and Spontaneous Intracranial Hypotension

Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Age 18 years and older
* Diagnosis of SIH:
* LP
* Brain MRI (SEEPS)

Exclusion Criteria:

* Pregnant and post-partum females
* Nursing mothers
* Patients with potential hyperprolactinemia due to:
* Hypothyroidism,
* Chronic renal disorder
* Liver disease (including cirrhosis)
* Primary or secondary amenorrhea
* Polycystic Ovary Syndrome
* Seizure disorder
* Illicit drug use
Dose-Exposure-Response in Type 1 Diabetes Mellitus

To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

-
Impact of Amino Acids to Enhance Anabolism After Home-based Exercise

An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB.

However, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA).

Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35 years
* Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week

Exclusion Criteria:

* Body Mass Index: \>29.9kg/m\^2
* Inability to perform physical activity as determined by the Physical Activity Readiness Questionnaire
* Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
* Regular tobacco use
* Illicit drug use (e.g., growth hormone, testosterone)
* Diagnosed medical condition under the care of a physician
* Inability to abstain from supplements (e.g., protein, creatine, HMB, BCAA, phosphatidic acid) at least three weeks before and during trials
* Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+rilpivirine

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

Randomized patients will receive Long Acting (LA) cabotegravir (CAB) + rilpivirine (RPV) administration in the hospital (standard of care) or out-of-hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.

Eligibility Criteria:
Inclusion Criteria:

1. Patients equal or older than 18 years old
2. Chronic HIV infection
3. HIV patients in whom LA CAB+RPV is prescribed
4. Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA.
5. Virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma HIV-1 RNA levels \< 50 copies/ml ) for ≥ 6 months preceding the study randomization.
6. Post-menopausal or fertile females that agree to avoid pregnancy during the study. If sexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first IMP administration until at least 13 months after the last Investigational Medicinal Product (IMP) administration;all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
7. Patients which have access to an out of hospital center in which can be treated without inconvenience
8. Patient who agrees to participate in the study and signs the informed consent.

Exclusion Criteria:

1. Hepatitis B infection (section 6.2).
2. History of virological failure or mutations to INSTI or NNRTI.
3. Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
4. Contraindication for intramuscular injections
5. Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.
6. Current use of any concomitant treatment as indicated in section 5.6.
Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers

This study aims to evaluate the performance of vibrational spectroscopy (Infrared and Raman spectroscopy techniques) in bladder cancer diagnosis using urine samples.

Urologic cancers affect the organs and structures of the male and female urinary tract and the male reproductive system. Bladder cancer (BCa) is the second urological cancer in incidence after prostate cancer and represents the 10th most common cancer in the world. This cancer has high recurrence and progression rates. Cystoscopy and urine cytology are the current gold-standard examination for bladder cancer. Nevertheless, the first is invasive and the latter has low sensitivity especially for low-grade bladder cancer. Therefore, it is critical to implement accurate, non- invasive and sensitive examination tool to diagnose patients with bladder cancer at an early stage.

On the one hand, urine is collected non-invasively and considered as a proximal biofluid from bladder. On the other hand, vibrational spectroscopy including Infrared and Raman spectroscopy is widely used for the analysis of biological samples and provides a molecular fingerprint of the sample with minimum or no sample preparation. Applied on urine, this technique may offer interesting alternative for bladder cancer diagnosis and monitoring. Hence, this research project aims to evaluate the analytical capabilities of urinary vibrational spectroscopy with the objective of developing a diagnostic test for urothelial bladder cancer.

The study is planned for 36 months. Patients that approve their participation in the study will respond to a questionnaire allowing us to have clinical information. From these patients, urine samples will be collected in Urology department of Reims University Hospital. Urine samples will be directly analyzed by Fourier Transform Infrared Spectroscopy and/or Surface-enhanced Raman spectroscopy then stored at -80°C for further analysis.

Eligibility Criteria:
inclusion criteria:

* Must be over 18 years of age
* Able to give consent and understand the purpose the study
* Agree to participate in the study and having signed the non-objection document
* Admitted to a urology consultation for cystoscopy

exclusion criteria: Patients with any of the following criteria will not be included in the study

* Refused to participate in the study or unable to give consent
* without a native bladder
* with a bladder fistula
Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.

Dentifrices have been recognized as one of the contributors in the increased prevalence of dental fluorosis, due to the fact that children in early childhood usually eat lots of them during brushing. As an alternative to the reduction of fluorosis have been suggested to reduce the concentration of fluoride toothpaste, however, its efficacy is not well established, increasing when the pH of the toothpaste is acidic, with a greater diffusion of F in the enamel. Therefore, this study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area. A randomized double-blind study will be conducted with approximately 360 children aged 2 to 4 years old at public daycare centers located in a fluoridated area. Children will be examined by two examiners and classified according to caries activity. For 12 months, children will use 3 times a day, one of the toothpaste to be tested, with different concentrations of fluoride and pH. At the end of this period, children will be examined by the same examiners to check the progression of lesions. Clinical examinations should be performed by 2 calibrated examiners (kappa 0.8) at baseline and after 12 months. The diagnostic criteria of caries activity (active, inactive) and integrity of the surface of the lesion will be used. There will be a quantitative assessment of carious lesions fluorescence with a portable QLF equipment. In half of the sample, nails and plaque will be collected 6 months after initiation of the dentifrices use. Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). The presence of nails F will be analyzed as described above. For statistical analysis will be used ANOVA and test for individual comparisons.

Eligibility Criteria:
Inclusion Criteria:

* \>= 2 years and \<= 4 years
* Not having participated in any other clinical study within 3 months prior to selection;
* Not having very large carious lesions or dentin sensitivity during the study (if this occurs, the child will be referred for treatment);
* Signature of informed consent by the parents

Exclusion Criteria:

* Using orthodontic appliances