cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Rationality of the International Guideline About Selective Coverage of Level Ib in CTV With NPC

The purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal CTV delineation in nasopharyngeal carcinoma(NPC).

Intensity-modulated radiation therapy (IMRT) has gradually replaced two-dimensional radiation therapy as it offers improved target conformity. Xerostomia is still the most common side effect of radiotherapy in patients with NPC treated with IMRT. Most stimulated saliva is secreted by the parotid glands (PGs), while the submandibular glands (SMGs) produce most of the unstimulated saliva and mucins, which may influence the degree of a dry mouth sensation.There are still differences in the understanding of nasopharyngeal cancer experts at home and abroad on the delineation of clinical target volumes., suitable criteria for elective irradiation of neck level Ib need to be re-evaluated.Therefore, we conducted a retrospective study to assess the feasibility of recommendation to level Ib in the International Guideline for Delineation of Clinical Target Volumes.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed NPC by biopsy (clearly recorded in the pathology report or medical history) ;
2. no evidence of distant metastasis at initial diagnosis and receiving radical IMRT in our center
3. the following conditions: ① level IB metastasis, ② involvement of the submandibular gland, ③ involvement of structures that drain to level Ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ④ involvement of level II LNs with extracapsular extension（because the judgment of extracapsular invasion is greatly influenced by subjective factors, this study only include patients who had high grade ENE(G2/G3 as demonstrated in our previous study: Oral Oncol. 2019 Dec;99:104438.)⑤ level II nodal involvement with maximum nodal axial diameter greater than 2 cm.
4. all patients who were treated at Lin Shaojun's attending group from June 2005 to December 2012.
5. presence of complete baseline magnetic resonance imaging data of the nasopharyngeal skull base and neck and treated in our center at initial diagnosis .

Exclusion Criteria:

1. disease progression during IMRT;
2. fail to obtain tumor efficacy evaluation information in the medical records of the research center;
3. previous malignancy or other concomitant malignant disease;
4. receiving blind treatment in clinical research.
Prospective Natural History Study of Patients With Myotubular Myopathy and Other CentroNuclear Myopathies

This is the 2 years extension of the prospective and longitudinal study of the natural history and functional status of patients with myotubular myopathy and other centronuclear (CNM) sponsored by Dynacure including ten additional pediatric patients with mutation in MTM1 or DNM2 genes). the patients are planned to be enrolled in one year leading to an expected total number of 70 patients followed at least over 1 year period. Data from the study will be used to characterize the disease course of CNM and determine which outcome measures will be the best to assess the efficacy of potential therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age (newborns included) may participate
* Patients over 18 years of age and parent(s)/legal guardian(s) of patients \< 18 years of age must be provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age when required by regulation.
* Myotubular Centronuclear myopathy (MTMCNM) resulting from a mutation in the MTM1, DNM2 or BIN1 gene
* Male or symptomatic female. A symptomatic female will be defined by the motor function assessment by Motor Function Measure (MFM) or North Star Ambulatory Assessment (NSAA) below 80% of the total score.
* Willing and able to comply with all protocol requirements and procedures.
* In France only: Affiliated to or a beneficiary of a social security category

Exclusion Criteria:

* Other disease which may significantly interfere with the assessment of the MTM CNM and is clearly not related to the disease
* Currently enrolled in a treatment study; or treatment with an experimental therapy other than pyridostigmine
* For women: pregnancy or current breastfeeding
In Vivo Study of Neuroinflammation in Tobaccosmoking: a Clinical PET Study of TSPO Using [18F]PBR111

Tobacco smoking is associated with multiple and well-recognized adverse health effects. However, the direct effects of smoking on the brain are less well understood. On of the mechanisms that could be associated with tobacco-related brain toxicity is neuroinflammation. PET/CT imaging constitutes an excellent means of assessment of neuroinflammation in vivo, with the quantification of TSPO using \[18F\]PBR111. Nonetheless, this radiopharmaceutical has not been authorized for human use in Switzerland.

Our study thus includes two parts. Part A involves a dosimetry study (i.e. measure the exposure of the body organs of healthy individuals to radioactivity after the administration of 200 MBq of \[18F\]PBR111. This is a prerequisite for the authorization of the use of this radiotracer in humans. Next, the main part of this study (part B) involves the comparison of the quantity of TSPO in the brain of otherwise healthy smokers and age- and sex-matched non-smokers.

Part A:

Primary objective: to establish the exposure of the organs/tissues to a standard radioactive dose (200 MBq) of \[18F\]PBR111.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 (3 male and 3 female participants)
* Fluent in French and able and willing to provide written informed consent.

Exclusion Criteria:

* Homozygosity for the rs6971 polymorphism on TSPO that results in low-affinity binding. This criterion is added because this polymorphism alters significantly the ability of the radiotracer \[18F\]PBR111 to bind to TSPO, hence precluding quantification.
* Absence of a stable contraceptive regimen (specifically, intrauterine contraceptive device or contraceptive treatment per os). Only women with stable contraception will be added to eliminate the risk of exposure of pregnant women and their foetus to radioactivity.
* Presence of any significant history or current diagnosis of chronic disease or syndrome (including neurological, psychiatric, cardiovascular, oncological, metabolic, rheumatological conditions).
* One or more episode(s) of acute infectious or allergic reaction in the last month before inclusion and during the study period. Again, we cannot exclude that such conditions might produce immune alterations in the brain, thus confounding the results of TSPO quantification with \[18F\]PBR111.
* Presence of clinically relevant laboratory abnormalities in the haematological and biochemical blood tests, as defined as laboratory values that require clinical workup and/or treatment (e.g. anaemia, hyperglycaemia, electrolyte imbalances)
* A body mass index \<20 or \>30 (this criterion is necessary because TSPO has been shown to be variable with respect to body mass index (113-115)).
* Exposure to research related radiation in the past five years that, when combined with this study, would place subjects above the allowable limits.
* Conditions precluding entry into the scanners (e.g. claustrophobia).
Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients

In the course of Coronavirus Disease-19 (COVID-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes.

Here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (HD) affected by COVID-19, evaluating the potential modulating effects of two different dialysis approaches

For this prospective randomized study, the investigators recruit maintenance hemodialysis patients with confirmed COVID-19 infection. After diagnosis, the patients are randomized to two different dialysis modalities, expanded HD (HDx), performed by use of a medium cut-off membrane, and standard treatment based on the use of a protein-leaking dialyzer (PLD).

The investigators collect clinical and laboratory data, including circulating pre and post-dialysis levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-g). Samples are collected at diagnosis (T0), and one and two weeks after the diagnosis (T7 and T14, respectively). Moreover, lymphocyte and immune cell profiles are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing maintenance hemodialysis
* Confirmed severe acute respiratory syndrome-coronavirus2 infection

Exclusion Criteria:

* Acute kidney injury
Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus

Virtual reality exercises have become increasingly popular in recent years. After the increase in usage areas in daily life, its use in healthcare has become widespread. Flatfoot is one of the orthopedic problems with high prevalence, especially in young individuals. In the literature, conservative treatment methods of flat soles are mentioned as exercise, shoe modifications, and orthotic methods. In the study, it is planned to investigate whether individuals with flat-footed virtual reality exercises contribute to conservative treatment.

The aim of this study was to investigate the effect of virtual reality exercises on individuals with pes planus.

To show whether virtual reality exercises will contribute to decrease of flat footing, improvement of balance and increase of performance of individuals with flat foot.

Eligibility Criteria:
Inclusion Criteria:

* Have pes planus,
* Volunteer for this study,
* Climb 10 stairs independently,
* Can stand one single leg

Exclusion Criteria:

* History of trauma, fracture or operation of the foot, knee, and hip that will affect the foot
* Having visual, hearing and mental problems that prevent participation in virtual reality exercises,
* Being diagnosed with orthopedic or neurological problems that prevent standing on a single leg
Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation

INTRODUCTION A variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. The idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. However, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. As these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius

OBJECTIVE The objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures.

STUDY DESIGN This is a prospective, randomized, controlled multicenter study. Patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/CT scans will be made.

STUDY POPULATION All patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction.

INTERVENTION Surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting.

USUAL CARE Open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest.

OUTCOME MEASURES Primary outcomes: complications and quality of life. Secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex over the age of 18 years
* Symptomatic malunion of the distal radius
* Eligible for open wedge osteotomy and plate fixation with or without bone grafting from iliac crest.
* Patients are able to undergo postoperative follow-up of at least 12 months.

Exclusion Criteria:

* Patients who are pregnant
* Patients who have known systemic or metabolic disorders leading to progressive bone deterioration
* Patients who take chronic use of glucocorticoids.
Restless Legs Syndrome in Stroke Patients

Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Hospitalization for stroke or transient ischemic attack

Exclusion Criteria:

* 18 years old or younger
* No stroke or transient ischemic attack
Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men

The goal of this study is to measure the safety, tolerability, and the hair growth response to topical DLQ01 solutions in comparison to the vehicle and a comparator solution in 120 males with Androgenetic Alopecia.


Eligibility Criteria:
Inclusion Criteria:

* Males with active AGA on the vertex area of the scalp consistent with Norwood-Hamilton Grades of IIIv through V, excluding IIIa, IVa, and Va grades.
* Willing to maintain the same hair style, approximate length, and hair colour throughout the duration of the study as documented in the global photograph at Day -2 of baseline.
* Willing to have target areas shaved and to have temporary dot tattoos placed on their scalp.
* Willing to comply with the study instructions and return to the site for required visits.
* Must be willing and able to communicate and participate in the entire study and willing to use an electronic diary to record investigational product dosing.
* Must provide written informed consent.

Exclusion Criteria:

* Participants with other type of alopecia other than AGA or any other concomitant skin or systemic disorder involving the scalp area.
* Participants with sensitive, irritated, or abraded scalp area.
* Participants who have undergone hair transplants or have had scalp reductions.
* Concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol
* Current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions.
* History of relevant sensitivity to any of the study products, or components thereof, or a history of drug or other allergy that contraindicates study participation.
* Known allergy or sensitivity to tattoo ink.
* Participant with relevant active or prior history of malignancies.
* Participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease.
* History of any relevant alcoholism, substance or drug abuse-related disorders in the past year or a positive toxicology screening panel, or alcohol breath test at Screening.
* Clinically significant abnormal biochemistry, haematology or urinalysis values.
* Any other relevant serious illness or medical, physical, or psychiatric condition(s) that, could interfere with full participation in the study, pose a significant risk to the participant; or interfere with interpretation of study data.
Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis

To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed,
2. Age \> 18 years,
3. Chronic infection with Hepatitis C virus genotype 1b,
4. HCV RNA \> 100 IU/mL,
5. HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
6. Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) \> 12.5 KPa; or FibroTest or FibroSure \> 0.75 with APRI \>2),
7. Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg (only in selected sites),
8. Albumin level ≥ 3.0 g/dl,
9. Platelet count ≥ 75 x 103/μL.

Exclusion Criteria:

1. Child-Pugh score greater than CP-A6,
2. Patients with HCV genotype 1a, 2, 3, 4, 5, 6,
3. Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance,
4. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive),
5. Decompensated cirrhosis/previous decompensation,
6. Pregnancy,
7. Breast-feeding,
8. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components,
9. Albumin level \< 3.0 g/dl,
10. Platelet count \< 75 x 103/μl,
11. Concomitant participation in any clinical trial.
Conscious Sedation for Outpatient Colonoscopy

Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.

Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II physical status
* 18-65 years
* Scheduled for elective colonoscopy

Exclusion Criteria:

* History of allergy to any of the study drugs
* Alcohol or drug abuse.
* Second and third-degree heart block.
* Morbid obesity.
* Pregnant and lactating women.
* Psychiatric disorders.
* Severe cardiac, respiratory, renal, and liver diseases
Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy

Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.


Eligibility Criteria:
Inclusion Criteria:

* All malignant melanoma patients who are candidates for ILND and 18 years of age or older

Exclusion Criteria:

* Patients suspected of having tumor residuals after ILND, previous groin irradiation or patients suffering from dementia or any psychiatric disorder making them incapable of informed consent or adherence to follow up, along with patients who are unable to communicate in Danish or English will not be included in the study.
Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment

This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD

PRIMARY OBJECTIVES:

I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD.

II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment.

OUTLINE:

Patients receive sirolimus orally (PO) once daily (QD). Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of

  * Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or
  * Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or
  * Absence of improvement after 3 months of primary treatment, or
  * Continued need for treatment with prednisone at doses \>= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen
* Patient or guardian able and willing to provide informed consent
* Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration \[FDA\] requirement)
* Stated willingness of the patient to comply with study procedures and reporting requirements
* Stated willingness of the physician most involved in management of chronic GVHD (the "managing physician,") to comply with study procedures and reporting requirements

Exclusion Criteria:

* Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy
* Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy
* Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions
* Inability to tolerate oral medications
* Absolute neutrophil count (ANC) \< 1500/uL
* Platelet count \< 50,000/uL
* Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled
* Pregnancy
* Known history of hypersensitivity to sirolimus