cyrilzakka/clinical-trials huggingface dataset:
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA

Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA

It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nasopharyngeal Carcinoma

Exclusion Criteria:

* Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participation in Allergan study 225678-004

Exclusion Criteria:

* Anticipates the need for surgery or hospitalization during the study
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants

This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* In good health (except for specific inclusion criteria related to hepatic impairment), as determined by the Investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs
* Females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge
* Males will either be sterile or agree to use male condom with spermicide from check-in (Day -1) until 90 days following the dose of study drug

Additional Inclusion Criteria for Healthy Subjects Only:

- Liver enzyme tests must be less than or equal to the upper limits of normal

Additional Exclusion Criteria for Hepatic Impaired Subjects Only:

- Hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening

Exclusion Criteria:

* History of ulcerative colitis or stomach or intestinal surgery or resection
* History of unstable diabetes mellitus
* History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1)
* Use of oral, implantable, transdermal, or injectable contraceptives from the time of signing the informed consent (females only) or 10 days prior to Check-in through 45 days after the dose administration
* Poor peripheral venous access
* Receipt of blood products within 2 months prior to check-in

Additional Exclusion Criteria for Healthy Subjects Only:

* Use of any tobacco- or nicotine-containing products within 6 months prior to check-in and during the entire study
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

Additional Exclusion Criteria for Hepatic Impaired Subjects Only:

* Any evidence of progressive liver disease that has worsened or is worsening within 1 month prior to the screening visit
* Participant has shown evidence of hepatorenal syndrome
* Ascites requiring paracentesis
* Participant has required treatment for GI bleeding within 12 months prior to Check-in
* Participant has required additional medication for hepatic encephalopathy within the 12 months (6 months for severe hepatic impairment) prior to check-in
* Total bilirubin levels \>6 mg/dL
Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients

This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.

This is a multi-center, prospective, non-inferior, randomized controlled clinical study. The sick individuals and their families participating in the trial voluntarily participate and sign the "informed consent" under the premise of fully understanding the treatment plan; The treatment plan was approved by the hospital ethics committee.

A total of 152 patients from six centers nationwide will be enrolled starting from the date when the center's ethics are officially approved. The qualified recipients of donor kidney transplantation were randomly assigned 1:1 to the control group and the experimental group. The control group was treated with glucocorticoid + MPA+ tacrolimus for 12 months, and the experimental group was treated with glucocorticoid +MZR+ tacrolimus for 12 months. All subjects were followed up on the day of renal transplantation, at 1, 2 weeks and 1, 2, 3, 6, 9 and 12 months after the operation: history collection, incidence of acute rejection, survival rate of recipients, survival rate of transplanted kidney, liver and kidney function, blood routine and urine routine; Cytomegalovirus (CMV)-DNA and BK virus (BKV)-DNA copy levels were detected in blood at 1, 3, 6, 9, and 12 months after renal transplantation to assess CMV and BKV infection. Adverse reactions were recorded during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 1) After donor kidney transplantation;
* 2) Adult recipients aged 18-75 years, regardless of gender;
* 3) First-time kidney transplant recipients;
* 4) Voluntarily sign written informed consent.

Exclusion Criteria:

* 1) Multiple organ transplantation;
* 2) DSA positive patients had ABO incompatibility and PRA\>30%;
* 3) Recipients with active signs of infection;
* 4) Recipients with leukocyte counts below 3,000/mm3;
* 5) Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
* 6) Patients with severe gastrointestinal diseases and active peptic ulcer disease;
* 7) suffering from any mental illness;
* 8) Patients with severe heart disease and abnormal heart function;
* 9) Subjects who are known to be allergic to the test drug;
* 10) Recipients judged unsuitable for inclusion by other competent physicians.
Dusquetide for the Treatment of Behcet's Disease

This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a clinical diagnosis of Behcet's Disease meeting the International Study Group criteria.
* Participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization.
* Participants willing to follow the clinical protocol and voluntarily give their written informed consent.
* Female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period.

Exclusion Criteria:

* Pregnancy or mothers who are breast-feeding.
* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to agree to the use of effective contraception during the trial.
* Evidence of significant renal, hepatic, hematologic or immunologic disease.
* Use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
* Having received concomitant immune modulating therapy (except colchicine or azathioprine) within:

  1. Ten days prior to enrollment for mycophenolate mofetil
  2. Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
  3. Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
  4. At least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. Four weeks prior to enrollment for etanercept; ii. Eight weeks prior to enrollment for infliximab; iii. Ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. Six months prior to enrollment for secukinumab.
* Having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment.
* Having received apremilast (Otezla) within 4 weeks prior to enrollment.
* Presence of non- Behcet's Disease related genital ulcers, including both infectious and non-infectious etiologies.
* Active organ involvement requiring immunosuppressive treatment.
External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
* Breast conserving surgery
* Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage
* Postoperative negative (no ink) final surgical margins
* Patient requires a whole breast radiotherapy plus a tumor bed boost
* Female patients aged ≥ 18 years of any menopausal status
* ECOG performance status 0-2

Exclusion Criteria:

* Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
* Mastectomy
* Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
* Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
* Pregnant or lactating patients
* Presence of ipsilateral breast implant
* Prior breast or thoracic radiotherapy for any condition
Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.

The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.

The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Patients who have been infected with the COVID-19 virus at least three months ago and have been diagnosed with a positive PCR
* Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
* Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
* Patients who are clinically stable

Exclusion Criteria:

* Patients with orthopedic/neurological problems that prevent walking and exercise
* Patients with uncontrolled cardiovascular disease
* Patients with uncontrolled medical conditions
Stylistic Memory Enhancement

Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.


Eligibility Criteria:
Inclusion Criteria:

Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.

Exclusion Criteria:

* History of alcohol or drug abuse/dependence,
* Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
* Corticosteroid use within the last month prior to the participation.
* Less than 1 month post most recent exacerbation.
Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks.

To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries.

Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinity™ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Man over 40 years old
* Indication of surgical management for BPH
* Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
* IPSS score ≥15
* Qmax ≤12 ml/s
* Affiliated to the French national social security system
* Patient suitable for IV sedation or general anesthesia and focal microwave ablation
* Wish and able to comply with planned visits
* Able to express his consent
* Signed informed consent form

Exclusion Criteria:

* Unwillingness to accept the treatment
* Neurological pathology responsible for micturition disorders
* History of prostatic surgery
* History of prostatic arterial embolization
* Prostate protrusion Index of grade 2 (\>5 mm) or more as evaluated by ultrasonography.
* Stenosis of the urethra
* History of prostate cancer
* History of radiotherapy or pelvic surgery
* Life expectancy \<2 years
* Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
* Participation in another clinical study involving an investigational product within 1 month before study entry.
Cognition After OSA Treatment Among Native American People (CATNAP)

This research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias in American Indians. The project will work with American Indian Elders, aged 50 years and older, from three Northern Plains Reservations and surrounding communities. A total of 300 American Indian elders with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP MI component (intervention condition).

The investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "Cognition After Obstructive Sleep Apnea (OSA) Among Native American People" (CATNAP) to: 1) provide participants with Motivational Interviewing sessions to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias (ADRD) in American Indians and 2) provide participants with electronic messaging to support PAP adherence among American Indian elders, aged 50 years and older.

This study will explore the relationship between OSA and cognitive function and evaluate OSA as a mechanism for the strong association between sleep disorders and Alzheimer's disease and related dementias (ADRD). CATNAP will be implemented as a randomized controlled trial at 4 community sites serving American Indians in the Northern Plains. A total of 300 American Indian elders, aged 50 years and older, with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP component (intervention condition).

The primary outcome is PAP adherence and secondary outcome cognitive function. The study will partner with Missouri Breaks Industries Research Inc., and Missouri Breaks Durable Medical Equipment to monitor participants PAP use, which is uploaded automatically to the cloud. Outcomes will be measured at baseline, 3-months, and 9-months.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years and older
* Self report American Indian or Alaskan Native
* diagnosed with obstructive sleep apnea
* prescribed PAP therapy and have a device
* \*Ability to understand written and spoken English; and
* \*Ability and willingness to follow all study protocols.

Exclusion Criteria:

* Living in a household with someone who is enrolled in the study
* Already using PAP device at Medicaid recommended standards
* Cognitive decline, unable to consent on their own
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.


Eligibility Criteria:
Inclusion Criteria:

* FOR TRIAL PART 1, THE FOLLOWING APPLIES:
* Gender: male
* Age: 18-55 years
* BMI (body mass index): 18-28 kg/m2
* Study participants considered to be healthy
* FOR TRIAL PART 2, THE FOLLOWING APPLIES:
* Gender: male or female of no childbearing potential
* Age: 18-65 years
* Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
* Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
* Type 1 or type 2 diabetes for at least 12 months
* Type 1 diabetes: Treatment with insulin for at least 12 months
* Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion Criteria:

* Known or suspected allergy to the trial product or related products
* Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
* Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department

This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital.

Patients treated by the ESP during a 3 month period will be included in this study.

Furthermore we aim to assess if ESPs treating patients with minor musculoskeletal injuries in the ED can predict the short-term prognosis of recovery. The prediction is made at hospital discharge using a (-7/+7) numerical rating scale (-7=poor prognosis; 7=best prognosis).


Eligibility Criteria:
Inclusion Criteria:

* 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
* 2 Has an email address
* 3 Signed informed consent form

Exclusion Criteria:

* 1 A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., not having access to the internet, cognitive impairments etc.)
* 2 Under the influence of drugs or alcohol