cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury

Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.

A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Grade II-III acute radiation-induced rectosigmoid injury
2. Signed informed consents
3. Age ≥18 years
4. Rstimated survival time \>1 year

Exclusion Criteria:

1. Absolute contraindications to glucocorticoids
2. A history of glucocorticoids treatment within 3 months
3. Inflammatory bowel disease or infectious intestinal disease
4. Recurrence of malignant tumor
5. Colorectal cancer or metastasis
6. Severe heart or lung diseases
7. Recent history of surgery or trauma
8. Poorly controlled hyperglycemia and hypertension
9. Active tuberculosis
10. Ssevere gastrointestinal ulcers
11. Glaucoma
12. Sychiatric diseases
13. Pregnant or lactating
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease

The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.


Eligibility Criteria:
Inclusion Criteria:

* hyperlipidemia
* urinary protein
* diabetes

Exclusion Criteria:

* previous rosuvastatin treatment \< 6 months prior to Visit 1
* statin intolerance
* severe hypertension
Transdermal Testosterone Nanoemulsion in Women Libido

This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75 years, with treatment-emergent loss of libido will be randomly allocated to the treatment with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.

The aim of this study is to investigate the efficacy of transdermal testosterone nanoemulsion (TNT) as a treatment for SSRI/SNRI-emergent loss of libido.

The primary outcome measures to be evaluated is the change in the Sabbatsberg Sexual Self-rating Scale (SSS) total score over 12 weeks. The 4-week frequency of Satisfactory Sexual Events (SSEs) and the Female Sexual Distress Scale-Revised (FSDS-R) will be also evaluate.

Eligibility Criteria:
Inclusion Criteria:

* a body mass index between 18 and 27 kg/m2;
* Diminished libido;
* Sexual behavior complaints;
* No evidence of severe clinical depression;
* General good health based on history and physical examination.

Exclusion Criteria:

* a past history of neurological disorder;
* Poor feelings for their partner;
* Had received pharmacotherapy for depression within 8 weeks before screening
* Taking medication known to interfere with normal sexual function (such as α-blockers and β-blockers);
* Recent psychiatric or systemic illness;
* Uncontrolled hypertension (blood pressure\>160/95mmHg),
* Unstable cardiovascular disease,
* Genital bleeding;
* Use of psychoactive medications, alcohol excess consumption or any other drug abuse;
* Women who had under gone treatment for acne, depression, dyspareunia.
A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration

Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered.

A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA).

Current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. However, these recommendations are based on limited data from over 15 years ago. More recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation

Exclusion Criteria:

* Patients outside the age range
* Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro)
* High-risk patients for infective endocarditis
* Bacterial infection or use of antibiotics within 6 weeks of EUS
* Pancreatitis within the past 6 months
* Underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin A1c above 7 or glucose \> 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; HIV/AIDS)
* Currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant)
* Radiographic or endosonographic evidence of cyst cavity debris / necrotic debris
* Severe systemic disease (for example, NYHA class III or IV heart failure, oxygen-dependent COPD)
Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes

This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. One group included participants with vitamin D deficiency and the other group did not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Having conscious satisfaction

Exclusion Criteria:

* Patients with a history of gastrointestinal surgery
* Patients with a history of renal failure
* Patients with a history of vitamin D intake and calcium-containing compounds
* Patients with a history of liver disease
Surgery for Male Stress Urinary Incontinence

The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.

Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported.

The surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon.

The patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.

Eligibility Criteria:
Inclusion Criteria:

* Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling
* Participant is willing and able to complete the questionnaires and give informed consent for participation in the study

Exclusion Criteria:

- Participant unable to complete the questionnaires and declining informed consent for participation in the study
Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients

Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.

The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response.

Sleep and immune system have reciprocal relationship. Sleep has a restorative role on immune system, influencing innate and adaptive immunity and sleep disorders can decrease immune response.

Healthy innate immunity is crucial into regulation of the response against SARS-CoV-2.

The hypothesis of the study is that the innate immunity response is blunted by sleep disorders and, this mitigated immune response, could influence on COVID-19 severity. Impaired immune response in patients with sleep disorders could be ameliorated inducing trained immunity by influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.

Exclusion Criteria:

* \>70 years and \<18 years
* Recent COVID-19 (\<6 months)
* Other infection (\<3 months)
* Obstructive sleep apnea in treatment with CPAP prior to COVID infection.
* Immunosuppressed
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.

Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
* Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
* Proton pump inhibitor compliance of \~70% (to be measured between screening and baseline (week 0)).
* Male or female patients from 18 to 65 years of age.
* Patients with a life expectancy of over three months.
* World Health Organisation (WHO) Performance Status of 0 to 1.
* Written informed consent given.

Exclusion Criteria:

* Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
* Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
* History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
* Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
* Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
* Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
* Previous G 17DT treatment.
* Haematological indicators:

Haemoglobin \<10.0 g/dL White blood cell count \<4.0 x 109/L Platelets \< 100 x 1 09/L
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer

This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (mCRC) refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres in China.

This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Obtained informed consent for patients to be follow-up prospectively
2. Age≥18 years old
3. Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
4. Received SIR-Spheres®

Exclusion Criteria:

1. Special contraindications from package insert, which includes

   1. Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL
   2. Portal vein thrombosis in the main trunk
   3. Disseminated extrahepatic disease
   4. Previous external beam radiation therapy to the liver
2. Women are lactating or pregnant during the study or plan to be pregnant during the study
3. Patients with mental illness or cognitive impairment
4. Per investigator, patients are non-adherent or reluctant to be followed up
Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.

Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
* Maternal age 18-45 years
* Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus

Exclusion Criteria:

* History of keloids
* Previous transversal suprapubic scars
* Clinical signs of infection and/or tattoos in the area to be studied
* Known patient hypersensitivity to any of the suture materials used in the protocol
* BMI below 20 or above 30
* Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c \> 6%, unbalanced daily glucose measurements, and fasting glucose \>95 mg/dL).
Clinical Application of CTDNA in Operable Breast Cancer Patients

Our study aims to evaluate the possibility of clinical application of CTDNA detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
2. Age of at least 18 and at most 70 years.
3. Performance status (Karnofsky-Index) \>80%.
4. Chemotherapy is necessary before or after surgery.
5. No clinical evidence of local recurrence or distant metastases.
6. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
7. Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
8. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
9. Patients must be available for and compliant to treatment and follow-up.
10. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances.
2. Local recurrence and/or metastasis of breast cancer.
3. No need of chemotherapy.
4. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.

   Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
5. Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
6. Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
7. Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
8. Males.
Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI

We will examine how stimulation of specific brain areas with transcranial magnetic stimulation (TMS) or transcranial electric stimulation (tES) changes specific aspects of behavior and brain activity, in order to test hypotheses about brain behavior relationships (basic research).


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 80 years of age (whereby for most studies the majority of recruited participants will be between 18 and 40 years of age)
* right-handedness and/or one specific gender (male or female) can be inclusion criteria to reduce variation in the data.

Exclusion Criteria:

* inability to understand the instructions and insufficient knowledge of the project language
* Internal electronic and/or metallic objects in the head, neck, or shoulders (e.g. artificial cochleae, deep brain stimulators, medical pumps, shrapnel, metallic splinters due to accidents during metal welding)
* One or more epileptic fits in the participant or a first-degree relative
* Vascular, traumatic, tumoral, infectious, or metabolic brain damage
* Use of medication that significantly alters cortical excitability
* Acute sleep deprivation or withdrawal from alcohol
* pregnancy
* to reduce bias, students of psychology or economics can be excluded if there is a possibility that they are familiar with the relevant paradigm.
Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention

Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention compared with Psycho-Educational-Supportive group in terms of tic severity.

Tourette Syndrome (TS) is a neuro-developmental disorder characterized by motor and vocal tics, frequently associated with behavioral and functional problems, impacting significantly on children's quality of life . Current evidence supports the contribution of individual behavioral treatment for TS both for reducing tics and improving children's quality of life. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). One of the developments of behavioral treatments is group interventions, supported in various types of psychological difficulties, adding benefit of providing peer support. However, group intervention for children with TS has not been empirically evaluated.

The aim of this study is to assess the efficacy of CBIT group intervention. We hypothesize that CBIT group intervention will be more effective than Psycho-Educational-Supportive (PES) group in terms of tic severity, and that both groups will be effective in quality of life measures.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Tourettes syndrome or chronic tic disorder
* age 9-15 years
* native Hebrew speakers

Exclusion Criteria:

* intellectual disability (FSIQ \< 80)
* current diagnosis of substance abuse/dependence
* life time diagnosis of pervasive developmental disorder, mania or psychosis.
* previous treatment with 4 or more individual sessions of CBIT

Children receiving medications for tics: eligible if the dose is stable for 6 weeks prior to study with no planned changes during study participation.
AMPLATZER™ LAA Occluder Post Approval Study (PAS)

The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Documented history of nonvalvular atrial fibrillation
* Subjects in whom an AMPLATZER LAA Occluder device is intended to be implanted or Subjects who underwent an AMPLATZER LAA Occluder implant attempt after the device was approved in the applicable geography

Exclusion Criteria:

* Women of childbearing potential who are, or plan to become, pregnant during the time of the study