cyrilzakka/clinical-trials huggingface dataset:
Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes

The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* Age 35-65 years
* BMI 27- 34 kg/m2
* HbA1c \<8%
* Fasting plasma cholesterol \<250 mg/dl
* Fasting plasma triglycerides \<300 mg/dl

Exclusion Criteria:

* Hypolipidemic drugs
* Plasma creatinine \>1.7 mg/dl transaminases \> 2 norma values
* Ischemic heart disease or positive treadmill stress test
* High intensity regular physical activity
* Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).
Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)

Precise description of behavioral signs denoting transition from unresponsive wakefulness syndrome/vegetative state (UWS/VS) to minimally conscious state (MCS) or emergence from MCS after severe brain injury is crucial for prognostic purposes. A few studies have attempted this goal but involved either non-standardized instruments, limited temporal accuracy or samples, or focused on (sub)acute patients. The objective of this study is to describe the behavioral signs that led to a change of diagnosis, as well as the factors influencing this transition, in a large sample of patients with chronic disorders of consciousness after severe brain injury.


Eligibility Criteria:
Inclusion Criteria:

* documented medical diagnosis of CRS-R-based diagnosis of UWS or MCS at admission to the neurorehabilitation program

Exclusion Criteria:

* none
Methotrexate in Symptomatic Knee Osteoarthritis

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis
* pain not responding to the usual therapy
* synovitis

Exclusion Criteria:

* any other inflammatory conditions,
* hepatic and renal insufficiency
Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

This was a multicenter, prospective, observational study of adalimumab. Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.

Eligibility Criteria:
Inclusion Criteria:

1. High disease activity, with poor prognostic factors (e.g., rheumatoid factor \[RF\]-positive, anti-cyclic citrullinated peptide \[CCP\] antibody-positive, or bone erosion)
2. Combination of adalimumab and methotrexate will be started
3. No prior history of treatment with disease-modifying anti-rheumatic drugs
4. No prior history of treatment with biological agents
5. Adalimumab dosed according to the registered product label
6. Signed informed consent

Exclusion Criteria:

There were no specific exclusion criteria.
Neural Mechanisms of Decision Making in Hoarding Disorder

The purpose of this study is to understand the neural mechanisms of decision making in hoarding disorder.

Hoarding disorder is a common and disabling disorder that represents a significant public health problem. This study aims to build on current research on decision making by examining these processes in hoarding disorder.

Eligibility Criteria:
Identify inclusion criteria.

Inclusion criteria for participants diagnosed with HD:

1. ages 18-70
2. primary diagnosis of hoarding disorder
3. sufficient severity of hoarding symptoms
4. stable on psychotropic medications for 1 month prior to study enrollment
5. capacity to provide informed consent
6. ability to tolerate clinical study procedures

Inclusion criteria for healthy control participants:

1. ages 18-70
2. capacity to provide informed consent

Identify exclusion criteria.

Exclusion criteria for participants with HD:

1. psychiatric or medical conditions that make participation unsafe
2. pregnant or nursing females
3. concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
4. presence of metallic device or dental braces

Exclusion criteria for healthy control participants:

1. any current or lifetime psychiatric diagnosis
2. current or past use of psychotropic medication
3. pregnant or nursing females
4. major medical or neurological problem
5. presence of metallic device or dental braces
Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Atogepant is a small molecule calcitonin gene- related peptide (CGRP) receptor antagonist, part of the gepants family. It is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine.

Previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile.

The most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation.

In this prospective multicentric study the investigators aim to evaluate atogepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline.

patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and eventual approval of reimbursability criteria.

Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence. The online database REDCap will be used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
* At least 3 monthly migraine days;
* Good compliance to study procedures;
* Availability of headache diary at least of the preceding months before enrollment.

Exclusion Criteria:

* Subjects with contraindications for use of gepants;
* Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
* medical comorbidities that could interfere with study results;
* Pregnancy and breastfeeding.
Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

Regional lymph node status is the most important prognostic factor for disease-free and overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery. Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common and most accurate way of lymphatic mapping is performed with the combined application of a gamma-emitting isotope labeled substance and blue dye, the so-called double labeling technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin and axilla present a number of uncertainties.

According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided the axillary region into four subregions: brachial (lateral), pectoral (anterior), central and subscapular (posterior) zones. They revealed clear relationship between the anatomic location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in Level I in 96% and in Level II in 4% by SPECT/CT.

Knowedge of relationships between the drainage of sentinel lymph node staining into the axillary subregions, location of the primary tumor, tumor size, SLN positivity and its location within the subregion are of particular importance in the decision making whether or not axillary lymphadenectomy (ALND) needs to be performed.

In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not performed in early breast cancer patients with clinically negative axilla and breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average follow-up of 6.3 years, data were compared to the traditional ALND group and no difference was detected in 5-year overall survival or disease-free survival at 5 years.

Aims of the investigation:

To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T \<5 cm).

To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN.

To statistically assess SLN positivity and its location within the sbregion.

To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.


Eligibility Criteria:
Inclusion Criteria:

* women with clinically node negative invasive or microinvasive breast cancer: T1-2(≤ 5cm)N0M0
* 18 years of age or older

Exclusion Criteria:

* previous ALND
* clinically positive axillary SLNB
* pregnant or lactating
* neoadjuvant breast cancer treatment based on surgeon's discretion (ASCO)
Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome

The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

Children with isolated, but severe and potentially life-threatening injuries ISS ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries

Exclusion Criteria:

Injury Severity Score (ISS) of \< 16 age \>18 no thoracic injuries
Adolescent PCIP Randomized Feasibility Trial

There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to treatment as usual (TAU) participants.

The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=44 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will,

1. Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction;
2. Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to:
3. Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.


Eligibility Criteria:
Inclusion Criteria:

1. Patient referred to the SHARK Program
2. Patients must be at least 12 years old
3. Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.
4. If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;
5. Patient is able to complete study activities in English.

Exclusion Criteria:

1. Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;
2. Inability to provide informed consent or assent, and/or complete procedures in English.
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
* tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
* C-peptide (fasting) \>=1.0ng/mL
* HbA1c \>=6.5% and \<=10.0% at screening;
* BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;
* stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
* evidence of clinically significant diabetic complications;
* symptomatic poorly controlled diabetes;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.

The investigators aim to investigate whether the sphenopalatine ganglion pulsed radiofrequency treatment is better than traditional sphenopalatine ganglion nerve block technology and provides medical evidence for the clinical application and promotion of sphenopalatine ganglion pulsed radiofrequency treatment to provide a minimally invasive, safe, and effective treatment for patients with cluster headache who do not respond to drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cluster headache is confirmed according to the diagnostic criteria of the 2018 International Classification of Headache Disorders 3rd edition (ICHD-3);
* patient's age is between 18 and 60 years;
* patients seek treatment in the pain clinics of hospitals participating in the study within 5 days of the onset of the cluster period; pain conditions of patients remain the same after conservative treatment of conventional oral medication, or the reduction rates are less than 50% in pain degree during headache attacks, headache attack frequency, duration of each headache attack, and auxiliary analgesic drug dosage; and
* patients signed the informed consent.

Exclusion Criteria:

* abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiogram, and chest radiograph;
* infection at the puncture site;
* previous mental illness;
* previous history of narcotic drug abuse;
* history of anticoagulant and antiplatelet aggregation drugs;
* implantable pulse generator;
* previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
* pregnant or breastfeeding patients.
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants

The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent poliomyelitis disease or vaccination.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
* Current febrile illness or axillary temperature \> 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation

Patients who undergo allogeneic stem cell transplantation lose previously acquired immunity and are routinely revaccinated against many infectious diseases. For several reasons, these patients have a long-term immune deficiency due to the transplant itself (lack of immune reconstitution) and due to possible complications, primarily GvHD and its treatment. The risk of secondary malignancy in the long-term following an allogeneic bone marrow transplant is greatly increased, and secondary cancer cases account for a significant proportion of late deaths in both women and men after transplantation. Some of these secondary cancers are associated with HPV. The risk of cervical cancer has been reported to be 13 times increased compared to a healthy population.

Therefore in this trial, the aim is to study immune response (antigen-specific antibody response) after vaccination with 9-valent HPV vaccine (Gardasil 9®) in adult women and men (up to and including 45 years of age) who have undergone allogeneic stem cell transplantation. In this trial, the sponsor will compare "early" (start 9 months after tx) with "late" (start 15 months after tx) vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of AlloSCT from related or unrelated donor.
* Adults (men and women) ≥18 years up to and including 45 years of age for vaccination.
* Patients can be included regardless of prior HPV vaccination prior to transplantation

Exclusion Criteria:

* Severe thrombocytopenia (under 50 x 10\^9) not allowing intramuscular injection
* Severe acute GvHD grade III-IV.
* Extensive chronic GvHD requiring treatment with prednisone doses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photopheresis).
* Prednisone doses above 1mg/kg/day at study start.
* Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion.
* Treatment within 3 months before start of vaccination with iv or sc immunoglobulin.
* Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.
* Treatment with blood thinning medication contraindicating intramuscular injection
* Allergy against Gardasil 9
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from high horseshoe anal fistula

Exclusion Criteria:

* Specific cause of fistula e.g. Crohn's disease.
* Previous anorectal surgery.
* Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
* Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.