cyrilzakka/clinical-trials huggingface dataset:
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal neovascularization(NV). The purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and PRP.

Proliferative diabetic retinopathy (PDR) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of PDR is retinal neovascularization at the disc or elsewhere.Panretinal photocoagulation (PRP) has been the standard treatment for PDR since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.Recent evidences have indicated that anti-vascular endothelial growth factor(VEGF) treatment can reduce the severity and delay the progression of DR.However,the impact of this treatment on visual function and the effect of anti-VEGF agents on retinal neovascularization compared with PRP remain unclear. It is possible that a long-acting anti-VEGF agent such as conbercept. So we design the study with is a prospective randomized controlled trial about Intravitreal injection of conbercept versus PRP on PDR.Primary outcome is the change in BCVA from screening to 12 months in the study eye measured in the ETDRS letter score at 4 m

Eligibility Criteria:
Inclusion Criteria:

1. Participants of either sex aged 18 years or over.
2. Diagnosis of diabetes mellitus (type 1 or 2).
3. Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
4. PDR with no evidence of previous PRP.
5. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

Exclusion Criteria:

1. a glycated haemoglobin (HbA1c) level of more than 10%;
2. Blood pressure \> 180/100 mmHg
3. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months
4. dialysis or renal transplant
5. Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization
6. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years
7. Traction retinal detachment involving the macula
8. Exam evidence of neovascularization of the angle
9. History of major ocular surgery or anticipated within the next 6 months following randomization
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis

To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28 days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.

Double blind controlled study versus placebo. Patients with suppurated CSD's lymphadenitis will receive immediately after the pus aspiration (performed for a diagnostic purpose) an intra-nodal injection of gentamicin or of placebo (NaCl 0,9%) and be treated with oral azithromycin for 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Suppurated CSD's adenitis:

  * Suppurated form of adenitis confirmed by echography
  * Serology positive for Immunoglobulin G and/or Immunoglobulin M against B. henselae

Exclusion Criteria:

* Suppurated adenitis non related to CSD
* Non-suppurated CSD's adenitis
* Suppurated CSD's adenitis already fistulized
* Suspected visceral B. henselae infection (neurologic or ophthalmic symptoms, hepato-splenic or valvular involvement confirmed by echography)
* Immunodepression (except diabetes)
* Pregnancy
* Contraindication to pus aspiration from lymphadenitis (history of bleeding or patient taking curative anticoagulation therapy or platelet count \< 50.000/mm3)
* Contraindication to azithromycin (history of QT interval prolongation, history of liver toxicity of hypersensitivity to macrolides or treatment with ergotamine, dihydroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosides (myasthenia, history of hypersensitivity to aminoglycosides).
Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days.

Aripiprazole plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for the study.
* Age 35 - 55 years
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the investigator's opinion.
* History of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

This is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology.

This research consists of two parts:

part 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor


Eligibility Criteria:
Part 1: development of microbiome biomarkers

\<Inclusion Criteria:\> 1.Patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy

1. Age ≥ 19 years old
2. Eastern Cooperative Oncology Group performance status 0-2
3. Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

\<Exclusion Criteria\>

1. A history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach)
2. A history of active primary immunodeficiency
3. Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)
4. Autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia)
5. Patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg/day prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction)

   --------------------------------------------------------------------------------------------

part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers

\<Inclusion Criteria for donors\>

1. Patients who have partial or complete response to immunotherapy at the time of stool donation
2. No history of exposure to HIV or hepatitis virus within the previous 12 months
3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea
4. No current communicable disease
5. No household members with active gastrointestinal infection
6. No history of inflammatory bowel disease
7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)

\<Inclusion criteria for recipients\>

1. Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis
2. Patients who have disease progression to immunotherapy as one of the following two patterns:

2-1) Patients who have disease progression due to primary resistance to immunotherapy

2-2) Patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy
Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).

This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.


Eligibility Criteria:
Inclusion Criteria:

* 18 yo or older
* CT scan and WSES classification
* surgical intervention within 48 hours for acute diverticulitis

Exclusion Criteria:

* underaged
* conservative treatment for acute diverticulitis
* other treatment
* diagnosis of colorectal cancer at histology
Exploring the Role of Almonds in Enhancing Immune Strength

The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function.

Investigators will conduct an 8-week parallel-arm trial of 48 overweight/non-obese (BMI=24-30) adult (aged 40-65 years) men (n=24) and women (n=24) who will be randomly assigned to consume daily isoenergetic portions of almonds or a common snack (pretzels).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 40-65 y
* Body mass index (BMI) 24-30 kg/m.2

Exclusion Criteria:

* Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), for 30 days prior to or during study participation, if currently taking these.
* Almond allergies
* Alcohol consumption \>2 drinks per day.
* Smoking or using nicotine containing products in the last 6 months.
To Document the Burden of Illness on the Quality of Life and the Impact on Healthcare Utilization in (Beta) β-thalassemia Subjects Who Are Transfusion Dependent (TD) and Non-transfusion Dependent (NTD) Receiving Standard of Care

This is a multi-site, prospective, observational study implemented in β-thalassemia treatment centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand). Approximately one to two study sites will be identified per country and approximately 20 β-thalassemia subjects will be enrolled per country (10 transfusion dependent (TD) and 10 Non-transfusion dependent (NTD) with a total of approximately 100 subjects. This study will not interfere with or influence the routine clinical management of β-thalassemia patients. Outcomes of interest will be collected prospectively for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

For the transfusion dependent (TD) subjects:

1. Male or female, \>18 years of age at the time of signing the informed consent document (ICF);
2. Documented diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia;
3. TD - defined as: ≥6 Red Blood Cells (RBC) units in the 24 weeks prior to study participation and no transfusion free period for ≥35 days during that period; and
4. Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.

For the non-transfusion dependent (NTD) subpopulation

1. Male or female, \>18 years of age at the time of signing the informed consent document (ICF).
2. Documented diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
3. NTD - defined as: 0 to 5 RBC units received during the 24-week period prior to study participation (not including RBC transfusions units administered for elective surgery);
4. Most recent hemoglobin ≤10 g/dL (hemoglobin values ≤ 21 days post-transfusion will be excluded)
5. Performance status: ECOG score of 0 to 1.

Exclusion Criteria:

For TD Subpopulation:

1. A diagnosis of hemoglobin S/β-thalassemia;
2. Any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study;
3. Inability to read or understand the local official languages; or
4. Participated in another clinical trial (interventional) \<30 days prior to study participation

For NTD Subpopulation:

1. Received RBC transfusion ≤ 8 weeks prior to study enrollment;
2. A diagnosis of hemoglobin S/β-thalassemia;
3. Any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study;
4. Inability to read or understand the local official languages; or
5. Participated in another clinical trial (interventional) \<30 days prior to study participation.
MOLECULAR BASIS OF LANGUAGE DEVELOPMENT AND ASSOCIATED DISORDERS

Developmental Language Disorder (DLD) refers to children who present with language difficulties that are not due to a known biomedical condition or associated with autism spectrum disorder (ASD) or intellectual disability. The prevalence of DLD is \~7%-8% or 2% if severe forms are considered.

However, the clinical heterogeneity of language disorders, the presence of co-morbidities and the inconsistent terminology used for many years have hindered research and clinical practice. Distinguishing sub-groups of children with language problems is crucial when tackling the underlying genetic causes of this disease. Recently, several studies using high-throughput sequencing have better define the genetic basis of CAS but such studies focusing on DLD are limited. The investigation of more homogeneous cohorts of individuals that clearly distinguish DLD cases, from ID and not including children with CAS should improve our understanding of the genetic basis of this disorder.

In this study, we aim to built and investigate a well-characterized cohort of DLD patients using pangenomic approaches to better define the molecular basis of this disorder. All individuals will be analyzed using chromosomal microarray analysis and whole genome sequencing. Multiple observations and preliminary results suggest strong links with the genetic basis of other neurodevelopmental disorders.

The goal is to identify CNV or SNV as causative allele or risk factor and already known to be involved in other neurodevelopmental disorders as well as potential new variants.


Eligibility Criteria:
Patients

Inclusion Criteria:

* Eligible families included at least one child over five years old with a formal diagnosis of severe and isolated DLD according to Phase 2 CATALISE criteria . Patients have undergone age-appropriate speech, language and reading evaluations by a speech-language physician and cognitive evaluations by a neuropsychologist, as well as evaluation by a pediatric neurologist to identify co-occurring developmental disorders (ADHD, ASD...) and a medical geneticist for known genetic disorders and genetic testing recommendations. All children included received appropriate speech therapy for at least one year, with a progress report indicating the persistence of language difficulties.

Exclusion Criteria:

* Cognitive impairment with non-verbal intellectual quotient (IQ) below 2 SD assessed with the Wechsler Preschool and Primary Scale of Intelligence (WPPSI), or the Wechsler Intelligence Scale for Children (WISC-IV or V) according to the age-appropriateness, ASD, moderate to severe hearing loss, orofacial structural abnormalities, known neurological or genetic disorders at the initial assessment. None of the patients met the diagnostic criteria for CAS according to the ASHA (American Speech-Language-Hearing Association, 2007. Childhood apraxia of speech www.asha.org/policy).
Real-time NIRS Neurofeedback Regulating Brain Cognitive Function in Obese Individuals

To determine the efficacy of real-time fNIRS neurofeedback for regulating the brain cognitive function in obese individuals.

In the current study, 60 obese subjects will be recruited, and they were randomly classified into the group who will receive real neurofeedback and the group who will receive sham neurofeedback. Participants will receive the real-time neurofeedback for 12 times, 3 to 4 times a week, each time the real-time neurofeedback consists of 12 sessions of liftstone as the index reflecting the brain activity. Sham group will receive the identical neurofeedback.

All of the subjects will undergo magnetic resonance imaging scan, during which T1, diffusion tensor imaging, resting-state, and task fMRI data will be collected. For task Fmri scan, the participants will be asked to finish four cognitive task, including 2-Back working memory, Go/No-Go task, Willingness to Pay for Food, and Delay Discounting tasks. Clinical measurements including BMI, eating behavior, psychiatric status will be assessed. Those aforementioned examinations will be performed at before the neurofeedback, 6th times and the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥ 25
2. 18 to 65 years old
3. No severe mental disorders(depression; schizophrenia; bipolar disorder; etc.).

Exclusion Criteria:

1. Severe dysfunction of heart, liver, kidney and hematopoietic system
2. Substance addiction
3. Patients who cannot be treated with fMRI or fNRIS neurofeedback
4. Those who take other weight loss drugs.
Text Messaging and Cognitive Behavioral Therapy for Depression

This study aims to asses whether adding automated text messaging to group cognitive behavioral therapy for depression increases engagement which may lead to improved outcomes.

Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy.

Objectives: The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, the investigators aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients.

Methods: Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills.

Eligibility Criteria:
Inclusion Criteria:

* Participation in CBT group at San Francisco General Hospital

Exclusion Criteria:

* Active suicidality
* Active and severe psychosis
RCT Comparing Invisalign and Traditional Orthodontic Treatment

Comparison of orthodontic patients treated with aligners and traditional (clear braces)

Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.

Eligibility Criteria:
Inclusion Criteria:

1. Class I molar and canine relationships
2. Non-extraction treatments
3. Mandibular crowding of 4 mm or less
4. No missing tooth (from second to second molar)

Exclusion Criteria:

1. Anterior or posterior crossbites
2. Anterior or lateral open bites
3. Maxillary overjet exceeding 3mm
4. Impacted tooth
Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.

This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.

The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .


Eligibility Criteria:
Inclusion Criteria:

* first cycle of ART
* age \< 35 years
* basal FSH \< 10 IU/L

Exclusion Criteria:

* previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
* only one ovary