cyrilzakka/clinical-trials huggingface dataset:
HIV Prevention Intervention for People Living With HIV/AIDS

HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to their medications and not transmit the virus to others. This study is testing a behavioral intervention designed to address both medication adherence and risk reduction in people living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will show improved medication adherence and safer sexual behaviors compared to a comparison group.

Non-adherence to antiretroviral medications can lead to the development of treatment resistant genetic variants of HIV which can then be transmitted to sexual risk partners. Interventions are urgently needed to reduce the risk of HIV treatment resistance and the risks of transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV-AIDS. Grounded in behavioral theory, the experimental intervention will be delivered in a mixed format model with five group sessions preceded by and followed by one individual counseling session conducted by community-based group facilitators. The intervention will be conducted at an AIDS service organization in Atlanta. Men and women will be recruited from a variety of AIDS services and infectious disease clinics. Following informed consent and baseline assessments participants will be randomly assigned to receive either the (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched sexual risk reduction intervention, or (c) a time matched non-contaminating comparison intervention. Participants will be followed over the course of a 9-month observation period. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence and HIV transmission risks and risk reduction, medication adherence, sexual transmission risk behaviors, viral load, and CD4 cell counts. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will improve HIV treatment adherence, reduce HIV transmission risk behaviors, and improve health as indexed by viral load and CD4 cell counts. The study will also examine the influence of theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model derived from a single, unified theory of health behavior. If shown effective, the intervention model will be ready for immediate dissemination to community services for people living with HIV-AIDS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older,
* Tested HIV positive,
* Able to provide informed consent.

Exclusion Criteria:

* Significant cognitive impairment.
The Effect of Bracing on Sagittal Balance in Scoliosis

The goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. In special we want to observe if there is a difference between two types of TLSO-brace, namely boston and cheneau.

Retrospective analyses of Full Spine X-rays of patients who underwent bracing-therapy in the context of scoliosis.

Different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis.

Four different X-rays will be reviewed for these parameters:

1. Profile before bracing therapy
2. Profile after initiation of bracing therapy
3. Profile immediately after termination of bracing therapy
4. Profile more than 3 months after termination of brace

It concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis).

Goal of the study is to check if treatment with TLSO-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis).

The zero-hypothesis: TLSO causes no decrease in lumbar lordosis.

Secondary goal is to compare the effect of the BOSTON TSLO-brace and otherwise the CHENEAU TLSO-brace on spinopelvic parameters and lumbar lordosis in special.


Eligibility Criteria:
Inclusion Criteria:

* late onset idiopathic scoliosis
* non-operative indication

Exclusion Criteria:

* early onset idiopathic scoliosis
* neuromuscular scoliosis
* congenital scoliosis
* associated spondylolisthesis
* operative indication
PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients with LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)

PRELUDE-1 study is a pilot intervention trial that aims to describe the immunologic and genetic evolutions induced by stereotactic body radiationtherapy (SBRT) treatment in oligometastatic Colorectal Cancer (omCRC) patients with two-three nodules lung-limited disease.

PRELUDE-1 study is a monocentric pilot interventional trial. The study concerns all patients enrolled with a diagnosis of oligometastatic Colorectal Cancer (omCRC) with two-three nodules lung-limited disease and treated with SBRT technique. SBRT will be delivered according to a risk-adapted protocol.

Tumor genetic background will be assessed on primary FFPE (Formalin Fixed Paraffin Embedded) tissues. Liquid biopsy will be done on blood samples collected before radiotherapy (RT) start and after 40 days to monitor tumor DNA evolution. The most direct method to assess cancer genetics relies on sampling of tumor DNA and its characterization through whole genome sequencing techniques (NGS, Next Generation Sequencing).

The study will last 48 months, divides as follow: 24 months of enrollment phase and up to 24 months of follow-up. Follow-up will be performed on the 40th day after the end of radiation treatment and then every 3 months until progression.

Eligibility Criteria:
Inclusion Criteria:

* Age \<80 years
* Cytological or histological diagnosis of colorectal adenocarcinoma
* Two or three asymptomatic lung nodules smaller than 25 mm
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Available Formalin Fixed Paraffin Embedded (FFPE) of resected primary tumor
* Negative pregnancy test for all potentially childbearing women
* Patient candidates to SBRT

Exclusion Criteria:

* Previous systemic anti-tumor treatments (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before)
* Neutrophils \<2000/mm³ or platelets \<100.000/mm³ or hemoglobin \<9 g/dl; serum creatinine level\> 1.5 times the maximum normal value; GOT and/or GPT \>5 times the maximum normal value and/or bilirubin level \>3 times the maximum normal value
* Previous or concomitant malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
* Active or uncontrolled infections
* Other concomitant uncontrolled diseases or conditions contraindicating the study drugs at clinician evaluation
* Presence of brain metastases
* Refusal or inability to provide informed consent
* Impossibility to guarantee follow-up
Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥ 18 years，≤ 75 years
* Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
* Ability to provide written informed consent prior to participation in any study-related procedure
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
* Adequate organ function

Exclusion Criteria:

* Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
* Known history of a serious allergy to any monoclonal antibody
* Any active malignancy prior to the start of treatment
* Active or history of autoimmune disease
* Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
* Pregnant or lactating women
Transcranial Magnetic Stimulation and Bulimic Craving

Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may be considered appropriately by using paradigms developed in the framework of embodied cognition theories.

In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for food in these patients, as measured by reaction time.

Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms have not yet been explored.

The exams / treatments of the study include:

* a 20 minute session of rTMS at a frequency of 10 Hz.
* cognitive testing and attention, which will be made on the computer before and 24 hours after the session of rTMS.

Cognitive test consist in , on a computer screen:

* Is first displayed, food and non-food words. The patient must pull a lever to it if the letter A is present in the word and push the lever if the letter A is missing the word.
* Then presents a series of food and non-food words. The patient must pull a lever to it if it deems that the word has a positive meaning and push the lever if it determines that the word has a negative meaning

Eligibility Criteria:
Inclusion Criteria:

* right-handed patient
* Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
* Normal BMI

Exclusion Criteria:

* Previous history of seizures or epilepsy.
* Participants with a somatic problem restricted movement or an uncorrected visual acuity problem.
* History of head trauma, neurological disease or unstabilized serious physical illness.
* Major Depressive Episode at the time of the study
Assessment of Effectiveness Ex-Press Surgery Modification

The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.

Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.

Eligibility Criteria:
Inclusion Criteria:

* co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
* patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
* documented progression of loss of field of vision,
* significant daily IOP fluctuations,
* no cooperation from patient with regard to application of anti-glaucoma treatment,
* allergy to topical medication
* written consent to involvement and participation in the study for a period of at least 24 months

Exclusion Criteria:

* no consent to participation in the study
* prior surgical and laser procedures in the area of the eye
* narrow- or closed-angle glaucoma
* post-inflammatory or post-traumatic secondary glaucoma
* chronic illness of the cornea or optic nerve
* advanced macular degeneration
* active inflammatory process
* pregnancy
* systemic steroid therapy
Relationship Between Acoustic Breath Sounds and Spirometry

The goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).

Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the Lung Function and Sleep Department (LF\&S) routinely as part of their standard clinical management pathway for Lung Function testing that includes Spirometry assessments.
* All patients irrespective of condition will be approached to participate.

Exclusion Criteria:

* Subjects who are contraindicated to perform spirometry on the day of testing
* Subjects who cannot speak or read English
* Patients accessing non-adult services
* Subjects who are unable or do not wish to consent
* Patients with known or suspected restrictive lung disease
Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients

Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, \[less than 0.2 Tesla or approximately 10 times less\] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others.


Eligibility Criteria:
Inclusion Criteria

Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.

Exclusion Criteria

No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.

Any patient who has a contraindication to having an MRI, such as:

Non-MRI conditional implanted device or device that is not able to be removed for MRI examination
Treatment of Pressure Ulcers Using Biological Skin Substitutes

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM)

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. They are prevalent in individuals with limited mobility, such as the elderly and those with spinal cord injuries, particularly in long-term care settings. Effective management of pressure ulcers is crucial to prevent complications and improve patient outcomes, includes pressure relief, wound care, and advanced therapies such as bioengineered skin substitutes. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in promoting the healing of pressure ulcers. While both products are used in wound management, direct comparative studies evaluating their efficacy in treating pressure ulcers are limited.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at least 18 years of age or older
2. Presence of a Stage II or Stage III pressure ulcer, as defined by the National Pressure Ulcer Advisory Panel
3. Ulcer size between 5 cm² and 25 cm²
4. Ulcer duration of at least 4 weeks prior to enrollment
5. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol
6. The subject must be willing and able to participate in the informed consent process
7. Adequate blood supply to the affected area, confirmed by clinical assessment

Exclusion Criteria:

1. A subject known to have a life expectancy of \<6 months
2. Presence of infection in the ulcer requiring systemic antibiotics.
3. Known allergy to components of HPTC or dHCAM.
4. Participation in another wound care study within the last 30 days.
5. A subject with autoimmune or connective tissue disorders.
6. Women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding.
7. History of autoimmune disease, immunosuppressive therapy, malignancy, or uncontrolled diabetes (HbA1c \>10%)
Placement of Permanent Pacemaker Study

The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation.

1. Type of cardiac surgery
2. Gender of patient
3. Patient's age
4. Preoperative heart rhythm and rate
5. Duration on cardiopulmonary bypass
6. Immediate post cardiopulmonary bypass heart rhythm and rate.
7. All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.
8. Underlying heart rhythm and rates when permanent pacemaker is placed.
9. Ejection fraction before surgery
10. Ejection fraction immediately post-cardiopulmonary bypass

The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation. Through investigation into the co-morbidities, diagnoses, or histories associated with an endpoint permanent pacemaker placement, it is possible that we will garner a better idea of who will require PPP.

Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 18-99 years.
* All patients undergoing cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients who have permanent pacemakers in place.
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation

The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Written informed consent
* Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
* Stable antidepressant treatment for 3 weeks
* MADRS score ≥ 20
* SSI score \> 3
* Subject affiliated to a health insurance system
* Woman with effective contraception and agreeing to maintain it throughout the study period.

Exclusion Criteria:

* Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
* Patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment
* Patient deprived of liberty
* Patient with high suicide risk (item 10 MADRS \> 4) in the absence of hospitalization
* Contraindication to tDCS: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area
* Pregnant, parturient or breastfeeding woman
* Simultaneous participation in another interventional research
Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years or older
2. Patients with Parkinson's disease, according to the most recent diagnostic criteria
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders
2. Patients with neurological diseases other than Parkinson's disease
3. Inability to sign an informed consent
4. Severe psychiatric diseases