cyrilzakka/clinical-trials huggingface dataset:
Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* Visual acuity letter score in study eye \< 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
* Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF);
* Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria:

* Inability to understand informed consent, cooperate with testing or return to follow up visits;
* Pregnant or lactating women;
* Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
Targeted Screening for Taenia Solium Tapeworms

The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection.


Eligibility Criteria:
Inclusion Criteria:

* All community members are eligible

Exclusion Criteria:

* Inability to provide informed consent
Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya

The overall research objective is to evaluate the impact of implementing a reminder system for medical providers to improve TB case-finding and isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya

The purpose of this study is to evaluate the impact of implementing a clinical decision support reminder system for medical providers (i.e., nurses, clinical officers, medical officers, consultants) to improve tuberculosis case-ﬁnding and the use of isoniazid preventative therapy for adults living with HIV in western Kenya.

Eligibility Criteria:
Clusters:

Inclusion Criteria

* active
* uses HIV initial and return encounter paper forms
* enters data into the AMPATH medical records system (AMRS) or sends forms to central location for data entry
* prints or receives printed paper summary sheets with reminders
* interprets chest x-rays
* interprets sputum smear results
* prescribes IPT and dispenses INH
* completed an average of 10 initial adult HIV positive encounters per month in 2012
* HIV Care Clinic

Exclusion Criteria -

Patients:

Inclusion Criteria

* HIV positive
* complete an adult initial encounter at an HIV Care Clinic during the enrollment period
* attend at least one additional appointment within 90 days after the initial encounter

Exclusion Criteria

- history of TB or IPT
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.

A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.


Eligibility Criteria:
Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking colchicine
* On screening, the patient shows that MDRD GFR \>= 10 ml/min and \<= 50 ml/min
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to colchicine
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* serum albumin \< 3.5 mg/dL or \> 5mg/dL
* urinary retension, prostatic hyperplasia
* the patient show gout attack on taking colchicine
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding
Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients

The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.

40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS.

Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation.

Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients between 18 and 65 years of age
* patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
* positivity to cocaine use, determined via an urine drug test
* patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol

Exclusion Criteria:

* major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
* illiteracy or cognitive impairment disorders
* women who are pregnant or lactating
* other medical diseases that contraindicate rTMS treatment such as epilepsy
* presence of devices, i.e. pace-makers or cochlear prosthesis
* previous rTMS treatments in order to avoid confounding factors
* patients who can not provide the written informed consent
* DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.
Integrative Approaches for Cancer Survivorship 2: Project 2

The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.

Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) greater than or equal to 60
* Have impaired quality of life
* Ability to give informed consent

Exclusion Criteria:

* Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 2 months
* Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
BeFit Toolbox Collaboration: Building Empowerment Through Fitness

This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.

Despite clear evidence of improved health outcomes with regular exercise (see Bliss et al., 2021; Kleinloog et al., 20,22 for recent reviews), national statistics suggest that a mere 48% of Americans meet the recommended levels of physical activity (Centers for Disease Control and Prevention \[CDC\], 2018). Alarmingly, fewer than 30% of African American women living in public housing meet these recommended levels, marking the lowest rate among all demographic groups (Lee \&amp; Im, 2010; Hilland et al., 2020). Cerebrovascular disease in this population is increasing in prevalence, as is early presentation underscoring the urgent need for innovative, culturally relevant strategies to promote and study the effects of physical activity engagement within this under-resourced community (Turney et al., 2022; Zuellsdorf et al., 2020). However, developing relevant research-based interventions requires understanding and adapting specific programs to local public housing challenges (Casagrande et al., 2008). Mistrust is the primary barrier to relationship development in this population, and engagement with an established community partner is critical for local implementation. This proposal aims to develop a physical activity education program for women at high risk of disease to promote healthy lifestyles and mitigate the risk of neurological pathology.

Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria for participants are as follows: female, at least 18 years of age, mothers of school-aged children (K-12), tenants of HABD in good standing with a minimum of one year of stable living arrangements, and availability during program hours.

Exclusion Criteria:

* Inability to understand study instructions
Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure

The stabilization surgical treatment by open Latarjet procedure is one of the reference treatments after anterior glenohumeral dislocation in athletes. This surgical technique allows low recurrence rates and high return to sport rates. Indeed, more than 90% of athletes return to sport after this type of surgery, but only 60% are able to resume the same activity as a preinjury level of performance. Therefore, adaptations in the postoperative management of athletes patients seem necessary. Isokinetic dynamometry is considered the gold standard to provide an objective assessment of muscle strength abilities, particularly in the clinical setting. Although rehabilitation exercises are prescribed early after the Latarjet procedure, muscle deconditioning occurs during the postoperative phase, limiting the abilities of the rotator cuff muscles to provide stability to the glenohumeral joint. Therefore, recovery of all components of strength, i.e. maximal strength, power, and strength endurance of the rotator cuff muscles appears crucial for the athletes to return to their sport at the pre-injury level. However, at present, the strength levels to be recovered remain to be defined.


Eligibility Criteria:
Inclusion Criteria:

Patient group:

* Be aged between 18 and 45
* Occurrence of the injury during the practice of a sporting activity
* Post-traumatic anterior glenohumeral subluxation/dislocation
* Contralateral shoulder with no history of injury
* No other associated shoulder pathology
* Patient scheduled for shoulder stabilizing surgery using an open Latarjet procedure performed by one of the surgeons at the Santy Orthopedic Center (Lyon)
* No contraindication to isokinetic assessment
* Patient having signed informed consent
* Subject affiliated or beneficiary of a social security scheme

Healthy volunteers:

* Be aged between 18 and 45
* Regularly practice a sporting activity
* No contraindication to isokinetic assessment
* Person having signed informed consent
* Subject affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Patient group:

* Contraindication from the sports clinician or surgeon
* Have another pathology in the upper limbs.
* Have constitutional hyperlaxity
* Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Healthy volunteer group (athletes without a history of shoulder pathology):

* Declare a history of pain/injury in the upper limbs in the last 6 months
* Declare a history of orthopedic surgery in the upper limbs
* Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Treatment (Compassionate) Use of Device - PK Papyrus

The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.

Exclusion Criteria:

1. Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
2. Adults who are cognitively impaired, pregnant women, and prisoners.
An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies

Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.

OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG \<3, with no contraindications to PA and no history or coexistence of other primary cancer.

Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 and over,
* With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
* Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
* Followed-up in one of the investigating centers,
* Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
* Having a ECOG \< 3,
* With a life expectancy \> 6 months,
* Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician,
* Available and willing to participate in the study for the duration of the intervention and follow-up,
* Able to understand, read and write French,
* Affiliated with a social security scheme,
* Having dated and signed an informed consent.

Exclusion Criteria:

* Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
* Treated by immunotherapy alone,
* Participating in concurrent physical activity studies,
* Deprived of their liberty by court or administrative decision.
RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms.

The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over ;
* Consultation in an emergency department of a participating centre;
* Trauma to the lower limb requiring rigid or semi-rigid orthopaedic immobilisation;
* Expected duration of orthopaedic immobilisation of at least 2 weeks;
* TRiP(cast) score ≥ 7 ;
* Patient affiliated to or benefiting from a social security scheme;
* Patient with prior informed consent.

Exclusion Criteria:

* Patient that have to be hospitalized after emergency department for other reason than lower limb trauma
* Active bleeding or high risk of bleeding,
* Known contraindication to rivaroxaban or LMWH;
* Taking any anticoagulant or antiplatelet agent before the trauma (only antithrombotic authorised: aspirin \< 325mg/d);
* Pregnant or breastfeeding woman;
* Any factor making 3-month follow-up impossible; 6. Patient subject to a legal protection measure, Imprisonment 7. Participation in any interventional study which modifies patient care or could influence study evaluation criteria
Treatment Resistant Bipolar Depression

To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.

Exclusion Criteria:

* Pregnant or breastfeeding
* History of seizure disorder or other unstable medical condition
* Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
* Experienced hallucinations or delusions
Leveraging Technological Advancements to Improve the Treatment of Trichotillomania

This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. Given that the Keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the Keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. The investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.

Novel technologies present one solution to help identify and reduce automatic pulling behaviors associated with trichotillomania (TTM). The Keen 2 is one such novel technology, which is a bracelet which gives the user alerts in the form of a vibration when the user is engaging in hair pulling behavior. Thus, using the Keen 2 could positively increase the awareness of automatic pulling behaviors, which is largely unaffected by existing evidence-based treatments like HRT. This information would be advantageous for the scientific community to determine the possible benefit of this approach to help individuals with TTM.

This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. Given that the Keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the Keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. The investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. meet diagnostic criteria for TTM using the TDI-R
3. have a MGH-HPS total score ≥ 12 at baseline;

(3) have an "automatic" pulling score ≥ 15 on the MIST; (4) able to wear the Keen2 device for four weeks; (5) able to attend three study visits; (6) unmedicated or a stable dose of psychiatric medication for 8 weeks prior to enrollment; (7) be English speaking.

Exclusion Criteria:

1. an inability to complete rating scales, and
2. an inability to attend study visits