cyrilzakka/clinical-trials huggingface dataset:
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.

Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest population of rural India where the disease is endemic are urgently needed. Resistance to antimonials, which have historically been the first line of treatment for VL in Bihar and adjoining states, is a major problem. Other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug Controller General of India (DCGI).

The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed, newly diagnosed or relapsed visceral leishmaniasis

Exclusion Criteria:

* HIV infection, tuberculosis
* Significant hematologic, renal or liver dysfunction
* Malaria
* Those unable to be treated as an outpatient.
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )

The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Major (adult subject over 18), with no upper age limit
* Enrolled in a social security scheme or beneficiary of such a scheme
* Agreement to participate (informed, written consent)
* Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
* Regular user of a glucose monitoring system for at least 3 months.

Non inclusion Criteria:

* Known hemoglobinopathy
* Inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit.
* Stage 5 renal insufficiency (CKD-EPI less than 15 mL/min/1.73 m2)
* Pregnant or breast-feeding
* Major under guardianship, curatorship or safeguard of justice
* Any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study

Exclusion criteria:

* Treatment with corticosteroids in the 3 months preceding the visit
* Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
* Pregnancy started
Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain

Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other pathology exists. The effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.However no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD. This study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for CPP.

This study will investigate the effectiveness of inclusion of trans-perineal trigger point dry needling with manual therapy treatment for chronic pelvic pain with dyspareunia and associated pelvic floor dysfunctions.The use of trigger point dry needling (TrptDN) for chronic low back pain has proved beneficial.This study will evaluate the treatment outcomes of trans-perineal trigger point dry needling and manual therapy to only manual therapy for CPP.

The outcomes will evaluate the number of treatment requirements between the dry needling with manual therapy group and the manual therapy group and review which group has faster resolution in pain and other associated pelvic floor symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients reporting non-cyclical CPP with dyspareunia and associated PFD with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (PFM) tone and tenderness will be referred for physiotherapy by the gynaecology team.
* Visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic CPP symptoms.
* Smokers and non-smokers included.
* Nulliparous, singleton and multiparous patients.

Exclusion Criteria:

* Body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available.
* Chronic back pain over 6 months duration, under pain management team.
* Orthopaedic back surgeries with implants.
* Pelvic pathologies like endometriosis, fibroids, cysts, etc.
* Pregnancy related pelvic pain.
* Pregnant during the trial.
* Pelvic organ carcinomas.
* Undergoing cancer treatment.
* Post gynaecology surgeries, less than 16 weeks.
* Cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month's post-operative.
* Neurological conditions like stroke, epilepsy, Parkinson's disease etc.
* Exclusion criteria for dry needling:
* Extreme needle phobia, Rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders.
* Participant with no significant learning disability and should be able to understand the procedure to consent for treatment.
* Participant should not require a chaperone during treatment.
Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)

Studies conducted assessing diabetic eye disease have shown a progression of diabetic retinopathy with rapid improvement of glycemic control during pregnancy and in patients with type 1 diabetes. It is also well documented that bariatric surgery may result in rapid improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will examine the effects of rapid glycemic control which is seen in type 2 diabetics following bariatric surgery on the progression of diabetic retinopathy.

Participants will be referred from the Department of Bariatric Surgery at NYU. The investigators plan to enroll 50 patients in this pilot study.

A baseline eye exam will be conducted prior to surgery. Data, such as preoperative HbA1c level, weight, BMI, duration and control of diabetes, current medication regimen, and the grade of retinopathy will be noted. Study participants will have a baseline eye exam within three months of the scheduled surgery, followed by regular follow-up visits at 3 months, 6 months, 9 months, and 1 year. At each visit the following measures will be assessed: (1) weight, (2) blood pressure, (3) glycemic control as assessed by HbA1C, (4)level of retinopathy, and (5) visual acuity using the EDTRS acuity chart.

The eye examinations will consist of a measure of best-corrected visual acuity, slit lamp examination to assess pressure, and a dilated funduscopic examination to determine the presence and/or level of retinopathy. The level of retinopathy will be characterized as:

(0)None, (1) Mild, (2) Moderate, (3) Severe, and (4) Proliferative. In addition, the presence or absence of cystoid macular edema (CME) will be noted as (a) no CME or (b) CME present.

At the initial visit, a baseline questionnaire will be given to participants to gather background information on demographics and pertinent medical history. During each follow up visit, an additional questionnaire will be given to monitor changes in factors such as medications, blood pressure, and weight that may occur after bariatric surgery.

HbA1c measurements will be checked every 3 months in accordance with current standard of care recommendations. Due to established evidence of rapid improvement in glycemic control shortly after bariatric surgery, it is essential that the investigators have this lab data and perform funduscopic examinations at these intervals, to monitor improvement in glycemic control ascertain associations between changes in HbA1c levels and progression of retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* All patients, both male and female greater than 18 years old, with type 2 diabetes referred for bariatric surgery.

Exclusion Criteria:

* Patients will not be included in the study if they are pregnant, have HIV or any retinal vascular diseases (e.g. BRVO, CRVO) besides retinopathy.
Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study

Human immunodeficiency virus (HIV) is a major global health concern which has resulted in an estimated 39 million deaths world-wide. Although it is now a treatable medical condition there is still avoidable morbidity and mortality associated with HIV infection in the UK. Late diagnosis (CD4 count of \<350 cells/mm3 or AIDS-defining illness irrespective of CD4 count) is associated with increased morbidity and mortality, increased risk of transmission, impaired response to antiretroviral therapy and increased healthcare costs. In Grampian, 49% of patients were diagnosed late between 1984 and 2011. Therefore, the aim of the study is to determine the factors associated with late HIV diagnosis in Grampian between 2009 and 2014 to ascertain whether diagnoses could have been made earlier.

The study constitutes a secondary data analysis. Individuals newly diagnosed with HIV between January 2009 and December 2014 were identified from a Health Protection Scotland (HPS) database. The majority of outcome data were extracted from the existing HPS database. Missing data were collected via a retrospective review of patient case-notes, laboratory reports and an electronic patient management system. Patients were classified as early or late diagnosis and comparisons were made between the groups using statistical tests. The study sought to provide a basis for recommendations for improvement of information and services to facilitate earlier HIV diagnosis in Grampian.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with HIV between January 2009 and December 2014
* Individuals diagnosed in NHS Grampian

Exclusion Criteria:

* Individuals aged \< 16 years of age
Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality

Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well.

Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia.

This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.

Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive.

Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or above
2. Being diagnosed nail surface abnormalities stably more than 3 months

Exclusion Criteria:

1. Having severe or uncontrolled concomitant diseases
2. Having nail infection
3. History of manicure within the last 1 month
4. Use of Biotin or other nail modifying drugs within the previous 3 months
5. Pregnancy or lactation
The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence

We aimed to evaluate the efficacy of locally applied injectable platelet-rich fibrin in women with stress urinary incontinence. We searched whether there was a decrease in the severity of urinary incontinence after the injection of platelet-rich fibrin.

The participants will answer questionnaires about urinary incontinence before and after the injectable platelet-rich fibrin treatment.

Female patients with pure stress urinary incontinence who gave written informed consent after being informed about the study were included in the study. Two tubes of venous blood samples taken from the patients were centrifuged and injectable platelet-rich fibrin was prepared. The obtained autologous material was injected into the patient within one minute after preparation, without applying a local anesthetic. The injection was given to the anterior wall of the vagina, approximately 1.5 cm below the urethral meatus, coinciding with the mid-urethral region, and the dose was applied to three adjacent points. The procedure was repeated three times at one-month intervals. Before and after the procedure, ICIQ-SF, UDI-6, and IIQ-7 questionnaires were filled and the severity of urinary incontinence was recorded.

Eligibility Criteria:
Inclusion Criteria:

* The patient who has pure stress urinary incontinence

Exclusion Criteria:

* The patient who had previous surgery for stress urinary incontinence
* Known platelet dysfunction
* Anti-coagulant users
* Critical thrombocytopenia
The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia

We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.

For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high \[4\]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.

Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size \<80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-80 years
* prostate volumes of 50-120 ml
* sexually active
* severe LUTS
* \[Q max\] of \<10 ml/s
* \[IPSS\] of \>20)
* failed medical treatment with alpha blockers

Exclusion Criteria:

* prostate cancer
* Neurogenic bladder
* urethral stricture
* urinary bladder stone
* previous prostatic surgery.
Ultrasonographic Evaluation of the Effect of Occlusal Splint Treatment on Masseter Muscle Thickness in Children With Sleep Bruxism:A Clinical Pilot Study

The aim of this study was to evaluate the effectiveness of occlusal splint in pediatric bruxist patients by ultrasonic measurements of masseter muscle thickness and pain perception.

The aim of this study was to evaluate the effectiveness of occlusal splint by ultrasonographic measurements of masseter muscle thickness and pain perception in a group of pediatric bruxist patients. The study included patients aged 7 to 12 years, all in the mixed dentition period, with class I occlusion and diagnosed with probable bruxism. A 2 mm thick soft occlusal splint was prepared for each patient. Ultrasonic measurements were used to assess the thickness of the masseter muscle (MMT) at baseline, one, two and three months.Visual Analog Scale (VAS) was also used to record subjective pain measurements. Repeated-measures ANOVA and Friedman test were used in the statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of tooth clenching or grinding when sleeping at night or during the day, including headaches in the morning, as reported by parents during anamnesis.
* Attrition-type tooth wear, as well as discomfort, fatigue, and/or pain in the jaw muscles when palpated during a clinical examination. The clinical diagnosis of attrition was based on the following findings:

  * Shiny and flat facets.
  * The enamel and dentin wear at the same pace.
  * Wear patterns on opposing teeth's occlusal surfaces.
  * Possible breakage of cusps or restorations.
  * Impressions on the cheeks, tongue, or lips.

Exclusion Criteria:

* Children with any chronic/systemic/psychological disease, presence of TMD symptoms, lack of posterior teeth that may cause unilateral chewing, use of any medication that may affect muscle activity, dental malocclusions (any skeletal jaw problems in anteroposterior and vertical dimensions) and ongoing orthodontic treatment
Comparison of the Effectiveness of High-Intensity and Low-Intensity Laser Therapies in Primary Knee Osteoarthritis

Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.

In the study, those who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital outpatient clinic between 01.10.2020-01.10.2021, were between the ages of 55-75, were diagnosed with primary knee OA according to the American Rheumatology Association, stage 2-3 knee according to Kellgren and Lawrence radiological classification. with OA; 72 volunteer patients with knee pain with a visual pain score of 4 and above for at least 3 months were included. The study was designed as a prospective, randomized, controlled, single-center. Patients were randomly divided into 3 treatment groups. Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients in the first group, conventional treatment and HILT were applied to 24 patients in the second group, and conventional treatment and LLLT were applied to 24 patients in the third group. All groups were evaluated clinically and ultrasonographically at the beginning of the treatment, at the end of the treatment and at the 3rd month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age range of 55-75 years
* Primary knee OA diagnosis according to ACR (American College of Rheumatology) and Knee OA classified as stage 2-3 according to the KL (Kellgren-Lawrence) radiological classification
* Visual pain score of 4 or higher for knee pain lasting for at least 3 months

Exclusion Criteria:

* Patients with secondary knee OA
* Patients who have undergone surgical operations related to the knee joint
* Patients with pathology in the hip and/or ankle on the same side
* Patients who have received intra-articular corticosteroid, hyaluronic acid, or PRP injections in the knee joint in the last 6 months
* Patients who have received physical therapy for the knee region in the last 6 months
* Patients with serious systemic diseases such as malignancy, congestive heart failure, or chronic obstructive pulmonary disease
* Patients with insufficient cognitive function