cyrilzakka/clinical-trials huggingface dataset:
Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

The investigators will enroll 40 female, postmenopausal, patients with T1DM, fracturing or non-fracturing, who are age 50 and over, and have had diabetes for more than ten years. The investigators will perform 2 transiliac (hip bone) biopsies on each subject, one for mechanical testing, tissue analysis of AGEs, enzymatic crosslinks and bone tissue-bound water in cortical bone, and the other for histomorphometry and high-resolution 3D imaging in trabecular bone. A matched, non-diabetic, healthy control will be enrolled at the time each T1DM is enrolled.

Eligibility Criteria:
Inclusion Criteria:

Criteria for enrollment of female diabetics

1. No chronic disease diagnoses that may affect bone, as confirmed by the PI.
2. Normal clinical history, physical, and clinical laboratory exam (except for usual complications of a 10+-year diabetic, i.e., \~minimal neuropathy or retinopathy, known, but asymptomatic mild vascular disease, etc.)
3. Glomelular Filtration Rate (GFR) \&amp;gt;45 ml/min (Renal Association lower limit for "mild" kidney failure).
4. Willingness to sign a consent form.
5. Willingness to undergo a transilial bone biopsy incision that yields 2 bone specimens.
6. No abnormalities in clinical blood chemistry measurements (small, age-related decreases in GFR, will be permitted).
7. Caucasian

Criteria for each non-diabetic subject, compared to their matched diabetic:

1. Dual-energy x-ray absorptiometry (DXA) measures (BMD, gm/cm) must be within +/- 15% in total hip.
2. Body mass index (BMI) must be within +/-10%.
3. Age must be within +/- 5 years.
4. Caucasian

Exclusion Criteria:

1. Women who have had Type 1 diabetes for less than 10 years.
2. Non-insulin dependent Type 1 diabetic.
3. Less than 50 years old.
4. Less than 5 years post menopausal.
Drotaverine in Dysmenorrhoea Treatment

The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.


Eligibility Criteria:
Inclusion Criteria:

* History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
* With regular menstrual cycles (25-35 days)
* Using an adequate barrier contraception method (except for virgins)

Exclusion Criteria:

* Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
* Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
* Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
* Oestro-progestative contraception within the last 2 months
* Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
* History or evidence of acute or chronic alcohol abuse
* Heavy smoking (\> 10 cigarettes/day)
* Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
* Lactation
* Pregnancy
* Participation in another clinical trial in the last 3 months prior to the start of this study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.

the investigators explore the possible role of DMSA to detect renal affection in diabetic \&/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control \& diabetic \&/or hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* • Patients with diabetes (type2), weather controlled or not.

  * Patients with essential hypertension.
  * Patients with diabetes \& hypertension.
  * Within normal renal function (urea \& creatinine).
  * Control cases may be normal individuals (apparently healthy) like donors for renal transplant.

Exclusion Criteria:

* • Patients with abnormal renal function.

  * Patients with diseases known to affect kidney function rather diabetes \& hypertension e.g. SLE, heart failure or liver cell failure.
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

This study is designed as two sequential trials. The first is a phase I open label trial to evaluate the safety and tolerability of MAT2203. The maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. The Phase II trial will investigate toxicity and early fungicidal activity (EFA) of MAT2203 with flucytosine.

Cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic infections in HIV patients. Historically, amphotericin B (AMB) has been considered the "gold standard" in antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance. However, the use of AMB is limited by side effects, including nephrotoxicity, anemia, and infusion-related reactions. MAT2203 or encochleated oral amphotericin B (cAMB) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug AMB for treatment of fungal and parasitic infections.

Eligibility Criteria:
Inclusion Criteria:

* Phase 1:

  * Age \>18 years
  * Calculated creatinine clearance \>70 mL/min/1.73 m2 (measured within 3 months)
  * Written informed consent

Phase 2:

* Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

* Phase 1:

  * Symptomatic Current illness
  * Known significant, untreated health problem
  * Inability to take enteral medicine
  * Pregnant or breast feeding
  * Receiving amphotericin B therapy in past 90 days
* Phase 2:

  * Presenting Glasgow Coma Scale (GCS) \< 15
  * Received 3 or more doses of IV amphotericin therapy within last 30 days
  * Inability to take enteral (oral or nasogastric) medicine
  * Cannot or unlikely to attend regular clinic visits
  * Pregnancy or breastfeeding
  * Receiving chemotherapy or corticosteroids
  * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
  * Recent initiation of HIV therapy or ART class switch (within 2 weeks)
Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension

Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (major bleeding).

In this study, patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (bleeding).

The only one study scaling the tolerance of anticoagulants for this population found major hemorrhagic levels discording with the clinical practice : really high for connectives associated to pulmonary arterial hypertension (PAHT), and lower in "simple" pulmonary embolism in CTE-PHT. These discoveries could belong to methodological failures of this study: a retrospective, monocentric one, without adjudication of events by an independent committee. Furthermore, there were no information about the existence of a validated indication for anticoagulant treatments.

Patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

Eligibility Criteria:
Inclusion Criteria:

* Patient insured or entitled to a social security scheme;
* Patient with confirmed pulmonary hypertension;
* Pulmonary hypertension among the following etiological diagnosis: idiopathic PAH, PAH associated with appetite suppressants, PAH associated with connective, or Chronic Thrombo-embolism Pulmonary Hypertension;
* Patients receiving oral anticoagulants.

Exclusion Criteria:

* Impossible following;
* Bleeding at baseline;
* Life expectancy of less than 3 months;
* Pulmonary hypertension in Group 2, Group 3 (in the absence of associated pulmonary embolism) and Group 5 (in the absence of associated pulmonary embolism).
Comparison of Sensory Analysis After Superficial and Deep Parasternal Intercostal Plane Blocks

Postoperative pain following cardiac surgery is a common issue that can negatively impact patients' quality of life. Effective perioperative pain management is crucial to improving patient outcomes. Pain is typically most intense during the first two postoperative days, and inadequate management can lead to chronic pain, further diminishing quality of life. Recent advances in ultrasound-guided regional anesthesia, including superficial and deep parasternal intercostal plane blocks, have enhanced acute pain control. These blocks aim to provide analgesia by targeting the anterior cutaneous branches of the T2-6 thoracic nerves. While their efficacy is recognized, sensory evaluation and dermatomal analysis remain unexplored. Cadaver studies suggest that the deep block may cover more parasternal space than the superficial block.

This observational study evaluates sensory blocks in patients undergoing open-heart surgery who receive superficial or deep parasternal intercostal plane blocks. Sensory assessment, conducted by a blinded researcher 30 minutes post-block, involves applying small ice tubes with cold sensations categorized as Normal, Reduced, or No cold. A successful block is defined as the loss or reduction of cold sensitivity, while normal cold sensation indicates block failure. Assessments start at the midline, moving laterally to the anterior axillary line. Marked areas are digitally analyzed. Block regression is evaluated at 12 and 24 hours post-procedure using the same cold assessment criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo effective open heart surgery with median sternotomy
* Patients who have undergone superficial or deep parasternal intercostal plane block

Exclusion Criteria:

* Patients with severe psychiatric illnesses such as psychosis or dementia that would prevent communication with the patient
* Patients who do not want to participate in the study
* Redo surgeries
* Patients whose block is considered unsuccessful with the cold application test at the 30th minute
* Patients who cannot be extubated 12 hours post-block.
Post-Hysterectomy Nursing Support Program

Objective: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy.

Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially.

Method: The study is a single blind, randomized controlled study conducted at the Department of Obstetrics and Gynecology in a university hospital between November 2017 and November 2018. 60 women who had hysterectomy were divided into experimental and control groups and It was evaluated on the 1-2 day, 6-7 day and 2nd month. In the study, the nursing support program was applied only to women in the experimental group.

Aim: This study was conducted to evaluate the effectiveness of the nursing support program developed for women who had hysterectomy.

Methods: A prospective, randomised controlled study was conducted in the gynaecology clinic of a university hospital between November 2017 and November 2018. It was conducted in a single-blind, randomised controlled trial with a total of 60 women in the experimental and control groups. A nursing support program had been developed for women who have had a hysterectomy. The program developed for the experimental group and the routine program for routine maintenance and control group were applied. The initial evaluation was carried out postoperative on the 1st-2nd day, the second assessment was carried out on the 6th-7th day and the third evaluation was carried out at 2 months. The first interview was carried out in the hospital, and the second and third interviews were carried out with home visits. The sociodemographic data form, postoperative evaluation form, Female Sexual Function Index (FSFI), Epidemiological Studies and Central Depression Scale (EAMDS), Menopausal Symptoms Evaluation Scale (MSDS) and SF-12 quality of life scale were used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis benign hysterectomy and bilateral oophorectomy
* Having no communication problems.

Exclusion Criteria:

* Clinical diagnosis vaginal hysterectomy
* Clinical diagnosis psychiatric disorders and therefore used drugs
Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People

Describe the frequency of use of nutrition education tools for undernourished older people

The description of the population will identify the characteristics of patients who use the tools and guide their use in patient care. To realize an impact assessment, It necessary to identify specific criteria for inclusion. It is important initially to assess the use of the nutritional tools. The assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.

Eligibility Criteria:
Inclusion Criteria:

* Subject of 75 years or more.
* Hospitalized geriatric day hospital.
* Living at home, within a radius of 40 km around the hospital Xavier Arnozan.
* Subject or caregiver (s) read, understand and speak the french.
* Undernutrition (criteria of the French high authority for health (HAS) 2007)
* Agreed to participate in the study: compendium of the opposition

Exclusion Criteria:

* Subject not wishing to participate in the study,
* MMSE (Mini Mental State Examination) \< 20, without presence of a caregiver with no cognitive problems scoring.
* Identified palliative care.
* Presenting a contraindication to oral feeding.
* Presence of supply of enteral or parenteral.
* Presence with a diagnosis of severe psychiatric pathology.
* Already participating in a study on undernutrition.
* One against medical advice.
Bone Microcirculation After Extracorporeal Shock Wave Therapy

In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human in-vivo setting for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid.
* Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
* Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid.
* Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

* below 18 years of age
* scar tissue above scaphoid or metacarpal bone
* osteoporosis or comparable bone disease
* medication that influences bones
FAPI PET for Lung Fibrosis

This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD).

The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease.

The study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung.

The study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview.

Participants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan and one High Resolution CT of the lungs.

The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.

ILD is a group of respiratory diseases that affect the interstitium of the lungs. A major problem is the highly variable course of fibrosing ILD: some patients remain stable without treatment, and others progress rapidly despite pharmacotherapy.

Novel diagnostic approaches for risk stratification with more accurate prediction of the course of fibrosing ILD could potentially improve prognostication and ultimately lead to better survival in these patients.

Persistent activation and local accumulation of myofibroblasts is a common feature of fibrotic diseases. FAP is a promising target for molecular imaging of fibroblast activation and detection of sites of active tissue remodeling.

Small molecule inhibitors of FAP have been labeled with positron-emitting isotopes for PET imaging. 68Ga-FAPi-46 can serve as diagnostic biomarker in ILD.

In this study, the investigators will evaluate the 68Ga-FAPi-46 biodistribution in patients with ILD and observe the correlation of FAP expression and FAPi radiopharmaceutical uptake.

The primary objective of this study is to evaluate the biodistribution of the new FAP-targeted PET tracer, 68Ga-FAPi- 46, in patients with ILD.

OUTLINE:

1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs
2. Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)
3. Biodistribution results will be assessed comparing pathological findings and PET/CT results

Eligibility Criteria:
Inclusion criteria

* Patients with ILD confirmed by CT at time of staging
* Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR Patients who are scheduled to undergo tissue biopsy or surgery of the lung
* Patients are ≥ 18 years old at the time of the radiotracer administration
* Patient can provide written informed consent

Exclusion criteria

* Patient is pregnant or nursing
* Patients with active infectious lung disease
* Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia

In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* Any condition possibly affecting drug absorption (e.g. gastrectomy).
Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain

Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered.

In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to provide informed consent to participate in the study;
* Subject is 21 years of age or older;
* Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief \>50% for chronic intractable pain;
* Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study

Exclusion Criteria:

* Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
* Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study
Diagnosis of Latent Tuberculosis(TB) Infection in Health Care Workers Using TST and Whole Blood Interferon-γ Assay

The investigators think that the health care workers who contact frequently with active tuberculosis patients have more increased prevalence of LTBI compared with those who don't.


Eligibility Criteria:
Inclusion Criteria:

* health care workers

Exclusion Criteria:

* active pulmonary tuberculosis
* previous Tuberculosis history
* below 20 years old
* history of hypersensitivity about PPD
* pregnant