cyrilzakka/clinical-trials huggingface dataset:
The Effects of Exercise Training in Vascular Function of Patients Living With HIV

Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.

Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.

Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.

Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.

HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.

Eligibility Criteria:
Inclusion Criteria:

* sedentarism for at least 6 months;
* diagnosis of HIV infection.

Exclusion Criteria:

* opportunistic diseases;
* nephropathies;
* cardiovascular diseases;
* locomotor limitations;
* liver diseases.
The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.

This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months. The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of Type 2 diabetes of at least three months duration
2. 50 years of age or older
3. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
4. Not taking or not expected to be taking any oral glucocorticoids (except for replacement therapy for those with adrenal insufficiency), amphetamines, anabolic, or weight-reducing agents during the course of the study
5. Not receiving chemotherapy or immunosuppressive therapy
6. Military healthcare beneficiary

Exclusion Criteria:

1. Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
2. Inability to communicate in written and spoken English
3. Organ (kidney, pancreas, liver) transplant recipients
4. Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
5. Pregnancy (Women who are pre-menopausal will be informed that pregnancy must be ruled out by a serum HCG test if they would like to be considered for participation in the study. Women who have had a hysterectomy or have not had a menstrual period for at least one year prior to consent will be considered post-menopausal and will not require a serum pregnancy test).
6. Patients who are routinely taking more than 81 mg aspirin (ASA)/day or who are using ASA or ASA-containing products to manage a chronic condition.
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

This will be a prospective, randomized, double blind trial enrolling patients who will undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either octreotide or placebo in the postoperative period. The patients will receive octreotide intravenously continuously for five days after operation. During this period the patients' health will be monitored by performing blood tests including complete metabolic profile, Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy and 3 months after hepatectomy to evaluate liver regeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have liver tumors requiring a major liver resection, defined as removing at least three anatomical segments in patients without liver disease and two segments in patients with cirrhosis/fibrosis of the liver.
2. Age \> 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
4. Patients must have acceptable organ and marrow function as defined below:

   * White Blood Cells \> 2,000/mcL
   * Absolute Neutrophil Count \> 1,000/mcL
   * Platelets \> 80,000/mcL
   * Alkaline Phosphatase \< 2.5 times institutional upper limit of normal
   * Aspartate Aminotransferase/Alanine aminotransferases \< 5 times institutional upper limit of normal
   * INR \< 1.5 times institutional upper limit of normal
5. Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
6. Q-T Interval of ≤ 450 ms as measured by EKG.

Exclusion Criteria:

1. Patients with known hypersensitivity to octreotide or somatostatin.
2. Patients who are receiving any other investigational agents.
3. Patients who are taking other medications that prolong QT interval.
4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
5. Pregnant or breast feeding.
Natural History Study of Patients With Hypophosphatasia (HPP)

Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective bone and teeth mineralization caused by mutations of the ALPL gene, which encodes for the tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and bone alkaline phosphatase levels. To date, over 250 different mutations in the gene encoding TNSALP have been associated with HPP. Clinically, the loss of TNSALP function results in progressive skeletal impact as well as progressive impact on all other major organ systems. It clinically manifests as rickets in infants and children and osteomalacia at all ages. The severe form of the disease has been estimated to have a prevalence of about 1 in every 100,000 live births.

Inheritance can be autosomal recessive or dominant, and penetrance is variable resulting in a wide range of clinical expressivity, with a spectrum ranging from stillbirth without mineralized bone to early loss of teeth without bone symptoms. Depending on the age at diagnosis six clinical forms are currently recognized: perinatal (lethal), perinatal benign, infantile, childhood, adult and odontohypophosphatasia. Severe forms of HPP (perinatal and infantile) are inherited as an autosomal recessive trait and in milder forms (adult and odontohypophosphatasia) autosomal recessive and autosomal dominant inheritance coexist.

Because of the rarity of HPP as well as the side spectrum of both clinical presentation and inheritance patterns of the HPP trait, a natural history study cataloging specific clinical data with HPP would prove invaluable for future research into this disease. Specifically, it is our goal to create a comprehensive multi-discipline modality for care for hypophosphatasia patients, researching clinical manifestations of the disease such as extent of bone disease, ophthalmologic manifestations, orthopedic issues, renal issues, musculoskeletal manifestations as well as other more anecdotal findings such as those seen with cochlear implant failures and/or early menopause.

Eligibility Criteria:
Inclusion Criteria:

* Patients or their legal representative must provide written informed consent or, if applicable, qualify for waiver of consent.
* Patients must have a pre-established clinical diagnosis of HPP, as indicated by one or more of the following:

  * Serum alkaline phosphatase (ALP) below the age-adjusted normal range
  * Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered for at least 1 week prior to determination)
  * Evidence of osteopenia or osteomalacia on skeletal radiographs
  * Genetic analysis fof the ALPL gene
* Must be current patient in the Duke University System.

Exclusion Criteria:

* Any patient without confirmation of clinical diagnosis of HPP.
Assessing the Effects of ELO Water on Diabetic Foot Ulcers

This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.

As hyperbaric chamber and topical oxygen therapies have demonstrated efficacy in improving DFU healing, the aim of this study was to evaluate ELO water, which has been shown to increase arterial oxygen levels, as a novel means of increasing oxygen delivery to poorly-healing DFUs as an adjunct to standard care. This proof-of-concept pilot study of drinking oxygen-enriched ELO water to treat diabetic foot ulcers (DFUs) was conducted on 16 adults with non-healing (for at least 30 days prior to the study) DFUs in Changi General Hospital in Singapore.

ELO water was delivered to participants' homes and their water consumption recorded in diaries, which was checked by the research co-ordinator at 2-weekly visits for 12 weeks. Minimum compliance was defined to be at least 85% of the water (12/14 bottles/fortnight), equivalent to 9 litres/week. No changes in diabetic therapy, diet or exercise were made during the study period.

All participants were seen by podiatrist for standard of care DFU treatment weekly. The ulcer size was captured following wound debridement each week using a standardized digital photographic protocol and the photos were encrypted and anonymized for confidentiality and data protection. All the images were assessed independently. Wound dressing was carried out twice per week in between visits at primary care clinics or at home.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes and haemoglobin A1c (HbA1c) at screening of 7.0-10.0% on oral glucose-lowering medication and/or insulin at a stable dose for the last three months

Exclusion Criteria:

* pregnant or lactating
* conditions which would independently worsen ulcer healing such as severe peripheral vascular disease or varicose veins
* immunosuppressive therapy
* comorbidities necessitating fluid restriction such as renal, liver or cardiac failure.
The Effect of Melatonin on Nocturnal Enuresis

Aim: To investigate the effect of melatonin in bedwetting.

Design: Double blind randomized placebocontrolled trial using crossover.

Eligibility Criteria:
Inclusion Criteria:

* Monosymptomatic nocturnal enuresis
* Age 6-14 years
* Clinical examination normal
* ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output

Exclusion Criteria:

* Constipation (by ROME III criteria)
* Day incontinence
* Overactive bladder (ICCS 2008 classification of symptoms)
* Current or past history of clinical or laboratory findings that can be related to diseases or - conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder.
* Clinical signs of urinary tract infection
* Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff
* Set treatment with one or more drugs
RCT on Telerehabilitation Efficacy in Parkinson's Disease

The implementation of regular prolonged, and effective rehabilitation in people with Parkinson's disease is essential for ensuring a good quality of life. However, the continuity of rehabilitation care may find barriers related to economic, geographic, and social issues. In these scenarios, telerehabilitation could be a possible solution to guarantee the continuity of care.

This trial aims to investigate the efficacy of non-immersive virtual reality-based telerehabilitation on postural stability in people with Parkinson's disease, compared to at-home conventional rehabilitation.

Parkinson's Disease (PD) is a chronic degenerative pathology characterized by both motor and non-motor symptoms that may have a significant long-term impact on Activities of Daily Living (ADL).

Subjects with PD need continuous, intensive, and tailored rehabilitation in order to improve motor function as well as their Quality of Life (QoL), and to reduce the risk of balance impairment and falls. Thus, the implementation of regular prolonged, and effective rehabilitation in people with PD is essential for ensuring well-being.

In this scenario, the delivery of rehabilitation services at distance, namely TeleRehabilitation (TR), is a possible solution to guarantee the continuity of care and physical exercise at home via digital healthcare.

Although the TR intervention has been proposed as a sustainable and innovative approach in people with PD, there are still conflicting results in the literature about its efficacy.

This study aims to investigate the efficacy of non-immersive VR-based TR on postural stability in people with PD, compared to at-home conventional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr (H\&Y) score between ≤3 (ON-state);
* the absence of moderate and severe dyskinesias assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with a score of items 4.1 and 4.2 \< 3;
* the absence of moderate and severe freezing episodes assessed by the MDS-UPDRS with a score of items 2.13 and 3.11 \< 3;
* the ability to perform the 6 Minutes Walking Test (6MWT) between 200 m and 600 m;
* age ≤ 80 years;
* the absence of cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) total score≥17.54 ;
* stabilized drug treatment;
* sufficient cognitive and linguistic level to understand and comply with study procedures;
* sign informed consent.

Exclusion Criteria:

* other neurological pathologies, psychiatric complications, or personality disorders;
* blurred or low vision problems;
* hearing and speech impairment affecting participation in the study.
Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance

The aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance

Hypothyroidism happens when the thyroid does not create and release enough thyroid hormone in the body this make the metabolism slow down .

Thyroid hormones T3 and T4 maintain a fine balance of glucose homeostasis by acting as insulin agonistic and antagonistic. Hypothyroidism can break this equilibrium and alter glucose metabolism, which can lead to insulin resistance.

Insulin resistance is defined clinically as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization in an individual as much as it does in a normal population.

In this work we assess the lifestyle modification (i.e. diet and exercise)and metformin on insulin resistance

Eligibility Criteria:
Inclusion Criteria:

* 1_ above 18 years with insulin resistance criteria according (The American Association of Clinical Endocrinologists (AACE)

  * 1)BMI of 25 kg/m2 or higher
  * 2)Waist circumference of more than 102 cm in men or more than 88 cm in women
  * 3)Triglyceride level of 150 mg/dl . or higher.
  * 4) HDL-C level of less than 40 mg/dl in men or less than 50 mg/dl in women
  * 5)Blood pressure of 130 /85 mmhg or higher
  * 6)Fasting glucose level of 110 ـ126 mg /dl
  * 7)Glucose level of more than 140 mg/dl2 hour after administration of 75 g of glucose

    2_ Patients known to have hypothyroidism and achieving diagnostic criteria of insulin resistance

Exclusion Criteria:

* Patients don't have other secondary causes of insulin resistance i.e. acromegaly, Cushing syndrome 3- patient have renal or hepatic impairment (contraindication to metformin )
Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 years or older at enrolment
* Who are treated for IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
* Who are prescribed REKOVELLE for the first time and using the dosing algorithm to define the dose regimen: a previous cycle with REKOVELLE should not be allowed
* Who have been informed verbally and in writing about this study content and who do not object to their data being electronically processed.

Exclusion Criteria:

* Participating in an interventional clinical trial in which any treatment or follow-up is mandated
* Women with a contraindication for prescription of REKOVELLE treatment
* Oocyte donors
* Women undergoing ovarian stimulation for fertility preservation
* Women undergoing their third or fourth attempt of IVF or ICSI for the current parental project.
* Subject non-affiliated to French Social Security
* Women placed under judicial protection, guardianship, or supervision
Direct Use of Non-centrifuged Autologous Fat Graft

There are a limited number of reports related to the direct use of non-centrifuged adipose tissue graft in the literature. This preliminary study aims to present our experience on the efficacy of autologous fat graft use without centrifuging in the treatment of lower extremity wounds.

16 wounds treated with non-centrifuged autologous fat grafts were included in the study. The data were retrospectively analyzed. VAC (vacuum-assisted therapy) or silver-impregnated dressing was used to achieve a healthy wound bed before fat grafting. Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.

Eligibility Criteria:
Inclusion Criteria:

1. diabetic,
2. venous
3. traumatic wounds

Exclusion Criteria:

1. Malignancy,
2. A life expectation \<1 year,
3. Chemical or radiation exposure.
4. Pregnancy
Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.

This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with distal subungual onychomycosis of the great toenail. Patients will receive four PDT treatments with PD P 506 A in weekly intervals.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 - 75 years of age
* Females up to an age of 75 years provided that they are postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months or not of childbearing potential because of tubal ligation or hysterectomy
* DSO of at least one of the great toe(s) affecting 20% to 60% of the target nail without spikes, confirmed before Visit 1 by at least one of the three methods: the methods of KOH test, periodic acid-Schiff (PAS) stain and mycology culture
* The toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte)
* Toenails have to be cut regularly (indicator for existing growth)
* Signed written informed consent

Exclusion Criteria:

* Patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold
* Presence of dermatophytoma (defined as demarcated and localised thick masses (≥ 3 mm) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
* Other conditions than DSO known to cause abnormal nail appearance
* Topical antifungal treatment of the nails within 1 month before PDT
* Systemic use of antifungal treatment within 3 months before PDT
* Patients who are unwilling to provide nail clippings
* Patients who have been previously reported to be allergic against 5-aminolevulinic acid or other ingredients of PD P 506 A
* Diagnosis of porphyria
* Diagnosis of polyneuropathy
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment