cyrilzakka/clinical-trials huggingface dataset:
Bone Properties Following Exercise Induced Changes in Insulin Sensitivity in People with Type 2 Diabetes

Diabetes mellitus type 2 is associated with low bone turnover and increased risk of bone fractures.

Bone mineral density, however, is increased and cannot explain the increased fracture risk per se. The pathophysiology is not completely understood, but the decrease in bone turnover is believed to cause an accumulation of microcracks in bone tissue leading to bone fragility. The decrease in bone turnover may arise directly from insulin resistance or indirectly through formation of advanced glycation end-products.

The main aim objective is to investigate how increases in insulin sensitivity following 12 weeks of moderate intensity bike exercise affect biochemical bone turnover markers and biomechanical bone properties in individuals with diabetes mellitus type 2.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2
* Age ≥ 45 years
* Male or female sex
* Women must be postmenopausal

Exclusion Criteria:

* Recent substantial changes in diet (within 3 months)
* Recent substantial changes in activity level (within 3 months)
* Recent substantial weight changes (within 3 months)
* Current or previous treatment (within the last 2 years) with non-oral anti-diabetics or oral GLP-1 analogs
* HbA1c ≥ 90 mmol/mol
* HbA1c \< 48 mmol/mol without anti-diabetic medication
* Premature menopause (menopause before 40 years of age)
* Current pregnancy
* Treatment with one of the following medications:

  * Systemic glucocorticoids (within the last 2 years)
  * Antiresorptive or bone anabolic medication (ever)
  * Lithium (ever)
  * Anticonvulsive medication (current)
  * Menopausal replacement therapy (currently)
* Estimered glomerular filtrationsrate (eGFR) \< 60 mL/minutes
* High level of physical activity, assessed by the investigators to interfere with the study results
* Substantial cardiovascular, endocrine, renal, hepatic, rheumatological, gastrointestinal or other disorders assessed by the investigator
* Electronic implants
* Osteoporosis or other bone disease
* Resent bone fracture (within 6 months)
* Previous bone fracture in either both tibial bones or both radial bones
* Parathyroid or calcium metabolism disorder
* Vitamin D deficiency (\< 50 nmol/L)
* Other substantial medical disorder in unstable phase or active cancer within the last five years except spino- or basocellular carcinoma
* Lack of ability to complete the intervention
* Patients assessed uneligible by the investigator to participate in the study
Platelet Rich Therapy for Scar Revision

This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.

Platelet therapy is quickly becoming an integral aspect of both medical and cosmetic procedures. Most notably, Platelet Rich Plasma (PRP) has been used in surgical settings to stimulate healing and promote tissue regeneration. In the field of cosmetic medicine, PRP has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss therapies, laser treatments, and microneedling. Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis. Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams. Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated. These properties make PRF useful in reconstructive and aesthetic medicine but may also be beneficial for scar therapy in the same way PRP is currently used.The purpose of this study is to evaluate the efficacy of platelet rich plasma vs. platelet rich fibrin for scar therapy in abdominoplasty who are at least one-year post operation.

Eligibility Criteria:
Inclusion Criteria:

* Ten (10) subjects
* male and female abdominoplasty procedures at least one year ago.
* must be able to provide healthy blood sample
* must be available for the duration of the study and all follow ups (12 months).

Exclusion Criteria:

* Pregnant and breast-feeding patients are not eligible for this study due to unstudied effects of injectables on the growing fetus and/or breast milk.
* patients who have undergone other scar therapies for the same scar.
* chronic health problems that may prevent the investigators from obtaining a viable blood sample,
* topical infection,
* any subjects who intend to have other scar procedures during the timeline of the study (12 months including punch biopsy procedures 3 months post treatment and 6 months post treatment).
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke

The main aim of this oral health intervention project is to compare the effect of providing 1) professional oral hygiene instruction alone versus 2) professional oral hygiene instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the oral health condition, the general health condition and health-related quality of life (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An additional aim is to assess potential longer term oral intervention-related health and HRQoL outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years and over
* Moderate to severe stroke (Barthel Index \>/= 70)
* Admitted to Rehabilitation Unit within 7 days

Exclusion Criteria:

* Patients with naso-gastric feeding tube
* Edentulous patients
* Patients with communication difficulties
Ventilator Hyperinflation With Increase of Inspiratory Time

The investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients under mechanical ventilation for more than 48h
* Mucus hypersecretion (defined as the need for suctioning \< 2-h intervals)

Exclusion Criteria:

* Severe bronchospasm,
* Positive end expiratory pressure \> 10cmH2O,
* PaO2-FiO2 relationship \< 150,
* Mean arterial pressure \< 60mmHg,
* Pleural effusion or pneumothorax undrained,
* Bronchopleural or tracheoesophageal fistula,
* Decompensated congestive heart failure.
Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis

This study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.

Arsenicosis has emerged as one of the main and hazardous public health problem in Bangladesh. Melanosis and keratosis are the most common manifestations of arsenicosis. The exact mechanism of development of keratosis is not clear. With chronic ingestion of arsenic contaminated water the excretion of arsenic through skin increases and also the oxidative stress, which in turn cause cellular damage. These changes may influence the growth of normal bacteria and consistency of skin, which may be responsible for keratosis. In different study results shown that, vitamin E, a potential antioxidant that halts lipid peroxidation and maintains cell membrane integrity, also detoxified arsenic from the body. Normal skin bacteria mainly composed of Gram +ve bacteria. In arsenicosis, this pattern changes from Gram +ve bacteria to Gram -ve bacteria. Still now no study have been conducted to see, the effect of vitamin E on skin bacteria in arsenicosis, as skin bacteria changes. Therefore, this study will be conducted to observe any change in aerobic bacterial pattern on the skin of arsenicosis before and after administration of vitamin E capsules. Fifteen patients with skin manifestations, 15 arsenic exposed control, 15 healthy volunteers will be recruited on the basis of inclusion and exclusion criteria. They will be provide vitamin E capsules 200 IU twice daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin samples will be collected two times (before and after giving vitamin E) for qualitative analysis of bacteria. All the patients, arsenic exposed controls and healthy subjects will be provided with same capsule in same dosage schedule. So, this study will find any change of skin bacteria pattern after administrating vitamin E capsule.

Eligibility Criteria:
Inclusion Criteria (Patients):

* History of drinking arsenic contaminated water (\>50 µg/L) for more than 6 months
* Patients having moderate palmar keratosis
* Patients those voluntarily agree to participate

Inclusion Criteria (Arsenic exposed controls):

* Family members of the patient
* History of drinking arsenic contaminated water (\>50 µg/L)
* Those voluntarily agree to participate
* No sign/symptoms of palmar keratosis

Inclusion Criteria (Healthy volunteers):

* Drinking arsenic safe water (\<50 µg/L)
* Those voluntarily agree to participate

Exclusion Criteria:

* Pregnant and lactating mother
* Any other chronic disease like tuberculosis, diabetes, asthma
* Patients under treatment of arsenicosis
Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program

The aim of this study is to assess changes in body and metabolism caused by this new five-day hypocaloric and ketogenic programme

Therapeutic effects of fasting are increasingly documented. Recent studies on a cohort of subjects doing a long-term fasting lasting from 4 days to several weeks demonstrated beneficial effects on health and well-being. In recent studies on the therapeutic efficacy of the Buchinger Wilhelmi fasting program, long-term fasting significantly improved risk factors for a variety of chronic diseases including hypertension even in medicated subjects, liver steatosis, inflammation, oxidative stress and lipoprotein distribution.

There is an increasing demand for dietary interventions which can be delivered at home. This has been amplified by the Coronavirus-19 disease (COVID-19) pandemic during which many countries kept their population in lockdown at home in isolation. The COVID-19 pandemic has also influenced the lifestyle of individuals, with an increased consumption of unhealthy food and a sedentary behaviour resulting in mental (anxiety, depression, and others) and physical (weight gain, rise in blood pressure) health issues. In order to adapt to this new context, the Buchinger Wilhelmi Clinics have created a hypocaloric, ketogenic program with interval fasting.

The five-day programme is designed to be easily integrated into everyday life and can be applied several times a year. The programme is based on ready-to-eat soups made with locally sourced organic ingredients. The ingredients represent a total daily intake of around 600 kcal per day - with a high share of fats and a limited quantity of carbohydrates and proteins. Minerals and micronutrients used at the Buchinger Wilhelmi Clinics are also supplied. Although the comprehensive medical care and assistance offered at the clinics cannot be replicated, medical professionals are available to support the customers remotely.

The investigators hypothesise that the metabolic changes caused by this new five-day programme can be similar to a short-term fast. In order to test this hypothesis, the investigators will perform a two-arm randomized controlled trial in which a group of participants will perform the five-day Fastingbox programme and a group of participants will receive an eucaloric diet as a control group.

Eligibility Criteria:
Exclusion Criteria:

* Not able to sign the informed consent
* diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency.
* Intake of antibiotics up to 2 months prior the study
* Medicated high blood pressure
* Diagnosed hyperuricemia
* Diagnosed diabetes mellitus type I and II
* Diagnosed kidney stone
* Active malignant diseases
* Known substance addiction
* Pregnancy or breastfeeding
* Participation in another study
Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.

It will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + L-arginine acetylsalicylic acid or acid + placebo). At the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. The data obtained were analyzed using SPSS statistical software version 22. It was considered statistically significant at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant before 12 weeks of gestation
* High risk of preeclampsia
* Signature of informed consent in writing

Exclusion Criteria:

* Noncompliance \> 20% of drug intake
* Lack of tolerability L-arginine or acetylsalicylic acid
* Compliance with at least one non-inclusion criteria during the course of the study
* Serious adverse event
* Withdrawal of consent
MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer

RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy.

PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.

OBJECTIVES:

* To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time).
* To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis).

OUTLINE: This is a multicenter study.

Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed, histologically proven breast cancer

  * Stage T2-4B, N0-3C, and M0 disease
  * Locally advanced primary disease
* Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
* Scheduled for neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Medically stable
* No renal failure
* No serious breast trauma within the past 3 months
* No known allergic reaction associated with previous administration of a paramagnetic contrast agent
* No known contraindication to magnetic resonance (MR) scanning

  * Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
  * No disability preventing MR scanning in the prone position
  * No body habitus incompatible with MR system entry

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy
* No prior surgery or radiotherapy for cancer in the ipsilateral breast

  * More than 4 months since prior surgery to the ipsilateral breast for benign breast disease
Tolerability Study of Xerecept® in Pediatric Patients

This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.

Steroid-related side effects are much more severe in a pediatric population than they are in adults. The side effects appear more quickly and are often apparent in as few as 14 days. Dexamethasone side effects in children include rounding of the face, acne, increased body hair, muscle weakness, osteoporosis, mood changes, weight gain, fluid retention, glucose instability, high blood pressure, increased susceptibility to infection, stunted growth and aseptic necrosis of the hip joints14-16.

Although extensive studies have been performed with Xerecept® in adults, no studies have been performed with Xerecept® in pediatric subjects. Therefore, this study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials. The study will also explore if Xerecept®, when administered to pediatric patients, is effective in allowing decreases in dexamethasone dosing

Eligibility Criteria:
Inclusion Criteria:

1. Have histologically confirmed primary, recurrent or metastatic cerebral tumors and require chronic steroid dosing to manage symptoms of peritumoral brain edema (No histological confirmation is required of optic pathway tumors or brain stem gliomas)
2. Have been taking dexamethasone (or equivalent) at a dose of ≥1 mg/day for a minimum of 14 days and have had a stable dose for at least 7 days.
3. Have one or more steroid-associated side effects at Screening (See Appendix A1 for a list of qualifying events)
4. Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
5. Karnofsky/Lansky performance status ≥ 40
6. Life expectancy of at least 6 months
7. Female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study

10. Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed

Exclusion Criteria:

1. Evidence of previous or current overt renal, hepatic or pulmonary diseases or active uncontrolled infection
2. Subject and/or parent/guardian is unwilling or unable to comply with this protocol
3. Subject has a known history of allergy or intolerance to hCRF or other ingredients in the Xerecept® solution (e.g., methionine, mannitol)
4. Subject has a known history of hepatitis C virus, hepatitis B surface, or human immunodeficiency virus (HIV).
Asthma Control Study 2011

Asthma control study 2011


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients above 18 y

Exclusion Criteria:

* COPD
* pulmonary cancer
* pulmonary tuberculosis
Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.

The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC).

Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer.

Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC).

Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent/assent for the trial.
* Capability to understand and comply with the protocol and signed informed consent document.
* Be ≥ 18 years of age on day of signing informed consent.
* Have measurable disease based on RECIST 1.1.
* Histologically confirmed, non-metastatic adenocarcinoma of the prostate
* Prostatectomy with extended lymph node dissection planned as primary therapy
* 10 year or longer life expectancy based on other co-morbidities
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Any one of the following three high risk features:

  * Gleason grade \> 8-10
  * PSA \> 20 ng/ml
  * Clinical stage T3a (resectable)
* No evidence of metastases .
* No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago).
* Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
* Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.