cyrilzakka/clinical-trials huggingface dataset:
Osteosarcopenia and Exercise

The purpose of this study is to assess the efficacy of combination of aerobic and resistive exercise on activities of daily living and risk of fall in osteosarcopenic patients

After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.

to begin with: assessment with bioelectrical body composition analyzer and first exercise and assessment clinical scales

1th month: assessment with bioelectrical body composition analyzer and assessment clinical scales 3th month: assessment with bioelectrical body composition analyzer and assessment clinical scales

Eligibility Criteria:
Inclusion Criteria:

* Over 70 years of age
* Clinical diagnosis of osteoporosis or osteopenia
* Independent mobilization
* Walking speed \< 0.8 m / sec
* Grip strength \< 20 kg for women, \< 30 kg for men

Exclusion Criteria:

* Uncontrolled hypertension (systolic blood pressure\> 200 mmHg, diastolic blood pressure\> 110 mmHg)
* Uncontrolled diabetes mellitus
* Stroke, hip fracture, knee and hip arthroplasty, spinal surgery in the last 6 months
* Severe cardiac arrhythmia
* Myocardial infarction in the last 6 months
* Severe dementia and difficulties in cooperation
* Cardiac pacemaker
* Dialysis
* Acute infection
* Severe edema
* Malignancy patients
* Severe anemia (Hgb \<8 mg / dl)
Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma

This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.

PRIMARY OBJECTIVES:

I. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \[ADCL\] \> 1.24 um\^2/ms) will have higher DCN protein expression compared with tumors exhibiting low diffusion measurements (ADCL \< 1.24 um\^2/ms.) (Aim 1A) II. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \[ADCL\] \> 1.24 um\^2/ms) will have higher deoxyribonucleic acid (DNA) expression compared with tumors exhibiting low diffusion measurements (ADCL \< 1.24 um\^2/ms.) (Aim 1B) III. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient \[ADCL\] \> 1.24 um\^2/ms) will have higher ribonucleic acid (RNA) expression compared with tumors exhibiting low diffusion measurements (ADCL \< 1.24 um\^2/ms.) (Aim 1C) IV. Mesenchymal-Like (MES-like) cells will have higher frequency of incidence of tumors with high diffusion measurements (ADCL \> 1.24 um\^2/ms) and higher overall DCN expression levels compared to other genotypes.

SECONDARY OBJECTIVE:

I. DCN immunohistochemistry (IHC), in-situ hybridization (ISH), and RNA expression within the tumor will be linearly correlated with continuous values of diffusion measurements (ADCL).

OUTLINE:

Patients undergo one MRI scan over approximately 1 hour prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Patients with newly diagnosed, suspected or recurrent glioblastoma (GBM) patients with enhancing tumors greater than 1.5 mL clinically indicated for surgical resection. Recurrent GBM must have occurred more than 3 months after the end of radiation therapy per Response Assessment in Neuro-Oncology Criteria (RANO) guidelines

Exclusion Criteria:

* Counterindication to magnetic resonance imaging (MRI) (Patient has a pacemaker or metal in the body)
* Patients \< 18 years of age
Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation

A prospective randomized controlled trial was conducted to collect patients with prolonged mechanical ventilation. Patients were randomly assigned to receive PAV+ or PSV as weaning mode. Weaning outcomes were compared between 2 groups.

Pressure support ventilation (PSV) the most frequently used mode of ventilator support in intensive care units, but has several demerits. Proportional assist ventilation with load-adjustable gain factors (PAV+) is a promising mode with better patient synchrony and weaning advantages. However, weaning outcome of PAV+ in patients with prolonged mechanical ventilation has not been evaluated before. We conducted a prospective randomized controlled trial in a tertiary medical center. This study aimed to compare the effectiveness between PAV+ and PSV for weaning adult patients with prolonged mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prolonged mechanical ventilation and transfer to respiratory care center, age of 20 years or older, at least 1 time of extubation failure or spontaneous breathing trial failure in ICU, stable hemodynamics, no vasopressor use, FiO2 = 0.40 or less, external positive end-expiratory pressure = 5 cmH2O or less, PaO2 \> 60 mmHg, and body temperature \< 38ºC (within 24 hours).

Exclusion Criteria:

* Patients with bronchopleural fistulas, central neurological disorders, hemodialysis, and those with pressure support level already \< 15 cmH2O.
Relationship Between "FODMAPs" and "GVHD"

With the stem cell transplanting increasing, patients which effected with "GVHD" were also increased. To evaluation the relationship between "FODMAPs" and "GVHD", Bone marrow transplant patients were recruited.

The feces were collected from the patients who had been successfully transplanted after bone marrow transplantation. After 24 hours of culture in the culture medium, the degradation rate of "FODMAPs" was detected, and the relationship between the degradation rate and the occurrence time and degree of "GVHD" was observed

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;
2. Must be treated with bone marrow transplantation;
3. The transplanted bone marrow was successfully planted

Exclusion Criteria:

1. Gastrointestinal diseases；
2. Age\>60; or Age\<10；
3. Probiotics or prebiotics were taken before enrollment
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified.

This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters.

This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 25-60 years
* Mild/Moderate/Severe OSAS

Exclusion Criteria:

* Female
* Other sleep disorders
* Previous CPAP therapy
* Type 1 diabetes mellitus
* Familiar Dyslipidemia
* Severe organ pathology
* Acute disease
Routine Use of Negative Pressure Wound Therapy THR TKR RCT

Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.

Exclusion Criteria:

* Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with VVC. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Adult, post-menarchal, pre-menopausal women aged 18 years or older
* Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:

  1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
  2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
* Having decisional capacity and providing written informed consent
* Negative urine pregnancy test at screening
* Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
* Refrain from sexual intercourse or use a condom until Day 7
* Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

* Patients with known or apparent signs of other infectious causes of VVC (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
* Patients who are pregnant or breastfeeding
* Patients who were treated for VVC within the past 14 days
* Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days
* Patients who have used pH-modifying vaginal products within the last 14 days
* Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
* Known/previous allergy or hypersensitivity to any product constituent or fluconazole
* Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion
Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.


Eligibility Criteria:
Inclusion Criteria

* Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with \< 7 days of prior antiretroviral therapy.
* Subjects had plasma HIV-1 ribonucleic acid (RNA) levels \>= 1,000 copies/mL at screening and were not acutely ill.
* Female subjects were nonpregnant and nonlactating.

Exclusion Criteria

* Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results:

  * Presence of hepatitis B surface antigen (HBsAg)
  * Hemoglobin \<= 8.0 g/dL
  * Absolute neutrophil count \<= 750 cells/microliter
  * Platelet count \<= 50,000 per mL
  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 3.0 x Upper Limit of Normal (ULN)
  * Calculated creatinine clearance \< 50 mL/min
Dapagliflozin in Type 1 Diabetes

Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (duration of disease at least 5 years)
* C-peptide concentration \< 0.2µg/l
* male sex
* aged 18 to 60 years
* Body Mass Index 20 - 25 kg/m2
* no measurable, clinically relevant ketonuria

Exclusion Criteria:

* insufficient venous status on both forearms
* renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)
* history of cancer
* intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion
* alcohol- and/or drug abuse, nicotine consumption \> 5 cigarettes / 24h
* brittle-diabetes
* history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured
* history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty

Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Penetrating keratoplasty for Keratoconus
* Penetrating keratoplasty for Fuchs endothelial dystrophie
* Penetrating keratoplasty for Bullous keratopathy

Exclusion Criteria:

* Glaucoma
* Limbal stem cell deficiency
* Herpetic eye disease
* Repeat Keratoplasty
Guideline for Hometitration With Duodopa for Parkinson Patients

The purpose of this study is to

1. Create a guide for hometitration of Duodopa for patients with Parkinson's disease
2. Outline which patients could be considered for "hometitration"

To start treatment with continuous intestinal levodopa infusion to the duodenum (Duodopa-pump) in patients with Idiopathic Parkinson Disease (IPD), it is usually required that the patient is hospitalised to test if Duodopa works for the patient and for the titration process to find the relevant dosage before operation and connection of the pump.

A hospitalisation is very costly. Experience shows, that this group of patients are often very stressed during hospitalisation because of noise, impaired sleep and unfamiliar surroundings. These conditions make fast and effective dosage titration very difficult, and experience also shows that the dosage often needs to be recalibrated once the patient is back home in familiar surroundings.

The use of TeleMedicin (TM) is on the rise in Denmark as well as other international health care systems.

These factors were the basis for the home-titration study where patients have their initial dosage titration done in their own home, supported by one visit from nursing staff, and one TM (video consultation) a day. The goal is to make the titration process more effective, reduce cost by treating the patient in their own home and making the patient more satisfied with the titration process.

Eligibility Criteria:
Inclusion criteria:

* Idiopathic Parkinson Disease (UK Parkinson's Disease Society Brain Bank criteria-UK PDSBB)
* Patient must be self-sufficient, or have access to support in own home (spouse, nursing home, home-nurse)
* Motivated and comfortable with home treatment and telemedicine (tablet provided by the clinic)

Exclusion Criteria:

* Patients not eligible for Duodopa-treatment
MOPEXE and RE in Treating Dysmenorrhea

The aim of this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms.

Quantitative research methods were used in the study and it was a randomized type study. The sample of the study consisted of women between the ages of 18-30 who volunteered to participate in the study, showed symptoms of dysmenorrhea and can be accessed online. The names of female participants who volunteered to participate in the study and met the inclusion criteria were written on papers and put in a bag. Papers will be randomly selected by the evaluator by drawing lots. Participants will be randomly divided into 3 groups: motor imagery focused pelvic floor exercise group, relaxation exercise group, and combined group. Among the participants who agreed to participate in the study, the sociodemographic and menstrual characteristics information form and the Visual Analogue Scale value of 5 and above on the day when the menstrual cycle is most severe were included in the study, and the McGill Pain Questionnaire-Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) they will be asked to fill in. After the groups are formed, video home exercise programs will be delivered online (whatsApp, mail, etc.) to the participants. Individuals will be asked to apply the created video home exercise program individually in their own environment. Before the participants start their exercise programs, exercise programs will be taught by online interview. You will be asked to do the exercises for 8 weeks, 3 days a week. After the 8-week exercise program is over, the participants will be asked to fill in the McGill Pain Questionnaire- Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) on the day when the menstrual pain is most severe. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Having a normal menstrual cycle (24-35 days),
* never having given birth
* According to the Visual Analogue Scale (VAS), the pain level during the menstruation period is 10.
* to give a score of 5 or more out of cooperative and oriented
* Volunteer to participate in the study.

Exclusion Criteria:

* Having an active sexual life
* Receiving psychiatric treatment for stress disorder or anxiety, using birth control pills,
* Those with irregular menstrual cycles (less than 21 days or longer than 35 days)
* those with a menstrual cycle period),
* undergoing any gynecological surgery,
* A mental, cardiovascular, pulmonary, or orthopedic disorder that may interfere with exercise have a disease
Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are candidates to receive both proton beam and TACE
2. Patients with no evidence of metastasis or macrovascular invasion
3. Patients with tumor burden that meets San Francisco criteria

Exclusion Criteria:

1. Patients who are candidates for surgical resection
2. Patients with lesion \< 2 cm
3. Patients who have contraindication to receive either TACE or proton
4. Patients with serum alpha fetoprotein \> 500
5. Patients with metastasis or macrovascular invasion
6. Patients treated previously for HCC by any locoregional treatment
7. Patients with prior liver transplant
8. Patients with Child class C
9. Patients with MELD score of \> 25
10. Patients with other comorbid diseases that may impact survival
11. Patients with ongoing alcohol intake
12. Patients with active sepsis
13. Patients with gastrointestinal bleeding within a week
14. Patients unwilling to sign informed consent form
15. Patients with history of noncompliance
Recalling the Treatment and Prognosis of Upper Tract Urothelial Cancer (UTUC)

Among urothelial cancers, upper urinary tract urothelial cancers, including renal pelvis and ureteral cancers have a higher incidence rate in Taiwan than Western countries. In particular, the proportion of female patients is similar to that of males. This situation is significantly different from that in foreign countries. The cause is currently uncertain.In the past, the arsenic contamination of groundwater made blackfoot disease become common and malignant in areas. Now, the number of kidney dialysis patients in Taiwan is increasing; and according to statistics, there is a significantly higher incidence of urothelial cancer among kidney dialysis patients. This may be caused by the use of traditional Chinese medicine or other unknown reasons.


Eligibility Criteria:
Inclusion Criteria:

* Case study of upper urinary tract urothelial cancer surgery

Exclusion Criteria:

* Cases of surgery for non-upper urinary tract urothelial cancer