cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure

Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.

Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.

A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.

Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure (NYHA class III b)
* peak oxygen uptake \<20 mL/min/kg body weight
* left ventricular ejection fraction \<25 %
* left ventricular end-diastolic diameter \>60 mm

Exclusion Criteria:

* exercise-induced myocardial ischemia
* cardiac decompensation within the last 8 weeks
* ventricular arrhythmias (\>Lown 4b) in patients not protected by an ICD
* insulin-dependent diabetes mellitus
* uncontrolled arterial hypertension
* orthopedic conditions excluding training participation
* body mass index \>30 kg/m2
A Study of MK0364 in Obese Patients (0364-014)

A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria:

* History of major psychiatric disorder
* History of seizures or at high risk of developing seizures
* Blood pressure greater than 160/100
* Fasting blood glucose greater than 126 mg/dL
* Triglycerides greater than 600 mg/dL
Predictors of Anticoagulation Control on Warfarin Therapy

The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.

This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.

Eligibility Criteria:
Inclusion Criteria:

* All Caucasians and African Americans who are new to warfarin therapy

Exclusion Criteria:

* Under 21 years of age
* Non caucasian
* Non african american
* Have an abnormal INR before warfarin or heparin therapy
* Unable to provide consent
A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder

The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months
* Bladder wall thickness of 5mm or more

Exclusion Criteria:

* Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder.
* Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years).
* Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Score: \>= 60
* Creatinin clearance \>= 50 ml/min or serum creatinine =\<1.5 mg/dl
* Total bilirubin, AST, ALT =\< 1.5 X laboratory uln
* ANC \>= 2000/mm3, platelets \>= 100,000/mm3
* Serum calcium within normal range
* T3 or T4 state tumors of paranasal sinuses
* Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma

Exclusion Criteria:

* History of other malignancy in the last 3 years
* Other serious comorbidity that may significantly reduce the survival in next 5 years
* Pregnant or lactating women
* History of radiation to the head and neck region
* Paranasal sinus tumor is recurrent after prior treatment
* Presence of cervical node metastasis
* Presence of distant metastasis
* Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study

Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.

The study is a multicentre retrospective study involving centres with experience in advanced colorectal resections.

Each centre is invited to submit information about the Centre and to report alle the consecutive cases corresponding to technical failure.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device

Exclusion Criteria:

* EFTR performed by exposed techniques and/or devices different from FTRD
* Patients not able to give informed consent for data collection
Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects

The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). Here we evaluate different potential explanations for this bias using both vision-dependent and vision-independent paradigms of verticality perception.


Eligibility Criteria:
Inclusion Criteria:

1. ages 18-65 years
2. informed consent
3. absence of exclusion criteria

Exclusion Criteria:

1. peripheral-vestibular deficit
2. disturbed consciousness
3. history of sensory deficits
4. visual field deficits
5. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
6. intake of antidepressants, sedatives, or neuroleptics
7. pregnancy, unless excluded by a negative pregnancy test
8. known neck pain or status post neck trauma
Bioinformation Therapy for Gastric Cancer

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable gastric cancer.

By enrolling patients with unresectable gastric cancer adapted to enrolled criteria,this study will document for the first time the synergistic effect of cancer according to local relief degree,progress free survival(PFS)and overall survival(OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan：3-6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
In Vitro Fertilization (IVF) and Acupuncture for Infertility

The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.


Eligibility Criteria:
Inclusion Criteria:

* females between 21 and 42 years old
* primary or secondary infertility
* no more than 2 previously failed IVF cycles
* undergoing IVF
* FSH \< 11

Exclusion Criteria:

* FSH \> 11
* using an egg donor
* using PGD
* using heparin or lovanox protocols
* estradiol level less than 20 or over 80
* taking herbal therapy
Enhanced Transcutaneous Delivery of Betamethasone for the Treatment of Vitiligo

Vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. Even though the pathogenic mechanisms of the loss of melanocytes are well researched, a permanent cure for the disease is still elusive. The key principle in the management of vitiligo is to attain stability and to induce active residual melanocytes to repopulate within the depigmented patch thus resulting in repigmentation. In recent years the use of various devices for enhanced transcutaneous delivery of various topical preparations has become more and more common in Dermatology. The aim of this study is to see whether using the Tixel device to enhance the penetration of topical betamethasone can improve the effectiveness of the treatment of pigment regeneration in vitiligo.

Vitiligo is a psychologically devastating disorder. The fact that it typically occurs in exposed areas (the face and hands) has a major impact on self-esteem and perception of self. While lesions are usually asymptomatic, the psychosocial impact on patients can be tremendous.

Currently available medical therapies for vitiligo are unsatisfactory and there is no FDA approved drug for the treatment of vitiligo. The perfect medication for this disease would be a topically applied formulation that can rapidly restore pigmentation without systemic absorption or cutaneous side effects.

Tixel is a novel non-laser thermo-mechanical system (Tixel, Novoxel, and Israel), that is, a registered medical device in several countries worldwide. The mechanism of action is by evaporation and thermal decomposition of stratum corneum and the dehydration of epidermis.

The aim of our study is to evaluate the clinical effectiveness and safety profile of a novel approach using an energy-based device (Tixel, Novoxel, and Israel), followed by the topical application of Bethametasone for the treatment of vitiligo.

Eligibility Criteria:
Inclusion criteria:

1. Symmetric vitiligo
2. Stable vitiligo for at least six months (\< 10% change in the last 6 months)
3. Diagnosis was made clinically by a dermatologist
4. Age over 18 -70 years men and women

Exclusion criteria:

1. Non Stable vitiligo
2. Contraindications for phototherapy
3. Pregnancy or lactation
4. Lack of willingness to go to phototherapy 3 times a week for at least 6 months
5. Segmental Vitiligo
6. Phototherapy or topical therapy for vitiligo in the last 1 month.

Exit criteria:

1. Intolerable to the the study treatment
2. Lack of patient's compliance
Reducing Disparities in Rural HIV Prevention

HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including rural Colorado. Many rural residents find it difficult to access HIV and STI prevention services.

In this study, an online survey on HIV and STI Prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural Colorado. In addition to the baseline survey, study participants who are interested and medically eligible may initiate PrEP services with the University of Colorado HIV Prevention Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured.

HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including rural Colorado. Many rural residents find it difficult to access HIV and STI prevention services. The goal of this study is to understand the risk for HIV and STIs, views on PrEP, and to determine if access to telemedicine visits and home lab kits increases engagement in PrEP services and persistence in care for at-risk rural populations.

An online survey on HIV and STI Prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural Colorado, comprised of increased proportions of minority residents (Hispanic, Native American, and Black). In addition to the baseline survey, study participants who are interested and medically eligible may initiate PrEP services with the University of Colorado HIV Prevention Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured through baseline and follow-up survey questionnaires and clinical chart reviews for those engaged in PrEP care.

Eligibility Criteria:
Inclusion Criteria:

1. Colorado rural or frontier county residents, Adults (age 18+)
2. Access to internet, smart phone or tablet to participate in online surveys
3. Able to complete online surveys in English or Spanish

Exclusion Criteria:

1. Residence in an urban Colorado county
2. HIV positive status
3. No internet, smart phone, or tablet access
4. Unable to complete online surveys in English or Spanish
Autologous Stem Cells in Osteoarthritis

Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups:

* The control group will receive Acetaminophen 750mg orally every 8 hours
* The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow (BMASC)

Signed informed consent is required, as well as answering a questionnaire.

Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia.

The procedure is ambulatory.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
* Age \> 30 years

Exclusion Criteria:

* Neurodegenerative, autoimmune, genetic or psychiatric diseases
* Active infection
* Recent joint infection
* Knee surgery history
* Knee joint fracture history
PET-imaging of Unruptured Intracranial Aneurysm Inflammation

The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.

Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings.

Correlation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).

Eligibility Criteria:
Inclusion Criteria:

* Fusiform intracranial aneurysms
* Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs.
* Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants)
* Patients who are allergic to contrast agents.
* Pregnancy
* Underage persons
* Patients on somatostatin analogue medication or with known neuroendocrine tumor

Exclusion Criteria:

* Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA
* Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm
* Age ≥18 and \<75 years.
* Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.
"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children

It was an intervention utilizing two toothbrushes on school going cerebral palsy children age (6 -18 yrs). The triple head tooth brush and single head brush was provided to parents along with dental health education to their parent on brushing technique and oral care for their child. Parents who give consent for their child were enrolled in the study. The plaque removal ability of toothbrush was assessed by Turesky modified Quigley Hein index. The reading for plaque score was recorded at base line and after the follow up of 4 weeks. Difficulties during brushing was also analyzed.

Study Design :Single blinded Randomized Control Trial

Study Setting: The study was conducted in schools that have cerebral palsy children in Karachi.

Study Duration :From June 2021 to June 2022.

Sampling technique: Non probability purposive sampling technique was used for selection of study population.

Sample Size: Total 58 individuals were recruited in the study. After including the 20% drop out rate 35 subjects were enrolled at each study group which make total sample size of 70 Cerebral Palsy participants. Random allocation was made in two groups in order to keep the sizes of intervention groups similar.

Study Instrument:

* For study intervention two types of tooth brushes were used. The single head and triple head tooth brush.
* For data collection a structured questionnaire was used that collect information on social demographic characteristics, oral hygiene behavior, dentition status, plaque status and difficulties associated with brushing.

Data Collection Method:

* The study used a single-blind, parallel, and randomized controlled trial (RCT) design.
* A total 70 Cerebral palsy children were recruited in the study which was stratified into two groups of 35 children each in intervention and control group.
* Intervention group was given triple head tooth brush with fluoridated toothpaste whereas control group was given single head tooth brush with fluoridated toothpaste.
* Dental health education on oral care was given to participant's parent along with brushing technique demonstrated on model as well on their child's teeth.
* Data was collected through structured questionnaire. Oral health assessment was recorded through DMFT/dmft index. Plaque index was calculated by Turesky modified Quigley Hein index by dyeing the plaque on tooth surface by plaque disclosing tablets. Difficulties during brushing were also evaluated.
* Statistical analysis involved pair sample t test, repeated measure ANOVA, Chi-square and Fisher's exact test.

Eligibility Criteria:
Inclusion Criteria:

* • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.

Exclusion Criteria:

* • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

This will be a prospective study using HbA1c values and continuous glucose monitoring (CGM) to assess changes in glycemic control in patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. The study cohort will consist of 40 patients with poor glycemic control who undergo POP. The investigators propose a prospective cohort study using CGM to compare glycemic profiles before and after POP in patients with diabetic gastroparesis. The investigators hypothesize that patients will have improvement in glycemic control and reduced variation in blood glucose levels (% time in hypo/hyperglycemia) after undergoing POP. These results will aid in clinical decision making, and may indicate an earlier need for endoscopic intervention in patients with uncontrolled diabetes and gastroparesis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age and older
2. Patients with gastroparesis with an average HbA1c\> 7.5% over the past 3 months
3. Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction.
4. Patients are able to complete all study requirements

Exclusion Criteria:

1. Patients \<18 years of age
2. Patients with gastroparesis with an average HbA1c\< 7.5% over the past 3 months
3. Patients unable or refuse to complete the study requirements
4. Patients who are unable or refuse to wear a CGM sensor
5. Patients with insulin pumps
6. Patients who already use a CGM