cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Respiratory muscle training applied to individuals with COPD is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. Although there is sufficient evidence in the literature about the benefits of IMT in individuals with COPD. There is little evidence showing the effects of EMT. Studies show that isolated IMT and EMT are effective in increasing respiratory muscle strength, endurance and exercise capacity. Results from a limited number of studies show that combined training of IMT and EMT is superior compared to isolated IMT or isolated EMT in improving exercise capacity and dyspnea. Incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. In the pulmonary rehabilitation guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. The personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. With the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD by a pulmonologist according to GOLD 2022 diagnostic criteria (GOLD, 2022) and in classes B, C and D according to GOLD
* Followed for at least 6 months
* Clinically stable patients without exacerbations or infections

Exclusion Criteria:

* Patients with a history of spontaneous or trauma-related pneumothorax
* Patients with middle ear-related pathologies (such as tympanic membrane rupture, otitis)
* Orthopedic and neurological problems that may interfere with exercise training
* Changes in medical treatment during the study
* Patients with unstable concomitant cardiac disease
* Patients who have been involved in another pulmonary rehabilitation program within the last 6 months
* Insufficient cooperation
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence

The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Women who have moderate to severe urge, stress or mixed Urinary Incontinence

Exclusion Criteria:

* Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression.
* Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD)
* Certain restricted medications
* Any other condition that would interfere with the safety of the subject
PF-06651600 Taste Study.

This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a specified sequence in 1 day.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Infection with Hepatitis B, C or HIV
* Participants with conditions that affect their ability to taste
* Participants who currently smoke
L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.

Preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. It usually appears in the third trimester and occurs most frequently in primigravidas. Preeclampsia may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. Preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in Mexico (25% of maternal deaths).

Specific Aim 1. To assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population. Two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. The primary hypothesis to be tested is that supplemental L-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is \> 140/90 after 20 weeks gestation without proteinuria). Secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental L-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma L-arginine levels, directly with the plasma levels of the endogenous NO synthase inhibitor, asymmetric dimethyl arginine (ADMA), and inversely with urinary NO metabolites, a marker of endogenous NO production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.

Eligibility Criteria:
Inclusion Criteria:

* Previous pregnancy complicated with pre-eclampsia/eclampsia
* Singleton pregnancy
* Gestational age \>20 weeks \<34 weeks
* Protein excretion \< 300 mg/day

Exclusion Criteria:

* Multiple gestation
* Major fetal anomaly
* Pre-existing hypertension
* Pre-existing renal disease
* Diabetes
* Collagen vascular disease
* Cancer or strong family history of cancer in first degree relatives
* Preexisting maternal disease requiring medication
Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses

This study will investigate the effect of a 7-day westernised high-fat (65% of kilocalories), high-calorie (150% of requirements) diet on markers of inflammation in the blood and white adipose tissue. Participants will firstly complete a 3-day weight maintenance phase (Days 1-3) before completing a 7-day high fat diet intervention (Days 4-10). On days 4 and 11 participants will complete a laboratory visit where anthropometric measurements, blood and adipose samples will be collected.

The investigators hypothesise that consuming a high-fat, high-calorie diet for 7 days will alter the inflammatory responses in white adipose tissue and will induce metabolic endotoxaemia / systemic inflammation.


Eligibility Criteria:
Inclusion criteria:

* 18-40 years
* BMI = 21.0-29.9 kg/m2
* Male or female
* Physically active (\> 3 x 30 min moderate exercise per week)
* Healthy
* No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness

Exclusion criteria:

* Inactive (\< 3 x 30 min moderate exercise per week)
* Smoker
* Women who are pregnant or lactating
* Medication/supplements known to interfere with study outcomes or prescribed antibiotics within the last 3 months
* Unstable weight history (≥3kg loss or gain in the previous 3 months)
* An allergy to lidocaine
* Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose) which could impede compliance to the diet
* Vegetarian/ vegan (as the high-fat diet is based on animal fats)
* Consumption of probiotics yogurts during or within the four weeks prior to the start of the study (e.g. Actimel, Activia, Yakult, Yeo Valley)
* Alcohol consumption \>28 units per week for a man (i.e. not more than 14 pints of beer or 28 small glasses of wine) or \>21 units per week for a woman (i.e. more than 10 and a half pints of beer or 21 small glasses of wine)
* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
* Restrained eaters (determined by Three Factor Eating Questionnaire)
A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1

The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults over the age of 55
* score of 25 or greater on MoCA

Exclusion Criteria:

* Severe sleep apnea
* restless leg syndrome
* obstructing cataracts
* macular degeneration
* diabetic retinopathy
* glaucoma
* use of sleep medications
* brain disease
Patient and Partner Intervention After an Implantable Cardioverter Defibrillator (ICD)

The goal of this study is to compare a patient only to a patient+partner intervention on recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD) implantation.

The goal of this randomized trial is to test a patient+partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By interventing with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. Over a five year period we will test the effects of a 12 week patient+partner intervention against a patient only intervention in the first year subsequent to ICD implantation, using a 2 group (N=150/group) randomized clinical trial design. Relevant data will be collected on ICD patients and intimate partners at hospital discharge, 1, 3, 6, 12 months post-ICD implantation. The four major outcomes are: physical functioning, psychological adjustment, health care utilization, and relationship impact. The primary analysis of treatment effect is the change in outcome variables from baseline to 3 months for the patient and partner. Secondarily, exploring long term effects of the intervention, theoretical elements, and the intervention effects by ICD implant reason will be determined.

Eligibility Criteria:
Inclusion Criteria:

* first ICD implantation due to either primary or secondary prevention of SCA
* intimate partner (spouse, lover, or life partner) living at the same residence and willing to participate
* able to read, speak, and write English
* access to telephone for 1 year after ICD implantation

Exclusion Criteria:

* clinical co-morbidities that severely impair cognitive and physical functioning at telephone screening
* Short BLESSED score \> 6
* age less than 21 years
* AUDIT-C score \> 4 for alcohol use
* ASSIST 2.0 score \> 4 for daily non-medical use of opiates or hallucinogens,
Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator.

Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.

The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis correction surgery, the blood loss and the transfusion need would be reduced significantly.

Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator. Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.

The investigators designed a a randomized double-blind clinical combining TXA with DDAVP in scoliosis correction surgery to observe if the blood loss and the transfusion need would be reduced or not.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic scoliosis patients undergoing posterior scoliosis correction surgery
* American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ
* patients who agreed to participate in this study and has signed the informed consent

Exclusion Criteria:

* blood disease，such as anaemia, idiopathic thrombocytopenic purpura(ITP)
* history of bleeding or ecchymosis
* disorders of laboratory examination on platelets(PLT),prothrombin time(PT),activated partial thromboplastin Time(aPTT),Fibrinogen,D-dimers
* hypertension
* cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease
* cerebral ischemia
* administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID)
* hepatic or renal disease or disfunction
* blood transfusion in recent one month
Functional Capacity and Quality of Life in Patients With Vascular Ring

To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.

Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.

data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.

Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).

Eligibility Criteria:
Inclusion Criteria:

* patients with history of vascular ring

Exclusion Criteria:

* refusal to participate
* inability to complete cardiopulmonary testing
Rectal Balloon Training in Female Urinary Incontinence

Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle training(PFMT) is the standard recommendation for conservative treatment but some patients had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not perform the PFMT properly or increase intensity of the exercise. The authors hypothesized that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as it is another option of progressive strengthening of pelvic floor muscle. This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters

This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters. The catheter would be inserted into the rectum and used as a tool to help the patient recognize the pelvic floor muscles. The advantages of Foley catheters are that they are cheap, safe for contacting the mucosa, easy for self-insertion, and can be reused. Furthermore, we can increase the load of exercise by increasing the amount of water pushing into the balloon, and can use that as a tool for progressive resistive exercise.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 25 - 70 years
* Have urinary incontinence problem
* Follow command
* Informed consent

Exclusion Criteria:

* Previous surgical correction of UI
* Use medications for treating overactive bladder symptoms
* Impaired recent and/or recall memory
* Brain and/or Spinal cord lesion
* Untreated Urinary tract infection
* Anal lesion which contradicted for inserting instrument
* Prolapsed rectum
* Prolapsed uterus
* History of pelvic injury
* Pregnancy
Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques

Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.It has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as irrigation agitation methods can help elimination of bacteria from root canal systems.

The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a single visit root canal treatment.

Thirty-six teeth with a single root and a single canal with posttreatment apical periodontitis which needed retreatment were selected for this study. Teeth were randomly divided into 3 groups according to the supplementary disinfection techniques used: Passive ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological samples were taken before any intervention, after conventional chemo-mechanical preparation, and after disinfection techniques with sterile paper points and held in thioglycollate broth, and then were transferred to the microbiological laboratory. The amounts of e.faecalis in these samples was measured by using PCR.

Eligibility Criteria:
Inclusion Criteria:

Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth

Exclusion Criteria:

Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal pockets deeper than 4 mm
Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study

Precision of 3 Dimensional Facial Analysis Using "Bellus 3D Face Camera Pro" Versus "Planmeca ProMax 3D Proface" is to be evaluated in comparison to direct anthropometry.

The aim of this study will be the evaluation of the precision and reproducibility of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely "Bellus 3D Face Camera Pro" and "Planmeca ProMax 3D ProFace system" and to compare them to physical linear measurements "Direct Anthropometry".

Eligibility Criteria:
Inclusion Criteria:

1. Age range from 18-35 years.
2. Normal balanced facial proportions.

Exclusion Criteria:

1. Craniofacial anomalies.
2. Obvious skeletal shifts.
3. Patients with incompetent lips.
Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age

This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology.

Healthy subjects performing \< 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by \> 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied.

Eligibility Criteria:
Healthy subjects performing \< 30 min exercise twice per week. Age 20-90 years. Willing to be randomized to exercise versus no exercise. Willing to be studied in General Clinical Research Center with studies including Muscle Biopsy.
The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders

The normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is located in the brain and is often referred to as the master gland. GnRH then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone.

The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.

This protocol is designed to accompany clinical protocol #81-M-0126, "The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders", as well as the submitted protocol, "The Phenomenology and Biophysiology of Climacteric and Menopause-Related Mood and Behavioral Disorders." Its purpose will be to evaluate hypothalamic-pituitary-gonadal axis regulation as measured by pituitary gonadotropin, i.e., follicle stimulating hormone (FSH) and luteinizing hormone (LH), response to intravenous administration of gonadotropin releasing hormone (GnRH) in menstrual cycle-related mood disorders.

Eligibility Criteria:
Age 18-65.

Female.

Use of barrier methods of birth control.

Not pregnant.

Not taking ongoing medications.

No medical illnesses.