cyrilzakka/clinical-trials huggingface dataset:
Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells

Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.

Effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of stress urinary incontinence (SUI) in animals (female rats).

After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area.

Injected volume was 3 ml per patient. For injection MSCs (6\*10\^6 cells) were mixed with collagen solution (3,5% w\|w).

Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence
* absence of acute inflammatory manifestations in the genitourinary system

Exclusion Criteria:

* urethral or bladder malformations
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
Controlled Hypotension During Functional Endoscopic Sinus Surgery

It is very important to decrease the bleeding during functional endoscopic sinus surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.

Background: It is very important to decrease the bleeding during functional endoscopic sinus surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.

Methods: Sixty patients aged between 18-65 years were enrolled. Patients were divided into two groups. In the magnesium sulfate group (Group M) patients were administered 40 kg-1 magnesium sulfate in 100 ml saline solution in 10 minutes as IV loading dose 10 minutes before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. In the dexmedetomidine group (Group D) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1 dexmedetomidine during the surgery. Deliberate hypotension was defined as a mean arterial pressure (MAP) being 60-70 mmHg.

Eligibility Criteria:
Inclusion Criteria:

18 and 65 years scheduled for functional endoscopic sinus surgery

Exclusion Criteria:

* Patients with kidney, liver, hematological and neuromuscular diseases, diabetic neuropathy, any known allergy history to studied agents.
* weight exceeding the ideal body weight more than 30%,
* Being treated with calcium channel blockers, non-steroidal anti-inflammatory drugs, agents affecting neuromuscular blockage,and agents contraindicated for controlled hypotension
Efficacy of the Nanodropper Device on Pupillary Dilation

Prescription eye drop bottles elute drops that exceed the capacity of the human eye by five times. This study describes performing in clinic dilation using a novel solution for combating medical waste with Nanodropper, an eye drop bottle adapter that creates smaller eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Participants under the age of 18 years old

Exclusion Criteria:

* Participants 18 years and older
* Pupillary or anterior segment abnormality
* Participants with pre-existing health conditions that would prevent pupillary dilation.
Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of 1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research Center, and fasted for 10 hours overnight until administration. The medicine was swallowed with 240 ml water at room temperature. Blood samples were taken before administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the plasma. The plasma samples were divided into two aliquots and stored at -80 °C until bioanalysis. The half-life of levamlodipine is 30 \~ 50 hours. Washout period, the interval between two administration, is 21 days. In the two periods, the operation was kept the same.

Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour before taking the medicine. Other procedures were the same as those in the fasting group.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged 18 and above.
* The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.
The Use of Nutropin Depot in HIV-infected Adult Males

This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass (LTM).

The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such as glucose intolerance and edema, will be monitored at every visit.

Patients will be recruited from the HIV clinics at University of Texas Southwestern Medical School and the Veterans Administration Hospital by direct invitation from Dr. Margolis (adult HIV clinic director and University director for the NIH-ACTG). We will recruit 20 HIV-infected adult males who have been treated with stable protease inhibitor therapy regimen for the past 6 months. One half of the subjects will have evidence of lipoatrophy (as defined by the ACTG29). Each subject will have baseline (BL) measures made, and then will start on GH depot or subcutaneous AQ. Patients will be followed every two weeks for the first six weeks, then every three months for the remainder of the study. Study parameters to be measured include (also see flow chart in appendix):

* Baseline, 3, 6 and 12 months: OGTT, testosterone level, whole body protein turnover, hepatic glucose production and gluconeogenesis measures, DXA scan (for measuring lean tissue mass and bone density), bone mineral markers, resting energy expenditure, calorie count, T cell subsets, TNF µ levels.
* Every 3 months: IGF-1 (will obtain every 2 weeks for first 6 weeks), body weight, and post-prandial glucose level.
* Baseline, 6 and 12 months- CT scan for measurement of thymus size

Eligibility Criteria:
Inclusion Criteria:

* adult males ≥ 18 years of age
* mild to moderate lipoatrophy
* stable protease inhibitor therapy for at least six months.

Exclusion Criteria:

* Con-current supra-infection with acute illness defined by fever or bacterial culture
* malignancy
* females
* diabetes mellitus
* CNS tumors.
Evaluation of Esthetic Outcomes of M-shaped Flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score

The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES.

Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osseointegrated dental implant in the anterior maxilla.
* Patients of 20 - 50 years
* Periodontally healthy patients.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate surgical intervention.

Exclusion Criteria:

* Intraoral soft and hard tissue pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Zilver PTX Drug-Eluting Peripheral Stent Study

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.


Eligibility Criteria:
Inclusion Criteria:

* One de novo or restenosed artherosclerotic lesion with \> 50% diameter stenosis
* Reference vessel diameter of 4 - 9 mm
* Rutherford category ≥ 2
* Resting ankle brachial index \< 0.9

Exclusion Criteria:

* Prior stent in the study vessel
* Significant stenosis (\> 50%) or occlusion of inflow tract not successfully treated before the study procedure
* Lacks at least one patent runoff vessel
* Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)

in this study the investigators are assessing the effectiveness and morbidity of rezum therapy for benign prostatic hyperplasia by collect data and assess all patient who treated by rezum from 2 to 4 years and report these results.


Eligibility Criteria:
Inclusion Criteria:

* patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years

Exclusion Criteria:

* previous prostatic intervention
* concurrent urological morbidity like urethral stricture
* neurological disease like parkinson's disease
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with end stage renal disease on hemodialysis
* Post-dialysis body weight \>45.0 kg
* BMI between 18.0 and 40.0 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
* Subjects with known history of liver failure or liver surgery
* Subjects with a history or current clinically significant chronic or acute blood loss
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.


Eligibility Criteria:
Inclusion Criteria:

* Suspected upper tract urothelial carcinoma (UTUC)
* Diagnostic ureteroscopy required
* Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy

Exclusion Criteria:

* Prior or concomitant urothelial carcinoma of the bladder
* History of UTUC
* Ureteroscopy within the preceding six months
* Untreated urinary tract infection
* Suspected or confirmed perforation of the upper or lower urinary tract
* Lower urinary tract fistula
* Leukopenia or thrombocytopenia
* ECOG performance status 2 or greater
* Known hypersensitivity to mitomycin C
* Pregnancy or breastfeeding
* Lack of capacity to consent
Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment

Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.

Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.

Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic breast cancer (in situ or invesive)
* End of active treatments (surgery, chemotherapy and radiotherapy)
* No recurrence nor palliative care
* Min. 18 years
* Able to speak French
* Willing to be randomized to study intervention group
* Accept to give their written informed consent

Exclusion Criteria:

* No cognitive dysfunction
* No severe or uncontrolled psychiatric illness
Long-Term Effect of Adolescent Diet on Hormones and Breast Cancer Risk in Women Previously Enrolled in the Dietary Intervention Study in Children

RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral density, and breast density later in life. This may affect the risk of developing breast cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density, and breast density may help the study of breast cancer in the future.

PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the Dietary Intervention Study in Children.

OBJECTIVES:

Primary

* Determine the long-term effect of the Dietary Intervention Study in Children (DISC) to lower total fat and saturated fat intake during adolescence on serum progesterone levels in young women previously enrolled in the DISC study.

Secondary

* Determine the long-term effect of the DISC intervention on serum estradiol levels in these women.
* Determine the long-term effect of the DISC intervention on bone mineral density in these women.
* Determine the long-term effect of the DISC intervention on breast density in these women.
* Determine the long-term effect of the DISC intervention on the prevalence of metabolic syndrome in these women.

OUTLINE: This is a multicenter study.

Patients undergo fasting blood collection on day 1 for assessment of serum hormones (progesterone, estradiol), lipids, lipoproteins, and fasting glucose. Patients also undergo blood pressure, height, weight, and waist circumference measurements. Patient then receive a snack and complete the Modifiable Activity questionnaire, Center for Epidemiological Studies Depression Scale short form, Spielberger State-Trait Anxiety Inventory, and Dietary Intervention Study in Children Medical History questionnaire (including demographics, medical history, menstrual history, medications, reproductive history, dietary supplements, alcohol and tobacco use, and family history of cancer). Patients also undergo dual-energy x-ray absorptiometry (DEXA) and MRI to measure bone and breast density. Patients complete an in-person 24-hour dietary recall using the Nutrition Data System for Research on day 1 and via telephone once in weeks 2 and 3.

Day 1 is scheduled during the patient's luteal phase of menstrual cycle. After completion of study, patients contact the clinic to report start of next menses.

PROJECTED ACCRUAL: A total of 301 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children"

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™

A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™


Eligibility Criteria:
Inclusion Criteria:

* A male or female age 50 years or older at the time of the first vaccination.
* non-childbearing female
* Availability to follow up by phone
* Subjects with residence status allowing free mixing with general community

Exclusion Criteria:

* Use of non-registered products
* Pregnancy
* Hypersensitivity to a previous dose of influenza vaccine
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine
* Any contra-indication to intramuscular administration of Fluarix™
* For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination
Mechanisms of Immune Deficiency

1. The purpose of this study is to learn more about the changes in genes, cells and proteins that cause immune deficiency diseases.
2. The early stages of the study will focus on two groups of patients:

   1. members of families in which several persons have symptoms or medical histories that suggest immune deficiency.
   2. Patients who have received treatments with medications or drugs that affect functions of the immune system (secondary immune deficiencies).

It is hoped that studies will provide guidelines for extension of the research to other patient groups. Up to 200 patients and family members will be invited to participate.

The experiments that are proposed in this portion of the study are intended to:

1. characterize the significance of the variant form of EZH2 identified in this family. They will characterize the degree of methylation of lysine 27 of histone H3 in subjects with the variant and members of the same family who have the wild type gene. The functional methyltransferase activity of the variant and wild type genes will be measured.
2. characterize the current status of B-cell maturation and function in subjects with either the variant gene and the wild type gene.
3. characterize B-cell function (antibody production) and the quality of antibody produced after immunizations in subjects with the wild type gene or the variant gene.

Eligibility Criteria:
Inclusion Criteria:

1. Immunodeficiency disease; or
2. family member of individual with immunodeficiency disease

Exclusion Criteria:

1. Persons with immune deficiencies that are secondary to other diseases such as malignancies.
2. Persons who do not have immune deficiencies, persons who are not meet eligibility criteria
Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients with Musculoskeletal Disorders

This study explores the effects on pain, function and illness perceptions, of participating in clinical research versus being treated with standard care in patients with musculoskeletal disorders.

Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social care systems. Increases in life expectancy and ageing populations are expected to make MSK disorders one of the leading causes of disability by the year 2020.

When faced with a potentially life changing diagnosis of a chronic disease, people (in general) develop an organized pattern of perceptions about their condition, and how it impacts their lives and often, the essentially same stressful event may cause significant variations in perceptions. These different perceptions and coping strategies might affect the way the individual chooses to handle the disease and seek health care assistance, which altogether eventually may affect the course of the illness.

Study participation besides reassurance, could be hypothesized to induce beneficial outcomes for the patients, but is it reasonable to expect an effect of study participation regardless of study intervention, design and group allocation? And is an eventual effect mainly derived from the intervention or from the participants being a selected group?

It remains to be clarified, whether and how study participation affects the individual's treatment effect and perceptions of the illness.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Diagnosed with a musculoskeletal disorder
* Currently enrolled in a health research study hosted by the outpatient osteoarthritis clinic at Frederiksberg Hospital OR Being treated in the outpatient osteoarthritis clinic at Frederiksberg Hospital and not participating in a health research study
* Reads and speaks Danish
* Consents to participation in this survey

Exclusion Criteria:

• We have no formal exclusion criteria