cyrilzakka/clinical-trials huggingface dataset:
UCon Treatment of the Symptoms of Faecal Incontinence (FI)

UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. This clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.

The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥ 18 years of age.
2. Participant is showing symptoms of FI.
3. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.

Exclusion Criteria:

1. Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
2. Participant has an active infection in the genital area.
3. Participant has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception\* during the interventional period judged by the investigator.
5. Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment.
6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy.
7. Participant is currently receiving cancer treatment.
8. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
9. Participant does not speak and understand Spanish.

   * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
Aliskiren and Renin Inhibition in Diastolic Heart Failure

This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.

Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years
2. NYHA classes I-III, symptomatically stable (for \>1month)
3. Age 21-70 years
4. Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
5. Patients on ACE inhibitor therapy (lisinopril)
6. Blood pressure \>100/75 mmHg
7. Adequate birth control
8. Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two visits since January 2008

Exclusion Criteria:

1. Acute coronary syndrome (within the last month).
2. Recent acute diastolic or systolic HF (within the last month)
3. Pancreatic disease
4. Renal artery stenosis
5. Pregnancy
6. History of angioedema
7. Severe hypotension (systolic BP\<90mmHg or mean arterial pressure \<65mmHg)
8. Hyperkalemia (defined by K+\>5 mEq/L)
9. Chronic Kidney Disease (Stage 3 and above)
10. Systolic dysfunction (ejection fraction below 50%)
11. Ethnicity other than Mexican American or non-Hispanic white
Trueness of Digital Occlusal Analysis

The aims of this observational study are to evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer versus intraoral scanner in comparison to conventional methods in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer (occlusense) versus intraoral scanner (Medit i700-medit occlusal analyzer) in comparison to conventional methods (8 um articulating paper) in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Eligibility Criteria:
Inclusion Criteria:

* Normal occlusion (Angle Class 1)
* No missing teeth
* No tempromandibular disorders

Exclusion Criteria:

Patients having:

* Dental prostheses
* Extensive restorations
* Severe malocclusion
* Periodontal disease
* Excessive tooth wear
* Orofacial pain
* Temporomandibular joint disorders
* Anterior or posterior open bite
* Active orthodontic treatment.
Iressa Expanded Access Program (EAP)

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.


Eligibility Criteria:
Inclusion Criteria

For inclusion in this trial, patients must fulfill all of the following criteria:

* previous documented histologically or cytologically confirmed non-small cell lung cancer;
* locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy.
* age 18 years or older;
* written informed consent to participate in the trial.

Exclusion Criteria

Any of the following will exclude a patient from entering the trial:

* receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. \* Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission;
* patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission;
* having other active malignancies;
* incomplete healing from previous oncologic or other major surgery;
* evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
* pregnancy or breast feeding (women of child-bearing potential).
Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Angiotensin converting enzyme inhibitors (ACEI) are the first-line treatment for high blood pressure and congestive heart failure, and have excellent effects in improving the prognosis of cardiovascular diseases. However, ACEI is frequently discontinued due to its adverse reaction. The adverse reaction to ACEI is not uncommon, especially in Asians. Discontinuation of ACEI is known to increase the risk of poor prognosis of cardiovascular diseases.

Biomarkers for predicting adverse reaction to ACEI have not yet been developed. Recently, genes related to adverse reaction to ACEI have been identified. This study is a randomized prospective study, in which the experimental group decides whether to administer the drug based on genetic information, and the control group decides whether to administer the drug without the information. In the experimental group, participants who are predicted to have a high risk of adverse reation to ACEI will receive angiotensin receptor blockers (ARB), and those who are predicted to have a low risk of adverse reaction will receive ACEI. Control group will receive ACEI. The frequency of adverse reaction will be investigated between control and experimental groups. In the genotyping and control groups, at least 45 and 31 will be enrolled, respectively, and after drug administration, a phone follow-up will be conducted at 3 weeks, followed by a visit at the 6th week, and the study will be terminated.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 20 years of age and less than 79 years of age
* Hypertension
* No history of ACEI use

Exclusion Criteria:

* Acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months
* Decompensated heart failure
* Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
* Hemoglobin A1c \>9.0%
* Thyroid dysfunction
* Serum transaminase \>2 times the upper limit of normal levels
* Serum creatinine \>2.0 mg/dL
* Cancer
* Pregnant or breast-feeding women, and women of childbearing potential
* Patients who refused to participate
Program to Prevent Osteoporosis in Girls

Osteoporosis is a condition defined by decreased bone mass. Osteoporosis generally affects older women and can lead to bone fractures. One way to prevent osteoporosis is to build strong, healthy bones during childhood. This study will evaluate a program designed to improve girls' bones. The program encourages eating foods rich in calcium and participating in physical activity.

Osteoporosis affects more than 25 million people in the United States. The majority of bone fractures in older women are related to osteoporosis. Calcium intake and physical activity are two modifiable behaviors associated with peak bone mass. Interventions targeting these behaviors among youth have tremendous public health potential for preventing osteoporosis. This study will assess the feasibility and effectiveness of a 2-year behavioral program designed to increase calcium intake and physical activity among girls ages 9 to 11.

Thirty Girl Scout troops will be recruited for the study. Girls will be randomized either to the eating and exercise behavior change program or to a control group. Program components focus on behavioral skills development, goal setting, and self-monitoring for dietary calcium intake and physical activity. The program also works to increase social support from peers and parents. The program will take place during 10 weeks of both the 5th and 6th grade years. The program also includes supporting programs during winter and summer breaks. Outcome assessments will be conducted at baseline, and at 6, 12, and 24 months. Primary outcomes will include dietary calcium intake, physical activity, and bone mineral density.

Eligibility Criteria:
Inclusion Criteria

* Member of a Girl Scout troop with at least eight 5th grade girls
* Member of the Greater Minneapolis or St. Croix Valley Girl Scout organization
* Only troops with unanimous parental consent will be included in the trial
HIV A6 Genome In ART Unsuccessful Patients On DOR

The aim of the study is to evaluate the efficacy of Doravirine (DOR) in the second-line therapy for patients infected with HIV-1 sub-subtype A6 and its derivatives and having the mutations to previously used drugs

During the study 60-80 HIV-infected patients in 2-4 investigation sites (AIDS Centers) across Russia with proven virological failure on first-line antiretroviral therapy (ART) including efavirenz (EFV) and nevirapine (NVP) will be enrolled. The blood samples, epidemiological, clinical and demographic data of patients participating in the study must be collected. All participants must provide written informed consent before the start of the study.

Virological failure on NNRTI regimen in all the participants will be confirmed by HIV genotyping. All the patients with confirmed NNRTI mutations will be switched to DOR instead of EFV/NVP in the second-line therapy and enrolled to the study.

The primary efficacy endpoints of ART with DOR will be weeks 8 and 24 (viral load + T-cell count). For all samples with virological failure at weeks 8 or 24 HIV-1 DNA sequences (full protease (PR) and partial reverse transcriptase (RT) regions) will be obtained using the in-house test system or commercial kit (Central Research Institute of Epidemiology, Moscow, Russia). In case of virological failure of DOR treatment, the analysis of drug resistance mutations will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infection confirmed
* \> 18 years
* Informed consent signed

Exclusion Criteria:

* Pregnant women
TOMUS-Trial Of Mid-Urethral Slings

The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Stress urinary incontinence (SUI) as evidenced by all of the following:
* Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
* Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
* Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
* Bladder capacity ≥ 200ml by stress test
* Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR \>100cc but ≤ 500cc is allowed
* Eligible for both retropubic and transobturator procedures
* No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
* American Society of Anesthesiologists (ASA) class I, II, or III
* No current intermittent catheterization
* Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
* Signed consent form

Exclusion Criteria:

* Age \<21 years
* Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
* Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
* Current chemotherapy or current or history of pelvic radiation therapy
* Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
* Urethral diverticulum, current or previous (i.e. repaired)
* Prior augmentation cystoplasty or artificial sphincter
* Implanted nerve stimulators for urinary symptoms
* History of synthetic sling for stress urinary incontinence
* \<12 months post-partum
* Laparoscopic or open pelvic surgery \<3 months\*
* Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
* Participation in another treatment intervention trial that might influence the results of this trial
* Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
* Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
Rotational Atherectomy: Long-term Results From a Single Center Experience

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

Severe coronary artery calcifications occur in about 10% of patients undergoing percutaneous coronary intervention (PCI). They constitute a strong independent predictor of an adverse cardiovascular event. Even though the risk factors and pathomechanisms leading to severe coronary calcification are well understood, the options for effective treatment remain insufficient.

In the presence of severe calcification, standard PCI has inferior immediate and long-term outcomes. In this situation, advanced lesion modification techniques are indispensable to improve PCI outcomes. Dedicated balloons and essentially ablative techniques are available. Rotational atherectomy (RA) is the oldest and best-recognized ablative technique. It is generally acknowledged that superficial modification of calcified atherosclerotic lesions is an optimal mechanism of action in RA.

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

The primary endpoints were device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, TLR, and target vessel MI), TVR, MI, and cardiac death. TVR and TLR were defined according to the definitions of endpoints for clinical trials. The secondary endpoints were the clinical success rate of the RA procedure (defined as successful revascularization of all treated lesions and the incidence of in-hospital complications including coronary perforation, coronary dissection, coronary low flow or no flow, emergency CABG, tamponade, MI, stroke or transient ischemic attack (TIA), bleeding events (according to the Bleeding Academic Research Consortium \[BARC\] classification and death.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years old
2. Lesions in target vessels requiring RA
3. Patient accepting the appropriate follow-up as per study definition

Exclusion Criteria:

1. Patient age \< 18 years
2. Patients who previously participated in this study.
3. Pregnant and/or breastfeeding females or females who intend to become pregnant.
4. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) .
5. The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.
Outcomes of Intrathecal Analgesia in Colorectal Surgery

Multimodal analgesia, sometimes including intrathecal analgesia (IA), is essential in any enhanced recovery pathway (ERP). This study aimed to evaluate the safety, feasibility, and optimal IA regimen in colorectal surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* All adult colorectal patients from October 2012 through December 2013 in which patients received single-injection IA as part of a multimodal analgesic strategy for ERP.
* Undergoing an elective colorectal operation (minimally invasive or open)

Exclusion Criteria:

* Patients aged \< 18 years
* American Society of Anesthesiologists (ASA) 5 and 6 classification
* pregnancy
* failure to provide research authorization.
* emergent operations
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

To determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I

Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints: virological and immunological

Eligibility Criteria:
Inclusion Criteria:

* HTLV-I-associated myelopathy

Exclusion Criteria:

* prior exposure to zidovudine or lamivudine on disease modifying therapy
* under age 16
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Age 21 to 65
* Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.
* Model for End-Stage Liver Disease (MELD) score \< 12.
* Child-Turcotte-Pugh (CTP) score \< 7 (Class A).
* Fibrosis stage F4 by FibroScan.

Key Exclusion Criteria:

* History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.
* Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.
* known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.
* Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients

Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Therefore, prevention should include the aspiration of secretions from the subglottic space. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. This method has been granted as a patent by Chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 Chinese ICUs have used it everyday. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

Eligibility Criteria:
Inclusion Criteria:Should meet all the criteria:

* Intubation less than 24 hours before admitting respiratory intensive care unit;
* Anticipated intubation for more than 72 hours;
* Anticipated survival time is more than 2 weeks

Exclusion Criteria:Meet any of these criteria:

* PEEP≥10cmH2O or FiO2≥0.8;
* unstable hemodynamics;
* severe bulla and pneumothorax;
* enrolled in other study;
* cuff leak test is positive.