cyrilzakka/clinical-trials huggingface dataset:
Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)

Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder

Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.

15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed
* OAB/urgency incontinence of at least 3 months duration
* Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit
* There is indication for cystoscopic injection treatment with Botox®
* More than 3 months since any previous treatment with Botox®
* Detrusor overactivity documented by cystometry is desirable, but not obligatory

Exclusion Criteria:

* Age below 18 years
* Mixed incontinence with predominant stress component
* Insufficient understanding of Norwegian and / or unable to fill out the necessary forms
* Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and leucocytes) with symptoms of UTI) must be treated before inclusion.
* Any contraindication stated in the Summary of product characteristics (SPC) for Botox
Protest Trial: TXA vs Saline

To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.

Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage.

The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Single or double lung transplant recipients
2. Patients \>18 years old
3. Willingness and ability to sign an informed consent for study participation

Exclusion Criteria:

1. Platelet count (\<50k/uL)
2. INR (\>1.6)
3. Active bleeding
4. Decompensated liver disease
5. History of uremic bleeding or BUN \>50
6. Severe pulmonary hypertension (mean PA pressure \>40 mmHg on RHC or estimated PA systolic pressure \>62 mmHg on TTE within one year of procedure)
7. Known bleeding disorder
8. Allergy to TXA
9. Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention)
10. Contraindications to topical TXA
11. Pregnancy
12. Vulnerable populations
13. Adults of limited English proficiency/non-English speakers
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome

this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women

This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise

Eligibility Criteria:
Inclusion Criteria:

* women with pco
* age from17 to 28 years
* BMI 25- 30

Exclusion Criteria:

* Asthma and chronic respiratory disease
* congenital spinal problems
* cardiopulmonary disease
* physical impairments
Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns, weak core activation and muscle tightness. Several recent RCT trials have looked at treating single impairments, but to date no RCT have address individualized patient impairments during a rehabilitation program. Abnormal muscle firing patterns have also been identified during functional tasks; such as jogging, stair climbing, and performing a single leg squat. Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns with those with PFP. The abnormal activation patterns has been suggested to be why strengthening programs alone do not improve movement patterns during functional tasks for those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of electrical stimulation that replicates proper firing patterns based off healthy electromyography patterns. The purpose of the study is to investigate the benefits of PENS with a impairment based rehabilitation program for the treatment of PFP. The rationale for this investigation is to assess the benefits of PENS with therapeutic exercise at improving altered firing patterns of the lower extremity muscles during functional tasks.


Eligibility Criteria:
Inclusion Criteria:

* Insidious onset of symptoms
* Presence of peri- or retro patellar knee pain during at least two of the following functional activities:

Stair ascent or descent, Running, Kneeling, Squatting, Prolonged sitting, Jumping

* Pain for more than 3 months
* Pain \>3/10 on VAS
* 85 or less on the Anterior Knee Pain Scale

Exclusion Criteria:

* Previous knee surgery
* Internal Derangement
* Ligamentous instability
* Other sources of anterior knee pain(patella tendonitis, osgood schlatter, knee plica, etc)
* Neurological Involvement
* Any biomedical device
* Muscular abnormalities
* Currently pregnant
* Hypersensitivity to electrical stimulation
* Active infection over the site of the electrode placement
Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Purpose of the study: Evaluate the effect of deep repetitive transcranial magnetic stimulation (deep rTMS; hereafter abbreviated as "dTMS") on synaptic density measured with positron emission tomography (PET) and the radiotracer \[11C\]UCB-J. The investigators also seek to link plasticity changes in the regions targeted by the electric field (especially, the insula) to changes in the functioning of insula circuits and behavioral cigarette usage in patients with schizophrenia (SCZ).

Importance of the study: This is the first study designed to directly evaluate the mechanism of action (MOA) of dTMS for smoking disruption in patients with SCZ. Patients with SCZ are a vulnerable population in high, immediate need of new smoking therapeutics for reducing premature morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-60
2. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS).
3. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire to cut down or quit.
4. Negative urine toxicology (other than cannabis) maintained throughout study participation
5. Fluent English Speaker
6. Capacity for informed consent

Exclusion Criteria:

1. Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
2. Current or past substance use disorder, except TUD
3. Current use of smoking cessation medications/products
4. Change in schizophrenia medication within 4 weeks
5. Hospitalization in the last 3 months
6. History of suicidal or homicidal tendencies
7. History of epilepsy, stroke, cerebral aneurysm, significant head injury resulting in \>10 min loss of consciousness, movement disorder, clinically significant electrolyte abnormalities, or use of clozapine (seizure risks)
8. Pregnancy or lactation (females)
9. Lack of effective birth control (females)
10. Contraindications to MRI or PET
11. Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
12. Prisoners
13. Contraindications to dTMS\*

    * The FDA website currently states that the Brainsway device used in this study is contraindicated for patients who have "metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes." The investigators will monitor the FDA guidelines and implement any changes to the inclusion/exclusion criteria based on their most updated recommendations.
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing to stay overnight at a sleep laboratory on 6 separate nights and is willing to stay in bed for at least 8 hours each night while at the sleep laboratory
* Participant's regular bedtime is between 9 PM and 12 AM (midnight)
* Participant is able to read and complete questionnaires and diaries
* Participant is willing to refrain from napping during the study

Exclusion Criteria:

* If female, participant is breast feeding, pregnant, or planning to become pregnant
* Participant is expecting to donate eggs or sperm during the study
* Participant has any history of a neurological disorder
* Participant has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.
* Participant has difficulty sleeping due to a medical condition
* Participant has donated blood products within the 8 weeks prior to the study
* Participant plans to travel across 3 or more time zones during the study
* Participant is currently participating or has participated in a study with an investigational compound or device within the last 30 days
Impact of a Personalized Multicomponent Exercise Program in Real Conditions Among Older Adults With HIV

Longitudinal prospective multicenter study with intervention and control groups and a two-year follow up. Participants will include 40 sedentary adults 50 years old or older with HIV infection and 20 sedentary adults 50 years old or older without HIV infection. Our main objective is to analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on physical function, frailty, and quality of life among older adults with HIV. As secondary objectives, we are going to analyze the effects of a PMEP on body composition, muscle function biomarkers, immunological biomarkers, microbiome, and adherence to PMEP in real conditions under intense, moderate nonexistent monitoring.

PMEPs will be designed according to the specific characteristics of each participant and their grade of usual physical activity. Physical activity will be registered on physical activity bracelets to get objective information in order to evaluate adherence to the PMEP. A global evaluation of the patients will be made at baseline and months 3, 6, and 12. At each evaluation, samples of blood, stool, urine, and saliva will be taken, and a phone meeting will be scheduled at month 24.

Eligibility Criteria:
Inclusion Criteria:

* People living with HIV (Control group not included)
* Age equal or older to 50 years old at initiation of study
* Sedentary individuals: \< 150 minutes per week of moderate physical activity.
* Absence of physical limitations which impede the performance of a light or moderate physical activity program

Exclusion Criteria:

\* Individuals with one or more of the following diseases:

* Acute myocardial infarction (in the previous 3-6 months) or unstable angina
* Uncontrolled cardiac arrythmias
* Severe aortic stenosis
* Acute Pericarditis/ Endocarditis
* Poorly controlled high blood pressure (\> 180/100 mmHg)
* Acute thromboembolic disease
* Acute severe cardiac heart failure
Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important.

This study is planned to assess the use of thrombotic biomarkers in patients with HIT, including thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and clinical outcomes, including new thrombus and death, were recorded during follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients undergoing cardiac surgery.
* Receiving unfractionated heparin anticoagulation.

Exclusion Criteria:

* history of heparin-induced thrombocytopenia
* pregnant woman
Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

The purpose of this study is to assess the efficacy and safety of Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.

This is a prospective, multi-center, randomized, open, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (Tonbridge).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years, any gender;
* Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
* Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.

Exclusion Criteria:

* Aneurysm rupture within 30 days before enrollment;
* Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
* Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
* Modified Rankin Scale (mRS) score ≥3;
* Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
* Major surgery within 30 days before enrollment；
* Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
* Known allergy to nickel-titanium alloy metal materials;
* Life expectancy \<12 months;
* Pregnant or breastfeeding women;
* Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
* Other conditions judged by the investigators as unsuitable for enrollment.
Preoperative Pain Catastrophizing and Intraoperative Analgesia Consumption

This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. During the preoperative period, patients will complete the Pain Catastrophizing Scale, the Beck Depression Inventory, and the Beck Anxiety Scale. During the intraoperative period, analgesia nociceptive index (ANI) electrodes will be placed, and remifentanil dosing will be adjusted accordingly. The correlation between preoperative Pain Catastrophizing Scale scores and intraoperative remifentanil consumption will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA scores of I-III
* Patients with Turkish literacy skills.
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patients unwillingness to participate in the study.
* Conversion of surgery from laparoscopic to open surgery.
* Patients undergoing emergency laparoscopic cholecystectomy.
Percutaneous Translumbar Vs Transhepatic Permcath

The aim of the study is to emphasize the technique , success rate , efficacy of translumbar and transhepatic approaches and shed light on the complications of both methods and through comparison we can give recommendations to either of these methods.

For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic permcath provide additional sites for access. This study will compare the two methods in terms of technical success (position of catheter tip), patency (primary defined as the number of catheter days from initial placement until removal \& secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients, function (adequacy of dialysis based on Urea Reduction Ratio URR \& Simplified Daugirdas Formula Kt/V) and complications (infectious; exit site infection \& sepsis and non-infectious; thrombosis, catheter migration, hematoma, intraperitoneal hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

- Chronic dialysis patients with failed classic routes of catheterization ( internal jugular, subclavian and femoral veins bilaterally ) as well as non-functioning a-v fistulas.

Exclusion Criteria:

1. Patients with uncorrectable coagulopathy.
2. Patients on long term anticoagulants
3. Concurrent active infection.
4. Sgnificant abdominal ascites. (transhepatic)
5. Cirrhotic liver disease patients. (transhepatic)
6. Morbid obesity. (translumbar)
Local Versus General Anaesthesia in Stapled Hemorrhoidectomy

The purpose of this study is to determine whether local or general anaesthesia in stapled hemorrhoidectomy leads to a shorter operation time with a better patient comfort.

Hemorrhoids are a frequent disease with the need of surgical intervention in 10-20% of the patients. The stapled hemorrhoidectomy according to Longo under general anesthesia (or spinal) is considered standard of care \[1\]. Cohort studies show that a pudendal bloc with local anesthesia is safe and efficient \[2-4\]. The majority of procedures are actually performed in private clinics or in an ambulatory setting underlining the importance of economic issues such as procedure time (anesthesia and operation time) and hospital stay.

We hypothesize that stapled hemorrhoidectomy under local anaesthesia shortens anaesthesia time and hospital stay and reduces costs with no disadvantages regarding pain, satisfaction and complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Hemorrhoids grade III suitable for elective stapled hemorrhoidectomy

Exclusion Criteria:

* Age \< 18 years
* No informed consent
* Emergency situation
* Contraindication to either anaesthesia method
* Patients not speaking french or german.
* Additional anal pathology (fissure, tumour).
Laparoscopic Sentinel Lymph Node Localization in Operable Cervix Cancer

The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Stage IAI to IIA cervix cancer undergoing primary surgical management

Exclusion Criteria:

* Previous pelvic dissection
* Previous para-aortic lymph node dissection
* Evidence of distant mets
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.


Eligibility Criteria:
Inclusion Criteria

* Patient with a suspected VS
* Recurrent VS with prior microsurgical resection or radiation therapy
* Clinical indication for microsurgical resection

Exclusion Criteria

* History of allergy to FS
* History of renal failure
* Pregnant women
* Those with inability to give informed consent
* Prisoners and inmates
Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

The main aim of this study, which was carried out in two parallel groups, is testing the efficacy of a specific micronutrients combination in adults with heart rhythm disturbances and accompanying symptoms.

It is therefore the investigators hypothesis that daily oral administration of the specific micronutrients combination will lead to a decrease of symptoms awareness and to a reduction of heart rhythm disturbances in adults with or without structural heart disease. The principal endpoints will be a decrease in the total score of symptoms awareness.


Eligibility Criteria:
Inclusion Criteria:

* PVB in the long-term ECG recording (registration at least 18 hours): at least 500 PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment

Exclusion Criteria:

* Left ventricular ejection fraction \[EF\] ≤ 40 %
* Therapy with spironolactone \> 50 mg/d
* Therapy with torasemide \> 20 mg/d
* Supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium)
* Creatinine in the serum \[i. S.\]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women)
* Potassium i. S. ≤ 3,4 mmol/l and \> 5,4 mmol/l
* Magnesium i. S. ≤ 0,7 mmol/l and \> 1,0 mmol/l
* Acute and chronic diarrhea
* Hyperthyroidism anamnestic or due to the current TSH (thyroid stimulating hormone)-value
* Pacemaker