cyrilzakka/clinical-trials huggingface dataset:
Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy

Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods.

Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine.

By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with prostate cancer undergoing robotic radical prostatectomy
* Incontinence
* Obesity
* Large prostate weight
* Mild and severe AUA symptom scores
* Urinary Bother

Exclusion Criteria:

* Contra-indication to Solifenacin
* Narrow angle glaucoma
* Hepatic impairment
* Renal impairment
* CYP3A4 inhibitors (e.g. Ketoconazole)
* Gastric Retention (delayed or slow emptying of the stomach)
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy

Cow's milk protein allergy is a sensitivity reaction against cow's milk protein and and is calcified as IgE-medaited, non- IgE mediated and mixed type according to the underlying immunological mechanism.

Cow's Milk related Symptom Score ( CoMiSS) Considers general manifestation and dermatological, gastrointestinal and respiratory symptoms.


Eligibility Criteria:
Inclusion criteria :

* Age: from birth up to five years...
* Sex: both Males and females
* All children who suspected to have Cow's Milk Allergy that have the following symptoms (chronic unexplained failure to thrive, regurgitation , chronic abdominal distension, skin manifestation such as urticaria \& eczema and respiratory symptoms such as chronic cough, recurrent wheezy chest).

Exclusion criteria

* Functional GIT disorders such irritable bowel syndrome , Gastroesophageal reflux disease according to Rome IV criteria in children
* Organic gastrointestinal diseases like coeliac disease , cystic fibrosis.
* Chronic gastrointestinal infections as parasitic infections.
Prevalence of Depression and Anxiety in Patients Seeking Medical Care at General Health Care Settings in China

Objectives: Primary: To estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in China.

Secondary:

* To estimate gender- and age-specific prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in China.
* To estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings such as departments of neurology, gastroenterology, cardiology, and gynecology.
* To describe the recognition and treatment rate by treating physicians as depression and/or anxiety for outpatients in the general health care settings in China.

This study is designed to investigate the status of identifying depression and/or anxiety disorder with somatic symptoms in general hospitals in China. The study will generate valuable information to the medical community; therefore the early and vigorous treatment is possible. It's in line with China government authorities' target to increase the recognition rate of depression and/or anxiety in primary care settings to more than 50% by the end of 2010. The study will also help to identify specific diagnosis and treatment patterns for depressive / anxious patients and their comorbid conditions.

Eligibility Criteria:
Main Inclusion Criteria:

* Greater than or equal to 18 years.
* Consecutive general internal medical outpatients attending the selected general hospitals in the investigate days(Department of neurology, gastrointestinal, cardiology and gynecology).
* Informed consent obtained for all patients who will undergo a standardized diagnostic assessment by specialized psychiatrists.

Main Exclusion Criteria:

* Patients who have been screened on a previous visit.
* Patients who are unable to complete the survey because of mental or physical incapacity.
Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.

PRIMARY OBJECTIVE:

I. To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.

SECONDARY OBJECTIVES:

I. To compare short-term perioperative outcomes between small bites and typical fascial closure technique.

II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.

III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).

IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).

V. To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.

VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.

ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study
* Elective surgery
* Age \>= 18
* Planned midline laparotomy incision or inverted-L incision

Exclusion Criteria:

* Pre-existing abdominal hernia
* History of mesh placement at prior laparotomy
* Pregnant women
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients

This study is a prospective observation study for lower respiratory tract infections in medical intensive care unit. Microbiologic and clinical characteristics and outcomes of patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.

All patients admitting medical ICU will be monitored for pneumonia. Both community-acquired (including health-care associated pneumonia) and hospital-acquired pneumonia will be included. Collecting data will include patient demographic characteristics, clinical features, microbiological characteristics including molecular work, and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitting medical ICU with pneumonia
* Medical ICU admitted patients who is developed new pneumonia

Exclusion Criteria:

* Patients already treated more than 48 hours for pneumonia in transferring hospital and no causative organism is isolated
CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery

The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.

The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.

Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.

A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.

A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.

Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.

210 patients will be included.

Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark
* 18 years or older
* Speak and understand Danish
* Providing written informed consent

Exclusion Criteria:

* Known ischemic heart disease prior to heart valve surgery
* Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention
* Unable to understand and cooperate to study instructions
* Pregnant and/or breast feeding
* Performing exercise training at high level and several times a week
* No written informed consent
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia

The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COVID-19 by RT-PCR or serology with presence of IgM positive antibodies;
* Lung image (X-ray or chest CT) with involvement of at least 25% of the parenchyma;
* O2 saturation in ambient air less than or equal to 93%
* Alteration of inflammatory tests

  * D-Dimer above the reference value and
  * Elevation of C-reactive protein, ferritin or lactic dehydrogenase
* Sign the consent form.

Exclusion Criteria:

* QT interval prolongation
* Imminence of orotracheal intubation (intubation prediction in the first 4 hours after randomization)
* Women who are pregnant or breastfeeding
* Corticosteroid allergy or intolerance
* Chronic corticosteroid users (prednisone equivalent \> 10 mg daily)
* Patients diagnosed with cancer with increased bleeding potential
* Patients in hemodialysis
* History of peptic ulcer
* Herpes zoster infection
* History or active treatment of tuberculosis
* Systemic fungal infection
* Use of anticoagulation due to previous pathology
* Glaucoma
* Live virus vaccine up to 90 days before randomization
* Known coagulopathy or thrombocytopenia (\<40,000/mm3) or hypofibrinogenemia (\< 50 mg/dL)
* Recent bleeding
* Another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion
Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection

A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).

A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs \& saliva samples).

The operators performing the diagnostic tests will be blinded from the RT-PCR results (i.e. participant's group will be anonymized). Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting.

Primary Objective:

• To evaluate the performance of EasyCov IVD as a point-of-care (POC) test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples.

Secondary Objectives:

• Collection and storage of saliva samples, nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19.

160 participants will be included in 1:1 ratio: 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test

Eligibility Criteria:
Inclusion Criteria:

Non-specific inclusion criteria:

1. Participant aged 18 and above
2. Participant agreeing to follow the study procedures
3. Participant able to understand the purpose, nature and methodology of the study
4. Participant having signed the informed consent

Specific inclusion criteria:

SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

SARS-COV-2 negative controls

- Participants tested negative for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

Exclusion Criteria:

* Minors, persons deprived of their liberty, protected adults or vulnerable persons.
* Refusal to sign the consent.
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis

Aim of the randomized controlled trial is to investigate the effects of endurance training with different intensities on physical performance, body composition and appetite regulation in people with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of cystic fibrosis by at least 2 sweat tests and / or by the presence of two CF mutations,
* willingness to participate in and to comply with the research project procedure,
* written informed consent of patients,
* age ≥ 18 years,
* FEV1 of pred. ≥ 40%,
* Stable condition (as indicated by absence of one or more signs: new or increased haemoptysis, increased malaise, fatigue or lethargy, temperature over 38°C, weight loss, sinus pain and a decrease in pulmonary function by 10% or more)

Exclusion Criteria:

* Severe pulmonary exacerbation,
* cor pulmonale,
* musculoskeletal discomfort that makes a regular exercise training impossible,
* untreated CF-related diabetes
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.

The investigators will be evaluating patients (1-7 days) post injections for:

1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).

This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 21 years
* Exam and OCT confirming Diabetic Macular Edema
* Visual Acuity of 20/400 or better
* No history of post injection pain or inflammation in the past

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study
* History of Endophthalmitis in either eye
* Current inflammation in either eye
* Uncontrolled or symptomatic Dry Eye Syndrome
* Intravitreal injection less than 3 months ago
* History of Anterior or Posterior Uveitis
* History of post injection pain with prior treatments
* Recent thromboembolic event (\<3 months)
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception.
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation

Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.


Eligibility Criteria:
Inclusion Criteria:

* patients with documented AF
* Drug refractory AF
* Non-valvular AF
* No structural cardiac disease
* No intracardiac thrombi in cardiac CT and TEE

Exclusion Criteria:

* permanent AF refractory to electrical cardioversion
* LA size \>55 mm as measured by echocardiography
* AF with valvular disease
* associated structural heart disease other than left ventricular hypertrophy
* prior AF ablation.
High Intensity Resistance and Aerobic Training Among Women With PCOS

polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.

PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.

After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS according to Rotterdam criteria
* Age limit: 18-30
* Women who are not part of planned physical activity for the last six months.
* BMI\<=30

Exclusion Criteria:

* Women with PCOS who are already on birth control or hormone therapy.
* Women with PCOS who are already are taking some medication for psychological issues
* Women who are already taking cholesterol control medications.
* Women who are a part of any physical activity already