cyrilzakka/clinical-trials huggingface dataset:
UrduTranslation And Validation Of The Pelvic Floor Distress Inventory Short Form (PFDI-20)

To translate and culturally adapt PELVIC FLOOR DISTRESS INVENTORY SHORT FORM (PFDI-20) into Urdu and To evaluate the reliability and validity of Urdu version of Pelvic floor distress inventory (short form).Urdu is the national language of Pakistan. The PFDI-20 has not been translated into Urdu so far. In order to use in Urdu speaking people, it is necessary to translate and culturally adapt PFDI-20 into Urdu language, so that it can be better understood by this population.

Pelvic floor disorders, which include urinary incontinence, fecal incontinence, and pelvic organ prolapse, are highly prevalent conditions in women, affecting overall, almost 25% of women in the United States Because there are different types of pelvic floor disorders (PFDs), symptoms of different PFDs can vary or overlap. For example, women with PFDs may feel: heaviness, fullness, pulling, or aching in the vagina that gets worse by the end of the day or is related to a bowel movement; See or feel a "bulge" or "something coming out" of the vagina, have difficulty starting to urinate or emptying the bladder completely, leak urine when coughing, laughing, or exercising, feel an urgent or frequent need to urinate, feel pain while urinating, leak stool or have difficulty controlling gas, have constipation and have difficulty making it to the bathroom in time PFDI-20 has been translated into many languages across the globe to check the validity, reliability and responsiveness of the scale, in their native languages.

A study was conducted to assess validity of PFDI-20 in Finnish by using Multistep translation method with sample size of 63, they found it a valid tool.

In Turkish language validity and reliability of this tool was addressed on larger number of women and was recommended as valid and reliable tool

Eligibility Criteria:
Inclusion Criteria:

* Menopausal women aged 45 years and older, those who can read and understand Urdu language

Exclusion Criteria:

* Previous pelvic surgery, Malignant tumor, Cognitive impairment and Dementia
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 or older
2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.

Exclusion Criteria:

1. Severe UC
2. Acute flare with onset greater than \>6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.
3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses \>3.2 g/day
5. Acute flare on a 5-ASA maintenance therapy of \>3.2 g/day
6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
7. History of biologic (anti-TNF agent) use
8. Antibiotic use or repeated use (\>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted
9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments
Prospective Cardiac Ultrasound Imaging Study With Demonstrator

The Prospective Cardiac Ultrasound Imaging Study is a single center, single arm, feasibility study. The study aims at collecting cardiac ultrasound data from patients diagnosed with ventricular tachycardia, during rest and short breath hold sequences. This study is part of the engineering studies linked to the CardioKit-Minimum Viable Product project. The CardioKit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.

The research will analyse the ultrasound image data quality, especially investigating the ability of the prototype system to automatically and correctly interpret ultrasound images and artifact issues which may arise from age, body composition, mechanical valves, leads from implanted devices, or other implants. The study will establish if it is appropriate to develop a new medical device supporting automated cardiac ultrasound image interpretation during non-invasive cardiac procedures, i.e. ventricular tachycardia stereotactic radioablation. This early research protocol did collect data from 24 adult patients. The data were not used for diagnostic nor treatment purposes and the protocol's procedure duration was limited to one hour, hence the research was considered of very limited risk for the participants. The research will provide a Proof-of-Concept for a Medical Device to benefit patients with ventricular tachycardia and other cardiac pathologies in the future.

Eligibility Criteria:
Inclusion criteria:

1. Patient with history of ventricular tachycardia
2. Over 18 years old
3. Ability and willingness to provide written informed consent

Exclusion criteria:

1. Patient in arrhythmic storm
Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle

By analogy with the mouse, the activity of control pathways for transposable elements (TE) in foetal primordial germinal cells could prove to be a determinant for fertility in adulthood in humans. Moreover, defects in the control of transposable elements (TE) could also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal instability and tumorigenesis. In this context, the aim is to analyse a specific type of adult germinal testicular cancers, seminomas. Directly related to our research interest, the histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent of germinal cells normally present in foetuses. The investigator postulates that these similarities could also extend to the biology of transposable elements (TE), and in particular to the initiation of the control of these elements. The management of seminomas requires surgery, orchiectomy, which consists of the total excision of the affected testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse the control pathways of transposable elements (TE) in tumour samples harvested from surgical pieces in comparison with adjacent healthy tissue. The results obtained in these tumour samples will be compared with those in normal foetal gonad samples.


Eligibility Criteria:
Inclusion Criteria:

* men who have provided oral consent
* men with germinal testicular cancer with negative or low serum markers (Alpha Foeto Protein AFP and Human Chorionic Gonadotrophin hCG), indicators of a seminomatous-type tumour
* men who have undergone orchiectomy (total excision of the affected testicle)
* confirmation of the diagnosis of seminomatous or non-seminomatous type by histology of the surgical piece
* absence of hepatitis B or C or infection with human immunodeficiency virus (HIV).

Exclusion Criteria:

* men without national health insurance cover
* Adults under guardianship
Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.

Staggered work affects about 20% of French employees and its health risks are now well known. They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders, nutritional problems, etc.) and psychological health. Faced with these "alarming" findings, it is necessary to find ways of improvement and levers of action to prevent them.

This project aims to set up and evaluate a nutritional health prevention programme for the benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.

The objectives of the project are twofold: to evaluate the impact of working conditions in shifted schedules on food behavior and on to improve their eating behaviors.

How? Focusing on the pleasure of eating through a nutritional prevention program in which various and varied actions will be proposed but always adapted to the life of the company (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Participants working at CITEO in staggered hours

Exclusion Criteria:

* Pregnant woman, person with severe pathology
Progenitor Cell Therapy in Dilative Cardiomyopathy

Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.

Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy

Eligibility Criteria:
Inclusion Criteria:

* Age 8-80
* Dilated Cardiomyopathy, Ejection fraction \< 40%
* LVEDD \> 60mm
* Stable clinical condition within last 6 months
* Written informed consent

Exclusion Criteria:

* Myocardial infarction or coronary intervention in the past
* Change of medical therapy within the last 6 weeks prior to cell therapy
* Tumor within last 5 years or incomplete remission
* Active infection
* Active bleeding
* Stroke within last 2 years
* Surgery or trauma within last 2 months
* Uncontrolled hypertension
* HIV infection
* Chronic inflammatory disease
* Liver disease (GOT \> 2x upper normal limit)
* Renal dysfunction (creatinin \> 2.0mg/dl)
* Thrombopenia \< 100.000
* Anemia (hemoglobin \< 8.5 g/dl)
* Mental retardation
Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database

This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for inclusion in ADOReg registry must be documented at study site
* Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV
* Participants received any systemic therapy to treat the advanced melanoma
* First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

Exclusion Criteria:

* Age \<18 years at index date
* Receipt of clinical trial study drug at any time
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

* Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results
Smartwatch App for Vibration Stimulation

The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.

More than 4 million stroke survivors in the U.S. suffer from post-stroke hand disability. As hands are our primary means of interacting with the world, post-stroke hand impairment diminishes stroke survivors' abilities for activities of daily living including self-care, hygiene, employment, and leisure, and lowers independence. Hand impairment is difficult to treat. Limited resources in rehabilitation services and financial burdens make it impractical to simply increase rehabilitation service visits within the current healthcare system.

One way to augment hand function recovery is peripheral sensory stimulation. Afferent input is a powerful driver of change in the motor cortex. Sensory stimulation has been shown to improve motor recovery in previous studies. In particular, promising preliminary results have been obtained by using imperceptible random-frequency vibration applied via a watch. However, the laboratory prototype device for delivering this vibration must be improved in the form factor for patient adoption.

Therefore, we developed an App that can be installed in smartwatches and control the vibrator within the smartwatch to deliver vibratory stimulation to the user. The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.

Eligibility Criteria:
Inclusion Criteria:

* Age = 18 or older
* At least 6 months post stroke
* The ability to perform The Box and Block Test with a score greater than zero and less than 40.

Exclusion Criteria:

* Rigidity (Modified Ashworth Scale=5)
* Complete upper limb deafferentation
* Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
* Language barrier or cognitive impairment that precludes following instructions and/or providing consent.
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.

Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.

This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) grade I-III
* Aged ≥ 18-80 years old
* Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection

Exclusion Criteria:

* Patient refusal
* Language barrier or inability to communicate with the operating team
* Allergy to local anesthetic
* Bleeding disorder
* Previous breast surgery or thoracic radiation therapy
* BMI ≥ 30
* Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
* Chronic pain patient
Floseal Treatment for Posterior Epistaxis Study

Effectiveness of Floseal for the treatment of posterior epistaxis.

Floseal, a hemostatic agent, is an effective treatment for anterior epistaxis as well as numerous other acute bleeding conditions throughout the body. The investigators hypothesize that Floseal is an effective treatment for posterior epistaxis. If so, then this will also lead to significant cost savings in comparison to any other method of treatment of posterior epistaxis. The investigators have planned a prospective, nonblinded, nonrandomised study with a total of 40 subjects with posterior epistaxis to be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years of age
* posterior epistaxis

Exclusion Criteria:

* patients with anterior epistaxis
* known sensitivity to any of the materials of Floseal or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride)
* pregnant or breast feeding woman
Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease

This clinical trial aims to assess the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease, based on changes in the Ankle-Brachial Index (ABI).

The clinical trial is a randomized, multicenter, open-label, parallel-group, Phase 4 study conducted to evaluate the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease. Eligible patients who sign the informed consent form voluntarily will receive the investigational products. Subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. The trial is designed to determine whether Sarpogrelate SR 300mg once daily is inferior to Sarpogrelate 100mg three times daily in terms of changes in the Ankle-Brachial Index (ABI).

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 19
* Diagnosis of chronic arterial occlusive disease
* Experience of intermittent claudication symptoms for at least 3 months
* Receiving Sarpogrelate for a minimum of 4 weeks prior to the baseline
* Lower limb pain measured at VAS 40mm or higher at baseline

Exclusion Criteria:

* Patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment
* Patients with a history of severe heart failure within the 6 months prior to the screening
* Patients with a history of bleeding
* Patients receiving anticoagulants or medications with antiplatelet activity at baseline
* Patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications
* Patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc
Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male.
2. age between 18 and 45.
3. BMI between 19 and 25 kg/m2
4. Normal physical exam.
5. Blood analysis without relevant findings.
6. Negative serology for hepatitis B, Hepatitis C and HIV.
7. Negative urine test for abuse drugs.

Exclusion Criteria:

1. Severe psychiatric disease.
2. Dyslipemia.
3. Alcohol intake above 30 g per day.
4. Smokers
5. Xanthine intake above 5 coffee cup -equivalents per day
6. Use of any drugs in the last month
7. Participation in other trials in the last 3 months
8. Diseases capable to modify drug ADME
9. Drug allergy
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
* Measurable disease according to RECIST criteria
* ECOG performance status 0-2
* Adequate haematological, renal and liver function

Exclusion Criteria:

* Previous chemotherapy or therapy against EGFR for metastatic disease
* History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
* Symptomatic cerebral metastases
* Pre-existing parenchymal lung disease such as pulmonary fibrosis
* Concomitant use of coumarins
Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells

Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.

The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
2. Patients must have provided informed consent for long-term follow-up study prior to participation.
3. Patients must be able to comply with the study requirements.

Exclusion Criteria:

1. There are no specific exclusion criteria for this study.