cyrilzakka/clinical-trials huggingface dataset:
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms

The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.

Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.

In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.

Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms

Eligibility Criteria:
Inclusion Criteria:

* Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia
* Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period
* Women age 40-90
* Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)\>40 to ensure post-menopausal status
* Community dwelling
* Ambulatory
* Ability to participate in a 12 month study

Exclusion Criteria:

* Post-void residual volume\>150ml
* Glaucoma without ophthalmologist clearance
* Hormone replacement therapy in the past 6 months
* Current anticholinergic treatment
* Breast cancer
* Impaired mental status
* Undiagnosed vaginal bleeding in the past 12 months
* Endometrial thickness on pelvic ultrasound \>5mm
* History of thromboembolic event
* Gynecologic cancer
* Untreated urinary tract infection (would be eligible after treatment)
* Stage III pelvic organ prolapse or greater
* Recent diuretic medication changes (one month from change)
* Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida)
* Congestive heart failure
* Prior pelvic irradiation
* Interstitial cystitis
Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography

Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

Eligibility Criteria:
Inclusion Criteria:

* Kidney-transplanted patient, whatever kind of organ donation ( alive donor, deceased donor included extended criteria Maastricht 2 or 3)
* More than 18 years-old

Exclusion Criteria:

* Dual kidney graft
* Hydronephrosis / urinary obstacle
* Pathologies with an intrinsic compression on the graft
* Stenosis hemodynamically significant of graft artery (lengthening of Systolic Ascent Time \> 70 ms)
* Contra-indication to systematical punction-biopsy on Month 3 :

  * Ischemia of post-transplanted graft
  * Alive donor HLA identical
  * Hemostasis disorder or unable to stop antiaggregant or anticoagulant
  * Hydronephrosis / urinary obstacle
* Opposition to use the data
Effects of a Dynamic Upper Limb Orthosis in Patients With Parkinson's Disease

This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity

Objective: To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.

Design and setting: A randomized controlled clinical trial of two parallel groups.

Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)

. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease according to "brain bank" criteria
* Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale

Exclusion Criteria:

* Moderate cognitive or language impairment
* Musculoskeletal or dermatological diseases in the upper limb
* Impossibility of follow-up for 6 months
* Difficulty to attend to assessment visits
* Allergy to glove composition
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours

High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis.

If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT + seminoma)of the testis
* Histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics
* Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching normal levels after orchidectomy AND no evidence of metastases on CT of chest, abdomen and pelvis)
* Men aged 16 years or over
* Creatinine clearance \> 50 ml/min
* No previous chemotherapy
* WBC \> 1.5 x 10\^9/l and platelets 100 x 10\^9/l
* Fit to receive chemotherapy
* Able to start BEP(500) chemotherapy as part of 111 study within 6\* weeks of orchidectomy
* Written informed consent \*If there are unavoidable delays this timescale can be extended to 8 weeks

Exclusion Criteria:

* All patients with pure seminoma
* All patients with non-seminoma or combined NSGCT + seminoma \> stage 1
* All patients with no vascular invasion
* Previous chemotherapy
* Patients with second malignancy except contralateral TIN and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years
* Co-morbidity precluding the safe administration of BEP(500) chemotherapy
* Patients with renal function impairment (bilirubin \>1.25 x ULN and/or AST \>2 x ULN)
* Patients with pre-existing neuropathy
* Patients with pulmonary fibrosis
* Patients with serious illness or medical conditions incompatible with the protocol
EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

The EVART study is a prospective epidemiological multicenter cohort study, including patients with newly diagnosed PAD (\< 1 year). Initial data on medical history, caracterisation of the PAD (risk factors, main sites and severity of the atherosclerotic lesions),clinical evaluation of undetected previous CV events, standardized US duplex examination of the abdominal aorta and carotid arteries and treatment (type and duration) are collected by the physician into an electronic medical record. A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. Data on mortality, revascularization, treatments prescribed (type and duration), cancer onset, cardiovascular events, carotid stenosis, abdominal aortic aneurysm are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.

Eligibility Criteria:
Inclusion Criteria:

* patient with newly diagnosed PAD \< 1 year
* symptomatic or asymptomatic : ABI\<0.9 at rest, claudicants with ABI\<0.85 after treadmill test, or symptomatic patients (Edimburgh questionnaire or trophic changes) with ABI\>1.30

Exclusion Criteria:

* history of previous coronory or cerebrovascular event
* previous investigation of the aorta and cervical arteries
* prisoners
* subjets with no affiliation to the social security system or equivalent
Changes in Aortic Diameter During Laparoscopic Surgery

Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 \& patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.

Purpose and design:This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.

Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study.

Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure.

Consent: Informed consent will be gained from each participant.

Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient.

Confidentiality: Caldicott principles will be adhered to.

Conflict of interest: None.

Use of tissue samples in future research: None.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital

Exclusion Criteria:

* Patient refusal
* Surgical refusal
* Conversion to an open procedure
Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids

To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.

Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.

According to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.

Recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-50 years
2. Diagnosed with uterine fibroids （by ultrasound or pathology）
3. Accept myomectomy.
4. Complete clinical data.

Exclusion Criteria:

1. Severe infectious disease
2. Previous history of malignant tumors
3. Incomplete clinical data.
4. Pregnant
Correction of Psoriatic T Cell Signatures by Deucravacitinib

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the Tyrosine kinase 2 (TYK2) blocker, deucravacitinib.

This is a one-arm, open-label study to examine the effect of deucravacitinib on cutaneous and blood immune cells of psoriatic patients. 25 subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for deucravacitinib-corrected signatures.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Patients with moderate-severe psoriasis (BSA \>= 10%, PASI \>=12, static Physician's Global Assessment (sPGA) 3 and above)

Exclusion Criteria:

1. taking systemic immunosuppressives in the last 12 weeks
2. pregnancy
3. severe immunodeficiency (either from genetic or infectious causes).
4. tuberculosis or other active serious infection
5. active systemic malignancy.
6. breast-feeding
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Analgesia After Total Knee Arthroplasty

The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II, \& III patients
* Elective primary total knee arthroplasty
* Spinal Anesthesia

Exclusion Criteria:

* Patients refusing consent
* Contraindications to regional anesthesia
* Pre-existing neurological disease
* Allergy/contraindication to drugs used in the study
* Revision knee arthroplasty
* Patients with chronic pain/on narcotics preoperatively
* Pre-existing Rheumatoid Arthritis/Ankylosing Spondylitis
* Alcohol or drug abuse
* Psychiatric disorders
* Inability to use the outcome assessment tools
* Wheel chair or walker dependent for mobilization
The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis

The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.

Exclusion criteria:

includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer

This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.


Eligibility Criteria:
Inclusion Criteria:

* Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
* Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
* Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions \[osteolytic or mixed (osteolytic + osteogenic) bone lesions\] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
* Expected survival time ≥ 12 weeks;

Exclusion Criteria:

* Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
* Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
* Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
* Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
* Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
* Pregnant or lactating females;