cyrilzakka/clinical-trials huggingface dataset:
Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study

This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.

The investigators seek to evaluate a commercial digital therapeutic, called CeCe, designed to provide first-line behavioral modification therapy for overactive bladder (OAB). This digital platform provides daily contact with the user to maximize compliance. It allows a provider to administer behavioral modification treatment while minimizing in-office visits.

The investigators expect that a proportion of participants using Cece will experience significant and satisfactory improvement in their voiding symptoms, to the point where no further treatment is necessary. Others will require additional treatment with the usual therapies such physical therapy and medications, per clinical standards.

Participants will download CeCe to their smart phones and interact with the program for 8 weeks. Participant consent and specific instructions will be provided during study enrollment and through the app. Study outcomes are collected through the program via in-app questionnaires and voiding diaries.

A total of 50 participants will be recruited. They will be compensated a total sum of $175; $50 at completion of an initial set of questionnaires, $50 at completion of 4 week follow-up questionnaires, and $75 at completion of 8 week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder with urgency urinary incontinence, with or without nocturia/nocturnal enuresis
* Symptoms of mixed urinary incontinence if urgency incontinence is the predominant complaint
* Post-void residual \<100ml
* English speaking
* Access to a smartphone
* Normal urinalysis without evidence of UTI, gross or microscopic hematuria
* Greater than 6 months since receiving intradetrusor injection of botulinum toxin
* Not currently undergoing sacral neuromodulation therapy
* Not currently receiving pharmacotherapy for overactive bladder

Exclusion Criteria:

* Less than 40 years of age
* Mixed incontinence with predominant stress urinary incontinence symptoms
* Diagnosis of chronic pelvic pain
* symptomatic pelvic organ prolapse
* symptoms of dysuria
* Diagnosis of interstitial cystitis/painful bladder syndrome
* Reported \>2 UTI in 6 months or \>3 in 12 months
* Do not have access to a smartphone
* Non-English speaking
* Diagnosis of neurogenic bladder
* Gross or microscopic hematuria
* Has diagnosis of dementia, cognitive impairment or other neurologic condition which impairs decision making
* Current Pharmacotherapy or neuromodulation therapy
* Less than 6 months since intradetrusor botulinum toxin injection
* Has decreased mobility or ambulation
* Has post-void residual \>100 mL
* Has BMI \> 40 kg/m\^2
* Inability to voluntarily contract the pelvic floor muscles (a 0/5 in strength).
* Has \>4/10 pain with palpation of levator ani, coccygeus, pyriformis, obturator internus or perineal body
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism

This study is a observational study applying 24-hour microdialysis methodology to perform dynamic multisteroid adrenal hormone profiling of patients with suspected or confirmed PA. Simultaneous registration of blood pressure, tissue glucose, sleep pattern, activity level and food intake registration may be performed. The overall objective is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including dynamic multisteroid hormone profiling from microdialysis fluid.

Primary aldosteronism is the most common cause of secondary hypertension. Primary aldosteronism has increased risk of organ complications compared with primary hypertension if left undiagnosed and without specific treatment. However, the current diagnostic work-up is a cumbersome, multistep process, relying on repeated single time point measurements of aldosterone, not capturing the rhythmic nature of aldosterone and related adrenal hormone secretion.

In this study we will apply the U-Rhythm microdialysis sampling system for 24-hour measurements from subcutaneous microdialysis fluid, analysed with LC/MS-MS methodology for dynamic multisteroid adrenal hormone profiling. We will further compare multisteroid hormone profiling results with variations in blood pressure and tissue glucose, sleep pattern, activity level and food intake.

The overall objective of the study is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including 24-hour dynamic multisteroid hormone profiling from microdialysis tissue.

Primary objective

• Assess dynamic multisteroid rhythmicity in microdialysis fluid of aldosterone, precursors and metabolites of the mineralocorticoid and glucocorticoid pathway, compared to standard diagnostic work-up in patients with suspected or confirmed PA.

Secondary objectives

* Quantify the influence of salt and volume loading during diagnostic saline infusion test on multisteroid adrenal rhythmicity.
* Quantify the influence of glucocorticoids/ACTH suppression on multisteroid rhythmicity.
* Quantify the influence of cortisol co-secretion on multisteroid rhythmicity in PA.
* Quantify influence of blood pressure, pulse, sleep, food intake and movement on multisteroid rhythmicity in PA.

Eligibility Criteria:
Inclusion criteria Age 18 to 70 years Suspected PA admitted for diagnostic saline infusion testing or confirmed PA diagnosis according to Endocrine Society criteria.. Written informed consent

Exclusion criteria

* Age \<18 or \> 70 years.
* Pregnancy.
* Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.

Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.


Eligibility Criteria:
Inclusion Criteria:

* Female;
* Non-palpable breast lesions;
* Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
* Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
* Written informed consent.

Exclusion Criteria:

* Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
* Clinically palpable breast lesion;
* Breast lesion localization for planned neoadjuvant chemotherapy.
Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients

Renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. This rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system.

Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal transplantation. Several mechanisms have been implicated to explain their pro-oncogenic properties. One related to an increase in VEGF expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of VEGF. Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with the survival of patients with renal carcinoma and the circulating level of VEGF in the general population. The search for an association between the polymorphisms of the VEGF gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain polymorphisms in the development of cRCC was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the Patients such as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a first, second or third kidney transplant;
* Patients receiving a transplant from a living or deceased donor, irrespective of the immunological risk;
* Patients with health insurance coverage;
* Live or deceased patients for which genomic DNA is available.
* in cases : first diagnosis of native kidney cancer (histological type: papillary or clear cell)

Exclusion Criteria:

* Minor transplant patients;
* Patients transplanted before 1 January 2002;
* Patients monitored in the interregion, but transplanted to another center;
* Patients receiving a double graft (kidney plus other organ) or a bi-graft;
* Patients not accepting that their medical data be included in the register;
* Patients not accepting that their specimen be used for scientific research purposes.
Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections

The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections

The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.

The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.

Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.

Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.

The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.

Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.

Eligibility Criteria:
Inclusion Criteria:

* Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season
* First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours
* Signed Informed Contest to participate in the study
* Contraception throughout the study

Exclusion Criteria:

* Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion
* Anti-virals intake, other then investigational drug, throughout the study
* Vaccination for Influenza less than 1 year before inclusion
* Pregnant or lactating
Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure

Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.

Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the treatment of moderate/severe disease is mainly supportive, including oxygen therapy and invasive mechanical ventilation when impending respiratory failure is established. Moreover, the associated mortality among mechanically intubated patients is overwhelmingly high. Prone position relieves the dependent lung regions from the compressive forces of the mediastinum's weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung regions. According to a few case series, and observational non-randomized studies with small sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during prone positioning, however there are no clinical evidence that this improvement is associated with a decrease in the risk of invasive mechanical ventilation. Considering that prone positioning is a low cost, low risk and widely available therapy, more high quality evidence is needed, to determine if the benefits of prone positioning in awake patients also include a lower requirement of mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed COVID-19, and requirement of a fraction of inspired oxygen (FiO2) ≥30% through high-flow nasal cannula (HFNC) to maintain a capillary saturation of ≥90%

Exclusion Criteria:

* Less than 18 years-old
* Pregnancy
* Patients with immediate need of invasive mechanical ventilation
* Contraindications for prone positioning therapy
* Do-not-resuscitate or do-not-intubate order
* Refusal of the patient or decision maker to enroll in the study
The Effects of an Intensive Lifestyle Intervention on Employment, Earnings, and Retirement

Starting in 2001, the Look AHEAD study randomized patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education," or DSE). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018).

Starting in 2001, the Look AHEAD study randomized 5145 patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education," or DSE).The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness, among other clinical benefits. After the conclusion of the intervention in 2012, participants were consented to be linked with administrative data. The investigators attempted to link 3188 consenting participants with Social Security Administration databases. Of these, the investigators were able to successfully link 3093 participants. In this study, the investigators will compare employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018). The investigators will determine ILI-versus-control differences in employment, earnings, and retirement in each year after randomization, relative to a pre-randomization assessment period. The investigators will also investigate ILI-versus-control differences in cumulative years of employment and earnings after randomization which occurred between 2001-2004. The investigators will use multivariate regressions controlling for baseline participant characteristics and clinic site and also survival analyses that estimate whether the time until retirement differs between the ILI and control groups.

Eligibility Criteria:
(Note: age limits above are at time of randomization, which occurred between 2001-2004)

Inclusion Criteria:

* Look AHEAD participation: met age requirements and other criteria at time of study enrollment which occurred between 2001-2004 (as noted in Look AHEAD Research Group (2013))
* Consented to administrative data linkages
* Provided individual identifiers that could be linked with Social Security Administration databases
* Were successfully linked to Social Security Administration data

Exclusion Criteria:

-
Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Eligibility Criteria:
Inclusion Criteria:

1. Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
2. If undergoing chemotherapy, have to finish for at least 2 weeks.
3. Have subjective dry mouth scores at least 3
4. Can perform oral intake without aspiration
5. Can communicate well

Exclusion Criteria:

1. Has recurrence of cancer
2. Has mucositis more than grade 1
3. Has oral infection such as candidiasis
Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
2. Age of 18 to 75, Karnofsky score higher than 70.
3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin.
4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
5. No clinical findings of distant metastasis.
6. Predictive survival time longer than 6 months.
Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component).
* Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of

  ≥ 24mmHg at Hour 0 (T0) at Baseline Visit 1 and Baseline Visit 2 (Day 1)
* Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of:

  ≥ 22mmHg at (T0 + 4h) and (T0 + 8h) at Baseline Visit 1 (note: the same eye must meet the IOP eligibility criteria at all 4 baseline assessments)
* Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1 and Baseline Visit 2 (Day 1)

Exclusion Criteria:

* Subject with any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
* Subject with mean baseline IOP \>34 mmHg in either eye at any time point during the Baseline Visits 1 or 2 (Day 1).
* Subject with a BCVA worse than 0.6 logMAR (20/80 Snellen) in either eye as measured using an ETDRS chart.
* Subject with a known or suspected allergy and/or hypersensitivity to travoprost, timolol, fluorescein or to any component of the study products.
Dairy Foods Compared to Dietary Supplements and Bone Health

Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.

Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 24 months since last menses
* No hormone therapy in the past 12 months
* Weight stable for the past 3 months
* Bone density T score -1.7 to 0.0
* No more than two dairy servings per day
* No history of inflammatory disorders
* No history of non-traumatic bone fracture
* No supplement use or willing to discontinue
* No lactose intolerance
* Willing to consume milk and yogurt

Exclusion Criteria:

* Less than 24 months since last menses
* Use of hormone therapy in past yr
* \> 5 pound weight change in past 3 months
* Osteoporosis
* Regular \>2 servings/d of dairy
* Auto-immune/inflammatory disorders
* History of non-traumatic bone fracture
* Unwilling to discontinue supplements
* Lactose intolerance
* Unwilling to eat yogurt or drink milk