cyrilzakka/clinical-trials huggingface dataset:
Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population.


Eligibility Criteria:
Inclusion Criteria:

* confirmed medical diagnosis of myotonic dystrophy type 1 (DM1) with adult phenotype
* symptoms of stress, urge or mixed urinary incontinence
* able to give a free and informed consent

Exclusion Criteria:

* being pregnant, have given birth by vaginal delivery in the last year or plan to become pregnant in the next six months
* present post-void residual urine ≥ 150 ml
* have medical conditions that may have an impact on the symptoms of urinary incontinence and the response to treatments
* present fecal incontinence (≥ 1/week) or significant prolapse (beyond the hymen)
* have already received physiotherapy treatments in pelvic floor rehabilitation or surgery on the perineum
* have a defibrillator, pacemaker or bladder stimulator
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.

Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears that Leishmania infections can be eliminated by T helper 1 immune responses. These findings argue that a vaccine that augments mucosal leishmaniasis patients' T helper 1 responses will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion Criteria:

* Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.
The Energy Balance Study

The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.

1. Changes in body weight and fat will be positively associated with increases in total energy intake.
2. Changes in body weight and fat will be positively associated with decreases in total energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 20-35 \*Note : For participants that come to Orientation, we are allowing participants with a variance of 0.1 either way in the BMI range: 19.9 - 35.1

  * 21-35 years of age
  * Men and women
  * Email address
  * Access to a phone

Exclusion Criteria:

* Currently on medications to lose weight

  * \>90th percentile on the Brief Symptom Inventory (BSI)
  * Planning to move from the Greater Columbia area in the next 15 months
  * Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
  * Changed birth control status in past 3 months
  * Currently taking birth control but plan to stop taking it within the next 12 months or are planning to start taking birth control in the next 12 months
  * Planning to have weight loss surgery
  * Started or stopped smoking in the past 6 months
  * Blood pressure ≥ 150/90
  * Blood glucose ≥ 145 mg/dL @ orientation
  * Blood glucose ≥ 126 mg/dL @ B3
  * Total cholesterol ≥ 240 mg/dl with LDL-C ≥ 190 mg/dl or Triglyceride levels ≥ 300 mg/dL
  * Currently diagnosed with or taking medications for a major chronic health condition
  * Presence of an eating disorder
  * Currently participating in another study
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis

This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.

This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with plaque psoriasis

Exclusion Criteria:

* Prior exposure to any tumor necrosis factor (TNF)-inhibitor
* Patients for whom Enbrel is contraindicated
* Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis

This study is a non-interventional observational study. On the baseline (Visit 1), we collect demographic data from all participating subjects according to their daily medical conditions, prescribe drugs and collect validity and safety data according to the research plan in Visit 1 and Visit 2. In addition, we collect data by application on subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days.

The investigator will enroll subjects according to Inclusion/Exclusion criteria after obtaining Informed Consent Form from each subject. Enrolled subjects will administer Zoledronic Acid 5mg/100mL once on baseline (Visit 1). The demographic data, prescription data, and medical history, etc will be collected based on the approved protocol. Additionally using application, subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days will be collected.

Investigator will also collect any occurrence of fracture through electronic medical record until 48 weeks (Visit 2) from baseline visit.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults 19 years of age or older at the time of screening visit
2. A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission
3. A person who can understand the information provided to the person and can voluntarily sign a written consent form

Exclusion Criteria:

1. Those subject to contraindications to administration according to the drug approval requirements for research

   * Patients with hypersensitivity to the components of this drug or other bisphosphonate drugs Hypocalcemia
   * Patients with severe renal impairment whose creatinine clearance rate is less than 35 mL/min (patients must measure serum creatinine and creatinine clearance before receiving the study drug).
   * Patients receiving Zometa for cancer as an indication
   * Pregnant women, women who may be pregnant, and lactating women
2. Patients participating in other clinical trials (However, registration is possible if you have not received investigational drugs or are participating in other non-interventional observational studies.)
3. In addition to the above, patients whom the researcher (physician in charge) determines are not suitable as subjects of this observational study.
Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies

This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.


Eligibility Criteria:
Inclusion Criteria:

* Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront.
* Age \> 18 years
* Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor

Exclusion Criteria:

* Age \< 18 years;
* Primary diagnosis other than Multiple Myeloma
Chlorhexidine Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis

The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. The main question it aims to answer is:

- Does controlled irrigation with chlorhexidin and N-asetil sistein in root canal treatment reduce the severity of postoperative pain? In the chlorhexidin group, unlike the control group, each root canal was irrigated with 3 mL %2 chlorhexidin solution in the final irrigation.

In the N-asetil sistein group, unlike the control group, each root canal was irrigated with 3 mL 200 mg/ml N-asetil sistein solution in the final irrigation.


Eligibility Criteria:
Inclusion Criteria:

* Mandibular permanent molars with chronic apical periodontitis
* Teeth with periapical index (PAI) score greater than 2
* Teeth with periodontal pocket depth less than 3 mm
* Patients without systemic disease (ASA 1-2)

Exclusion Criteria:

* Patients who have used analgesic, anti-inflammatory or opioid drugs in the last 7 days or antibiotics in the last 3 months
* Patients who report pregnancy, lactation or psychiatric disorders
* Teeth with a history of root canal treatment, sinus tract or abscess, and teeth planned for prosthetic restoration
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures

Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.

The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients of either sex.
* Between 18 and 75 years of age.
* With a single, chronic, posterior midline anal fissure.
* Defined as having anal pain for the 6 weeks prior to Screening.

Exclusion Criteria:

* More than one anal fissure.
* A fistula-in-ano or anal abscess.
* Inflammatory bowel disease.
* Fibrotic anal stenosis.
* Anal fissure secondary to an underlying condition.
* Any anal surgery.
* Concomitant medication that may interfere with study evaluation.
Estimating the Short-term Effectiveness of Online Advertisements for Improving Health

Bing ads designed to encourage people to adopt healthier practices (e.g., stop smoking, become physically active, stop consuming harmful content) are shown using the advertising system, to test which ads are more effective as apparent in the subsequent queries to Bing submitted by users who saw the ads.


Eligibility Criteria:
Inclusion Criteria:

* Use of the Bing ad system with target phrases.

Exclusion Criteria:

* None
An International Pulmonary Embolism Registry Using EKOS

This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site.

For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.

Eligibility Criteria:
Retrospective Inclusion Criteria:

* Treated with APT procedure between January 1, 2014 and one year prior to site activation
* RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
* PE symptom duration ≤ 14 days
* Troponin elevation

Retrospective Exclusion Criteria:

* Enrollment into the OPTALYSE PE study

Prospective Inclusion Criteria:

* Male or female ≥ 18 years of age and ≤ 80 years of age
* RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
* PE symptom duration ≤ 14 days
* Troponin elevation
* Signed informed consent obtained from participant or legally authorized representative
* Investigator has selected the EKOS device to treat participant with massive or submassive pulmonary embolism

Prospective Exclusion Criteria:

* High-risk for catastrophic bleeding
* Life expectancy \< one year
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms

Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Participants \> 18 years old with ECOG performance status 0-2 and ASA score ≤3
* Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms
* Surgery scheduled at least 2 weeks after the initial surgical evaluation
* Fluency in English

  * Willingness to answer questionnaires, complete daily exercise \& nutrition log, as well as participate in follow-up telephone calls
* Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)

  * PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity.

Exclusion Criteria:

* Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)

  * Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded.
* Inability to provide own informed consent
* Inability to read or verbally understand questionnaires in English
* Impaired hearing that creates a barrier for telephone follow-up
* Visual deficit that would cause exercise to be hazardous
* Emergent or urgent surgeries
Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.


Eligibility Criteria:
Inclusion Criteria:

1. Participants are aged 18-65 years.
2. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
3. MADRS score of 20 or more.
4. Right handed
5. A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

Exclusion Criteria:

1. DSM-V psychotic disorder.
2. Drug or alcohol abuse or dependence (preceding 6 months).
3. Inadequate response to ECT (current episode of depression).
4. Regular benzodiazepine medication
5. Rapid clinical response required, e.g., due to high suicide risk.
6. Clinically defined neurological disorder or insult.
7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Pregnancy.
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.

Eligibility Criteria:
Inclusion Criteria:

• Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.

Exclusion Criteria:

* Preceding use of Picato® on the area planned for treatment
* Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
* Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
* Open wounds on the area planned for treatment
* Contraindications according to prescribing information
Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)

A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD

This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch \& Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).

Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.

  2. The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

  3. The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.

Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.

Exclusion Criteria:

* 1. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

  2. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.

  3. The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.

  4. The subject has any condition which prevents reliable specular microscopy in the operative eye.