cyrilzakka/clinical-trials huggingface dataset:
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?

A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg.

Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent form.
* Healthy.
* Female.
* Non-smoker.
* Age 18 to 55, both inclusive.
* Normal weight: BMI 19.5 to 30.0 kg/m2. Weight minimum 50 kg.
* No breastfeeding.
* No pregnancy during the study.
* No other clinical trials during the study.

Exclusion Criteria:

* Known allergy to imipramine or any of the other known constituents.
* Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
* Medical history of urinary incontinence.
* Infectious disease 1 week prior to study day 1 or study day 2.
* Clinically significant findings during the physical examination.
* Pregnancy.
* Heart rate \< 40 or \> 100 beats per minute. Mean systolic blood pressure \> 140 mmHg or mean diastolic blood pressure \> 90 mmHg (mean of the measures on the screening day).
* Prescription, over the counter or herbal medication two weeks prior to study day 1 or study day 2. Excluding paracetamol and excluding oral contraceptives.
* Smoking 3 months prior to study day 1 or study day 2.
* Alcohol abuse, meaning \> 14 units (12 g alcohol) per week within three weeks prior to study day 1 or study day 2.
* Drug abuse 3 months prior to study day 1 or study day 2.
* Any condition as assessed by the investigator.
National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes

The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.

In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes;
* Do not have a psychiatric pathology;
* At least 18 years old;
* Affiliated to the Social Security;
* Having read the non-opposition form and not objecting to it.

Exclusion Criteria:

* Patient who has declared his opposition using the electronic non-opposition form
* Patient with type 2 diabetes
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects of any race and at least 12 years of age.
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
* Truncal acne IGA score of 3.
* Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

* Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
* Subjects who have an allergy or sensitivity to any component of the test medication.
* Subjects who have not complied with the proper wash out periods for prohibited medications.
* Evidence of recent drug or alcohol abuse.
* Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
* Exposure to an investigational drug within 30 days of the Baseline visit.
* Medical condition that contraindicates the subject's participation in the study.
* History of poor cooperation, non-compliance with medical treatment or unreliability.
Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.

The aim of this study is to evaluate the validity of perfusion index to determine the level of anesthesia in comparison with auditory evoked potential in children undergoing tonsillectomy.

The use of the perfusion index as an added monitoring tool during anesthesia provides the anesthetist with a number of benefits. It is a useful tool to forewarn the clinician of possible light planes of anesthesia, allowing for agent dose adjustment. It is a preexisting technology that is already widely available and used in most urban, regional,and rural centers, in both developed and developing countries, is noninvasive, continuous, and inexpensive.

The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3-12 years
* Elective tonsillectomy due to recurrent or chronic tonsillitis

Exclusion Criteria:

* Cerebral disease
* Cardiac disease,
* Renal disease,
* Pulmonary disease
* Hepatic disease.
Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion > 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies

Colorectal cancer has become a public health priority considering its increased prevalence and high mortality rate when diagnosed late. As a consequence, many countries have promoted and uptaken of colorectal cancer screening programs leading to an increasing detection of advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy) guidelines states that the majority of those colonic and rectal superficial lesions can be removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion. Histologically, a resection is curative for the patient when the adenocarcinoma is well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion), with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer


Eligibility Criteria:
Inclusion Criteria:

Patients with colorectal lesions\> 2 cm because any gastroenterologist must be able to resect 2 cm polyps on their own and therefore should never need to take biopsies to clarify the histology before resection.

Patient consenting after information If the lesion is defined by an endoscopist as CONECCT IIA, simple adenoma, the lesion will be resected by en bloc mucosectomy or piece meal depending on its size (after a biopsy, secondary objective).

If the lesion is defined by an endoscopist as CONECCT IIC, adenoma at risk or superficial cancer (\<1000µm depth), the lesion will be resected by R0 en bloc by mucosectomy or dissection if the lesion is greater than 20mm (after a biopsy, secondary objective).

If the lesion is defined by an endoscopist as CONECCT III, deep adenocarcinoma (≥1000µm depth), it will be sampled from the most severe part by biopsy forceps and the patient will be referred to oncology or surgery according to the extension assessment .

Pathology available of endoscopic or surgical resection piece Follow-up at 6 months after treatment for CONECCT IS, IIA, IIC lesions by endoscopic control and III by clinical or imaging control.

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Exclusion Criteria:

Metastatic lesion immediately before colonoscopy Patients under guardianship Age \<18 Pregnant woman Contraindication to colonoscopy.

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Study of Alterations in Tumor Metabolism Associated With the Development of Immunotherapy Resistance in Melanoma

Among the mechanisms responsible for resistance to immunotherapy, metabolism seems to play a major role. A better understanding of tumor metabolism appears to be absolutely necessary in order to propose efficient therapeutic alternatives to target tumor cells without exerting a deleterious effect on the cells responsible for the anti-tumor immune response. The main objective is to evaluate metabolism modulations in melanoma cells extracted from metastases of patients sensitive and resistant to immunotherapies (anti-PD1 or anti-PD1+anti-CTLA4).


Eligibility Criteria:
Inclusion Criteria:

* Female or male, 18 years of age or older
* Stage III unresectable or histologically confirmed stage IV cutaneous melanoma (melanoma of unknown origin is accepted), treatment naïve (metastatic stage) and for which immunotherapy will be started
* Performance Status ≤1
* BRAF status available; BRAF status determination is required but patient will be eligible regardless of BRAF status
* For women of childbearing potential, effective contraception must be initiated during the study.
* Patient affiliated to social security plan
* Patient having signed informed consent

Exclusion Criteria:

* Breastfeeding or pregnant patients: for women of childbearing age, a urine pregnancy test will be performed
* Patients with ocular or mucosal melanoma of metastatic ocular melanoma
* Patients with metastatic melanoma not treated with immunotherapy (i.e. treated with a combination of targeted therapies).
* Contraindication to the initiation of immunotherapy: HIV and/or HCV and/or HBV positive, active autoimmune disease (chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease, vasculitis, etc.), patients with autoimmune motor neuropathy (such as Guillain Barré syndrome).
* Vulnerable patients: minors, adults under guardianship or curatorship, deprived of liberty
* Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
* A psychiatric or addiction history that will compromise the patient's ability to consent and follow the proper protocol procedures
* Any other clinical finding that, in the opinion of the principal investigator, could interfere with the results of the study or pose a risk to the patient during the study.
A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis

The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with inadequate response to a least one biologic disease-modifying antirheumatic drug (bDMARD)or targeted synthetic disease-modifying antirheumatic drug (tsDMARD).

Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/EULAR classification criteria.
* Have moderately to severely active RA, at screening (Visit 1) and baseline (Visit 2), defined by the presence of

  * ≥6 swollen joints based on 66 joint count (and ≥4 swollen joints on 28 joint count), and
  * ≥6 tender joints based on 68 joint count (and ≥4 tender joints on 28 joint count).
* Have active synovitis in ≥1 joint, in hands or wrists, of the investigator choosing at screening, having an MRI synovitis RAMRIS score of ≥2 as determined from the central reading of the images.

Exclusion Criteria:

* Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of

  * basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
  * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.
* Have estimated glomerular filtration rate (eGFR) of \<45 milliliter per minute (mL/minute) from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
* Have a current or recent active infection.
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to

  * poorly controlled diabetes or hypertension
  * chronic kidney disease Stage 3a or b, 4, or 5
  * symptomatic heart failure according to New York Heart Association Class 2, 3, or 4
  * myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before baseline
  * severe chronic pulmonary disease, for example, requiring oxygen therapy major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to
  * systemic lupus erythematosus
  * psoriatic arthritis
  * axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
  * reactive arthritis
  * gout
  * scleroderma
  * polymyositis
  * dermatomyositis
  * active fibromyalgia, or
  * multiple sclerosis
* Have received any prior B-cell targeted therapy (for example, anti-CD19 antibodies or anti-CD20 antibodies, such as rituximab).
* Received corticosteroids, opioids, conventional disease-modifying antirheumatic drug (cDMARD), with changes in dose or have received Janus kinase (JAK) inhibitors within 28 days prior to the screening MRI or plan on receiving these drugs during the study.
A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
* Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 - 1.
* Participants with adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:

* History of inflammatory bowel disease
* Active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
* History of primary immunodeficiency, allogenic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
* History of immune-mediated pneumonitis
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects of non-childbearing potential between the ages of 21 and 70.
* Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight \>110 lbs.

Exclusion Criteria:

* Recent (6 months) unstable concurrent disease.
* History of allergic disease or drug allergies.
* Any condition affecting food consumption or absorption.
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.


Eligibility Criteria:
Inclusion Criteria:

* Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy

Exclusion Criteria:

* There are no exclusion criteria for participation in this program.
Melody PB1016 Surveillance Study

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
* Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Exclusion Criteria:

* Implantation in the aortic, tricuspid, or mitral position
* Venous anatomy unable to accommodate a 22-Fr size introducer sheath
* Obstruction of the central veins
* Clinical or biological signs of infection including active endocarditis
* History of intravenous substance abuse
* Currently participating in an investigational drug or device study
HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined by distinct patterns of immune effector and regulatory responses: The investigators propose that one or more immune regulatory are induced during chronic hepatitis B that define the extent of immune tolerance vs. activation with associated disease activity and viremia. Towards this end, the immune effector and regulatory responses relative to serum HBV DNA, alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen (HBsAg) and liver histology will be examined in a cross-sectional manner in patients with chronic HBV and control groups.

Aim 2: Clinical hepatitis flares during chronic hepatitis B reflect altered balance between immune regulatory and effector responses.

Eligibility Criteria:
Inclusion Criteria:

• Providing informed consent for this ancillary study.

Exclusion Criteria:

* Children under 18 years of age, participants with anemia
* Hgb\<10 or Hct\<30, congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis or renal failure, other significant medical conditions, autoimmune disease or immunosuppression.
Vestibular Rehabilitation and Dizziness in Geriatric Patients

The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.

Community dwelling older individuals who present to a specialty dizziness clinic (Atlanta VAMC or Emory University) with a primary complaint of dizziness will be recruited to participate in this study. Before beginning the study, the presence of normal vestibular function will be measured directly using standard vestibular function tests. Individuals will be randomly assigned to the vestibular exercise group (VR) or to the control group (CON). Data will be collected prior to the initiation of physical therapy and at the completion of the 6-week intervention period.

The VR group will perform vestibular exercises plus balance and gait exercises. The CON group will perform saccadic eye movements without targets against a blank wall, as well as balance and gait exercises. The balance and gait exercises for each group will be based on identified impairments and functional limitations, as is the standard of care in physical therapy. All subjects within a group will follow the same exercise progression for the vestibular or eye movement exercises. Subjects will be seen in the clinic on a weekly basis to review and modify the exercises according to a standard protocol and to reinforce compliance.

Eligibility Criteria:
Inclusion Criteria:

Patients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.

Exclusion Criteria:

Abnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.
Use of Methazolamide to Lower Intraocular Pressure

The purpose of this study is to evaluate the effect of methazolamide, 25 mg or 50 mg tablets once a day for a week than twice a day for a week, on lowering intraocular pressure and the safety of methazolamide.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 50 and 90 years old
* Current diagnosis of open angle glaucoma (OAG) in both eyes
* Ability to read and write in English

Exclusion Criteria:

* Glaucoma other than OAG
* Severe or end-stage glaucoma (cup to disc ratio \>0.8 or Mean Deviation on Visual Field worse than -12)
* Pregnant or breast-feeding women
Training-induced Cerebral Reorganization in Schizophrenia

The purpose of this study is to reveal the effects of computer-aided cognitive-auditory training on cerebral reorganization in schizophrenia.

Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease.

In this study we compare effects of two computer-aided training programs. One focused on auditory perception and processing as a basic ability underlying higher order information processing.

The other training involves a variability of cognitive abilities.

Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia and disorders with psychotic features
* Intact hearing abilities

Exclusion Criteria:

* Mental retardation
* Age over 60
* Insufficient German language knowledge