cyrilzakka/clinical-trials huggingface dataset:
The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence

This is a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream \[EVC\] at bed time 3 times a week), and those receiving placebo.

1. This will be a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream \[EVC\] at bed time 3 times a week), and those receiving placebo. Study subjects will be patients diagnosed with stress urinary incontinence by urodynamic evaluation. They will have filled out the IIQ-7 and UDI-6 validated questionnaires as is routine for all patients being evaluated for stress incontinence. After enrollment and informed consent, their initial screening will include a Pap smear for vaginal maturation.
2. Subjects will then be seen at 4, 8 and 12 weeks. At each visit, they will turn in their medication tubes and receive new study medication. They will also be screened for any adverse reaction to the study medication at each visit.
3. At the end of the study period, the subjects will fill out the same validated questionnaire as they did at the beginning of the study and they will also have their urethral pressure profile and PAP smear repeated.
4. The urethral pressure profile is part of the standard complex urodynamic testing that all patients undergo for evaluation and diagnosis of urodynamic stress incontinence. Urethral Pressure Profile is a technique used to provide information about the ability of the urethra to prevent leakage. The Urethral Pressure Profile is a specific study, in which a special design catheter is pulled through the urethra at a slow, continuous rate. The resulting "bell shaped" curve illustrates the function of the urethra from the beginning of the bladder neck out through the meatus.
5. The placebo cream will be a pharmacologically inert formulation which will be packaged similarly to the active premarin cream and visually indistinguishable from the active drug to both the study subjects and researchers.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Postmenopausal women (No menses for a minimum period of 1 year)
* Urodynamic stress urinary incontinence

Exclusion Criteria:

* History of breast or uterine cancer
* History of venous thrombolic event
* Hormone replacement therapy within 3 months of study
* Sensitivity or allergy to premarin cream
* Current use of any medications for urge or stress incontinence
* Prior surgery for stress incontinence
* Overactive bladder or Detrussor instability
* Active vaginal/ bladder infection (patients will be treated and have a negative test for cure in order to be enrolled in the study)
* History of pelvic or vaginal radiation therapy
Laboratory Studies Into the Pathology of Leukaemia

Ongoing laboratory work into the pathology of Leukaemia:

The investigators will test AML samples sent to the diagnostic laboratory from participants with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general hospitals and teaching hospitals.

Results will be returned to referring clinicians in the same way investigators currently return results for samples sent for standard tests. The service will be advertised through the Royal Marsden Website with visibility to both participants and HCPs). The investigators will also inform all the clinicians involved in the AML working party (Dr Taussig is a member of the AML working group).

In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification.

An initial comparison of 50 samples by three analysis methods will be conducted.

IDH1 and IDH2 variant discovery will first be performed using an established standard in house SOP (SOP: SMD103) for CE-SSCA

Eligibility Criteria:
Inclusion Criteria:

18 \& Over Diagnosis of AML Generic Research consent given

Exclusion Criteria:

Under 18 No generic research consent
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations

Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.

Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects who are at least 18 years of age
2. Subjects who are scheduled to undergo examination in a telemedicine setting
3. Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.

Exclusion Criteria:

1. Subjects who are unwilling to undergo additional examination in a telemedicine setting,
2. Any subject requiring time-critical medical intervention.
3. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.
Exploration of the Neo-Vagina Study

The current study will explore behavioral, surgical and biological neovaginal and rectal HIV transmission risks and feasibility of collection of blood and ano-genital samples (rectal, genital and neo-vaginal, including urine) for microbiological, immunological and cytological characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV infection in TGW. This includes the feasibility of home self-collection of ano-genital samples prior to habitual cleansing of the anatomical collection site.

A computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant. The questionnaire can be completed online from any location or at the study clinic and will take about 15-20 minutes.

Eligibility Criteria:
Inclusion Criteria:

Participants will be recruited through existing social networks among TGW and from the Thai Red Cross Anonymous and Tangerine Clinics providing HIV testing, care and treatment services. TGW attending clinic services will be offered enrollment in the study. Particular attention will be paid to offering enrollment to those attending HIV treatment and care services. The current study offers medical evaluation and a range of laboratory testing specific to the health of TGW, which may be of interest and beneficial to them. At the same time, the study may benefit from their participation.

Exclusion Criteria:

not TGW
Ventricular Arrhythmias After Pulmonary Vein Isolation

The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.

Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably modulates the intracardiac autonomic nervous system. While this ablation might alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

Exclusion Criteria:

* Age \< 18 years
* Persistent atrial fibrillation
* Life expectancy less than 12 months
* Acute myocardial infarction, coronary artery bypass graft surgery, open heart surgery, or percutaneous transluminal coronary angioplasty within less than 3 months prior to inclusion
* Documentation of \>30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation
Basic Mobility and Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used

Present study aim to gain an understanding of functions needed and strategies used for patients following hip fracture surgery to be independent in basic mobility activities during acute hospitalization, and establish knowledge of how much (or little) patients get out of bed.

Within the patients included in this cohort study (1), a subgroup will also be included in a satellite study (2), with a separate objective. Definitions are presented in the detailed description below (objectives 1-2).

The objectives are;

1. To determine levels of physical activity among a broad representation of patients hospitalized following hip fracture surgery, and secondly to explore the association with 30-day readmission, and mortality.
2. To understand and define which functions and strategies are needed for patients hospitalized following hip fracture surgery to be independent in the basic mobility activities: getting in/out of bed, sit-to-stand from a chair and walking.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgery for hip fracture at Hvidovre Hospital admitted to department 210/212 or at Bispebjerg Hospital department M1.
* Being able to participate in basic mobility activities with assistance pre-fracture (Cumulated Ambulation Score (by recall) ≥ 3)
* Able to give written informed consent or having a relative/legal guardian to give written consent, not later than on 3rd postoperative day

Exclusion Criteria:

* Postoperative weightbearing restrictions
* Multiple fractures
* Suspected pathological fracture due to cancer
* Terminal illness
* Post operative medical complications limiting the patient from getting out of bed
* Patients with permanent residence in a nursing home
* Patient unwilling to cooperate for testing
Long-term Respiratory Complications in Infants With Perinatal COVID-19

Study outcomes and endpoints:

* Primary outcome: to assess clinical characteristics of infants with confirmed COVID-19 infection at birth and to evaluate long-term respiratory consequences of neonatal COVID-19 infection.
* Secondary outcome: to evaluate the prevalence and natural history of lung function impairment among infants with confirmed COVID-19 compared to infants with no history of COVID-19. To this end, infants will undergo pulmonary function testing (PFT) with the Exhalyzer D device (Eco Medics, Switzerland).

In this prospective, observational longitudinal study, infants will undergo clinical and growth assessment at 6 and 12 months' follow-up. Respiratory complications, such as wheezing, infections, chronic cough will be recorded along with hospital admissions and drug prescription or use.

Infants will undergo PFT with the infants in the supine position, during quiet, natural sleep, according to American Thoracic Society/European Respiratory Society recommendations with measurement of lung volumes, flow, functional residual capacity, time to peak tidal expiratory flow/expiratory time ratio (tPTEF/tE)10. Lung ultrasound will be performed to rule out lung abnormalities. After allowing adaptation to the mask, the investigators will record tidal breathing, flow volume loops for \>2 minutes or \>20 artifact-free breaths. Using commercially available software (Spiroware, Ecomedics), the investigators will extract tidal breathing parameters: ratio of time to reach peak tidal expiratory flow to expiratory time (tPTEF/tE), tidal volume (VT), and respiratory rate (RR). tPTEF/tE is a reproducible and reliable marker of airway obstruction, can detect severe expiratory airway obstruction in infants with respiratory complaints and is associated with subsequent wheezing in infancy.

Appropriate statistical methods will be used to describe clinical characteristics of patients and compare groups (T-test, Mann-Whitney test, chi-squared test, multivariate analysis, mixed models depending on data distribution - evaluated with Shapiro-Wilk test - and data characteristics).

Eligibility Criteria:
Inclusion Criteria:

* term infants;
* informed consent;
* history of perinatal COVID-19 (confirmed by nasopharyngeal swab tests, study group)

Exclusion Criteria:

* congenital malformations (particularly airway malformations);
* lack of informed consent
Diagnostic Investigation of Sudden Cardiac Event Risk

The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).

This is a prospective, multi-center, observational study. The research will be performed in three phases, each using distinct patient cohorts:

Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation

The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.

Eligibility Criteria:
Inclusion Criteria:

* Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for primary prevention
* Left ventricular ejection fraction (LVEF) ≤ 50 %
* Ability to collect clinical follow-up and endpoint information, including device interrogation data

Exclusion Criteria:

* Congenital heart disease
* Known inherited arrhythmia disorder
* Organ transplantation
* Inability to give informed consent
Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis

This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Severe Acute Pancreatitis
* Biliary pancreatitis
* 7 days of the onset

Exclusion Criteria:

* Surgical patients
* Serious diseases and infection
* Alcoholic pancreatitis
* Hypertriglyceridemia pancreatitis
* Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI\>30
The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection

To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.


Eligibility Criteria:
Inclusion Criteria:

* All patients of different age
* Gender
* Risk factors and procedures candidate for surgical intervention during the period of the study

Exclusion Criteria:

* Patients with an established pre-operative infection at the operative site
Myofascial Trigger Point Release and Paced Breathing Training for Chronic Low Back Pain

A study to explore whether two different treatment approaches, myofascial trigger point release and core stabilization exercises, both with and without additional paced breathing training, can help patients with chronic low back pain (CLBP) and whether one of the two treatments is superior.

This is a randomized controlled trial to evaluate the effect of myofascial trigger point release therapy compared to core stabilization exercises, both with and without additional paced breathing training, on patients with chronic low back pain (CLBP). The main focus is on changes in pain severity, anxiety and depression, heart rate variability, and use of analgesic medication. Outcomes are measured at baseline (pre-intervention), after ten treatments (post-intervention), at three- and at six-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 20 and 70 years
* LBP at least once a week during the last three months
* Pain intensity rated at least 4 on an 11-point scale (0=no pain, 10=worst pain imaginable)
* Muscular pain during flexion, extension and lateral flexion

Exclusion Criteria:

* Acute hernia
* Acute local or generalized inflammation
* Neurological disorders such as multiple sclerosis, Parkinson's disease, hemiplegia
* Fibromyalgia
* Radicular symptoms (Lasègue's sign, weakness of foot dorsiflexion muscle, needles or tingling in the legs)
* Paraspinal tumors or metastases
* Cancer under chemo- or radio-surgical treatment or requiring such during the next 12 months
* Leg prostheses
* Rheumatic, cardiovascular or chronic pulmonary condition precluding 45-minute physical therapy (contraindication declared by a physician)
* Severe depression or severe anxiety currently requiring psychotherapy and/or pharmacotherapy
* Suicidal tendencies
* Drug abuse or addiction
* Pregnancy existing or planned during the study period
Prediction of Anxiety and Memory State

The purpose of this study is to look at how signals in the brain, body, and behavior relate to anxiety and memory function. This project seeks to develop the CAMERA (Context-Aware Multimodal Ecological Research and Assessment) platform, a state-of-the-art open multimodal hardware/software system for measuring human brain-behavior relationships.

The R61 portion of the project is designed to develop the CAMERA platform, which will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy, as well as to build CAMERA's passive data framework and active data framework.

CAMERA will record neural, physiological, behavioral, and environmental signals, as well as measurements from ecological momentary assessments (EMAs), to develop a continuous high-resolution prediction of a person's level of anxiety and cognitive performance. CAMERA will provide a significant advance over current methods for human behavioral measurement because it leverages the complementary features of multimodal data sources and combines them with interpretable machine learning to predict human behavior. A further distinctive aspect of CAMERA is that it incorporates context-aware, adaptive EMA, where the timing of assessments depends on the subject's physiology and behavior to improve response rates and model learning. In this study, CAMERA focuses on predicting anxiety state and concurrent memory performance, but the platform is flexible for use in various domains.

Currently, it is challenging to study complex, longitudinal relationships between the brain, body, and environment in humans. Most existent tools do not allow the investigator to measure transient internal states or cognitive functions comprehensively or continuously. Instead the investigators typically rely on sparsely collected and constrained self-reports or experimental constructs, including EMA.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have known or suspected Temporal Lobe Epilepsy.
* Native or proficient in speaking English or Spanish.
* Stereoelectroencephalography (sEEG) cases: The implant plan must include hippocampal head, body, and tail electrodes either unilaterally or bilaterally.
* 7th grade reading level (minimum level considered literate for adults)

Exclusion Criteria:

* Hearing impaired (i.e., not corrected with a hearing aid)
* Unable to read the newspaper at arm's length with corrective lenses.
* Objective intellectual impairment (estimated IQ \< 70)
* Any history of Electroconvulsive Therapy or psychosis (except postictal psychosis for patients)
* Psychotic disorder (lifetime)
* Current Anxiety disorder, Major Depressive Disorder, or Bipolar Disorder
* Neurodegenerative diseases, presence of widespread brain lesions, language problems (other than naming difficulty)
* Medical conditions that could potentially affect cognitive performance (e.g., human immunodeficiency virus (HIV) infection, cancer with metastatic potential).
* Acute renal failure or end-stage renal disease
TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.

TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed:

  1. adenocarcinoma of the pancreas (pancreatic cancer)
  2. adenocarcinoma of the colon or rectum (colorectal cancer)
  3. adenocarcinoma of the gastric (gastric cancer)
  4. esophageal cancer
  5. gastrointestinal stromal tumor (GIST)
* Relapsed or refractory disease
* Measurable lesion by RECIST 1.1

Exclusion Criteria:

* Known Hepatitis B, C or HIV infection
* Previous therapy with any drug that inhibits the PI3K pathway
* Anti-tumor therapy within 21 days of study Day 1