cyrilzakka/clinical-trials huggingface dataset:
Multiphoton Laser Scanning Microscopy in Cutaneous Optical Pathology

We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy.

For skin diseases, the most convincing method for diagnosis to date is surgical biopsy. However, a skin biopsy is an invasive procedure which carries the risk of tissue damage, wound infection and scar formation. To solve the inconvenience from surgical biopsy, multiphoton laser scanning microscopy is a developing, non-invasive method for observing the cutaneous anatomy and pathology. Multiphoton laser scanning microscopy is good in tissue penetration and resolution with less tissue damage. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy. A good correlation in multiphoton image may serve as optical biopsy for cutaneous pathology and spare the invasive procedure of skin biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving cosmetic surgeries such as removal of moles

Exclusion Criteria:

* No special exclusion criteria
An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases

This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.


Eligibility Criteria:
Inclusion Criteria:

* Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
* First-line treatment with bevacizumab for potentially resectable metastatic disease

Exclusion Criteria:

* Outright resectable disease
* Clearly inoperable disease
* Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

Androgen deficiency in the aging male is poorly understood. The objective of this study will be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual performance.

120 men with a diagnosis of Erectile dysfunction (ED) will be randomized to one of three arms in the study, DHEA (50 mg), testosterone \[T\] (80 mg) or placebo. Patients will be evaluated after starting blinded medication at 30 day intervals for a total of 90 days. Response will be evaluated with blood parameters, physical examination including rectal examination, validated questionnaires and global assessment scales.

Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction (ED)

Exclusion Criteria:

* Prior use of DHEA or T
Effects of Hand Massage Applied With Two Different Methods

There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography. Therefore, the aim of this study is to examine the effects of reflexology hand massage and classical hand massage on pain, anxiety and physiological parameters after coronary angiography.

There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* • Patients who are over 18 years old

  * Can speak Turkish
  * Agree to participate in the study
  * Have not undergone emergency coronary angiography
  * Have not consumed coffee or hypnotic drugs at least 12 hours before
  * Have no history of chronic pain (e.g. arthritis)
  * Are not addicted to alcohol or drugs
  * Have no psychological problems (such as depression, anxiety disorder)
  * Have no problem with having their hands massaged; those who do not have any skin lesions, sensory and motor disorders, amputations, burns, or pathological diseases related to muscles and bones
  * Have not used anxiolytics

Exclusion Criteria:

* • Those who do not volunteer to participate in the study

  * Those who have any skin lesions, burns, open wounds, muscle and bone pathological diseases on their hands,
  * Those who develop delirium during the follow-up period
  * Those who develop complications after coronary angiography (such as bleeding, etc.)
  * Arrhythmia
  * Hemodynamic instability
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).

Pilot Study

Eligibility Criteria:
Inclusion Criteria:

* Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
* Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)

Exclusion Criteria:

* Pregnancy or intention to become pregnant during the course of the study
* Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
* Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
* Prone to excessive bleeding or bleeding diathesis
Post Pandemic Pneumococcal Carriage Among Children and Adults

The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas.

The SARS-CoV-2 pandemic profoundly impacted human health directly and indirectly. As such, elucidating pre- and post-pandemic trends in the epidemiology and population genomics of human respiratory pathogens including those such as the bacteria Streptococcus pneumoniae, a human commensal and the causative agent of invasive pneumococcal disease (IPD), merits study.

Nasopharyngeal samples will be processed at the PIs Laboratory to identify S. pneumoniae. If present, the isolate will undergo bacterial whole genome sequencings and population dynamic analysis. Carriage prevalence and serotype composition will be compared to extant studies and pneumococcal genomic data will be analyzed in the context of samples from the US and abroad.

Eligibility Criteria:
Inclusion Criteria:

* Children, ages 7 to 59 months (less than 5 years)
* Adults, ages 50 and older
* Ability to provide informed consent (from parents for children participants)
* ability to read and speak in English
* Agree to comply with study procedures (complete online data questionnaire and provide a nasopharyngeal collection).

Exclusion Criteria:

* Have been on an antibiotic in the last 2 weeks
* Have a respiratory infection that would make an nasopharyngeal collection improbable
* Have underlying developmental or chronic conditions impacting immune or respiratory function (e.g., immunocompromised, cystic fibrosis, cerebral palsy, paralysis)
* Adults unable to consent, individuals who are not yet adults, and prisoners will be excluded from this study.
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.

II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.

III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.

Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment

Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis

At least 1 of the following signs and symptoms required:

* Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment
* Weight loss greater than 5 kg
* Pulmonary involvement in at least 1 lobe on x-ray

Night sweats on at least 2 occasions within 1 week prior to treatment

--Prior/Concurrent Therapy--

Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed

--Patient Characteristics--

* No neuropathy and not at risk for neuropathy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older at obtaining informed consent
* Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
* Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment

Exclusion Criteria:

* Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
* Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
* Patients with undiagnosed abnormal vaginal bleeding
* Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
* Patients aged 35 years or older who smoke at least 15 cigarettes per day
* Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)
* Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
* Patients who are regularly taking nutritional products that contain St. John's Wort
* Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
* Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.


Eligibility Criteria:
Inclusion Criteria:

* The patient has advanced active cancer for which there is no known curative therapy.
* The patient is able (in the investigators opinion) and willing to comply with all study requirements.
* The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
* The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder.
* The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.

Exclusion Criteria:

* The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
* Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
* Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
* The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
* The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.
Comparison High-density Silicone Oils in Retinal Detachment

The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.

Five to 10% of retinal detachments progressed to proliferative vitreoretinopathy (PVR), the common more cause of surgical failure of retina detachment.

Despite the use of internal tamponades, the treatment of retinal detachments due to a progressed proliferative vitreoretinopathy (PVR) is still a problem. At present, conventional silicone oil, having a lower specific gravity than water, is an excellent tool in advanced PVR retinal detachment especially of the upper circumference.

In the past, to diminish the re-detachments diverse heavier-than-water density endotamponades were investigated by to use in in cases of inferior PVR. However,heavier-than-water density endotamponades have demonstrated adverse short term effects. (Example: silicon dispersion: hypotension and inflammation)

Recently, two new long-term heavier-than-water internal tamponades were introduced: Oxane HD \[oil-RMN3-mixture\] and Densiron \[mixture of 30.5 vol% perfluorohexyloctane (F6H8) with 69.5 vol% polydimethylsiloxane (silicone oil)\], showing satisfying anatomical results and good intraocular tolerance.

In the present study, we will compare the anatomical outcome, functional results and intraocular adverse effects of two types of heavier tamponades.

Eligibility Criteria:
Inclusion Criteria:

* Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Exclusion Criteria:

* Diabetes
* Uveitis
* Glaucoma
The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation

Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the current practice of over-pressurizing the eye at the end of surgery.

Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT) for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical protocol with current practice, where the eye is over-pressurized for a set period of time, in terms of surgical efficiency, clinical outcomes, and adverse events.

Study design: International multicentre non-inferiority randomized clinical trial Study population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell dysfunction above the age of 18 years.

Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients will be randomized for either the iOCT optimized surgical protocol or current standard surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups will be evaluated with iOCT at the end of surgery.

Main study parameters/endpoints:

The main study parameter is the rate of adverse events (particularly graft dislocations). Secondary parameters/endpoints are surgical time, the recovery of visual acuity and endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the extent/duration of surgical tissue manipulations.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of iOCT during surgery does not entail additional risk to the patient. Participants to this study will adhere to the standard of care after corneal transplant surgery. In addition, they will receive study specific measurements and questionnaires. The additional measurements and questionnaires will be combined with regular follow up moments.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Irreversible corneal decompensation caused by Fuchs corneal endothelial dystrophy or pseudophakic bullous keratopathy
* Eligible for posterior lamellar keratoplasty, specifically Descemet Membrane Endothelial Keratoplasty (DMEK)

Exclusion Criteria:

* Any ocular co-morbidity other than cataract, mild dry eye disease, ocular hypertension, simple primary open angle glaucoma, and mild age-related macular degeneration
* Prior corneal transplant surgery
* Human leukocyte antigen (HLA) matched keratoplasty
* Any disability that will interfere with performing or understanding the procedures and questionnaire fulfilment except if it is temporary of nature.
* Combined phaco-emulsification-DMEK surgery (triple procedure)
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.

Not Provided

Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

* Japanese Healthy Male subjects
* Age 20 to less than 40 years of age
* Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
* Written informed consent must be obtained on a voluntary basis before any assessment is performed.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

* Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
* Past medical history of cancer, cerebral infarction or cardiac infarction
* Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
* QTcF \> 450ms at the screening examination
* NT-proBNP \> 125 pg/mL at the screening examination
* Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
* Patients willing to give a written informed consent

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information
* Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible.
* Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
A Study Comparing Oxymetazoline 1% Cream to RHOFADE

randomized, double-blind, placebo controlled

Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
2. Provided IRB approved written informed consent;
3. A CEA score of ≥3 prior to study drug application
4. A PSA score of ≥3 prior to study drug application

Exclusion Criteria:

1. Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
2. History of hypersensitivity to the study product;
3. Presence of ≥3 facial inflammatory lesions of rosacea;
4. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
5. Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
7. Presence of significant hypertension or circulatory disease
Non-invasive Measurements of Elastance and Resistance

The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.


Eligibility Criteria:
Inclusion Criteria:

* intact respiratory drive;
* PaO2/FiO2 ratio \> 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
* pH between 7.35 and 7.45;
* patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.

Exclusion Criteria:

* infection, sepsis or septic shock; (with fever no)
* hemodynamic instability;
* respiratory centres depression;
* esophageal deformity, or gastric/esophageal illnesses;
* previous recent gastric/esophageal surgery.