cyrilzakka/clinical-trials huggingface dataset:
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.


Eligibility Criteria:
Inclusion Criteria:

* subjects who had any concomitant meniscus or cartilage injuries

Exclusion Criteria:

* subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
* subject who wanted reconstruction with autograft
* subject who denied participation in this study
* subject who would meet the national reimbursement criteria
Assessment of Implantation Potential of Embryos by Time-lapse Technology

1. Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions.
2. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
3. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.

1. There will be two arms of the study. The Study arm in which embryos of patients will be cultured in the Embryoscope. The control arm in which the embryos of patients will be cultured under conventional conditions.
2. Embryos to be transferred will be identified by the Embryoviewer in the Study arm and the ones in the control arm will be identified by established subjective morphological criteria.
3. Embryos with definite implantation potential will be transferred in both arms.
4. Embryos not transferred will be frozen and/or discarded in both arms.

Eligibility Criteria:
Inclusion Criteria:

1. Women of age 21-39 yrs.
2. Basal FSH \< 12mIU/ml
3. Anterior mullerian hormone(AMH) \> 1.0 ng/ML
4. Antral follicle count (AFC) \> 8
5. Body mass index (BMI) \< 35 mt2/kg
6. Estradiol (E2) \< 50PG/ML

Exclusion Criteria:

1. Women with one ovary.
2. Women in whom both ovaries are not seen on ultrasonography.
3. Women with too small uterine cavity.
4. Women with history of recurrent pregnancy loss
5. Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc.
6. Human immunodeficiency virus (HIV) I and II positive women.
NMES Effects on Substrate Metabolism and IGF-1

The aim of this study is to investigate whether neuromuscular electrostimulation (NMES) training coupled with high-intensity interval training (HIIT) and moderate intensity continuous aerobic training has an effect on the metabolic, cardiovascular and hormonal components compared to respective training protocols without concurrent NMES as a exercise performance enhancement strategy.


Eligibility Criteria:
Inclusion Criteria:

- All participants were healthy with no musculoskeletal injuries and had not participated in lower-body resistance training for six months prior to the study.

Exclusion Criteria:

* Individuals with musculoskeletal injuries and had participated in lower-body resistance training for six months prior to the study has been excluded from the enrollement for the current study.
Liver Transplantation and Metastatic Colo-rectal Cancer.

Survival of colo-rectal cancer patients after liver transplantation.

Survival, time to progression, other malignancy, side-effects, quality of life.

Eligibility Criteria:
Inclusion Criteria:Colo-rectal cancer -

Exclusion Criteria:

-
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.

The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.

Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.

Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.

Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
* Patients classified as American Society of Anesthesiologists (ASA) class I-III
* Patients who are willing and capable of understanding and cooperating with the requirements of the study.
* Patients able to understand and communicate in English.
* Patients who have provided written informed consent and signed the IRB approved consent form.

Exclusion Criteria:

* Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
* Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) within one year before the start of the study.
* Patients with an allergy or hypersensitivity to opioids.
* Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the dose of study drug.
* Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
* Female patients who are pregnant (positive pregnancy test) or breastfeeding.
* Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
* Patients who present to the ER using supplemental oxygen.
* Patients who have participated in a clinical trial of an investigational drug or device within 30 days of enrollment.
* Patients who are active or reserve duty with the US military.
Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)

The purpose of this clinical trial is to test whether or not the medication amantadine is effective in reducing behavioral disturbances in patients with frontotemporal dementia.

Behavioral disturbances are a major cause of morbidity in frontotemporal dementia (FTD), yet little is known about the effectiveness of medications to treat these disturbances. Preliminary data suggests that the dopaminergic agent amantadine may reduce these disturbances. This 6-week, prospective, randomized, placebo-controlled trial will compare amantadine to placebo to assess its effectiveness in reducing behavioral symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Frontotemporal dementia meeting diagnostic criteria of the Report of the Work Group on Frontotemporal Dementia and Pick's Disease (McKhann et al, 2001). Diagnosis will be established by clinical interview by a geriatric psychiatrist or neuropsychiatrist, experienced with the diagnosis of FTD. Patients with the language presentation of FTD will be enrolled if their behavioral disturbance meets the inclusion criteria. Use of these diagnostic criteria would allow for enrollment of patients who in a clinical setting carry the diagnosis of: semantic dementia, primary progressive aphasia, cortical-basal degeneration, progressive supranuclear palsy, (amyotrophic lateral sclerosis (ALS) with dementia, and Pick's disease, as all of these diagnoses are now classified under the rubric of FTD.
* Frontal Behavioral Inventory (FBI) disinhibition subscale score of \>16 (Kertesz et al,1997; Kertesz et al 2000). Explanation of this subscale is found under outcome measures.
* Men, women and minority groups will be included, ages 40-90 years old.
* Judged by the attending psychiatrist to be in sufficiently good health so as to be treated using the study protocol in usual outpatient care circumstances.
* Patient, caregivers and or legal representatives provide informed consent for participation in the study, using standard Johns Hopkins Division of Geriatric Psychiatry and Neuropsychiatry procedures.
* Caregiver is available who spends at least 10 hours per week with the patient and is able and willing to accompany the patient in the course of the study and to provide collateral information.

Exclusion Criteria:

* Presence of a brain disease that might otherwise fully explain the presence of dementia or behavior disturbance, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and the like.
* Treatment with amantadine is contraindicated in the opinion of the study attending psychiatrist. Examples of this would be patients with advanced heart, liver or kidney disease or a seizure disorder. Creatinine clearance \>50mL/min will be required, calculated using the Cockcroft-Gault equation.
* Failure of treatment with amantadine for behavior disturbance of FTD in the past.
* Treatment with a medication that would prohibit the safe concurrent use of amantadine.
* Ongoing regular alcohol use and an unwillingness to stop drinking alcohol during the study period.
* Pregnancy or lactation.
Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer

This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;
* Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;
* Good compliance and signed informed consent form.

Exclusion Criteria:

* Patients who cannot lie prone for a long time;
* Pregnant women;
* Lactating women
Assessing the Use of Mobile Technology in Adult Asthma Patients

This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes:

1. HeroTracker sensor that counts dosage and monitors real-time medication adherence
2. BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Male and female adults (aged ≥ 18 years)
* Diagnosis of asthma for at least 6 months
* ICS (inhaled corticosteroid) use for at least 3 months
* Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker
* Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher)

Exclusion Criteria:

* Currently pregnant or planning to become pregnant during the study period
* Primary language other than English (BreatheSmart mobile app is currently available only in English)
ProACT Post-Approval Study

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male of at least 50 years of age.
2. Subject demonstrates stress urinary incontinence.
3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
4. Subject is willing and able to undergo surgical implantation of ProACT devices.
5. Subject is willing and able to comply with study-required

   follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies.
6. Subject is willing and able to sign the approved informed consent.
7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).
8. Subject has a negative urine culture.
9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.
10. Subject meets ONE of the following criteria:

    1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
    2. Baseline PSA \> 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA;
11. Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria:

1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.
2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.
3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.
4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.
5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.
6. Subject has an atonic bladder.
7. Subject had, presently has, or is suspected of having bladder cancer.
8. Subject has untreated or unsuccessfully treated bladder stones.
9. Subject has detrusor sphincter dyssynergia.
10. Subject has known hemophilia or a bleeding disorder.
11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).
12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.
The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning

The aim of the study is to test whether oxygen therapy delivered through high-flow nasal cannula devices in patients admitted to the emergency department for acute carbon monoxide poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin (COHb) concentration and delayed neurological sequelae incidence.


Eligibility Criteria:
Inclusion Criteria:

* Age v 18 years
* Carbon monoxide intoxication as major problem leading to emergency department admission
* Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment

Exclusion Criteria:

* Age \< 18 years
* Glasgow coma scale ≤ 13
* Refusal to give consent
PPROM Erythromycin Versus Azithromycin

Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging latency in PPROM.

The current standard regimen for PPROM patients between the gestational age of 24 0/7 and 32 0/7 weeks, is to administer ampicillin 2gm IV every 6hours for 48hrs followed by amoxicillin 250mg orally every 8 hours for 5 days, with erythromycin 250mg IV for 48hours followed by 500mg orally every 8hours for 5 days. Our study design would be a prospective randomized trial. Consented, eligible women will be randomized to receive ampicillin as above plus either azithromycin 1 gm orally at enrollment or erythromycin 250mg IV every 6 hours for 48hours followed by 500mg orally every 8hours for 5 days. Those who are unable to tolerate the 1gm of azithromycin within the first 30 minutes of administration, a 1000mg powder suspension will be given. In conjunction with standard protocol, a course of steroids for fetal lung maturity will be administered upon the treating staff's discretion, and all Group B Beta Streptococcus positive patients will be treated.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at least 18 years old
* Gestational age of 24 0/7 to 32 0/7 weeks
* Singleton gestation
* Randomization within 36 hours of rupture of membranes.
* Cervical dilation less than or equal to 4 cm.

Exclusion Criteria:

* Known lethal fetal anomaly
* Vaginal bleeding
* Maternal or fetal indication for delivery
* Diagnosis of chorioamnionitis on admission
* Cervical cerclage in place
* Placenta previa or other known placental anomalies
* Use of antibiotic therapy within 5 days.
* Allergy or other contraindications to erythromycin/azithromycin or steroid use.
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects, at least 27 years old.
2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (\<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
3. History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
4. History of genital herpes with \> 3 outbreaks per year.
5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Usefulness of the Evaluation of the ROSC With Carotid Ultrasound During CPR

The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.

However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.

Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients. However, there has been no clinical study on actual cardiac arrest patients.

The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.

However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.

Ultrasound is a key technique that guides to discern and treat causes of cardiac arrest patients. Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients.

However, this is just a case study. There has been no clinical study on actual cardiac arrest patients whether it is possible to accurately determine the ROSC by evaluating the carotid artery compressibility and pulsatility by ultrasound. Also there has been no clinical studies on actual cardiac arrest patients comparing the time taken to evaluate the ROSC of carotid ultrasound and manual palpation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent CPR among cardiac arrest patients 18 years of age or older who visit the emergency room
* Patients who applied carotid ultrasound to determine the presence of carotid artery compression and pulse

Exclusion Criteria:

* Patients who have stated their intention to do not resuscitation for future treatment (including cardiopulmonary resuscitation)
* Patients who have difficulty applying carotid ultrasound due to head and neck trauma
* Patients who have difficulty applying carotid ultrasound due to deformed neck structure by surgery or head and neck cancer
* Return of spontaneous circulation before ultrasound application
* Patients who could not evaluate carotid artery compressibility and pulsatility by ultrasound