cyrilzakka/clinical-trials huggingface dataset:
Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ART

The objective of this prospective randomized clinical trial is to investigate whether the addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation with rFSH from the onset of the follicular phase and throughout stimulation in sub fertile women undergoing IVF, improves pregnancy rates.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, two parallel group of patients, Phase IIIb clinical study to test the efficacy and safety of adding low-dose hCGs in a short protocol with GnRH agonist and ovarian stimulation with recombinant FSH (rFSH) from the onset of the follicular phase and throughout the duration of stimulation in enrolled women to the increase in the rate of clinical pregnancies.

Main end point will be the rate of clinical pregnancy (positive heart rate at 7 weeks of gestation in the ultrasound), while secondary endpoints will be

* The number of follicles (\> 11,\> 14,\> 18 mm) on the day of triggering with hCG
* The thickness of the endometrium on the day of follicular maturation
* Live birth rates
* Automatic abortion rates (loss of pregnancy after positive heart function up to 20 weeks of gestation)
* The rate of ongoing pregnancy (positive heart function after 12 weeks of gestation),
* The percentage of ovarian hyperstimulation syndrome (after triggering) with hCG for the next 2 weeks
* The rate of multiple pregnancy.

Participants will be randomly divided into two groups: the intervention group (Group 1) and the control group (Group 2). Randomization will be done using sealed envelopes marked "Group 1" and "Group 2". The randomization list will be prepared centrally for the four participating clinics (research centers) and there will be a "stratification" per center, per 30, respectively, and will be shared among the participants.

"Group 1" will indicate the application of the protocol by adding hCG with the initiation of controlled ovarian stimulation protocol for IVF / ICSI with rFSH, and "Group 2" will indicate the application of the conventional protocol without the addition of hCG .

Each patient's assignment to a treatment group will be made by calling the unit's midwife who will have 2 envelopes with the above indications and who will not be present when the pair is informed by 2 members of the research team.

Eligibility Criteria:
Inclusion Criteria:

1. Age: between 35 and 40 years of age,
2. Physiological menstrual cycles (24-35 day cycle),
3. Normal endocrine function (normal PRL and TSH, FSH ≤ 15 IU / ml),
4. Transvaginal ultrasound (TVS) without pathological findings,
5. Free personal medical history,
6. Indication for IVF / ICSI (NICE, 2016)
7. 1st or 2nd IVF / ICSI cycle

Exclusion Criteria:

1. Endocrine or metabolic disorders, e.g. PCO (S)
2. Pathology of the uterus and / or endometrium,
3. Pelvic inflammatory disease (PID),
4. Basal FSH levels\> 15 IU / ml,
5. Surgery in the ovaries,
6. Body Mass Index (BMI) ≥ 35 kg / m2,
7. Age: \<35 years \&\> 41 years old
External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation


Eligibility Criteria:
Inclusion Criteria:

* Age≥18
* Patient undergoing colonoscopy

Exclusion Criteria:

* Patients with prior colectomy
* Unable to provide written informed consent
The Surrogate Project (Surrogate Storytelling)

Research Protocol Abstract:

This is a phase II controlled trial (RCT) of a "storytelling" intervention compared to no treatment among surrogates who have participated in a decision to limit life-sustaining treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned to "storytelling" (a facilitated elicitation of the experience 2-4 weeks after bereavement) or no treatment with follow up "monitoring of well-being". Subjects will receive print bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks, 3-months, and 6-months after bereavement.


Eligibility Criteria:
Inclusion Criteria:

Screening/Re-contact (1st phase)

* Eligible patients will:

  * lack decision-making capacity
  * have a surrogate decision maker (family member or friend)

Eligible surrogates will:

* be 18 years of age or older
* self-identify as having primary decision-making authority for the patient
* live within approximately 50miles or less of the University of Pittsburgh
* be able to conduct a 1hr interview in English

  * Court-appointed power of attorney will be excluded, as they are not expected to experience the same emotional distress as a family member or friend of a critically ill patient.

For Assignment to Intervention/Control (2nd phase)

* Eligible surrogates will:

  * have previously given consent for study staff to follow their loved one's course in the hospital and to be re-contacted
  * have participated in decision making about limitation of life-sustaining treatments (LST) for their loved one (ICU patient)
  * have had their loved one (ICU patient) die in the hospital

Exclusion Criteria:

Screening/Re-contact

* Ineligible patients will:

  * be less than 18 years old
  * prisoners
  * be of other legal concern, such as malpractice
* Ineligible surrogates will:

  * be less than 18 years old
  * be unable to complete a 1-hour interview and questionnaires in English
* For Assignment to Intervention/Control

Ineligible patients will:

* have fully and permanently regained decision-making capacity and therefore no longer require a surrogate to make treatment decisions
* be discharged from hospital alive
Fluorescent Imaging of Nerves with Illuminare-1 During Surgery

This study will test the safety of using Illuminare-1 during standard surgery for prostate cancer. The study researchers will test increasing doses of Illuminare-1 to find the dose that makes the nerve structures fluoresce (light up) but causes few or mild side effects. When the researchers find this dose, it will be tested in new groups of study participants to see whether surgery performed using Illuminare-1 guidance is better than surgery performed without intraoperative guidance. The researchers will also do tests to study the way the body absorbs, distributes, and gets rid of Illuminare-1. This study is the first to test Illuminare-1 in people. Illuminare-1 has received Fast Track designation from the US FDA.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and capable of signing their own consent form
* Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection

Exclusion Criteria:

* Prior pelvic surgery or pelvic radiation therapy
* Known central nervous or peripheral nervous system disease or insult (including neurodegenerative diseases), current use of neurotoxic medications, or use of cytotoxic chemotherapy with known neurotoxicity within 1 month
* Exposure to investigational agents in the immediate 30 days before or 15 days after study drug administration
* Patients with significant renal dysfunction (\<60 mL/min as assessed by the Cockcroft Gault calculation for creatinine clearance)
* Clinically significant hepatic/liver impairment (liver function tests more than 2x institutional normal upper limit)
* Exposure to phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines, should be avoided. If safe to discontinue use for a limited time, patients may participate on this trial but will discontinue the use of the interfering drug for 5 half-lives before Illuminare-1 injection to permit full washout, as well as for 48 hours after administration of Illuminare-1.
Tc-99m Renography and Cisplatin-induced Nephrotoxicity

Cisplatin is a heavy-metal complex widely used in the treatment of a variety of malignancies, including small cell and non-small cell lung cancer, ovarian, bladder, head and neck, esophageal, cervical and germ cell tumors. The administration of cisplatin is commonly associated with certain drug-induced toxicities that may limit their clinical utility and adversely affect the quality of life of patients undergoing treatment. Although many advances have been made in reducing some of the toxicities associated with platinum drug therapy, it is clear that dose-limiting nephrotoxicity remains a major stumbling block in the use of this compound. Subtle changes in renal function occur without overt renal insufficiency, consisting of a decrease in effective renal plasma flow and tubular dysfunction despite aggressive hydratation. Early tubular damage occurring within 1 to 3 hours after cisplatin administration has been demonstrated by measurement of urinary beta 2-microglobulin, a sensitive marker of tubular injury. The chronic lesion has become of greater concern in recent years as many patients have been cured or placed into long-term remission due to cisplatin treatment. It consists of a decrease in glomerular filtration rate, which is not necessary characterized by a remarkable increase in serum creatinine. Cumulative tubular damage has been demonstrated by increased urinary excretion of tubular enzymes such as alanine aminopeptidase and beta 2-microglobulin. In this setting, predicting the occurrence of chronic cisplatin-induced nephrotoxicity remains a clinical challenge.

Tc-99m mercaptoacetyltriglycine (MAG3) is predominantly a proximal tubular secretion renal agent without cortical fixation indicated for dynamic renal studies to evaluate cortical tubular function and collecting system drainage. Tc-99m MAG3 and is the agent of choice for obstructive uropathy and diffuse functional abnormalities of the renal cortex. The aim of this study was to evaluate by means of Tc-99m MAG3 scintigraphy the acute and subacute impairment of tubular secretion after cisplatin administration in patients with head and neck cancer receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck cancer
* Receiving a chemotherapy including cisplatin administration (\>80 mg/m2)
* WHO score \< or = 2
* Estimated life expectancy \> 6 month
* Normal renal function
* Signed informed consent

Exclusion Criteria:

* Congestive heart failure
* History of cisplatin treatment
* Metastatic carcinoma
* History of radiation therapy
* History of renal insufficiency
* History of chronic renal disease
* Pregnancy
Posturing Effects on Perception of Time and Perceptions of the Provider-Patient Interaction in the Emergency Department

Study Objective:

* To examine the perceptions of time spent at the bedside; perceptions of bedside manner; and patient perceptions of the provider-patient interaction offered by emergency providers when they sit versus when they stand during the initial evaluation.

This project is clinically relevant research different from prior Emergency Department (ED) satisfaction studies since this study will contribute information about factors that could increase patient satisfaction with his/her provider in the ED setting. This research may guide specific guidelines for quality improvement efforts. The investigators hypothesize that patients will perceive that the emergency providers are at the bedside longer, demonstrate better bedside manner, and have better provider-patient interactions when they sit versus when they stand. Additionally, the investigators hypothesize that providers who sit will perceive that they are at the bedside longer than those who stand for the same period of time.

Methods: A convenience sample of adult patients will complete a 5-item questionnaire concerning the perceived time spent with the emergency provider and the qualities of the provider-patient interaction. Emergency providers will be randomly assigned to either sit or stand during the initial evaluation. The providers will complete a 4-item questionnaire. These data will be compared to the actual time spent in the evaluation, measured in seconds, using a stopwatch. These data, combined with demographic data obtained from the patient chart, will be analyzed to examine whether there are statistically significant differences in patient perceptions and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* The subject population represents a convenience sample of patients 18 years and older who give consent.
* All English speaking individuals with adequate health status and cognitive function to communicate answers to the investigator.
* There are no foreseen reasons to exclude pregnant women as they are not likely to be vulnerable in this study.

Exclusion Criteria:

* Unstable patients and patients seen in the critical care area will be excluded from study.
EuroPainClinics® Study III (Prospective Observational Study)

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

Patients will be selected from 4 participating clinics from Czech and Slovak republic. Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Back pain due to Lumbar Disc Disease in our population is a very common problem. The treatment options range from physiotherapy to fusion surgery. When all conservative treatment is failed than in some cases with suitable conditions of intervertebral disc is possible to avoid classical disc surgery with minimally invasive surgery techniques. A number of minimally invasive procedures have also been developed in the recent past for its management. One of them is Disc FX procedure. Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. This method provides an option for those people who have not benefited from conservative treatment, and are not yet ready for major surgery. It is a minimal-access procedure performed on an out-patient basis. Its big advantage is the fact that the patient may go home the same day. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional pain release procedure - disc FX.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo Disc FX therapy

Exclusion Criteria:

* No
Evidence Based Decision Making: Integrating Clinical Prediction Rules

Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).

Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. CPRs are proven tools that translate evidence into practice, increase quality while reducing costs, and can be used by physicians in a wide variety of clinical settings, such as primary care offices, emergency rooms, and hospitals. While many CPRs have been developed and validated over the years, health care providers have yet to incorporate them into everyday care.

CPRs aid providers in assessing the impact of individual components of a patient's history, physical examination, and basic lab results to estimate probability of disease or potential response to a treatment. Prediction rules use data that is readily available at the time of a patient encounter and often reduce unnecessary treatments and diagnostic testing. CPRs differ from reminder systems or alerts in that CPRs pull in aspects of the history and physical exam and in an evidence based fashion estimate probabilities, prognosis, or make treatment recommendations.

The goal of this study is to utilize patient electronic health records to incorporate CPRs into the face-to-face patient encounter. We propose to select certain clinical situations where well-validated CPRs are available and likely to be needed on a frequent basis. We will randomly assign an integrated CPR versus usual care into the point of care and evaluate the impact of this integration on doctor behavior and evidence-based decision making. Mount Sinai's Division of General Internal Medicine (DGIM) has significant experience with all aspects of CPRs, including derivation, validation, implementation, and systematic review. Furthermore, the Division has developed an interactive web library of CPRs for clinical use that is one of the most widely sites of its kind. We propose to collaborate with Epic, one of the nation's largest and most respected electronic medical record (EMR) companies, to integrate validated CPRs into EMRs and assess the impact on provider behavior and patient care.

Eligibility Criteria:
Inclusion Criteria:

* Providers who are part of Mount Sinai's Division of General Internal Medicine

Exclusion Criteria:

* Not a provider at Mount Sinai's Division of General Internal Medicine
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
* Signed informed consent form, or in countries where waiver of informed consent is allowed by IRB/IEC, a completed waiver form

Exclusion Criteria:

* Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
* Patients with secondary ICH related to infarction, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
* Surgical haematoma evacuation planned or performed within 24 hours of onset
A Study of TCR-Redirected T Cell Infusion in Subject With Recurrent HBV-related HCC Post Liver Transplantation

Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 10 patients with Hepatitis B virus (HBV) related HCC who underwent liver transplantation and are confirmed to have recurrent HCC. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population.

This is a phase I, single armed and open labelled trial in patients with recurrent HBV related HCC after liver transplantation. Subjects who meet eligibility criteria will receive escalating doses of HBV specific T cell receptor (TCR-T) on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycle. A 21-day treatment break will be given between each cycle. Treatment will be continued until disease progression unless otherwise specified per investigator's discretion. Subjects will be followed up post treatment for safety monitoring, including monthly follow up for the first three month and every 2-monthly follow up up to 24 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis as hepatocellular carcinoma (HCC)
* Underwent liver transplantation and confirmed recurrent HCC post operation
* Seropositive for hepatitis B surface antigen
* No major post-operative complication
* Life expectancy of at least 12 weeks
* Ability to provide informed consent
* Ability to comply with study procedures
* HLA profile matching with HLA-class I restriction element of the available T cell receptors

Exclusion Criteria:

* Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR-T, stem cells or combined therapy of the kind within 3 months prior to enrolment
* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment
* Likelihood to require steroid treatment during the period of the clinical trial
* Any other concurrent liver infections such as hepatitis A, C or D infection
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumours including metastatic brain disease.
* Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
* Patients with reproductive potential who tested positive for serum or urine pregnancy test result within 14 days prior to enrolment.
Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

To compare the anti-nausea and vomiting effect between glycopyrronium in combination with tropisetron and normal saline in combination with tropisetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Non-cardiac surgery
* American Society of Anesthesiologists classification I-III
* Receive general anesthesia
* Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

* Puerpera or lactation women
* Allergy or existing contraindication to glycopyrronium and tropisetron
* Participate in other clinical drug trials within three months
* Can not follow with the study procedure