cyrilzakka/clinical-trials huggingface dataset:
Pericervical Analgesia Versus Analesia With Nitrous Oxide (N2O) in Outpatien Operative Hysteroscopy With Miniresector

This research will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature in the control of pain caused during Outpatient Operative Hysteroscopy maneuvers with Miniresector.

Pain is the primary cause of hysteroscopy failure. It can be attributed to multiple causes, such as manipulation of the cervical canal , uterine distention due to the liquid distension media used during the procedure , operating procedures on the endometrium (as a possible cause of uterine contraction) , until the release of prostaglandins following manipulation of the cervix and uterine distension.

There are few studies in the literature that have compared the various methods of pain control during the hysteroscopic examination. Among these, Ahmad et al., for example, compared the use of the paracervical block and inhalation anesthesia during hysteroscopy: although both proved to be effective in controlling pain, the paracervical block was associated with a greater number of complications. More recently, Solano et al. they defined how the administration of nitrous oxide was equally effective (but with many more advantages) to the paracervical block with 1% lidocaine in controlling pain during hysteroscopy performed using the Bettocchi hysteroscope.

However, for the purposes of this research it is important to take two aspects into consideration:

* all the studies in the literature that compared the various pain control methods during hysteroscopy were conducted using the Bettocchi Hysteroscope and not the Miniresector;
* more in detail, there are no studies comparing the use of nitrous oxide and pericervical analgesia during outpatient operative hysteroscopy with miniresector.

Objective This clinical trial will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature1) in the control of pain caused during Outpatient Operative Hysteroscopy maneuvers with Miniresector.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous or primiparous women (a previous Spontaneous Vaginal Birth -PS- or a previous Cesarean Section -TC- the latter comparable to nulliparous women as no previous cervical dilation -)
* age between 25 and 50 years

Exclusion Criteria:

* age \< 25 or \> 50 years
* multiparity
* positive history of previous operations on the cervical canal (e.g. conization)
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.

Eligibility Criteria:
Inclusion Criteria:

* Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
* Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
* Patients considered at high risk for new revascularization procedure by at least two independent observers.

Exclusion Criteria:

* Expected life span less than six months
* Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
* Evidence of osteomyelitis in the ischemic extremity.
* Current or previous history of neoplasia.
* Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
* Proliferative retinopathy.
* Debilitating disease with a life span less than one year.
* Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow.
* Use of alcohol in excess of twice-daily doses or history of illicit drug use.
* Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day).
* Positivity for HIV or syphilis
Creation of Bone Marrow Microenvironment for Treatment of Myelodysplastic Syndrome (MDS) in Conjunction With Allogeneic Stem Cell Transplantation

Normal bone marrow function depends on the coexistence of normal hematopoietic stem cells and a microenvironment mostly located in the medullary part of the bones. Stem cells cannot function properly in the absence of an adequate microenvironment. Whereas in malignant and non-malignant hematologic diseases caused by a deficiency or abnormal stem cells, stem cell transplantation is the treatment of choice that results in a cure, in diseases such as MDS, myelofibrosis, and other conditions associated with an abnormal microenvironment, pancytopenia may occur despite the presence of apparently normal hematopoietic cells with no recognizable cytogenetic abnormality.

We, the investigators at Hadassah Medical Organization, proved in experimental studies that the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic microenvironment (of stromal origin) and hematopoietic tissue has been successfully transferred directly into ablated bone marrow cavity in a one-step transplantation procedure.

The goal of this study is to enhance hematopoiesis in patients with myelofibrosis syndrome by intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone marrow cells (BMC).


Eligibility Criteria:
Inclusion Criteria:

* Patients with impaired marrow stem cells by cytogenetic analysis or morphology (blasts), considered normal candidates for allogeneic BMT. Such patients will also be entitled to allogeneic bone marrow transplantation with intraosseous DBM.
* Patients with documented myelofibrosis will be entitled to allogeneic bone marrow transplantation with intraosseous DBM.

Exclusion Criteria:

* Patients with anticipated life expectancy of \< 4 weeks.
* Pregnant or lactating women.
* Patients with an unrelated disease or relevant clinical problem that may not permit evaluation of the results of the study.
* Patients under 18 years old.
The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma

The aim of this work is to study the role of long non-coding RNAs WRAP53 and urothelial carcinoma-associated 1 (UCA1) as potential biomarkers in diagnosis of hepatocellular carcinoma.

Sample size calculation was done in department of medical statistics, Medical Research Institute, Alexandria University and the total minimal sample size was calculated.

A prospective case control study will be conducted on 80 subjects divided into three groups:

Group (1): Thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic CT.

Group (2): Thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination.

Group (3): Twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2.

Patients will be recruited from the outpatient clinics and inpatient wards of Alexandria Main University Hospital and Medical Research Institute Hospital. Full informed consent will be taken from the patients and approval of the ethical committee of the Faculty of Medicine will be fulfilled. Exclusion criteria: Patients with any inflammatory diseases or other malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Any subject without any of the exclusion criteria

Exclusion Criteria:

* Patients with any inflammatory diseases or other malignancies.
Collection of Information to Better Understand Young Onset Colorectal Cancer

The purpose of this registry study is to create a database-a collection of information-for better understanding young onset colorectal cancer. Colorectal cancer patients are considered to have young onset colorectal cancer if they are diagnosed with their cancer before the age of 50. Researchers will use the information from this database to learn more about how young onset colorectal cancer may be similar to or different from colorectal cancer that is diagnosed later in life. Researchers will also use information from the database for current and future research on young onset colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

Participant Inclusion Criteria for database and questionnaire (YOGI)

* Histological or cytological diagnosis of gastrointestinal cancer
* 18 - 49 years old at time of consent
* No Known hereditary CRC or other cancer predisposition syndrome (stool collection cohort only)
* No history of inflammatory bowel disease (stool collection cohort only)
* No prior diagnosis of gastrointestinal cancer (stool collection cohort only)

Participant Inclusion Criteria for database and questionnaire (Controls)

* Histological or cytological diagnosis of colorectal adenocarcinoma
* No previous treatment for CRC (including surgery, chemotherapy, immunotherapy or radiation)
* Age 50 or older at time of consent
* No Known hereditary CRC or other cancer predisposition syndrome
* No history of inflammatory bowel disease
* No prior diagnosis of CRC
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Currently treated with Oral Antidiabetic Drugs
* BMI lesser than or equal to 40 kg/m2
* HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
Feasibility of a New Silicone Hydrogel Lens

The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have clear central corneas and be free of any anterior segment disorders.
* Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria:

* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Participants with any systemic disease affecting ocular health.
* Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants with an active ocular disease or are using any ocular medication.
* Participants who have had any corneal surgery (eg, refractive surgery).
* Participants who are allergic to any component in the study care products.
Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach

The goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. The investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus a CBT therapist coach (n=35

The need for evidence-based mental health treatments i.e., 'treatment based on the best available science or research evidence"1, has been stressed from scientific, ethical, and marketing perspectives. While empirical evidence supports both the efficacy and effectiveness of cognitive behavior therapy (CBT) for Obsessive-Compulsive Disorder (OCD), demand for clinicians trained in these approaches far exceeds supply. New technologies provide the opportunity to facilitate access to this specialized treatment. A growing body of research has found that web-based self-administered psychotherapy is highly effective, cost-efficient, and can achieve clinical improvements similar to those obtained with clinician administered therapy. The long-term goal of this project is to improve clinical and occupational functioning and decrease disability associated with OCD by improving access to effective treatments through the use of web-based CBT treatment. The intervention involves a computer program (BT STEPS) and human interaction via telephone. The inclusion of human interaction for coaching and encouragement has been found to significantly increase compliance and success rates in computerized self-help. Whether treatment outcomes differ when this coaching is done by a therapist versus when done by a trained non-therapist has not been studied. This is the first program to examine a hybrid model involving different levels of remote clinician coaching in combination with an on-line self-help tutorial. In Phase I the investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus nontherapist coach (n=35) and computer plus CBT therapist coach. In phase II the investigators will do a fully powered study comparing our model to traditional face-to-face therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Have clinically significant OCD
* YBOCS score of 16-32

Exclusion Criteria:

* Significant comorbid depression
* Serious suicide risk
* Psychosis or psychotic disorder
Using Personalized Letters and Emails to Increase Health Insurance Take-up and Improve Plan Choice Quality

With the passage of the American Rescue Plan (ARP) in March 2021, more consumers than ever before are now eligible for $0 -- or $1 per member per month (PMPM) in Marketplaces that include abortion coverage -- health insurance coverage across the ACA Marketplaces. But many individuals may not be aware of the new subsidies, or of their eligibility for Cost-Sharing Reduction (CSR) Silver plans. This project's goal is to examine whether personalized letters and email reminders can increase health insurance enrollment, CSR Silver take-up and $1 PMPM coverage.


Eligibility Criteria:
Inclusion Criteria:

* Submitted a Covered California application for the 2021 coverage year and found eligible for a $1 PMPM Enhanced Silver 94 plan

Exclusion Criteria:

-
Supplement to Hospital to Home Outcomes

Post-discharge nurse phone call

Previous work has identified barriers to successful transitions that are most meaningful to patients and families. Investigators used these learnings to iteratively adapt an existing nurse home visit program to address these barriers, and have been studying the effectiveness of the redesigned nurse home visit in a randomized control trial (NCT02081846).

Eligibility Criteria:
Inclusion Criteria:

* Patient is under 18 years of age
* Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, ,community pediatrics, or adolescent medicine.

Exclusion Criteria:

* Patient to be discharged someplace other than home (e.g., residential facility, psychiatric facility)
* Patient's home residence is outside the home nursing service area
* Patient is eligible for "traditional" home nursing services
* Caregiver is non-English speaking
Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

This prospective study aims:

1. to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia \[Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)\] to determine whether scores reveal differential profiles between the groups,
2. to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI at 7T.

The imaging arm of the study include:

1. to demonstrate differences in brain iron levels between different dementia syndromes and healthy volunteers using ultra high-field MRI, quantitative susceptibility mapping (QSM) at 7T.
2. to demonstrate variations in the resting oxygen usage as an important biomarker to discriminate between different dementia syndromes.
3. to demonstrate cerebral blood flow changes in the brain, particularly in the hippocampus region, and its correlation with different dementia syndromes using Arterial Spin Labelling MRI technique.
4. to demonstrate increased blood brain barrier leakage in the brain, particularly in the hippocampus region, and its correlation with Alzheimer's Disease (AD) and Vascular Cognitive Impairment (VCI) using a new dynamic contrast-enhanced MRI (DCE-MRI) technique.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent.
2. Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.

Exclusion Criteria:

1. Lack of mental capacity to consent to study involvement.
2. Not speaking English before age 5 years.
3. Learning disability.
4. MRI contraindications
Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration

The purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized- controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.


Eligibility Criteria:
inclusion Criteria:

* degenerative knee pain
* age: \> 18 years
* informed consent
* none to moderate comorbidity
* arthroscopy under general anaesthesia indicated

exclusion Criteria:

* trauma of the knee within the last 6 weeks before surgery
* circumscribed cartilage lesion with possibility of repair microfracture or autologous chondrocyte transplantation - procedures
* contraindications against PRP. application
* malignancies
* severe comorbidities
* age \<18 years
* physically or mentally not able to provide informed consent
* severe knee instability
* corticosteroid injections within the last 6 weeks before surgery
Mental Health Apps for Mild Psychological Distress Amongst Adolescents

This study investigates mental health mobile apps, to understand their efficacy in reducing mild levels of psychological distress amongst adolescents. All participants will be provided with an app which is already available in the public domain, and will be asked to use the app for guided self-help. Half of participants will receive a weekly telephone call, whilst the other half will not.

The subscription version of the app "Sanvello" has several self-help exercises based on Cognitive Behavioural Therapy (to identify and challenge their thinking styles) and Mindfulness practices (to connect them with the present moment). Participants will be asked to complete these exercises on a daily basis for five weeks.

Telephone calls will be provided weekly to half of participants to provide information about the app, or a rationale for its use. This phone call will not serve to provide any extra intervention or therapy to the participants.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 13-18 years, as the proposed research aims to investigate "adolescents".
* Have capacity to give informed consent, to ensure the integrity of participants and prioritise their best interests.
* Be awaiting input from the Healthy Minds Lincolnshire service, given the method of recruitment, prospective participants will be on a waiting list for the named service.
* Be experiencing psychological distress, to fulfil the research aims.

Exclusion Criteria:

* Accessing crisis support, to ensure that necessary support is not being withheld due to research participation.
* They do not speak and understand English, to ensure the app-intervention and measures (which are in English) may be completed, and so interviews may be conducted without a translator.
* They are unable to access or use a smart device, the internet, and the app, as they must be able to access a device daily and be technology literate to utilise the intervention.
* For 13-15 year olds: parental consent must also be provided to take part. If this is not provided, they will be unable to participate. Those aged 16-18 years can provide consent for themselves.
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
* Use of protocol specified methods of contraception

Key Exclusion Criteria:

* Current or prior history of clinically significant illness that may interfere with participation in the study
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.