cyrilzakka/clinical-trials huggingface dataset:
Intracervical Lidocaine Gel for IUD Insertional Pain

The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain

The intrauterine device (IUD) is a highly effective, long-acting, reversible method of contraception used by approximately 8% of women in the developed world. In the United States, historically candidates for IUDs were monogamous, parous women. Recent research has shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous women. Nulliparous and parous women can experience significant amounts of pain during IUD insertion. Concerns about insertional pain could be a barrier to IUD initiation women and their healthcare providers.

This study will recruit women at either the Family Planning Clinic or the offices of Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for birth control. Women who consent to participating in the study will be randomized to two groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement and the other group will receive a placebo inert gel. The primary objective of this study is to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring of the uterus) and at speculum removal; these are standard procedures during IUD insertion. Secondary outcomes include provider assessment of the patient's pain, patient's level of satisfaction with the insertion, and whether any adverse events such as nausea/vomiting, fainting, or IUD insertion failure occurred.

Eligibility Criteria:
Inclusion Criteria:

* Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
* Age 18-45
* Speak English or Spanish

Exclusion Criteria:

* Lidocaine allergy
* First trimester abortion or miscarriage in the previous six weeks
* Second trimester abortion or miscarriage in the previous 12 weeks
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study

One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals aged over 75 years. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals.

This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovascular disease in elderly individuals.

Healthy elderly individuals who are eligible to use of statin for primary prevention will be enrolled. They are randomly assigned to moderate intensity statin group and low intensity statin group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin associated muscle symptoms are conducted every 3 months after enrollment. General medical care for prevention of cardiovascular disease is continued after 6 months. The accrual period is 2 years and follow-up period is 4 years, so the total study period is 6 years.

Eligibility Criteria:
Inclusion Criteria: (1 and, 2 or 3)

1. Individuals aged 76-85 years old.
2. Individuals who have serum LDL-cholesterol of 160-189 mg/dL.
3. Individuals who have serum LDL-cholesterol of 80-159 mg/dL and ≥1 cardiovascular risk factor (male, diabetes, hypertension, smoking, serum HDL-cholesterol \<40 mg/dL, or family history of premature cardiovascular disease).

Exclusion Criteria: (any)

1. Individuals who have been diagnosed with cancer within the last 5 years.
2. Individuals who have high level of serum aspartate aminotransferase (AST), alanine amino- transferse (ALT) (\>2 upper normal limit).
3. past history of myopathy or rhabdomyolysis or Creatine Kinase (CK)\> 2-fold of upper normal limit
4. Individuals who have serum creatinine ≥2 mg/dL.
5. Individuals who have been diagnosed with cardiovascular disease (\>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial infarction).
6. Individuals who have been diagnosed with peripheral artery disease (\>50% stenosis of peripheral artery on imaging study, or ankle brachial index \<0.9 or ≥1.3).
7. Individuals who have been diagnosed with hyperthyroidism or hypothyroidism.
8. Individuals who are taking drug that can interact with statin.
9. Individuals who have physical disability to live daily life.
10. genetic disorder such as galactose intolerance, etc
Target-specific immunoPET Imaging of Breast Cancer

The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

Enrolled patients will undergo whole-body \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4(Trop2-targeted imaging probes ) or \[68Ga\]Ga-DOTA-H2D3/\[18F\]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years old and of female gender；
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Comparative Effectiveness of Treatments to Prevent Dental Caries

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New Hampshire.

Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries.

This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income children enrolled in public elementary schools in New Hampshire from 2017-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Caries arrest will be evaluated after two years, and caries prevention will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05.

Notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children.

Eligibility Criteria:
Inclusion Criteria:

* Any primary school with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.

Exclusion Criteria:

* Children without informed consent or those with consent but without assent.
Effects of PECS 1 Block on Venous Cancer Port Catheter

In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath .

Cancer is one of the most important reasons of mortality in the world. There are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. However, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. Traditionally this implantation is adminstered with infiltrative anesthesia. Recently, USG is used in anesthesia practice world wide. Blanco R et all (1) defined PECS 1 block as an alternative to paravertebral block. PECS 1 block aims to anesthetize the medial and lateral pectoral nerves. In this study our aim is to investigate the effects of USG guided PECS 1 block in the administiration of an implanted port-a-cath .

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18- 75
* ASA (American Society of Anesthesiologists) Score I-IV
* Undergoing elective port-a-cath replacemnet

Exclusion Criteria:

* Patients with neurological deficits
* Patients who have major vascular damage at the same side
* Mentally retarded patients
* Patients with alcohol or drug addiction
* Patients who are allergic to local anesthetics
* Pregnancy
* Paitents with coagulopathy
* Patients with skin infection at the side of the procedure
* Patients with pneumothorax at the side of the procedure
* Patient with a pacemaker
Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.


Eligibility Criteria:
Inclusion criteria:

1. Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:

   * Sub-optimal: HbA1c level \>7% and fasting blood glucose \<130mg/dL
2. Male or Female ≥18 years old
3. Body Mass Index (BMI) \<40
4. 10% ≥HbA1c ≥7%
5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
6. Patients willing to sign data release consent form

Exclusion criteria:

1. Diabetes other than T2DM
2. Enrolled in other clinical trials
3. Previous treatment with an insulin other than insulin glargine
4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
5. Pregnant or lactating women
6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter
8. Treatment with any investigational product within the last 3 months prior to study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of CMV Status on HIV Viral Load Decay

Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV infection. No study to date has investigated the impact of CMV infection on HIV viral load decay during antiretroviral therapy.

Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were enrolled. Clinical, biological and virological data were collected from HIV antiretroviral therapy initiation to the day of HIV viral load undetectability if any.


Eligibility Criteria:
Inclusion Criteria:

* HIV patients starting an antiretroviral therapy
* CMV serology available at antiretroviral therapy initiation
* HIV viral load assessed at each follow-up visit after treatment initiation

Exclusion Criteria:

* HIV antiretroviral treatment initiation before June 2005
Effect of Probiotic on Constipation

Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS) shows potential effect on alleviating constipation. This study evaluated the impact of fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty acid and gut microbiota were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* meet ROME Ⅲ criteria for functional constipation
* normal body mass index between 18.5 and 29.9

Exclusion Criteria:

* had a serious disease;
* used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study;
* allergic to milk protein;
* constipated because of organic or neurological lesions;
* participated in any other studies within 2 months prior to this study.
CCT for Older Diabetic Adults

The current study examines the efficiency of a home-based computerized cognitive training (CT) intervention targeting older adults with diabetes.The primary aim of the study is to evaluate the effects of CCT on cognitive and disease management in non-demented older diabetes adults. Investigators will also evaluate the effect of the intervention on a range of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.

Evidence suggests a link between diabetes-related processes and increased risk of cognitive decline and dementia in older adults. Optimal disease self-management may be key in the prevention of cognitive decline among older diabetic patients, but this may be compromised due to sub-clinical cognitive impairment.

In the current study, 120 community-dwelling, non-demented participants aged 65 and over, with a diagnosis of Type 2 diabetes will be randomly assigned either to an 8-week, home-based individually-tailored CCT program with adaptive difficulty level, and regular performance feedback, or to an 8-week, home-based active control (AC) condition, involving training on a generic CCT program with fixed difficulty level and without performance feedback. Both intervention groups also include a range of theory-informed behavior change techniques (BCTs), including self-efficacy management, self-monitoring and goal-setting in order to enhance treatment fidelity, and to maximize treatment compliance and adherence. In both groups, participants train approx. 30 min. per day, 3 times per-week for 8-weeks. Participants undergo a comprehensive evaluation of all outcomes at baseline, immediately after the intervention, and at a 6-month follow-up, with 1-week booster training completed 3 months from completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and over
* diagnosis of type 2 diabetes
* Health cover provided by Maccabi Health Services (MHS)
* Access to a home computer and internet connection
* Availability of a close relative/informant with regular and frequent contact with the participant (at least 10 hours per week), willing to respond to questionnaires at all time points.
* Fluency in Hebrew or English
* Living in the Tel-Aviv metropolitan area and surrounds

Exclusion Criteria:

* An existing diagnosis of dementia
* Prescription of dementia-related medication.
* Participation in a previous cognitive intervention study in the preceding year.
* Significant hearing/vision impairment likely to interfere with assessment and/or training
* Significant psychiatric/neurological or medical issues that may affect cognitive function.
Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection

The aim of this study is to validate a near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it with the established diagnostic methods (visual examination and bitewing radiography). The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.


Eligibility Criteria:
Inclusion Criteria:

* ASA-Status 1
* Complete permanent dentition
* Bitewing radiography already existing (\< 4 months)
* Minimum of one cavitation-free approximal surface, symptomless, interproximal enamel or dentin caries lesion in the posterior teeth without restorations and/or sound tooth surface.

Exclusion Criteria:

* Children younger than 15 Years
Neuroimaging Studies of Depression in Parkinson's Disease

The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.

Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications.

Eligibility Criteria:
Inclusion Criteria:

* right-handed
* willing/able to undergo magnetic resonance imaging (MRI)

Exclusion Criteria:

* history of neurological condition other than Parkinson's disease
* history of psychiatric condition other than depression
* history of substance abuse/dependence
The Choosing Healthy Eating for Infant Health (CHErIsH) Study

The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP) level implementation strategy to support delivery. The primary aim of CHErIsH pilot feasibility study is to collect and examine data on the acceptability and feasibility of the delivery of the brief infant-feeding intervention by HCPs to parents at child vaccination visits, and the strategy to support the implementation of this intervention in primary care for HCPs. Furthermore, half of all potential participants will be invited to provide maternal and infant biomarkers and/or take part in SWAT (study within a trial) which includes questions about infant feeding that were put together as part of a Core Outcome Set. These questions are important as they give a better understanding about what works and what doesn't. This will facilitate the refinement of the intervention and its implementation strategy, and inform the next step of the CHErIsH study, such as a definitive trial.

The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with embedded process evaluation and economic evaluation.

The CHErIsH feasibility study will address the following research questions:

1. Are the intervention content, delivery and implementation procedures acceptable to parents who will receive the intervention, and HCPs who will deliver the intervention?
2. Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to parents and HCPs?
3. Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?
4. Is the study feasible in terms of recruitment and retention procedures and data collection?
5. What are the costs associated with the intervention and its implementation strategy?

Eligibility Criteria:
Inclusion Criteria (Health care professionals):

* Involved in the delivery of routine infant vaccinations
* Completed training to deliver the intervention.

Inclusion Criteria (Parents):

* Parent of an infant ≤ 6 weeks of age at study recruitment.
* Intends to attend a participating GP and/or PN in the primary care centre for child's vaccination visits.
* Is over 18 years of age.
* Can provide written informed consent to participate.

Exclusion Criteria:

* n/a
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of adenocarcinoma of the prostate
* low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20ng/mL. PSA to be drawn within 60 days of registration
* prostate volume \< 60 cc as determined by ultrasound, CT or MRI
* willing to give informed consent ot participate in this clinical trial
* able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

* documented nodal or distant metastases
* previous pelvic radiotherapy
* previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
* use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
* poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
* significant medical co-morbidity rendering patient unsuitable for general anaesthetic