cyrilzakka/clinical-trials huggingface dataset:
Cognitive Control Training for Remitted Depressed Patients

The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.

Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD samples. Furthermore, studies exploring the potential of cognitive control training in at-risk undergraduate students indicate that cognitive control training has beneficial effects on rumination, an important vulnerability factor for depression. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. The investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion regulation (directly following training and at 3 months follow-up), and indices of functioning (at 3 months follow-up).

Eligibility Criteria:
Inclusion Criteria:

* History of ≥ 1 depressive episode(s)
* Currently in stable full or partial remission (≥ 6 months)

Exclusion Criteria:

* Major depressive disorder (MDD; current)
* Bipolar disorder (current and/or previous)
* Psychotic disorder (current and/or previous)
* Neurological impairments (current and/or previous)
* Excessive substance abuse (current and/or previous)
* No other comorbid disorders (current)
* No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 weeks)
* Use of antidepressant medication is allowed if kept at a constant level
Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery

This phase of the project will evaluate the utility and efficacy of a personalized online patient education platform developed from efforts in Phase 1 in 1) increasing patients' and caregivers' pre- and post-operative preparedness and satisfaction, and 2) reducing readmission, ED/Urgent care/unplanned clinic visits and telephone calls to clinic staff.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have had or are undergoing free flap surgery and/or total laryngetomy
* Have internet access
* English speaking

Exclusion Criteria:

* Younger than 18 years of age
* No internet access
* Non-English speaking
Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)

Registration study


Eligibility Criteria:
Inclusion Criteria:

* Patient has had an absolute neutrophil count \< 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever \>38.0 Degrees Centigrade within the last 24 hours prior to study entry

  * Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage

Exclusion Criteria:

* Patient has an inadequately managed bacterial infection at the time of enrollment
Understanding Blood Pressure Changes After Birth

Research Question How does maternal blood pressure respond in the postpartum period for women who had a hypertensive disorder in pregnancy?

Aim To evaluate the recovery of maternal blood pressure after a pregnancy affected by new onset hypertension after twenty weeks gestation

Objectives

* To identify rates of persistent hypertension after pregnancies affected by HDP
* To assess and compare the accuracy of HBPM against the gold standard of ABPM
* To assess the maternal acceptance of HBPM and ABPM
* To explore what CVD-related care information is provided at the 6-8 week GP appointment

This research aims to investigate how women's blood pressure responds after birth and assess the time it takes to return to normal ranges. This will be calculated by participants undertaking three consecutive days of home blood pressure monitoring, every fortnight from two until twelve weeks postpartum. At twelve weeks postpartum, women will have a twenty-four ambulatory blood pressure assessment. This will highlight the prevalence of persistent high blood pressure and how often GPs will need to monitor women's blood pressure in the immediate few weeks after birth. Women will be asked to complete a questionnaire after their six to eight week GP appointment, assessing if women recall having their blood pressure checked and/or the risks of heart disease explained to them and if they received any lifestyle advice to reduce these risks. Women will be asked to complete a second questionnaire at twelve weeks postpartum assessing their acceptance and preference of home and twenty four hour blood pressure monitoring. This research aims to identify any gaps in the current care of women in the postnatal period and use this information to provide better quality of care to women so they can lead healthier lives and reduce their risk of heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a confirmed diagnosis of new onset of high blood pressure after twenty weeks gestation
* Maternal Age \>16 years old
* Mental capacity to give informed consent
* Ability to be able to communicate to HCP if their BP range is above target (for example women where English is not their first language).

Exclusion Criteria:

• Pre-existing hypertension
Drawing as a Measurement of Dental Anxiety

In the present study, we aimed to assess children's anxiety levels by using different dental anxiety scales and children's drawings evaluated according to two different scoring systems: Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD).

Background: Drawings can be used as a method of communication that represents an individual's self-concept, anxiety, attitude, or conflict.

Aim: The purpose of this study was to evaluate children's drawing as a measure of dental anxiety in a dental setting.

Design: Seventy- eight children, aged 6-12 years, were enrolled in this study. Pulp therapy and/or restorative treatment was performed during the first therapeutic session for all participants. Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective assessment of dental anxiety during treatment. After the treatment session, the children were instructed to draw a picture of a person at a dental clinic. Children's drawings were scored by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale and emotional indicators of Human Figure Drawings (HFD). The findings were compared with Frankl and SEM scores.

Eligibility Criteria:
Inclusion Criteria:

* 6-12 years of age-independent of sex, and ethnic characteristics
* Children without previous dental treatment experience.
* Children with carious primary teeth which required pulp therapy and restorative treatment
* Children who are not considered medically compromised
* Obtained written informed consent from parents or caregivers and obtained verbal informed consent from the child for their participance in the study where procedures are explained in an age-appropriate attitude
* Children who accept to draw a picture

Exclusion Criteria:

* Children with a compromised physical and mental health history
* Children who already received dental treatments
* Children who only needed preventive treatments
* Children who reject to draw a picture
ReZolve2 Clinical Investigation

The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.


Eligibility Criteria:
Primary Inclusion Criteria:

* Patient has evidence of myocardial ischemia or a positive functional study
* Patient has a normal CK-MB
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm
* Target lesion length must be ≤ 14mm

Primary Exclusion Criteria:

* Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
* Patient has a left ventricular ejection fraction \< 30%
* Patient has unprotected lest main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus
Evaluation of the Reliability, Validity, and Acceptability of the London Measure of Unplanned Pregnancy in a U.S. Population of Women

The aim of the study is to evaluate the reliability, validity, and acceptability of the London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and valid.

The concept of "unplanned pregnancy" is used frequently in health research and policy. The majority of tools used to assess unplanned pregnancy planning have not been validated. Recently the London Measure of Unplanned Pregnancy (LMUP) has been developed and validated. The LMUP had been found to be valid and reproducible, but has not been studied outside of the United Kingdom. If we are able to validate this measure in a U.S. population, its use in studies will improve the quality of data about family planning in U.S. women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Basic literacy in English or Spanish needed to participate.

Exclusion Criteria:

* Literacy level lower than 11 years of age
Usefulness of Multi-parametric, Quantitative MR Imaging for Staging of Hepatic Fibrosis in the Patients With Chronic Hepatitis

Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric MR imaging at the enrollment and one year later to evaluate changes in quantitative values in MR.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had chronic hepatitis
* Patients who underwent liver biopsy within 6 months
* Patients older than 18 years old

Exclusion Criteria:

* patient who had pregnancy
* patient 18 or below 18 years old
Balance Recovery Training for Fall Prevention in Retirement Communities

Falls are the leading cause of injuries and injury-related deaths among older adults over the age of 65 in the United States. To help reduce the number of these falls, there is growing interest in using reactive balance training to improve the reactive response to common perturbations (e.g., tripping and slipping). The goal of this study was to compare treadmill-based reactive balance training versus Tai Chi performed at, and among residents of, older adult senior housing. We hypothesized that participants randomized to reactive balance training (RBT) would show better performance on reactive balance tests compared to participants randomized to Tai Chi. We also hypothesized that participants randomized to Tai Chi would show better performance on clinical tests of balance and mobility compared to participants randomized to RBT. The long-term goal of this work is to demonstrate the value of RBT over Tai Chi for preventing falls resulting from sudden, external perturbations.

Thirty-five residents of five senior housing facilities were allocated to either treadmill-based reactive balance training or Tai Chi training. Both interventions were performed three times per week for four weeks, with each session lasting approximately 30 minutes. A battery of balance tests was performed at baseline, and again one week, one month, three months, and six months post-training. The battery included six standard clinical tests of balance and mobility, and a test of reactive balance performance.


Eligibility Criteria:
Inclusion Criteria:

* Must be age 70 or older
* Must be a resident of local continuing care retirement community (CCRC)
* Must be able to walk down a long hallway without any aids (cane, walker, etc.)
* Must not have a fragility fracture in the past 10 years
* Must not smoke
* Must not be in physical therapy
* Must not perform more than 150 minutes/week of moderate to vigorous aerobic activity
* Must score 24 or higher on Folstein Mini Mental Status Exam
* Must have less than 20% probability of major osteoporotic fracture as assessed by the fracture risk assessment tool (FRAX) score
* Must not have recently (within 1 year) participated in Tai Chi
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy

The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
* Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
* Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
* Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
* Have venous access sufficient to allow for blood sampling
* Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Had blood loss of more than 500 milliliters (mL) within the last month
* Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Alzheimer's Disease: Potential Benefit of Isoflavones

The purpose of this pilot study is to evaluate the potential effects of soy isoflavone supplements on cognitive function for men and women with Alzheimer's Disease (AD). Preliminary studies evaluating the effects of soy supplements on memory in cognitively healthy older adults have yielded promising results that are now being evaluated in patients with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Has reliable and available caregiver to assist with medication and appointments
* On a stable dose of cholinesterase inhibitor, or if unable to tolerate medication, patient has no plans to re-initiate cholinergic therapies while in the study

Exclusion Criteria:

* Current or recent use (\<6 months) of menopausal Hormone Replacement Therapy (HRT)
* Current or recent use (\<4 months) or oral antibiotic therapy
* Typical dietary intake of soy isoflavones \>5 mg/day
* History or significant gastro-intestinal or colon disease, or colon/intestinal resection
* Irritable bowel syndrome
* History of breast cancer, or abnormal mammogram within 12 months
* History of chronic obstructive pulmonary disease, diabetes mellitus, liver disease or unstable ischemic heart disease
* Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis
* Primary and secondary traumatic arthritis
* Avascular necrosis of the femoral condyle
* Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)

Exclusion Criteria:

* Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
* Insufficient bone stock on femoral or tibial surfaces
* Skeletal immaturity
* Neuropathic arthropathy
* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
* A stable, painless arthrodesis in a satisfactory functional position
* Severe instability secondary to the absence of collateral integrity
* Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.
* Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up
* Patient is not willing or able to give informed consent to participate in the follow-up program
* Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.
Solo and Non-solo Approach for Laparoscopic Cholecystectomy

To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Eligibility Criteria:
Inclusion Criteria:

1. The patients planed to undergo elective laparoscopic cholecystectomy
2. Benign gallbladder diseases requiring surgery
3. The patients who are indicated for single-port laparoscopic cholecystectomy.

Exclusion Criteria:

1. the patients with complicated cholecystitis
2. the patients with the gallbladder with a thickness more than 4mm.
3. the patients who are expected to have severe peritoneal adhesion.
4. the patients with malignant gallbladder diseases.
5. the patients whose operation appears to need human assistant(s)
Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial

To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).

Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.

Eligibility Criteria:
Inclusion Criteria:

* None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.
* Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.
* Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) \< 25%39 and full-mouth bleeding score (FMBS) \< 25%.

Exclusion Criteria:

* Smokers
* Gingival recesstion RT 2 or RT 3 (Cairo 2011).
Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma

Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.

Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Primary Cutaneous Malignant Melanoma
* Cutaneous Malignant Melanoma Metastases
* Benign Melanocytic Naevi

Exclusion Criteria:

- Other Skin Cancer than Primary Cutaneous Malignant Melanoma