cyrilzakka/clinical-trials huggingface dataset:
Cognitive Training for Depression II

This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major MDD, working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 6 weeks of cognitive training sessions, with three sessions per week.

Eligibility Criteria:
Inclusion Criteria:

* Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
* Age 18-55
* Able to give informed consent

Exclusion Criteria:

* A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
* Visual impairment that would affect the ability to observe the computerized presentation of faces.
* Motor impairment that would affect the ability to provide a response by quickly pressing a button.
* Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
* Primary, current Axis I diagnosis other than Major Depressive Disorder
* Primary, current Axis II personality disorder.
* Currently attending a cognitive-behavioral psychotherapy regimen
* Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
* Pregnancy in women. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason.
* Enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). Accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. We do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. No medications will be discontinued for the purpose of enrollment into the study.

Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (\> 8 ounces/day for men and \> 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.
Food Intake in Older Patients

Unintentional weight loss and undernutrition are well described problems in elderly inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries. Not only are a large number of elderly patients undernourished at admission but a substantial proportion will lose weight and become malnourished during their hospital stay, putting them at increased risk of morbidity, mortality, poor clinical outcomes and prolonged length of hospital stay. However, as it is frequently impossible to correct undernutrition prior to hospital admission, every effort should be made to prevent weight loss and correct undernutrition during hospitalization. Therefore, screening and identification of predictors of patients at risk of weight loss and undernutrition at admission, and identification of modifiable factors (e.g. eating preferences and poor food hospital intake), where intervention might be helpful, are important aspects in the management of these patients.

Before designing a food intervention study, there is a need to, firstly:

1. describe hospital food intake, eating habits and preferences in elderly inpatients during hospitalization
2. describe predictors of hospital food intake in elderly during hospitalisation
3. compare energy and protein intake in elderly inpatients during hospitalisation with the United Kingdom Dietary Reference Values (DRVs)

This study is a hospital based observational study. Eligible participants will be 125 patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of Scotland. Eligible participants will be seen 96 hours after admission in order to explain the study process and to obtain written consent. The researcher will record basic body size measurements and will ask the patient questions about living conditions, feelings, memory, health, eating habits, opinions about the hospital food service. Nursing staff will be asked about patient's functional activity. The researcher will also take pictures of a subset of patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after eating. The researcher will meet each patient three times in total. The first time 4 days after admission; a second time, during the hospital stay and, finally, around the time of discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm circumference, grip strength and calf circumference.


Eligibility Criteria:
Inclusion Criteria:

* Screened for study participation within 96 hours after admission
* Duration of hospital admission expected to be more than 3 days
* Able to provide consent or consent obtainable from their legal representative

Exclusion Criteria:

- Receiving palliative care
The Effects of Fiber Fortified Foods to the Diets of Chronic Kidney Disease Patients

A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.

Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.

Eligibility Criteria:
Inclusion Criteria:

Participants must:

* Be 18 years of age or older
* Have eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis)

Exclusion Criteria:

Participants must not:

* Have been diagnosed with acute kidney injury (AKI)
* Have been diagnosed with glumerulonephritis (GN)
* Have been on immunosuppressant/steroid medications
* Be taking a probiotic supplement and refuse to discontinue it
* Be scheduled for dialysis within 3 months of study initiation
* Have a history of liver disease
* Be on dialysis
* Have undergone renal transplantation
* Be breastfeeding
* Have active gastrointestinal bleeding
* Have a change in medications over the past 4 weeks
Ablelite Pediatric Device Clinical Study

The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis
2. MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder
3. Ability of subject to raise their forearm off of their lap or laptray
4. Willingness to comply and participate with the study protocol and attend the study sessions
5. Ability to communicate verbally and respond to questions and commands
6. Ability to provide informed consent
7. Selected for participation based on investigator discretion

Exclusion Criteria:

1. Use of ventilator
2. Open wounds or chronic pressure sores on upper extremities, neck, back or torso
3. Significantly unstable upper extremity joints
4. Unhealed bone fractures in the upper extremities
5. Active rotator cuff tear, grade 2 or 3
6. Surgical fixations limiting full passive range of motion
7. Uncontrolled upper-limb spasticity that significantly limits normal range of motion
8. Uncontrollable pain in the neck, shoulders or upper limbs
9. Ability to fully raise both hands simultaneously above their head with ease
10. Lack passive shoulder abduction of 120 degrees
11. Lack 90 degrees of passive elbow extension
12. Unable to follow instructions
13. Exhibit significant behavioral problems
14. Inability to provide consent
Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for bariatric surgery

Exclusion Criteria:

-
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the urine can be found in a specific type of cancer, called carcinoid tumor. This study will examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. It is claimed to improve sleep problems, depression, anxiety, compulsive disorders, restless leg syndrome, migraines, fibromyalgia, and low pain threshold.Increased levels of 5-HIAA in the urine can be a of a specific type of cancer, called carcinoid tumor. Urinary 5-HIAA levels can also be increased by a number of food products and drugs. Oral 5-HTP is not known as a cause of elevation of 5-HIAA in urine. However, recent information suggests that 5-HTP may cause an increase.

In this study we examine the effect of oral 5-HTP intake (100 mg at bedtime for 10 days) on 5-HIAA excretion in the urine, following a prospective, double-blind placebo-controlled study design.

Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* in good health

Exclusion Criteria:

* Pregnancy
* Intake of drugs that affect 5-HIAA excretion in urine
* Anti-depressants
* Participation in other studies
Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer

This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

This was a prospective phase II study on patients with LARC or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

The primary aim was to asses the pathological response rate. Key secondary aim was the acute toxicity. Secondary aims were local control, disease-free survival (DFS) and overall survival (OS).

The follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.

Eligibility Criteria:
Inclusion Criteria: i) histologically proven rectal adenocarcinoma (cT3-4N0-2 or cT2N1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria: i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.
In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee

Anterior knee pain has been an enigmatic problem for orthopedic surgeons. Recent studies, as well as the clinical observation of the principle investigator have suggested that arthroscopic resection of the infrapatellar plica (IPP), a vestigial remnant from embryonic development of no known clinical or biological significance, may eliminate this pain. The mechanism whereby this pain is related to the IPP is unclear. This study will document the mechanical behavior of the IPP, its kinematics, as recorded on video among a group of subjects who are undergoing arthroscopy. Radiographic visualization of the observed behavior will be obtained by injection of contrast material, and then fluoroscopic recording of a standard series of motions. The plica will then be resected to avoid any possibility of residual symptoms related to its presence. Further fluoroscopy of the knee without plical attachment, will allow the kinematic behavior to be assessed. The procedure will then be terminated.

The infrapatellar plica (IPP) of the human knee is vestigial remnant of the embryologic division between the medial and lateral compartments of the knee, present in 85.5% of knees1, felt by some to be of no clinical significance other than acting as a block to visualization an movement during arthroscopy.2 S.J. Kim 3,4, C.R. Boyd 5, and B. Demirag 2006 have documented successful relier of anterior knee pain after resection of the IPP. This study seeks to assess the relationship between knee motion, activation of the extensor apparatus, and the IPP, in essence, the kinematics of the contents of the anterior compartment of the knee. The hypothesis to be evaluated is:

the infrapatellar plica is a structure of fundamental biomechanical significance, allowing the transmission of force from the extensor apparatus to the distal femur through the fat pad, and acting as a restraint and a modulator of fad pad mobility.

Subjects will be identified by the PI at their office visit. The subject will be consented. The consent will be discussed and verified in a second office visit before surgery. The subject will undergo arthroscopy specifically directed toward identifying and treating known pathology. Once this is finished, if an IPP is present, it will be injected with radiographic contrast material. A series of maneuvers will be performed involving passive and active motion of the knee and active contraction of the quadriceps apparatus. Videotape recording and fluoroscopy will be undertaken. The plica will be removed. Another fluoroscopy will be performed. The patient will be followed according to the standard practice for arthroscopy and the defined pathology.

Eligibility Criteria:
must be Healthy subject must be \>18 years of age, skeletally mature must bePending knee joint arthroscopy.

may not have Active infection
Ultrasonography SWE for Hepatic Fibrosis Evaluation

The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.

The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= \> F2) will be measured using histologic grade as a reference.

Eligibility Criteria:
Inclusion Criteria:

* volunteers who agree to undergo US shear elastography OR
* patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy.

AND

* = or \> 18 years
* sign informed consent

Exclusion Criteria:

* none
Saw Palmetto Extract in Benign Prostatic Hyperplasia

The purpose of this study is to test whether an extract of the saw palmetto plant is effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).

This proposal describes a double-blind, placebo-controlled randomized clinical trial of the effect of saw palmetto extract on symptoms, objective parameters of disease severity, and quality of life in men with moderate-to-severe benign prostatic hyperplasia. BPH, one of the most common morbid medical conditions in middle-aged and elderly men, is generally treated with alpha-adrenergic blocking agents, finasteride, surgical interventions, or no specific therapy ("watchful waiting"). In the past several years, however, many patients have begun to self-medicate with an extract of the saw palmetto plant (Serenoa repens), a medicinal herb grown in the southeastern United States. Saw palmetto has become the fifth leading medicinal herb consumed in the U.S. and is considered first-line therapy for BPH in several Western European countries. Several small studies suggest that saw palmetto may have clinical benefit, but the methodologic quality of most prior studies has been poor. Very few side effects of the herb have been observed, but few studies have been conducted for more than three months. We propose to conduct a high-quality clinical trial of saw palmetto, with careful attention to the methodologic deficiencies of prior studies. After a single-blind placebo run-in period, 224 patients with mode moderate-to-severe BPH (American Urological Association Symptom Index score greater than or equal to 8) and objective measurement of urinary obstruction, will be randomized to receive either 160mg BID of the herbal extract or an identical placebo. Patients will discontinue any other medical therapy for BPH prior to enrollment and all participants will undergo a trans-rectal ultrasound examination at baseline and closeout. Participants in the trial will be seen at 3-month intervals for a total one-year follow-up. Outcome measurements include changes in the AUASI score (the primary outcome measurement), the peak urinary flow rate, the post-void residual urine volume, the BPH Impact Index, the Olmstead County Study Questionnaire of BPH-specific symptoms and quality of life, and the Short-Form 36 (a generic health status instrument). Numerous laboratory parameters will measured at intervals throughout the trial and symptomatic side effects will be assessed.

Eligibility Criteria:
Eligibility Criteria:

* Participants must be men, aged 50 years or older with moderate-to-severe BPH.
* Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study.
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.

1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy

Occurrences of malignant tumors and serious infections will be compared with a control group.

All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria:

Not Applicable
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis

Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female 9 years of age or older
2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
3. Must be able to self-administer study medication
4. Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.

Exclusion Criteria:

1. Congenital ptosis
2. Horner syndrome
3. Myasthenia gravis
4. Mechanical ptosis
5. Previous ptosis surgery
6. Resting heart rate outside the normal range
7. Hypertension with resting diastolic blood pressure
8. Pregnancy or lactation
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

The product is being tested to see if exposure to light causes photoallergic reactions on the skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Less than 18 years