cyrilzakka/clinical-trials huggingface dataset:
Bone Material's Histomorphometric Analysis In Socket Preservation

This prospective, multicentre, split-mouth randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with full legal capacity, male and female;
* Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
* Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
* Patients who respect the follow-up recalls.

Exclusion Criteria:

* Presence of bone lesions;
* Patients with alcohol or substance abuse;
* Patients with smoking habits (more than 10 cigarettes per day);
* Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
* Pregnant or breast feeding women;
* Patients currently participating in any other clinical investigation.
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)

Major depressive disorder (MDD) is the most common psychiatric disease worldwide with a huge socio-economic impact. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (TRD). TRD is associated with specific clinical features and genetic/gene expression signatures. To date, single sets of markers have shown limited power in response prediction. The aim of this project is the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop TRD.

In this phase of the project a naturalistic cohort of 300 MDD patients will be recruited. The data collected will be used to assess, in real-world conditions, the capability of an innovative algorithm (integrating clinical, omics and gender data of other 300 patients con MDD) to predict the treatment outcomes. This project represents a proof-of-concept study. The obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of MDD resistance.


Eligibility Criteria:
Inclusion Criteria:

* A current diagnosis of moderate to severe MDD according to the DSM-IV was confirmed using the SCID-I diagnostic scale

Exclusion Criteria:

* Mental retardation or cognitive disorder
* A lifetime history of schizophrenic, schizoaffective, or bipolar disorder Substance abuse in the last 3 months
* Personality disorders, substance abuse, alcohol abuse, obsessive compulsive disorder, post-traumatic stress disorder, as primary diagnosis
* Comorbidity with eating disorders
* Substance or alcohol dependence
Epidemiology of Hypertensive Emergency

To test the hypotheses that hypertensive emergency was associated with non-compliance with antihypertensive medication, low level of contact with the medical care system, and alcohol abuse and cigarette smoking. Also, to describe the clinical characteristics of patients hospitalized with hypertensive emergency including morbidity, mortality, and cost, and the extent to which hypertensive emergency occured among previously diagnosed and treated hypertensives.

BACKGROUND:

While less frequent than in the era before effective treatment for hypertension, hypertensive emergency remains a relatively common cause of hospital admission in some sub-populations. In 1989, hypertensive emergency accounted for approximately 60 admissions per year to the Medical Service at Presbyterian Hospital, and a somewhat higher proportion of intensive care unit admissions and utilization. The importance of hypertensive emergency may have been underestimated because the International Classification of Diseases discharge codes included only malignant hypertension, a severe form comprising only about half of the admissions for hypertensive emergency. There had been almost no epidemiologic studies of hypertensive emergency since 1969, and very little was known about risk factors.

DESIGN NARRATIVE:

A matched case-control study design was used. Cases were obtained from admissions to the Medical Service at Presbyterian Hospital. Morbidity and mortality data were obtained by follow-up of the case series.

Eligibility Criteria:
Inclusion criteria

1. Patients admitted in the emergency room and for the medical and surgical services at the Presbyterian Hospital and Harlem Hospital Center in New York City

* patients with incidents of hypertensive emergency or hypertensive urgency
* hypertensive patients with other acute conditions who were admitted to the hospital or were treated in the emergency room and released

Exclusion criteria

1. Under 21 years of age
2. Pregnancy
External Validation Study for Risk Prediction Model for Unsuccessful Elbow Flexion Recovery After Nerve Transfer Surgery in Patients With Brachial Plexus Injury

The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. The main question it aims to answer is how well a risk prediction model perform in a different dataset, which are patients with brachial plexus injury who underwent surgery in a different time period or a different hospital.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic brachial plexus injury patients underwent nerve transfer operation for re-innervation of elbow flexion at Siriraj Hospital between 2018 and 2020 and Lerdsin General Hospital between 2008 and 2022
* Patients had follow-up duration at least 24 months after surgery

Exclusion Criteria:

* Incomplete medical records
* Patients underwent free functioning muscle transfer as primary surgery for elbow flexion
* Obstetric brachial plexus injury
* Radiation-induced brachial plexopathy
Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent
* World Health Organization (WHO) performance score 0-2.
* Signed written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Other invasive malignancy
* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.
* Prior neo-adjuvant chemo- of radiotherapy
* History of infusion reactions to bevacizumab or other monoclonal antibody therapies.
* Inadequately controlled hypertension with or without current antihypertensive medications
* Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
* Anticoagulant therapy with vitamine K antagonists
* Patients receiving Class 1A (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Evidence of QTc (corrected QT interval) prolongation on pretreatment ECG (greater than 44ms in males of greater than 450ms in females)
* Magnesium, potassium and calcium below the lower limit of normal range.
Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer

RATIONALE: Gathering information about genetic and environmental factors may help doctors learn more about a person's risk for developing prostate cancer.

PURPOSE: This research project is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer.

OBJECTIVES:

* To determine the association between variation in genes involved in ROS detoxification, oxidative stress response, and prostate cancer risk.
* To determine the association between fatty acid levels and prostate cancer risk.

OUTLINE: Probands undergo blood and saliva sample collection for fatty acid, DNA, and polymorphism analyses. Archived blood and tissue samples from probands who previously participated in Dr. Shannon's Diet and Prostate Cancer Risk study are also analyzed. Medical records of probands are reviewed for demographics, history and course of disease, and clinical laboratory test results.

All probands completed the "Genetic Risk Easy Assessment Tool Family History of Cancer" and "Diet History and Environmental Risk Factor" questionnaires at baseline. If a proband previously participated on our Diet and Prostate Cancer Risk study, he was asked to complete the "Changes in Diet, Prescriptions, Supplementals and Herbal Remedies" questionnaire in addition to the "Genetic Risk Easy Assessment Tool Family History of Cancer" questionnaire at baseline for this study.

PROJECTED ACCRUAL: A total of 750 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Prior diagnosis of prostate cancer or negative prostate biopsy AND previously participated in Dr. Shannon's Diet and Prostate Cancer Risk study and consented to future studies (proband)
  * Referred to the Portland VA Medical Center urology clinic for a prostate biopsy (proband)

    * Introduced to this study by a proband OR found to be related to a proband who is part of a homogenous high-risk subgroup after completion of the family history of cancer analysis

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Orbicularis Oris Z-plasty Modification of Modified Millard Technique and the Esthetic Outcome of Cleft Lip Repair

This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip

forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).

Eligibility Criteria:
Inclusion Criteria:

* non-syndromic cleft lip patients.
* Primary, unilateral, complete or incomplete cleft lip.
* The patient's age is younger than six months.
* lip repair performed by one craniofacial surgeon

Exclusion Criteria

* syndromic cleft lip.
* Secondary lip treatment (previously operated cases)
* Bilateral cleft lip
* Patients are older than six months. Associated Cardiac anomalies. Any systemic condition
Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain

The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.

The purpose of this study is to determine whether exposure to acute sitting compared to sitting interrupted with brief bouts of light intensity walking exerts short term effects on resting pain, endogenous pain modulation measured via quantitative sensory testing (QST), and movement-evoked pain (MEP) in older adults. Participants will be asked to complete two study sessions, with the first study session lasting 3 hours and the second study session lasting 2.5 hours. All sessions will take place in the National Institute of Sport Fitness, where the Physical Activity and Pain laboratory is located. The first session will include the following procedures in the following order: informed consent process, healthy history for screening purposes, quantitative sensory testing (QST), 6-minute walk test, completion of questionnaires, QST, experimental conditions of either 1 hour of sitting or 1 hour of sitting with bouts of light intensity walking, QST, and the 30-second chair stand test. Session 2 will take place at least 7 days after session 1 and will be identical except for the informed consent and screening will be replaced by questionnaires and the experimental condition will consist of the one not performed in session 1. Participants will be asked to take their medications at the same time prior to each study visit and we will assess medications taken the day of each visit prior to the visit.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling men and women
* Answer yes to the following question: Have you experienced any musculoskeletal pain (pain affecting joints, bones, ligaments, tendons or muscles) in the past month?

Exclusion Criteria:

* Cardiovascular issues such as uncontrolled blood pressure over 150/99 mmHg, heart failure, or history of acute myocardial infarction;
* Angina in the last month (squeezing, pressure, heaviness, tightness, or pain in chest)
* Serious systemic disease or condition (e.g., severe osteoarthritis, injury) that restricts normal daily activities
* Neurological disease (e.g., Parkinson's Disease, multiple sclerosis, epilepsy)
* Serious psychiatric conditions (schizophrenia, bipolar disorder) or hospitalization within the preceding year for psychiatric illness
* Known peripheral neuropathy
* Chronic opioid use (defined as ≥ 90 days)
* Unable to walk for 6 minutes without assistive devices

Session exclusion criteria:

• Participants will be asked to not participate in vigorous or unaccustomed exercise 48 hours prior to each study session.
Negative Work Exercise for the Treatment of Knee Arthritis

The purpose of this study is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. In this study, the investigators are examining the effectiveness of negative work exercise over a 12-week period in older, male, Veterans.

Purpose: To develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). Given that the medical management of chronic PTOA is similar to idiopathic OA, the investigators propose a randomized, clinical trial to pilot negative work exercise in Veterans with knee OA as a proof-of-concept study for a subsequent investigation for people with PTOA.

Research Setting: DC VAMC, Physical Medicine \& Rehabilitation Laboratory

Participants: Men between the ages of 50 and 70 years with a history of bilateral knee osteoarthritis will be consecutively recruited from the DC VAMC Rheumatology Service, Geriatrics Service, and Primary Care Medical Service.

Implications/Significance: The use of negative work exercise to enhance the force attenuation properties of muscle is an innovative approach to the treatment of OA and PTOA, and represents a significant departure from previous rehabilitation studies concerning arthritis. Use of a negative work paradigm may prove to be beneficial for older Veterans with OA and active military personnel with PTOA since similar muscle mechanics are involved in the energy absorption at the knee joint during gait. Despite the functional importance of lengthening muscle actions in protecting weight-bearing joints affected by arthritis, the authors are not aware of a study that involves the sole use of a negative work intervention for OA or PTOA. Addressing the aims of this proposal would lay the ground work needed to justify larger clinical trials featuring the negative work paradigm for soldiers with PTOA.

Eligibility Criteria:
Inclusion Criteria:

* Adult men 50 y.o. 70 years old will be recruited for this proposed study.
* Participant inclusion criteria includes having bilateral knee OA (Kellgren-Lawrence Grade 2 or 3) and sedentary (e.g., have not engaged in 3 exercise sessions per week for 3 consecutive months).
* Gait aides and orthoses will not preclude participation in this study.

Exclusion Criteria:

* Exclusion criteria include uncontrolled cardiovascular disease, non-ambulatory status, neurogenic weakness, knee extensor and flexor manual muscle test \< 3 out of 5, lower extremity amputation, and current participation in a supervised exercise program.
* In addition, major surgical procedures within the last six months, unstable joints, endocrine or metabolic disorders that result in excessive fatigue or muscle weakness, or use of medications that may impair exercise tolerance would also preclude participation in this study.
staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback

Previous research suggests that biofeedback can outperform traditional interventions for RSE, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback. The objective of this aim is to use the staRt app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition. With a network of cooperating SLPs, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include or exclude the visual biofeedback display. Randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.


Eligibility Criteria:
Inclusion Criteria:

* Normal performance on a pure-tone hearing screening at 20 dB HL, a screening examination of oral-motor structure and function, and a test of receptive language.

Exclusion Criteria:

* History of major behavioral, neurological, or hearing impairment, per parent and/or SLP report.
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All participants received relugolix 40 mg orally once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 28 weeks.

Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. The objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with E2/NETA.

Screening and baseline procedures were to be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincided with the Week 24 Visit from the pivotal study and was to be defined as the date of completion of the last Week 24 procedure in the pivotal study. Participants will have received their last dose of study drug in the pivotal study on the day prior to the Week 24/Baseline Visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 was to define enrollment into this study. Study participants were to then take the open-label study treatment orally once daily for 28 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002

Key Exclusion Criteria:

1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the pivotal study (MVT-601-3001 or MVT-601-3002)
2. Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.

To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible.

Exclusion Criteria:

* Ineligible patients are those who had other liver diseases, as well as those who are affected by cancer, severe jaundice, pulmonary and renal chronic diseases, prostatic diseases, autoimmune diseases and diabetes mellitus. Excessive use of alcohol (\>20 g/die) or hepato-toxic drugs. Other causes of exclusion include decompensated cirrhosis, pregnancy, and contraindications for Peg-IFN-a or RBV therapy such as cardiopathy, hemoglobinopathies, hemocromatosis, major depression or other severe psychiatric pathological conditions.