cyrilzakka/clinical-trials huggingface dataset:
Epidemiologic and Genetic Study on Familial Prostate Cancer

The aims of the study are:

* to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
* to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:

1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy).
2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance).

The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples:

* For men with known prostate cancer.
* For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.

The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Eligibility Criteria:
Inclusion Criteria:

* patient with a histological confirmed prostate cancer
* member of a hereditary prostate cancer family
* healthy control men without prostate cancer

Exclusion Criteria:

* Absence of signed informed consent
* refusal to participate in the study
Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy

Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).

Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Lateral epicondylitis
* Age \>18

Exclusion Criteria:

* Operation history about elbow
* Received physical therapy, or had a steroid injection to the elbow in the three months
* Cervical radiculopathy,
* Elbow deformities,
* Fibromyalgia syndrome,
* Carpal tunnel syndrome,
* Neurological impairments in the upper extremity,
* Chronic inflammatory conditions,
* Hemophilia,
* Pregnant,
* History of malignancy
Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB

In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.

In remimazolam-based MAC group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. The dose of remimazolam and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).

In inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. Mechanical ventilation will be maintained by inserting laryngeal mask airway (LMA) or endotracheal tube. The doses of sevoflurane and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).

Surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, PONV score and the incidence of hypotension and hypoxemia will be compared.

Eligibility Criteria:
Inclusion Criteria:

patients undergoing transurethral bladder resection

Exclusion Criteria:

* ASA class 4
* emergency surgery
* history of hypersensitivity to sevoflurane, propofol and remimazolam
* galactose intolerance
* patient refusal
* patients in whom muscular relaxation are needed.
Wearable Gait Sensors

This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.

Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.

Eligibility Criteria:
Inclusion Criteria:

* Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.
* Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.

Exclusion Criteria:

* Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.
Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)

Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Lymphangioleiomyomatosis
* performed a pulmonary Rehabilitation program at the reference center

Exclusion Criteria:

* missing data
* repeated stay for pulmonary Rehabilitation at the reference center
Gait Stability of People With Lower-limb Amputations

The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons.


Eligibility Criteria:
Inclusion Criteria:

* be over the age of 18;
* be able to walk comfortably for a minimum of two (2) minutes;
* be willing to take part in the study, including signing the consent after carefully reading it;
* be able to read and understand English and follow verbal and visual instructions;
* are competent to give informed consent or have a proxy with power of attorney.
* have an unilateral, transtibial amputation;
* been fitted with a prosthesis for over six weeks.
Effect of Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery

This study aimed to compare continous intravenous lidocaine infusion and placebo on the effect to brain relaxation, opioid consumption and postoperative cognitive status in adult patient undergoing craniotomy tumor removal surgery

Fifty subjects were given informed consent one day before surgery and then randomized into two groups: continous intravenous Lidocaine intraoperative and Placebo. Patient, the Anesthesist as data collector, and the Neurosurgeon as the outcome assessor are blinded to the randomization and the intervention given. Non invasive blood pressure, ECG, and pulse oxymetry monitor were set on the subject in the operating room. General anesthesia induction was done by Fentanyl 3 mcg/kg, Lidocaine 1.5 mg/kg or Placebo (according to allocation group), Propofol 1-2 mg/kg and Rocuronium 1 mg/kg. After the intubation, maintenance continous intravenous Lidocain dose 2 mg/kg/hours or Placebo were set until the completion of surgery. Other than intervention (Lidocain or Placebo), maintenance was done by volatile Sevoflurane 0.8 -1.0 MAC, intermittent Fentanyl, continous Atracurium dose 5 mcg/kg/minutes and Manitol 20% dose 0.5 g/kg 30 minutes before Neurosurgeon reach the duramater. At the time Neurosurgeon reach the duramater, before and after they open the duramater, Neurosurgeon will assess brain relaxation by direct inspection and palpation. Total Fentanyl intraoperative will record and Cognitive status pre and postoperative will assess using MMSE. Postoperatively patient will transport to the ICU for monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient age 18-65 years old undergo craniotomy tumor removal surgery
* Physical status ASA 1-3
* Compos mentis (GCS 15)
* Operation using pin head fixation

Exclusion Criteria:

* Patient or family refused to participate
* Has Atrioventricular block rhytm on ECG
* Has sign of circulation shock
* Midline shift \> 5.4 mm on brain imaging
* Diagnose with Glioblastoma multiforme or Metastatic
* Vascular surgery
* Using CSF drainage (EVD, VP shunt, or Lumbal drain)
* Routine using or in treatmet using adrenergic agonist or antagonist drugs
* Routine consumption of opioid in last two weeks before surgery
* History of Local anesthetic hypersensitivity
An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis

The purpose of this pilot study is to investigate feasibility and patients´ assessment using an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console) for patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the 1987 and 2010 American College of Rheumatology (ACR) criteria for rheumatoid Arthritis
* Disease activity (patients' global assessment, PtGA) \< 30 mm under therapy with a biological DMARD according to label

Exclusion Criteria:

* Epilepsy
* Flare of RA
* A previous use of a Wii console for more than 5 hours
EDIT Management Feasibility Trial

Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as possible to minimise the amount of time they have to spend in hospital.

Standard treatment for MPE involves an admission to hospital to drain the fluid and then attempt to prevent the fluid from returning by sticking the lung to the inside of the rib cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but unfortunately it fails in about 30% of patients. This is usually because the lung has not fully re-expanded and has not made contact with the inside of the ribs. When this happens, the fluid can be effectively treated with a different type of drainage tube called an indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the district nurses.

It is thought that pressure measurements taken from the fluid as it is drained may be able to show doctors whether or not the lung will re-expand before patients are committed to either TP or an IPC. In this research we wish to test if these measurements can be used to choose which is the best first treatment option (TP or IPC) for patients with MPE. We have called this 'EDIT management'. Since it is uncertain whether this new approach will work, patients will be randomised to have either standard treatment or EDIT management. We will compare the two groups to assess whether the patients who had EDIT management had to have fewer repeat procedures over the following 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:

  1. Pleural effusion with histocytologically proven pleural malignancy OR
  2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
  3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
* Degree of breathlessness for which therapeutic pleural intervention would be offered
* Age \>18 years
* Expected survival \> 3 months
* Written Informed Consent

Exclusion Criteria:

* Females who are pregnant or lactating
* Clinical suspicion of non-expansile lung for which talc pleurodesis would not be offered
* Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
* Previous ipsilateral failed talc pleurodesis
* Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
* Any contraindication to chest drain or IPC insertion, including:

Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC tunnel site

- Any contraindication to MRI scanning, including:

Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign body Previously documented reaction to Gadolinium-containing intravenous contrast agent Significant renal impairment (eGFR\<30 ml/min)
Effects of Periodontal Therapy on Systemic Inflammation

The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.

Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.

Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.

Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.

The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.

The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and \>30 % of sites with bleeding on probing.

The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosis of marginal periodontitis
* No history of periodontal treatment
* At least 14 natural teeth present
* Dyslipidemia
* And at least one of the following factors:

  * obesity
  * diabetes
  * smoking, hypertension

Exclusion Criteria:

* Rheumatoid arthritis
* Any type of cancer in the previous 2 years
* Pregnancy and lactation
* Indication of the use of antibiotic for invasive procedures
* Use of antibiotics in previous three months.
Safety of Antibiotic Intake During Pregnancy

this study will be conducted to assess the knowledge of the pregnant females regarding safety of antibiotic intake ,also their attitude toward any prescribed antibiotics during their pregnancy .

this study will be conducted on pregnant females from two Arab countries to assess their knowledge and attitude toward any prescribed antibiotics while they are pregnant .Also to assess any malpractice while their intake for any antibiotics . this study is a cross sectional study that will involve a questionnaire including the three mentioned domains .

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at any gestational age

Exclusion Criteria:

* pregnant women who refused to participate
Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.


Eligibility Criteria:
Key Inclusion Criteria:

1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening
3. History of inadequate relief of CLBP from non-pharmacologic therapy
4. Willing to undergo joint replacement (JR) surgery, if necessary
5. History of regular analgesic medication use
6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP

Key Exclusion Criteria:

1. Patient is not a candidate for MRI
2. History of major trauma or back surgery in the past 6 months prior to the screening visit
3. History or presence of pyriformis syndrome
4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
5. History or evidence on joint imaging of conditions that may confound joint safety evaluation
6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
7. Recent use of longer acting pain medications
8. Other medical conditions that may interfere with participation or accurate assessments during the trial

Note: Other protocol defined Inclusion/ Exclusion criteria apply.
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab


Eligibility Criteria:
Inclusion Criteria:

• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Exclusion Criteria:

* Symptomatic obstructive intestinal strictures
* Bowel resection within 4 weeks
* Current total parenteral nutrition
* Short bowel syndrome
* Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:

1. Alcohol use
2. Dietary intake
3. Drug use (legal and illegal)

in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.

The study is intended to explore potential precipitants of alcoholic hepatitis.


Eligibility Criteria:
Inclusion Criteria:

* acute alcoholic hepatitis
* aged over 18 years
* able to give informed consent

Exclusion Criteria:

* evidence of other acute or chronic liver disease
* episode of alcoholic hepatitis in 6 months before admission
* severe hepatic encephalopathy
* delirium
Age 9 Follow-up of Preventive Intervention (Denver)

To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.

This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.

The project is organized around seven questions:

1. Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
2. To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
3. To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
4. To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?

6. To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?

Eligibility Criteria:
Inclusion Criteria:

* Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.