cyrilzakka/clinical-trials huggingface dataset:
Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism

The purpose of this study is to determine whether clonazepam is effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

RBD is one of the representative non-motor symptoms of PD and other synucleinopathies. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. These can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. Therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of RBD.

Clonazepam has been used for treatment of choice of RBD. It decreased RBD symptoms completely in 55-79% and partially in 11-32% of patients. However, these results are based on open-label or descriptive studies. There has been no randomized placebo controlled study that evaluated the efficacy and safety of clonazepam for treating RBD.

Eligibility Criteria:
Inclusion Criteria:

* Subject was enrolled voluntarily and understood the contents of this clinical trial
* Subject was diagnosed as Parkinson disease (PD) or Parkinson's syndrome
* Hoehn and Yahr (H\&Y) stage 1, 2, or 3
* Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant
* Existence of RBD by answering "yes" to the question (RBD-1Q): "Have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?"

Exclusion Criteria:

* Existence of cognitive decline hard to participate in the clinical trial
* Subject has confusion or visual hallucination in daytime
* Diagnosed as obstructive sleep apnea or severe snoring
* Previous clonazepam treatment within 4 weeks
* Current treatment with benzodiazepines at bedtime
* Alcoholics or drug abuser
* Lactating, pregnant, or possible pregnant
* Hypersensitivity to clonazepam or benzodiazepines
* Prior participation to other clinical trials within 3 months
* Presence of severe comorbidities or a cancer
* Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians
Metabolic Effects of a Diet Replaced With Essential Amino Acids

The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.

1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.


Eligibility Criteria:
Inclusion Criteria:

- Obesity (BMI \>35kg/m2)

Exclusion Criteria:

* Type 2 diabetes mellitus
* Renal failure
* Heart failure (New York Heart Association NYHA, class IV)
* Liver cirrhosis
* Neoplasms
* Muscular or non-autonomic pathologies
* Neurological-neurodegenerative pathologies
* Cognitive decline
* Non-menopausal women.
* Patients who have undergone bariatric surgery in the previous 12 months
* Patients on pharmacological treatment for weight loss in the last three weeks
* Patients using vitamin and amino acid supplements in the last three weeks
* Patients on hormone therapy (e.g. L-thyroxine, testosterone).
Mandibular Fracture Reduction Using Bone Reduction Forceps

Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.

10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.

The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months

Eligibility Criteria:
Inclusion criteria

* Adult patients aged from 20 to 45 years will be included.
* Patients suffered from recent and uninfected.
* Patients with isolated mandibular fractures.

Exclusion criteria

* Medically compromised patients that will be not fit for surgery.
* Edentulous patients.
* Non-displaced
* Comminuted fracture with bone loss
* Old fracture, more than 3 weeks
Dietary Salt During Pregnancy and Maternal Vascular Function

The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association. Also, the aim is to investigate whether there is an association between excessive salt intake during pregnancy and the outcome of pregnancy.

During the study pregnant women at the third trimester of pregnancy (37-38 weeks of pregnancy) will have one study visit during which following procedures will be done:

* measurement of maternal systemic microvascular function by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside)
* measurement of maternal systemic macrovascular function by vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
* measurement of maternal uteroplacental function by ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
* venous blood sampling; serum will be stored for measurement of oxidative stress, matrix metalloproteinase 9 and endocan level
* 24-hour urine natriuresis (to estimate daily salt intake)
* measurement of blood pressure, heart rate, height and weight, body composition

Immediately after the childbirth following procedures will be done:

* assessment of pregnancy outcome (duration of pregnancy, child birth weight, child birth length and Apgar score)
* placental tissue will be taken and stored for measurement of matrix metalloproteinase 9

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)

Exclusion Criteria:

* smoking
* prenatal hypertension
* thrombophilia
* low molecular weight heparin use
* coronary heart disease
* preconception diabetes
* gestational diabetes
* renal impairment
* cerebrovascular and peripheral artery disease
* any other preconception disease that could affect vascular and endothelial function
Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery

Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made

Background and Objective: Whether partial or complete, mastectomy with axillary lymph node dissection is a painful surgery. Acute postoperative pain management is challenging and crucial due to high chances of it transforming into chronic pain. Erector spinae plane (ESP) block has been shown to be effective in managing post mastectomy pain.Dai et al showed the effectiveness of dexmedetomidine in prolonging the duration of sensory block, motor block and analgesia when dexmedetomidine as an adjunct is added to ropivacaine in brachial plexus block (1). The aim of our study is to show the effectiveness of dexmedetomidine in prolonging the analgesic effect of ropivacaine when added to it in ESP block compared to using ropivacaine alone in patients undergoing mastectomy with axillary lymph node dissection, and to study its impact on postoperative opioid consumption.

Methods: 44 American Society of Anesthesiologist (ASA) physical status classification class I, II and III will be randomly allocated to one of two groups, both receiving a single injection erector spinae plane block at T4 vertebral level using 20ml ropivacaine 0.375% 20 minutes before the induction of anesthesia. The first group will receive 0.5mcg/kg of dexmedetomdine added to the ropivacaine solution. The control group will receive no dexmedetomidine.

Postoperatively, patients in both groups will be receive acetaminophen 1g orally every 6 hours and oxycodone 5 mg orally as needed every 6 hours if VAS is more than 4. Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours.

Conclusion: This study will be the first of its kind to investigate the impact of adding dexmedetomidine as an adjunct to ropivacaine in prolonging the ESP block duration in patients undergoing mastectomy with axillary lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

1. ASA class I, II and III patients
2. Age range: 18-80 years old
3. Elective partial or unilateral radical mastectomy with sentinel lymph node dissection

Exclusion Criteria:

1. Pregnant woman
2. Bilateral mastectomy.
3. Skin infection at the site of needle puncture
4. Coagulopathy problems
5. Allergy or contraindication to any of the study drugs
6. Recent use of opioid drugs
Shared Decision Making for Patients With First-admission Schizophrenia

To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to an acute care psychiatric ward.
* Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
* Aged 16 to 65 years old at admission
* No prior experience of psychiatric admission (first-admission)

Exclusion Criteria:

* Diagnosed with moderate to severe mental retardation
* Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
* Having poor Japanese language skill
* Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.


Eligibility Criteria:
Key inclusion/exclusion criteria

* Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer.
* Measurable disease (revised RECIST, version 1.1).
* Hormone receptor (ER/PR) positive or negative, HER2 negative.
* Subjects were eligible for the study regardless of their previous lines of endocrine therapy.
* No prior chemotherapy is allowed in metastatic disease.
* Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day.
* ECOG performance status ≤1.
* Neuropathy grade \<2.
* Subjects with central nervous system metastasis should be excluded.
The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial

Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. Current controversy about the use of ABC exists around the world. Without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent to which ABC compared to regular cement reduces the infection rate in patients over the first two years following TKA and, 2) the resource use implications associated with the use of ABC for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. All patients will be administered IV antibiotics immediately prior to surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. A blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. Blinded radiologists will interpret the 2 year series of radiographs for each patient. We will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. This study includes a full economic analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients with osteoarthritis of the knee,
* patients who are undergoing primary knee replacement,
* patients who are able to provide informed consent.

Exclusion Criteria:

* patients with a prior joint infection,
* patients who have a known allergy to tobramycin, and
* patients who have no fixed address.
Use of Wearable Digital Sensors After mRNA Vaccination in Adults

The purpose of this study is to explore the physiological and behavioral impact of the immune response to vaccines after receipt of investigational or approved messenger ribonucleic acid (mRNA) vaccines using wearable medical sensors, with the potential of establishing a digital biomarker of vaccine response due to stimulation of the immune system.

Participants will be provided wearable medical sensor equipment and instructions at the start of the study. Participants will have access to device support throughout the study period. The wireless medical devices will be applied prior to vaccination in the concurrent Moderna-sponsored vaccine trial in order to establish an initial baseline of participants' daily physiological patterns.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a concurrent Moderna-sponsored vaccine clinical trial.
* Investigator assessment that participant understands and is willing and physically able to comply with wearing the sensors and follow-up as outlined in the study protocol, including all procedures.
* Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in the study protocol.

Exclusion Criteria:

* History of hypersensitivity or allergic reaction to medical adhesive or other history of skin irritation, that, in the opinion of the investigator, contraindicates their use of a wearable medical device.
* Broken skin at the site of wearable location
* Implanted, permanent pacemaker
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis

The aim of EFEX-OA-02 is to explore how running, cycling, exercise simulation and resting acutely influence collagen and proteoglycan homeostasis in OA, as reflected by changes in collagen and proteoglycan levels in urine and serum.


Eligibility Criteria:
Inclusion Criteria:

1. Cumulated Osteoarthritis Kellgren-Lawrence radiological grade of at least 2 in the tibio-femoral joints diagnosed by screening X-ray.
2. 40 to \< 75 years of age at time of signing the informed consent.
3. Body weight \> 50 and \< 100 kg and BMI in the range 18.5-35 kg/m2 .
4. Male or female.
5. Able to attend all four study sessions and comply with the dietary and activity restrictions.
6. Able to provide informed consent

Exclusion Criteria:

Medical conditions:

1. Osteoarthritis Kellgren-Lawrence radiological grade of 4 in one or both knees.
2. Cumulated osteoarthritis Kellgren-Lawrence radiological grade no higher than 1.
3. History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
4. Previous arthroplasty of knee or hip.
5. Intention to have major surgery during the timeframe of the study.
6. Secondary OA related to e.g. any known trauma including cruciate ligament tears, meniscus tears and cartilage damage, dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout).
7. Current treatment with beta-receptor adrenergic antagonists (beta-blockers), MAO inhibitor, systemic corticosteroid treatment in doses equivalent to \> 10 mg prednisolone per day, or vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated heparin.
8. Active systemic infection.
9. Active systemic inflammatory or autoimmune disease.
10. Any sign of previous or current cardiovascular disease.
11. Not currently an active athlete or highly trained individual.

Other exclusion criteria:

1. Legal incapacity or limited legal capacity.
2. Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
3. Categorized as being very difficult to draw blood from, as evaluated by the investigator.
4. Current alcohol abuse and/or inability to refrain from intake of alcoholic beverages for 24 hours prior to the study intervention.
5. Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.
6. Site staff, study staff members and study staff family members.
7. Other concomitant disease compromising or otherwise significantly affecting ECM turnover in the opinion of the investigator.
Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose

Response Surface Pathway (RSP) design was previously developed for dose-finding studies with one interventional and one response variable, but RSP to higher dimensions is requested. The aim of this study is to introduce and evaluate the RSP design with two interventional and one response variable exemplified by estimating Minimum Efficacy Dose (MED) of Osteopathic Manual Therapy (OMT) in treatment of gastroesophageal reflux disease (GERD).

15 GERD patients, divided in three design-level with three, five and seven patients. The study was performed as a two-dimensional randomized, between-patient RSP designed multicenter study with two interventional- and one response variable. The interventional variables "Number of OMT's" and "Treatment Interval" with common response variable formed two independent one-dimensional randomized between-patient RSP studies. The response variable was the percent reduction in sum of the five GERD score from baseline. Three GERD patients were allocated on the first design level given six OMT with five days' interval. Based on results obtained in the first and second design level, five patients were included to the second design level and seven to the third.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed Gastroesophigual Reflux Disease
* Known effect of anti-reflux medication

Exclusion Criteria:

* Hiatus hernia ≥5 cm
* gastric ulcer
* cancer
* uncontrolled bacterial, viral, fungal or parasite infection.
Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).

Vascular dementia is a significant cause of intellectual and functional impairment in young patients consequent to cerebrovascular disease. Post-mortem studies show that VaD patients have a cholinergic deficiency like in Alzheimer's disease (AD). Cholinesterase inhibitors are now standard treatment for mild to moderate AD. This study aims to determine if donepezil, a cholinesterase inhibitor, would benefit patients with VaD by decreasing their scores in the VaDAS-cog and improvement in their CIBIC rating over a period of 24-weeks treatment. Adverse events will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

The subjects eligible for this study are men and women outpatients, age 40-60 years old, who fulfill the criteria for VAD according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences International Workshop (NINCDS-AIREN). Subjects shall undergo extensive clinical examination by a stroke specialist and radiological examination (CT or MRI) to document presence of cerebrovascular disease. The clinical diagnosis has to be relevant to the imaging findings.

Other Inclusion criteria:

Subjects with clinically stable hypertension, diabetes mellitus, and cardiac disease for the last 3 months. Subjects with history of recent stroke, who have not been hospitalized for stroke in the previous 3 months. Subjects with depression controlled with medications. Subjects should have no hearing or visual impairment and live with a reliable caregiver.

Exclusion criteria:

Subjects should have no radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery) have no depression or other psychiatric disorders, infectious disorders, neoplastic condition, and metabolic and toxic encephalopathies, dementia due to AD or prior diagnosis of AD, and major depression or other psychiatric disorders.

Subjects with clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases; pregnancy, history of alcohol or drug abuse, and sensitivity to cholinesterase inhibitors; use of investigational agents, cholinomimetic and anticholinergic agents.