cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia

The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
* Patients must meet PANSS criteria
* Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose

Exclusion Criteria:

* Patients with current major depressive disorder (MDD)
* Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
* Patients currently using anticholinergic medications
* Recent in-patient hospitalization
Sleep Bruxism and (Peri-)Implant Complications

Excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. Therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.


Eligibility Criteria:
Inclusion Criteria:

* Planned for treatment with implant-supported fixed suprastructure(s).
* 18 years of age or older.

Exclusion Criteria:

* Opposing teeth of implant-supported fixed suprastructure(s) are restored with removable artificial teeth.
* Patients categorized in the classes 3 or higher according to the ASA system for classification of physical status.
* Use of occlusal splint, mandibular repositioning appliance or any other bruxism mitigating device during sleep.
* Active periodontitis at the time of implant placement.
* Known allergy to Grindcare® electrode material.
* Patients with a pacemaker.
* Swollen, infected or inflamed tissues or skin eruptions, e.g. phlebitis, varicose veins etc. in the placement area of the Grindcare® electrode.
* Pregnant women will not be treated with dental implants. Pregnancy after placement of implants will not be a reason to stop participation of the subject in the study.
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.

In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent
* Any T, N and M
* Age: 18 years or older
* WHO performance status ≤ 2
* Life expectancy \> 3 months
* Dysphagia score \> 0
* Adequate laboratory findings: hemoglobin \> 90 g/L, absolute neutrophil count

  * 1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN
* Fertile men and women must use effective means of contraception
* Signed written informed concent
* The patient must be able to comply with the protocol

Exclusion Criteria:

* Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease
* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
* Severe pulmonary disease e.g. pulmonary fibrosis
* Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0)
* Known hypersensitivity to any contents of the study drugs
* Pregnancy ( positive pregnancy test) and/or breast feeding
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin.

The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.

Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with fibromyalgia will have pain of duration \> 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
* healthy, pain-free age matched controls without chronic pain

Exclusion Criteria:

* Allergy to red chili peppers;
* Pregnant;
* Significant hearing loss;
* Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
* FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.
En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity

A randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group

This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65 years) with overweight type II (27-29.9 kg/m2) or obesity type I (30-34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent.

Eligibility Criteria:
Inclusion Criteria:

1. Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
2. Age between 18 and 65 years old
3. Compliance with all evaluation phases.

Exclusion Criteria:

1. Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
2. Presence of several psychological problem, i.e. depression, anxiety
3. Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
4. Use of drugs, i.e. slimming, anovulatory or psychotropic
5. Pregnancy or planned pregnancy for the next six months
6. Following another weight control program at the time of selection.
Evaluation Of The Effectiveness Of The Peer Bullying Consultancy Program Based On The Interpersonal Relations Model

The research was conducted in experimental design with intervention-control group and pretest-posttest in order to examine the effectiveness of the Peer Bullying Consultancy Program (PBCP), is based on the Interpersonal Relations Model (IPM), on 11-12 years old children who are bullying. The sample group of the study consisted of children (intervention group/n=29; control group/n=32) were attending 5th and 6th grades in two different randomized designated secondary schools after stratified sampling, had high Peer Bullying Determination Scale Bully Behavior. The PBCP was implemented to the children in the intervention group in 2 face-to-face and 5 online individual interviews in 26 days. To increase the peer bullying cognition level, to develop empathy skills, to improve friendship relations, to increase anger control of children who are bullying in intervention group, content suitable for age characteristics was developed within the scope of PBCP various training techniques (brainstorming, educational game, demonstration, case study, video watching) used. The data were collected using Sociodemographic Information Form, the Bullying Related Cognitions Scale for Children (BRCSC), the Empathy Scale for Children and Adolescents (ESCA), Friendship Relations and Anger Control Assessment Form. Data collection tools were applied to the children in the intervention group at the beginning and at the end of the PBCP, and to the children in the control group with an interval of 26 days. In the study, children in the intervention group had lower scores on the BRCSC; had higher scores on the ESCA, Self-Reporting Happiness Level in Friendship Relations, Sample Behavior Knowledge Level for Happy Friendship, Understanding Level of Anger Symtoms, Knowledge Level of Anger Control and Self-Reporting Anger Control Level than the children in the control group (p\<0.05). It has been determined the PBCP based on the IRM is effective for children aged 11-12 who are bullying. It is recommended nurses develop model-based, individual counseling and training program in which different educational techniques are used in accordance with the age characteristics in order to support the growth, development of children who are bullying within the framework of their roles such as advocate, consultant, leader.


Eligibility Criteria:
Inclusion Criteria:

* The criteria for inclusion in the study are as follows.

  * Being 11 or 12 years old,
  * Having an internet connection at home,
  * Having a computer and/or phone for internet access,
  * Having at least one standard deviation above the school average in the PBIS-SSB sub-dimension score,
  * The voluntary acceptance of the child and his/her parents to participate in the research

Exclusion Criteria:

• Having any physical or mental health problems,

. Having a diagnosis of chronic disease
SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation

Given the critical role of sleep in enhancing neural recovery, motor learning, neuroprotection, and neuroplasticity, interventions to enhance sleep that target sleep could improve recovery and rehabilitation outcomes for stroke patients. In this proposal, a multidisciplinary group of researchers with expertise in rehabilitation medicine, sleep medicine, nursing, physical therapy, wearable technologies, and implementation science will adapt, implement and evaluate a state-of-the-art intervention to promote sleep for stroke patients undergoing acute rehabilitation. SIESTA-Rehab, adapted from a previous unit-based intervention, bundles two sleep-promoting interventions to address the unique sleep challenges stroke patients face during acute rehabilitation: (1) nursing education and empowerment to reduce unnecessary disruptions; (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing if present during acute stroke rehabilitation.


Eligibility Criteria:
Inclusion Criteria

* Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient)
* Age 18 or older
* Able and willing to give written consent and comply with study procedures . Medical clearance from physician

Exclusion Criteria

* Serious cardiac conditions or neurological degenerative pathologies as co-morbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
* Pregnant or nursing
* Skin allergies or irritation; open wounds
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
First-line Therapy of Stage IV Colorectal Cancer

Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.

The monoclonal anti-VEGF antibody bevacizumab has been approved for the treatment of stage IV colorectal cancer. The tyrosine kinase inhibitor imatinib mesylate has been shown to efficiently target PDGF-signalling. Blocking PDGFR-signalling leads to disruption of pericytes from the endothelium and reverses the maturation status thereby enhancing the sensitivity to anti-VEGF therapy.This background forms a rationale for a combined therapeutic PDGF and VEGF inhibition. Since bevacizumab shows best activity when used in combination with chemotherapy, capecitabine and oxaliplatin are included in this protocol. Patients with stage IV colorectal cancer and no prior chemotherapy can enter the study. Patients receive oral imatinib once a day on days 1-21. Oral Capecitabine is given on days 1-14 bid, Oxaliplatin and Bevacizumab are given on day 1. Courses are repeated every 22 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven inoperable colorectal cancer
* Adult patients \>= 18 years of age
* ECOG \<2

Exclusion Criteria:

* Preceding chemo- or immunotherapy with the exception of adjuvant or neoadjuvant treatment of non-metastatic disease ending ≥ 6 month prior to study inclusion. Progression within 6 month after the end of adjuvant therapy must be excluded.
* Other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri.
* No history of severe comorbidities, i. e. uncontrolled hypertension, GI-bleeding, congestive heart-failure NYHA class II-IV, symptomatic coronary heart disease, myocardial infarction within 1 year prior to study inclusion, serious cardiac arrhythmias requiring medication, Grade II or greater peripheral vascular disease and other severe uncontrolled co-morbidities
* No history of stroke or other CNS-diseases (tumors, seizure, transient ischemic attack etc.)
* ≥ Grade II peripheral artery vascular occlusive disease
* Preexisting neuropathy ≥ Grade 1
* Interstitial pneumonia or lung fibrosis
* Serious, nonhealing wound, ulcer, or bone fracture
* Preceding irradiation an indicator lesion except for documented progressive disease during irradiation and termination of irradiation ≥ 4 weeks from study inclusion
* Thromboembolic or bleeding events within the last 6 month
* Need for therapeutic anticoagulation (heparin, cumarin)
* Use of ASS \> 325 mg/die or NSAR
* Proteinuria \> 1+ (stix) as long as urine protein \>1g/24h
Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with Alzheimer's disease

Dementia is frequently observed in the elderly, often associated with psychotic symptoms such as delusion or hallucinations, or with behavioral disturbances such as aggressive behavior, wandering, and aimless behavior induced by the psychotic symptoms. This is a double-blind, placebo-controlled study of the effectiveness and safety of risperidone (taken twice daily over 8 weeks) in the treatment of psychotic symptoms in patients with Alzheimer's disease. Assessments of effectiveness include: Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD), a scale used for global assessment of symptoms associated with dementia; the Psychosis Cluster Scale of BEHAVE-AD, a subscale that assesses paranoid and delusional ideation as well as hallucination; and Clinical Global Impression-Change (CGI-C), a measure of an improved or aggravated condition. Safety evaluations include the incidence of adverse events throughout the study; physical examinations, electrocardiograms (ECGs), laboratory tests (hematology, biochemistry, urinalysis), and assessment of extrapyramidal symptoms at specified intervals. The study hypothesis is that treatment with risperidone shows greater improvement in psychotic symptoms, as measured by the BEHAVE-AD psychotic cluster score, in patients with Alzheimer's disease, as compared to placebo. In addition, it is hypothesized that risperidone is well tolerated. Risperidone tablets (0.25 mg or 0.50 mg) or placebo tablets taken orally twice daily. Total daily dosage of 0.5mg on Day 1, 1.0mg on Days 3-5, and 1.5mg (maximum dose) on Days 5-13. Optimum dose maintained during Weeks 3-8 of treatment.Dose may be increased or decreased at investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dementia of the Alzheimer's type with or without a vascular component, a score of 2 or more on any item of the BEHAVE-AD psychosis subscale at screening, and a Mini-Mental State Examination (MMSE) score of 5 to 23
* Residents of nursing homes or long-term care facilities and deemed in need of treatment with an atypical antipsychotic medication.

Exclusion Criteria:

* Disease that could significantly diminish cognitive function
* history of neuroleptic malignant syndrome
* hypersensitivity to risperidone.
Evaluation of Patient Education in Irritable Bowel Syndrome

About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.

The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.

Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.

The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
* Must be able to participate in a education-group

Exclusion Criteria:

* Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
* Serious, untreated psychiatric disorder
18F-LN1 PET/CT in Urothelial Carcinomas

The clinical feasibility of 18F-LN1 PET/CT will be evaluated in 30 patients with urothelial carcinoma, and the results will be compared with those of 18F-FDG.

This study aims to evaluate the recognition efficiency of 18F-LN1 and 18F-FDG PET imaging for tumor target Nectin-4 in patients with urothelial carcinoma. The main method is to compare the results of visually interpreted PET images with histopathological results (through surgery or biopsy), which are the gold standard for final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* No gender difference
* Patients who have been diagnosed with, or are clinically highly suspected of, urothelial carcinomas and have had no other treatment within 3 months

Exclusion Criteria:

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
* Complicated with chronic liver disease, myocardial infarction, stroke
* Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
* Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
Phototherapy Applied in Association With Muscular Training

The effects of phototherapy has been widely studied by some research groups. The investigators know that there are positive results with light application to improve muscle performance and delay fatigue. However, there are few studies showing its´ effects on muscular training. Therefore, the aim of this study was to assess the effects of phototherapy applied at different times during 12 weeks of strength training. For such, 48 volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength training protocol for the anterior muscle of the thigh development. Volunteers performed the training protocol three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, concentric peak torque, 1-repetition maximum test in the leg extension and leg press machines and bilateral thigh perimetry.

This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight participants performed muscular training protocol. Subjects practiced a protocol training with 60% of the load followed by 80% of the load, measured through 1-repetition maximum test, in all sessions of the training protocol. The training protocol consisted in performing 3 sets of 7 repetitions with 60% of 1-RM, and 4 set of 7 repetitions with 80% of 1-RM. This protocol was performed in every sessions, three times a week, employing leg press and leg extension machines.

Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the thigh before and after each training session. Only one investigator, that did not participate in any phase of the assessments and trainings sessions, knew about what program is active or placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. Either strength training lasted 12 weeks and assessments were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary contraction (MVC), concentric torque, bilateral thigh perimetry and 1-repetition maximum test (1-RM).

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals,
* active, that performed less than two exercise sessions per week
* when they presented musculoskeletal injury to the hips or knees in the previous 2 months,
* used pharmacological agents or nutritional supplements regularly, and
* Subjects that did not attend a minimum rate of 80% of all strength training sessions
* Suffered musculoskeletal injury during the ongoing of the study were also excluded.