cyrilzakka/clinical-trials huggingface dataset:
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)

This clinical trial will determine whether the addition of radiotherapy to standard of care systemic therapy improves objective progression-free survival compared to systemic therapy alone in patients with oligometastatic castration-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have biopsy-confirmed adenocarcinoma of the prostate
* Subjects must discontinue any prior systemic therapies (excluding GnRH agonist/antagonists) without PSA withdrawal effects if using first generation anti-androgens. Luteinizing hormone-releasing hormone (LHRH) analogues must be continued if they have not undergone orchiectomy. (Subjects who recently started systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) are eligible to enroll if new therapy was started ≤ 14 days to consent date.)
* Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (\<50 ng/dL) of testosterone:
* A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval.
* B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria
* C) Progression of bone disease on bone scan as defined by two new lesions arising
* Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
* Subjects must be medically fit to undergo radiotherapy and systemic therapy as determined by the treating physician.
* Age ≥ 18
* ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
* No prior invasive malignancy in the past 3-years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible.
* Subjects must freely sign informed consent to enroll in the study.
* Subjects must use contraception up to 90 days after last drug dose.

Exclusion Criteria:

* Planned systemic therapy with Radium-223 dichloride or sipuleucel-T
* Tumor requiring emergent radiation in view of provider
* Life expectancy estimate of \<3 months
* Presence of known parenchymal brain metastasis
* Uncontrolled intercurrent illness
* Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
* Biopsy proven pure small cell or neuroendocrine prostate cancer
"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

Background: Zingiber cassumunar Roxb., frequently known as Phlai in Thai, has been safely used as an antihistaminic and anti-inflammatory drug in Thai traditional medicine. Individual with allergic rhinitis may have positive response to Phlai.

Objective: Investigators assessed the efficacy and safety of Phlai as a treatment for allergic rhinitis Design: The study was a 1-month, double-blind, randomized, parallel-group, intent-to-treat, multicenter, controlled trial in 267 patients at 7 hospitals in Thailand. Skin prick test-positive adults with allergic rhinitis ages 18 to 50 who were randomized into 3 groups (Phlai 8mg/d, Phlai 4mg/d, placebo).

Main outcome measures: Primary outcome was defined: improvement of total 5 symptoms scores (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes) over a 4-week interval among Phlai 8mg/d, Phlai 4mg/d and placebo. Secondary endpoints were: assessments of rhinoconjunctivitis quality of life questionnaire, peak inspiratory nasal flow, nasal examination, adverse events, AST, ALT, Creatinine and BUN over a period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* Allergic rhinitis following diagnostic criteria of ARIA guideline
* Reflective total 5 symptoms score 2-10 per day for 3 consecutive days (total score=15) and not greater than 10 in any days during the past week
* Positive skin prick test to at least one aeroallergen: wheal size ≥ 3 mm greater than negative control
* Not receiving intranasal corticosteroid + intra antihistamine for 2 weeks , intranasal corticosteroid for 2 weeks, systemic corticosteroid for 4 weeks, antihistamine for 1 week, nasal decongestant for 1 week and leukotriene receptor antagonists for 1 week

Exclusion Criteria:

* Serious medical underlying diseases e.g. COPD, Heart disease, Chronic renal failure, chronic hepatic failure
* Allergic rhinitis and asthma which require immunotherapy
* Receiving antidepressants, sedative, anxiolytic, opioids, neuroleptic
* Uncontrolled asthma which requires steroid inhaler, LABA and does not use leukotriene receptor antagonists
* Previous nasal surgery for nasal polyp, nasal septum deviation
* Acute or chronic rhinosinusitis
* Pregnancy and lactation (Urine pregnancy test is allowed and paid by researchers)
* Allergic to any kinds of herb
* Refusal to participation
Online Coping Skills Counseling for Problem Gambling and Trauma

This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG. Both models are delivered via telehealth.

Our key study question is whether an integrated focus on PG and PTSD (Seeking Safety; SS) offers a useful new option for clinical care compared to a purely problem gambling approach (Cognitive-Behavioral Therapy for PG; CBT-PG). This question-the impact of integrated versus non-integrated treatment for co-occurring disorders-is one of the key issues in the field currently and has never been studied in relation to PG and PTSD.

Our aims are:

1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold).
2. To evaluate outcomes from baseline to end of treatment and 12 month followup on two primary variables (money lost gambling and number of gambling sessions) and several secondary variables.

Our hypotheses are: (a) SS will do no worse than CBT-PG on the primary PG outcomes as both treatments are designed to address addiction; i.e., both will show improvement from baseline to end of treatment and maintenance of gains through the followup. (b) SS will show superior results on trauma symptoms as SS is designed to address those, whereas CBT-PG is not.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Recruited from the province of Manitoba, Canada
* Meets criteria for PTSD (full or subthreshold) on the Clinician-Administered PTSD Scale (CAPS)
* Meets gambling disorder criteria per the DSM-5 Diagnostic Interview of Gambling Severity

Exclusion Criteria:

* Current uncontrolled psychotic or bipolar I disorder
* Suicidal or homicidal ideation with intent and/or plan
* Currently engaging in or planning to engage in any manualized, formal, evidence-based PTSD therapy
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome

Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics. Despite cognitive and motor difficulties, there is a possibility of intervention based on the knowledge of motor learning. However, it is important to study the motor learning process in individuals with DS during a virtual reality task to justify the use of virtual reality to organize intervention programs. The aim of this study was to analyze the motor learning process in individuals with DS during a virtual reality task. Methods: A total of 40 individuals participated in this study, 20 of which were with DS (24 males and 8 females, ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender to the individuals with DS. To examine this issue, we used software that uses 3D images and reproduced a coincidence timing task.


Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of DS and the ability to understand the task.

Exclusion Criteria:

* disorders in cognitive function that would prevent comprehension of the experimental instruction
Beta-alanine and Elder Endurance

The purpose for this study is to determine if beta-alanine supplementation combined with endurance-based resistance training can increase gains in muscular endurance to a greater extent than endurance-based resistance-training alone in older adults.


Eligibility Criteria:
Inclusion Criteria:

* 60-90 years of age
* Living independently (not residing in an assisted living facility)
* Through testing are found not to have sarcopenia
* Gait speed \> 1 m/s
* Skeletal Muscle Index \> 37% in men and \> 27.6 % in women
* Exclusion Criteria
* Responding with a "yes" to any question on the PAR-Q.
* Are currently pregnant, or plan to try and become pregnant during the study
* Functional impairments that could impede the person's ability to participate in a resistance training program
* Current or recent use of supplements (within the past 3 months for non-alanine containing supplements or one year for supplements containing beta-alanine). Individuals taking only basic multivitamins (without any herbal co-ingredients) may still be allowed to participate. These situations will be reviewed on a case-by-case basis.
* Are currently enrolled in a regular exercise program (more than once per week)
* Current or recent smoker
* Use of medication containing corticosteroids
* Mini-mental score of 21 or below
* Severe musculoskeletal impairment
* Uncontrolled chronic disease
* Major depression
* Severe vestibular problems

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Knowledge, Attitudes and Clinical Practices of Pediatric Dentists Regarding Covid-19

This study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children

Aim: This cross sectional study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children.

The study population is pediatric dentists recruited through five pediatric dentists Facebook groups. Web-based questionnaire was created using Google forms, structured of multiple-choice questionnaire, and divided into: (demographic, knowledge, practices, and behavior management techniques) sections. Descriptive statistical analysis was used to describe items included in the survey. Numbers and percentages were used to describe categorical data.

Eligibility Criteria:
Inclusion Criteria:

Practicing pediatric dentists working in private practices or institutions

Exclusion Criteria Dentists specialized in other disciplins
In Vitro NMR Spectroscopy in Neurological Diseases

The search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders.

This approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. As a consequence, only limited parts of the metabolism can be studied simultaneously.

The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

It is now established that most inborn errors of metabolism may present in adulthood as a neurological disorder. The diagnosis of these diseases is essential because, unlike the so-called neurodegenerative diseases, metabolic diseases are often accessible to specific treatments.

Conversely, many patients are followed for a complex neurological disease of unknown cause. We hypothesize that a significant proportion of these patients carry yet undetected inborn error of metabolism.

Recently, the use of Nuclear magnetic resonance spectroscopy (NMRS) has uncovered new metabolic diseases leading sometimes to specific treatments. However, the place of this technique in the investigation of patients with complex neurological diseases remains to be determined.

The primary goal of this project is to assess the interest of NMRS in urine and CSF to search metabolic abnormalities, not detected by conventional biochemical techniques. It is an open study. The study will be conducted in close collaboration between the neurology and genetic departments of the Pitié-Salpêtrière hospital, on the one hand and the nuclear medicine department of Poitiers in the other. 250 patients will be included over a period of 2-3 years and will be divided into 4 groups: Group 1: patients with complex neurological disease of unknown cause (200 patients) for whom urines and CSF will be collected. Group 2: positive controls (25 patients): patients with already known metabolic disease for whom we already have CSF or urines. Group 3: negative controls (25 patients): patients with non metabolic neurological disorders of known cause hospitalized for a lumbar puncture.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: Any patient with an unexplained complex neurological disease
* Group 2: Patients with known inborn error of metabolism
* Group 3: patients with known non metabolic disease

Exclusion Criteria:

* none
Atrial Fibrillation in Beta-Thalassemia

The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.

Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation.

The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.

Eligibility Criteria:
Inclusion Criteria:

1. Transfusion-dependent Beta-thalassemia;
2. Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
3. Electrocardiogram performed;
4. Echocardiogram performed.

Exclusion Criteria:

1. Age \<18 years;
2. State Of pregnancy;
3. Inability to give informed consent.
Multi-scale Modeling of Sleep Behaviors in Social Networks

The project is designed to document in college undergraduates the relationships among sleep/wake timing and duration, use of mobile phones and other electronic devices, food timing and content, self-reported mood and physiological measures.

College undergraduates are studied in cohorts of \~ 50 in fall or spring semesters. They complete diaries once in the morning and once in the evening about sleep/wake timing, timing of social and school activities, and mood. They wear physiological sensors. They install (1) an application on their mobile phone that tracks timing, duration and de-identified sender/recipient of phone calls and text messages, use of internet or apps (but not the content or names of those internet sites and apps) and (2) meal content and timing. They also spend at least one overnight session providing saliva samples for later assay for hormones.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate at institution at which we have permission to perform study
* owning a mobile device on which the phone app can be installed
* ability to wear the wrist-worn sensors

Exclusion Criteria:

* no travel outside one time zone starting approximately 2 weeks before monitoring begins through end of approximately one month of monitoring.
* participation in a prior group studied
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Eligibility Criteria:
Inclusion Criteria:

* past or present history of vaginal bleeding during pregnancy
* open cervical os
* evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
* surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
* generally in good health
* woman lives or works within one hour of study site
* woman willing to provide contact information for follow up purposes
* informed consent given

Exclusion Criteria:

* contraindications to study drug
* uterine size larger than 12 weeks LMP
* signs of severe infection
Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients

The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI).

The fundamental questions that investigators want to answer are as follows:

* \[question 1\]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
* \[question 2\]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"

Spinal cord injury results in loss of sensory and motor function below the level of injury, causing difficulty with unaided sitting and activities of daily living, especially at the thoracic level in SCI patients. The paraspinal muscles that provide trunk balance are weakened in these patients. Methods such as neuromuscular electrical stimulation and EMG ES are used to improve trunk balance and restore muscle function. This study aims to investigate the effect of EMG ES applied to the multifidus and erector spinae muscles on trunk balance in patients with complete thoracic SCI.

Eligibility Criteria:
Inclusion Criteria:

* have traumatic SCI and this injury occurred at least 3 months ago,
* be between the ages of 18 and 65,
* have a neurological injury level between thoracic 4 and thoracic 12
* be fully paraplegic according to the American Spinal Cord Injury Association (ASIA) impairment scale
* be able to sit unsupported in a wheelchair

Exclusion Criteria:

* patients with a diagnosis of heart failure
* malignancy
* intracardiac defibrillators
* epilepsy
* open wounds
* patients using trunk corsets
Different Treatment Modality in Necrotic Primary Molars

Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.

the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.

Eligibility Criteria:
Inclusion Criteria:

* A child with one or more necrotic primary teeth
* Presence of abscess/fistula
* Sensitivity to percussion
* Presence of maximum grade 2 mobility ( Not more than 1 mm)
* Increases of the dental lamina dura
* cooperative patients

Exclusion Criteria:

* Medically compromised children
* Patient allergic to any of the used materials
* Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
* Presence of vitality in the canals
* Presence of grade 3 mobility
* Non-restorable teeth
Tanezumab in Osteoarthritis of the Hip or Knee (2)

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

* pregnancy or intent to become pregnant
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychiatric disease
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3804 in patients with advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

- 1. Understood and signed an informed consent form. 2. 18 and 70 years old. 3. Histologically or cytologically confirmed advanced malignant tumor. 4. Has EGFR mutations. 5. Life expectancy ≥12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

7.Adequate organ system function. 8.At least one measurable lesion.

Exclusion Criteria:

* 1.Hypersensitivity to TQB3804 or its excipient. 2. Has diagnosed and/or treated additional malignancy within 5 years with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.

  3.Has interstitial pneumonia. 4.Brain metastases with symptom . 5.Has currently uncontrollable congestive heart failure. 6.Has history of arterial thromboembolism within 6 months. 7.Has any bleeding tendency or coagulopathy within 6 months. 8.Has skin toxicity ≥ grade 2 within 4 weeks. 9.Has serious gastrointestinal diseases within 4 weeks. 10.Has received any major surgery within 4 weeks. 11.Participated in other clinical trials within 4 weeks. 12.Has active viral, bacterial and fungal infections within 4 weeks. 13.Has received any cancer therapy within 4 weeks or 5 times of t1/2. 14.Has ≥ grade 2 toxicity caused by previous anti-tumor treatment. 15. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.

  16. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.

  18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.