cyrilzakka/clinical-trials huggingface dataset:
Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits, arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal recessive family disease characterized by abdominal pain, chest pain, joint pain and fever attacks as a result of inflammation of the serous membranes. FMF patients have been shown to experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and this has increased sleep disturbance and reduced quality of life. FMF and BiH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In December 2019, after the officially detected coronavirus (severe acute respiratory syndrome coranavirus-2 \[SARS-CoV-2\]) resistant to unknown treatment and rapidly spreading coronavirus in our country on March 11, 2020 in Hubei province of China, the number of cases increased rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the spread of Covid-19 infections have caused many measures to be taken. Among them, social isolation, home quarantine and avoiding collective places are the most important. In our country, in the process of social isolation, the areas of movement of Behçet and FMF patients, like everyone else, were restricted, their stress and anxiety levels increased and their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue, physical activity level and quality of life and question exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
* A diagnosis of BiH at least 1 year ago according to the International Behçet Working Group
* Having signed the informed consent form
* Having a cooperative level that will respond to evaluation scales

Exclusion Criteria:

* Pregnant women
* Having other chronic diseases
* Psychiatric disorders and treated
* Those with cognitive impairment
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).

A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
3. Not suitable for surgery (either for medical reasons or patient's choice);
4. Age at diagnosis 18 to 70 years;
5. Eastern Cooperative Oncology Group performance status ≤ 2
6. No prior cancer therapy;
7. No history of concomitant or previous malignancy;
8. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
9. Renal function: Cr ≤ 1.25×UNL;
10. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
11. Documented informed consent to participate in the trial.

Exclusion Criteria:

1. Younger than 18 or older than 70 years of age;
2. ECOG performance status of 3 or above;
3. Other cancer history;
4. Previous radiotherapy history;
5. Subjects with distant metastases;
6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
8. Evidence of bleeding diathesis or serious infection.
Laparoscopic Gynecology Curriculum for Residents

Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Currently there is no standardized laparoscopy curriculum for gynecology residents. This study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. The investigators will then validate the curriculum using Obstetrics and Gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room.

HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. The investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. The operating room performance will be judged by blinded experts on a previously validated evaluation tool.


Eligibility Criteria:
Inclusion Criteria:

* Novice residents (defined as having performed less than 10 laparoscopic salpingectomies)
* Patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies.

Exclusion Criteria:

* Residents who have performed more than 10 laparoscopic salpingectomies
* Residents in PGY3 or higher
* Patients with multiple prior abdominal surgeries, high BMI, significant adnexal pathology, and extensive endometriosis
Nabilone for the Treatment of Phantom Limb Pain

The purpose of this proposed study is to conduct a randomized double-blind placebo controlled trial assessing the benefit of nabilone in pain management and improvement of quality of life in patients with phantom limb pain.

Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the phantom limb pain and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the Groningen Sleep Quality Scale and daily prosthetic wearing time.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been diagnosed with phantom limb pain by a Rehabilitation Medicine Specialist.
* 18-70 years old.
* Any gender.
* The patient has not had resolution of their phantom limb pain with other treatments, such as a tricyclic antidepressant, or anticonvulsant medication.
* No previous use of oral cannabinoids for pain management.

Exclusion Criteria:

* The patient's pain is better explained by a treatable cause of stump pain, such as neuroma or bony overgrowth.
* Gross abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH) that are twice the limit of normal. Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn.
* Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of symptomatic angina, MI or CHF as well as a clinical exam.
* Schizophrenia or other Psychotic disorder
* Severe liver dysfunction.
* History of untreated non-psychotic emotional disorders.
* Cognitive impairment.
* Major illness in another body area.
* Pregnancy.
* Nursing mothers.
* History of drug dependency.
* A known sensitivity to marijuana or other cannabinoid agents
Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change

* Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen.
* Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases.
* Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source.
* The investigators hypothesis is that increased BPA exposure from canned beverage would disrupt normal physiology in a short term.
* In the present trial the investigators are to investigate whether increased BPA exposure by consuming canned beverage actually affect cardiovascular indices and epigenetic feature.
* For this aim, the investigators will conduct a cross-over trial.


Eligibility Criteria:
Inclusion Criteria:

* Reside in Seoul
* Who provided Informed consent

Exclusion Criteria:

* Who has cancer
* Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
* Who does not provieded informed consent
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?

This study aims to explore the relationships between tooth wear (TW) and musculoskeletal disorders (MSDs). The null hypothesis is that TW is not associated to MSDs. It also explores the influence of bruxism signs, life habits and stress on TW and MSDs.

This study is based on questionnaires and clinical examination performed by a dentist.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years old
* Have the mental abilities to participate in study
* Understand the language of the survey (French)
* Sign free and informed consent

Exclusion Criteria:

* Consult for a painful dental emergency
* Do not have at least 8 teeth per maxilla, with natural dental tissues in contact with the antagonistic teeth
* Being in the process of an orthodontic treatment
* Wear of a bimaxillary orthognathic nightguard
TBI Evaluation and Management (TEaM)

The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.

Emergency, urgent care, and primary care providers participating in the study will be block randomized in a 1:1 ratio by practice type to receive the intervention or continue with their standard practice. All enrolled clinicians (both trained and control providers) patients they care for will be screened for inclusion in the trial.

Additionally, a pre/post intervention will be layered upon the randomized educational intervention to evaluate the effects of the information technology decision support tool (i.e. eMR) in isolation of the clinician education intervention. The 32-month mTBI patient enrollment period will be divided into two 16 months segments. The first 16 months will be without the eMR intervention being visible, and the remaining 16 months post eMR screening and decision support deployment in the ED and UC. This study design allows us to evaluate the independent and interactive effects of the decision support tool and educational intervention.

Enrolled children will be followed for up to three months post injury to ascertain the effect of the interventions on the primary aim (reduction of school problems/performance) and secondary aims.

Eligibility Criteria:
PROVIDER INCLUSION CRITERIA

* Actively practicing physician or APP in the CHOA System
* Primary practice in either ED, UC, and/or PCP

PROVIDER EXCLUSION CRITERIA

* Inability or unwillingness to provide written/electronic informed consent
* Unable to fulfill study training / education requirements

CHILD INCLUSION CRITERIA - RETROSPECTIVE

* School age (5-18 yoa)
* Evaluated in ED / UC / PCP within 72 hours of injury
* Discharged home from ED / UC / PCP (e.g., not admitted to hospital)

CHILD EXCLUSION CRITERIA - RETROSPECTIVE

* Non-English speaking
* Known severe developmental delay or known severe psychiatric history
* Known prior severe brain injury
* Known mTBI within past 3 months
* First mTBI visit outside of CHOA network

CHILD INCLUSION CRITERIA - PROSPECTIVE

* Meets above inclusion for retrospective portion plus:
* mTBI likely present as defined by:
* Positive diagnosis by clinician or mTBI OR
* Positive triage screen plus positive symptom checklist

CHILD EXCLUSION CRITERIA - PROSPECTIVE

* Does not meet above exclusion for retrospective portion plus:
* Requests to Opt-Out via e-mail or first phone contact
* Inability or unwillingness to provide verbal informed telephone consent/assent
Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series

A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.


Eligibility Criteria:
Inclusion Criteria:

* Student athlete at CSUN
* Diagnosed with Osteochondral dissecans (OCD)
* Underwent surgical procedure to treat OCD
* Treated postoperatively by the team physical therapist and/or athletic trainers at CSUN.

Exclusion Criteria:

- No concurrent ligamentous injures to the knee during the time of subject participation in the study
Investigation of the Effects of Motor Imagery and Action Observation in People With Multiple Sclerosis

It was planned to examine the effects of motor imagery and action observation applied in addition to standard rehabilitation in individuals with Multiple Sclerosis on walking, fatigue, and muscle oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* A definitive diagnosis of MS by a neurologist according to the 2017 McDonald Criteria
* Expanded Disability Status Scale (EDSS) score of 4.0 and below (it is determined routinely by the physician during the examination)
* Not having an attack in the last 3 months
* A minimum score of 4 in each motor imagery ability (internal visual imagery, external visual imagery, and kinesthetic imagery) on the Movement Imagery Questionnaire-3 (MIQ-3)

Exclusion Criteria:

* cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score of less than 24
* Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
* Having severe vision and hearing problems
Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part.

The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age: 18-65 years
* Approx. 3-5 bowel movements per week
* Caucasian
* Availability and presence in the trial unit for approx. 4 hours/ week for 4 times in a row with approx. 1 week of washout in between
* Signed informed consent form

Exclusion Criteria:

* Known (family) history of diabetes mellitus or use of anti-hyperglycaemic drugs or Insulin
* Clinically relevant renal or hepatic disease, liver enzymes \> 10% above reference range
* Fasting blood glucose \> 100 mg/dL or HbA1c outside of reference range
* Total cholesterol \> 250 mg/dL or triglycerides \> 150 mg/dL
* Haemoglobin \< 11 g/dL (women); \< 12.5 g/dL (men)
* BMI \< 19 kg/m² and ≥ 30 kg/m²
* Intentional and unintentional weight loss \> 5% in the previous 6 months
* Smoker
* Major medical or surgical event requiring hospitalization within the previous 3 months
* Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
* Intake of medications known to affect glucose tolerance, e.g., steroids, protease inhibitors or antipsychotics (stable doses of e.g., oral contraceptives, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable)
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
* Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption
* Suspicion of drug abuse
* Abuse of alcoholic drinks, defined as an average daily intake of more than one litre of beer per day or equivalent amount of alcohol in other beverages
* Pregnant or breast feeding women
* Known or suspected allergy to any component of the investigational product(s)
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 4 weeks prior to visit 1 or during the study
* Volunteer unable to co-operate adequately
* Participation in a clinical trial with an investigational product within one month before start of study
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors

The aim of this study is to determine the relationship between the percentage of calories from dairy intake and long-term glycemic control and weight maintenance in patients with type 2 diabetes who participate in an intensive lifestyle intervention program.

The investigators hypothesize that overweight and obese patients with type 2 diabetes who consume higher percentage of calories from dairy products during intensive lifestyle intervention programs have better glycemic control and maintenance of weight loss as compared to those who consume lower percentage of calories from dairy products.

This is a prospective, observational clinical study where the daily intake of dairy products will be recorded and analyzed in 50 overweight/obese subjects with type 2 diabetes enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary program developed by Joslin Diabetes Center for intensive diabetes weight management in clinical practice. It includes the following components that are provided in a group setting: (1) intensive medical treatment provided by an endocrinologist and a registered nurse; (2) a structured dietary plan provided by a registered dietitian; (3) an individualized exercise training program provided by an exercise physiologist; (4) cognitive behavioral modification provided by a behavioral therapist.

Participants will be enrolled in this study for a period of 24 weeks. They will attend the Weight Achievement and Intensive Treatment (Why WAIT) program during the first 12 weeks of the study and will be followed for another 12 weeks after the program (the maintenance phase). During the intervention phase, participants will receive group education on a weekly basis for 12 consecutive weeks. During maintenance phase, participants will receive a monthly, 15 minute long, follow up phone call from the study dietitian.

Participants will be instructed to complete a 3-day food log before each visit. They will also be asked to record their dairy intake on a daily basis in a dedicated log book. These logs will be collected and analyzed by the study dietitian. Dairy consumption will be calculated as the sum of servings per day of milk, cheese, yogurt, and other dairy foods.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is participating in the Weight Achievement and Intensive Treatment (Why WAIT) program
2. Subject is male or female ages 18-75
3. Subject has type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication

Exclusion Criteria:

1. Subject is pregnant or lactating
2. Subject has a heart pacemaker
Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients

The current study will investigate the tolerability and efficacy of inhaled Carragelose® versus saline in hospitalized COVID-19 patients. As SARS-CoV-2 replicates readily in the lung, it is planed to apply Carragelose® in an inhalative form. Hospitalized COVID-19 patients with respiratory symptoms will inhale Inhaleen for 5 days.

The tolerability and efficacy of inhaled Carragelose® will be investigated in a randomized, double blind, placebo-controlled trial in hospitalized COVID-19 patients.

Patients will inhale Inhaleen or Placebo 3 times a day for 7 minutes for 5 days.

The primary objective of the trial is to demonstrate that Inhaleen inhalation improves the clinical status of hospitalized COVID-19 patients on day 8 compared to placebo inhalation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any trial related procedures are performed
* Age ≥ 18 years
* Hospitalized patients with PCR confirmed SARS-CoV-2 infection and symptom onset ≤ 10 days before randomization
* Patients with respiratory COVID-19 symptoms
* Randomization ≤ 48h from admission
* Peripheral capillary oxygen saturation (SpO2) ≥ 90% on room air or supplemental oxygen at screening
* Patient agrees to refrain from taking other carragelose products (e.g. throat spray, lozenges)

Exclusion Criteria:

* No informed consent
* Persistent hypoxemia with SpO2 \< 90% despite supplemental oxygen of \> 6LO2/min at screening.
* Patients with predominantly extrapulmonary COVID-19 symptoms (e.g. gastrointestinal, neurological, etc.)
* Subjects who demonstrate respiratory and/or cardiac instability that is considered by the investigator as a reason for exclusion. Additionally, any other clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions are asthma, immune deficiency, autoimmune disease, clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or any disease that is considered by the investigator as a reason for exclusion.
* Known hypersensitivity or allergy to any component of the test product
* The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor.
* The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
* Current medication other than oral contraception,that is considered by the investigator as a reason for exclusion.
* Pregnant/lactating women at the time of recruitment will be excluded from the study
* Participation in another antiviral clinical trial