cyrilzakka/clinical-trials huggingface dataset:
IORT in Local Advanced Laryngocarcinoma

The incidence of laryngeal cancer accounts for about 1 \~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .


Eligibility Criteria:
Inclusion Criteria:

1. adults over the age of 18;
2. radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
3. the expected survival time ≥ 3 months;
4. sign informed consent for treatment and research with self-knowledge.

Exclusion Criteria:

1. there is distant metastasis;
2. pregnant women;
3. patients with CT/MRI contraindications;
4. the patient fails to receive treatment and/or follow-up as scheduled;
5. bad fluid and organ function decompensation;
6. multiple primary cancers;
7. patients participating in other trials.
Effectiveness of Cricoid Pressure During Videolaryngoscopy Versus Direct Laryngoscopy

Compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Even with appropriate cricoid pressure, the lifting force of the laryngoscope during direct laryngoscopy for tracheal intubation may counteract the cricoid pressure, making esophageal obstruction ineffective. Compared to direct laryngoscopy, videolaryngoscopy requires less lifting force, and thus, the success rate of esophageal obstruction may be higher. This study aims to compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to have general anesthesia with tracheal intubation

Exclusion Criteria:

* Gastroesophageal reflux disease, achalasia, bowel obstruction,
* BMI \> 35 kg/m2
* Uncontrolled diabetes
* Pregnancy
* Previous esophageal, and gastric surgery
* Dental damage or anticipated difficult airways
* Who do not consent to the study
An Internet-Based Smokeless Tobacco Cessation Program for Teens

To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.


Eligibility Criteria:
Inclusion Criteria:

* 14-25 years of age
* Have access to the Internet
* Currently using smokeless tobacco products
* Currently contemplating quitting all tobacco products
* Able to read and write English; and
* Willing to share phone number, e-mail, and mailing address with the research project
Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near

Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing. During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the International Federation for the Surgery of Obesity and Metabolic Disorders.

The constant and strict follow-up is mandatory in this special subset of patients. Therefore, starting from the telemedicine experience in different medical fields, in our bariatric surgery division we designed and started a dedicated project to follow-up obese patients using remote counselling.

Eligibility Criteria:
Inclusion criteria:

* obese adults (\> 18 years of age, BMI\> 40 or \> 35 with comorbidities) older than 18 years
* patients undergoing bariatric surgery within 6 months
* patients who required clinical and instrumental control
* presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.

Exclusion criteria:

* virtual visit decline
* the internet or smart devices unavailability
* need for physical examination or radiological investigations established during a preliminary contact by phone.
Acute High Fat Bulletproof Coffee vs Black Coffee on Metabolism, Inflammation and Cognitive Function in Healthy Adults

This study will determine whether acute ingestion of a high fat "Bulletproof Coffee" will lead to changes in plasma triglycerides, immune cell function, as well as cognitive function when compared to a black coffee.

In a randomized crossover design, participants will consume a single bulletproof coffee or a single black coffee separated by \~7 days. Each visit commences in the morning after an overnight fast of 10-12 hours, with no exercise the day prior, no coffee consumption the morning of testing, and completion of a food log for dietary duplication prior to visit 2. A fasting blood draw is obtained and cognitive function tests administered, along with questionnaires to assess gastrointestinal distress, arousal, and hunger/fullness before coffee consumption. Following this, one of the coffee beverages is consumed (randomized to each visit). Cognitive testing and questionnaires are completed at 60 minutes after finishing the coffee, another blood draw at 90 minutes, and then cognitive testing, questionnaires and a final blood draw 180 minutes after consuming the coffee. This procedure is repeated during their second experimental visit, in which they consume the remaining coffee based on their randomization.

Eligibility Criteria:
Inclusion Criteria:

* Must be over the age of 18
* Must drink between 1-4 cups of coffee per day (on average)
* Must be able to tolerate lactose and dairy products
* Have not been sick for the past 3 weeks (immune function)
* Non smoker
* Must be able to fast for 10-12 hours

Exclusion Criteria:

* If you are required to take corticosteroids (immune function)
* Cannot understand or speak English
* Individual has an auto-immune disease and requires medication
* Individual is following a ketogenic diet
* Individual has allergy or sensitivity to dairy, coffee or caffeine or coconut oil
* Individual has hypertension
Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial

This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.

This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences

Eligibility Criteria:
Inclusion Criteria:

* engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the BPI, and non-cancer related pain

Exclusion Criteria:

* psychoactive medication for pain or alcohol use for fewer than 2 months
* history of bipolar disorder or schizophrenia
* current expressed suicidal intent
* prior history of alcohol withdrawal related seizures or delirium tremens
* current behavioral treatment for pain or alcohol use
* any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Dementia Management With Interactive Technology

To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Residents living in a specific locked memory care unit in Southeastern Louisiana or
* Family or staff identified as part of the care team of the resident
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics

The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Type II diabetes for at least 2 years
* Type 2 diabetics on oral hypoglycemic agents and/or insulin
* Fasting blood sugar of \>200mg% on at least two occasions
* Willing to keep a weekly diary and undergo observation for 12 months

Exclusion Criteria:

* Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions

This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.

A growing body of research reveals that dating violence (DV) plays a significant role in adolescent girls' HIV risk. Dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. Thus, prevention strategies that address dating violence and HIV risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. In this study, a cognitive-behaviorally based intervention named "Skills to Manage Aggression in Relationships for Teens" (Date S.M.A.R.T.) is being developed and compared to a psychoeducational program for dating violence and HIV prevention. The program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. A primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent must be English-speaking
* Adolescent must have a lifetime history of physical dating violence perpetration or victimization

Exclusion Criteria:

* Current enrollment in an intervention for dating violence or HIV prevention
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.

Infants 2 months of age who have been diagnosed with a deformational head shape will be begin repositioning therapy (and physical therapy if torticollis is present) and be followed at least monthly. At 4, 5, and 6 months of age, if the head shape has not resolved, they will be given the option to pursue treatment with a cranial remolding orthosis. All affected infants will undergo active treatment until the head shape is resolved or the infant is 12 months of age (whichever comes first).

Normal infants will be evaluated at 2, 6, and 12 months of age and will not be enrolled in any active treatment.

All infants will return at 12 months of age for a final evaluation.

Eligibility Criteria:
Inclusion Criteria for Control Group:

* Healthy infants with normal physical development and no need for physical therapy intervention

Exclusion Criteria for Control Group:

* Infants with abnormal head shapes (plagiocephaly or craniosynostosis)
* Infants with growth abnormalities (such as genetic conditions)
* Infants with developmental delay significant to warrant physical therapy or occupational therapy
Enhanced Recovery Protocols in Gynecologic Oncology

Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. The present study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria.

Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. ERAS protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (MMA), early mobilization, and early removal of urinary catheters.

ERGO study study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria. Patients will be registered into the trial before surgery. Quality assurance program will be in place for both patients that will fulfill the ERAS criteria as well as for those that will not fulfill them.

Eligibility Criteria:
Inclusion Criteria:

patients with gynaecological cancer and an ECOG performance status \<4, ASA score \<4.

Exclusion Criteria:

patients with metastatic cancer of non-gynaecological origin patients that are not able to follow ERAS protocol due to medical reasons patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)
The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes

The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.

Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older with non-infected, non-ischemic foot ulcers
* active neuropathic foot ulcer

Exclusion Criteria:

* major foot amputation
* active Charcot arthropathy
* ankle brachial index of 0.5 or less
* history of substance abuse within 6 months
* inability to walk 20m
Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?

The aim of this project is to investigate the effect of Raloxifene 120mg in men with schizophrenia. This trial will adopt a 12 week randomised controlled model.

Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM) will have a significantly greater reduction in psychosis symptoms over the course of the study than men receiving adjunctive placebo.

Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater improvement in cognitive function than men receiving adjunctive placebo

With the recent advent of selective estrogen receptor modulators (SERMS), such as raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on central nervous system (CNS) neurotransmitter systems. While the CNS effects of raloxifene have not been fully studied, its actions are mediated through binding to estrogen receptors and can thereby regulate gene expression that is ligand, tissue or gene specific. By inference then, raloxifene would be expected to impact on dopamine and serotonin pathways in a similar fashion to unconjugated estrogen.

This study aims to examine the impact of adjunctive SERM (120mg oral Raloxifene daily) treatment on the psychopathology and cognition of men with schizophrenia and related disorders

Eligibility Criteria:
Inclusion Criteria:

* Physically well
* DSM-IV diagnosis of schizophrenia, schizoaffective or schizophreniform
* 18- 45 years
* Able to give informed consent
* PANSS total score \> 60 (1 - 7 scale) and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness

Exclusion Criteria:

* Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.
* Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilization.
* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance abuse or dependence during the last six months, or consumption of more than 30gm of alcohol (three standard drinks) per day
* Smoking more than 20 cigarettes per day.
* Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet.
An Interaction Study With Digoxin and AZD1305

The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range
Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304

The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing open-label extension (OLE) Studies VRX-RET-E22-303 and VRX-RET-E22-304.

Data from the October 2009 data-cut of ongoing Studies VRX-RET-E22-303 (Study 303) and VRX-RET-E22-304 (Study 304) will be pooled, summarized, and published with the goal of providing updated long-term safety and efficacy information for subjects and prescribers following the recent positive CHMP opinion for retigabine for adjunctive use in patients with partial seizures. Studies 303 and 304 are the open-label extensions of two Phase 3 studies (VRX-RET-E22-301 and VRX-RET-E22-302), respectively. Studies 301 and 302 were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg per day (Study 302) and 1200 mg per day (Study 301). All subjects who wished to enter the OLE studies and, in the opinion of the investigator, were expected to benefit from participation in the OLEs, entered a 6-week (Study 301) or 4-week (Study 302) transition phase in which their dose of retigabine was titrated to or maintained at 400 mg TID (Study 301) or 300 mg TID (Study 302). Upon completion of the Transition phase, subjects enrolled into the extension studies. Once enrolled in the OLE, doses could be adjusted within the range of 600 mg to 1200 mg per day. Treatment in Studies 303 and 304 is planned to continue until regulatory approval and commercialization of retigabine or until the program is discontinued.

Eligibility Criteria:
This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.
Education-based Physical Therapy Approach for Adhesive Capsulitis

This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically relevant outcomes (range of glenohumeral motion, psychological factors, pain, shoulder function, quality of life) and on parameters derived from arthroscopic glenohumeral investigation by means of MRI.

Furthermore, associations between (1) the results on the MRI investigation, (2) the range of glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be assessed at different time-points (before and at 6-12-18 and 52 weeks after the first injection).


Eligibility Criteria:
Inclusion Criteria:

* 50 % loss of passive GH external rotation motion, together with motion losses greater than 25% in at least two other GH movements, as compared to the unaffected side
* the pain accompanying the motion losses has to be present for at least one month. During that month, the pain and mobility deficits have to be stable or get worse

Exclusion Criteria:

* bilateral frozen shoulder
* systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand