cyrilzakka/clinical-trials huggingface dataset:
Theory of Planned Behavior and Implementation Intentions

Diet quality has been associated with a variety of chronic diseases including obesity. One measure that has been studied as an indicator for diet quality is fruit and vegetable intake. Although the US government has suggested that American's increase their intake of fruit and vegetables, epidemiological data suggest that most Americans have not been successful doing do, with the strongest disparity seen in people of low socioeconomic status (SES). This disparity in fruit and vegetable intake is thought to be the result of both individual and environmental factors that influence this health behavior. To help decrease the disparate rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy to implement interventions to improve fruit and vegetable intake and diet quality are needed.

Theoretical models of health behavior change have been successfully used in research targeting individual factors associated with health behaviors. One theory, the Theory of Planned Behavior (TPB), and a proposed extension of this model (implementation intentions) have been shown to be effective to increase fruit and vegetable intake in (mostly) white adults of average socioeconomic status. It is not know whether an implementation intention intervention to increase fruit and vegetable intake would be effective in women who are of low socioeconomic status. The primary aim of this research is to study (using quantitative and qualitative analysis) an implementation intention intervention to produce a positive change in fruit and vegetable intake. We theorize that the setting of an implementation intention in this group will be effective, cost-effective, and easy to implement intervention to promote an increase in fruit and vegetable intake.

Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention) measured via survey using 1 question each, bivariate semantic differential scale.

Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.

Demographic data measured via survey. Height measured via tape measure. Weight measured using a standing scale.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Boston Public Housing
* Identifies as female
* Age 18-72
* Able to give informed consent
* Agrees to be randomized into either the intervention or the control groups
* Understands English sufficient to comprehend purpose, risks, benefits and voluntary nature of the study, and to complete the surveys and provide information in this language

Exclusion Criteria:

* Does not consent to study participation
* Currently pregnant
* Identifies as following a strict medically prescribed diet, as having an allergy to fruit and/or vegetables, or as currently taking medications that necessitate the avoidance or reduction of fruit and/or vegetable intake.
* Does not agree to be randomized into either the intervention or control groups
SIS Evaluation of the MRI Defined Subthalamic Nucleus*

Retrospective review of images used to target the STN during DBS procedure and ability of the Surgical Information Sciences ("SIS") system to visualize the STN location.

The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.

Eligibility Criteria:
Key Inclusion Criteria:

* Idiopathic PD
* Bilateral or unilateral STN-HFS for PD
* 40% improvement response to medications preoperatively

Key Exclusion Criteria:

* Missing required MR/CT imaging data
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study

1. Prospective, randomized, head-to-head, double-blind, cross-over study.
2. Total patients: A group 51, B group 51
3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
4. Compare the TSUI change score from baseline to 4 weeks after injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age of both genders,
* Cervical dystonia
* symptoms with a minimum duration of 18 months,
* Negative pregnancy test in sexually active women,
* Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).

Exclusion Criteria:

* Patient with cervical contractures
* Known significant underlying dysphasia
* Patients who have received botulinum toxin treatment within the past 4 months.
* Contraindication to botulinum toxin treatment
* Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS ...)
* Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
* Patients who required more than 500 units of Dysport or 200 units of Botox.
* Any concomitant treatment that could interfere with the action of botulinum toxin,
* Subjects having participated within the last 3 months or currently participating in an investigational drug study,
* Pregnancy,
* Lactation.
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction

The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of all genders
* Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring segmental or total jaw resection
* Patients eligible for jaw and oral cavity reconstruction combined with immediate/delayed implant loading for fixed prosthetic rehabilitation
* Patients not eligible for conventional removable prosthetic rehabilitation

Exclusion Criteria:

* Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
* Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
* Patients eligible for conventional removable prosthetic rehabilitation
Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .


Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy.
2. The score of Karnofsky ≥70
3. Patients of either gender and older than 18 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
7. Life expectancy≥ 6 months
8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Active skin infection
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
9. Brain metastases
10. Women in pregnant and lactating period
The Effect of Mannitol on the Serum Potassium During Craniotomy

This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.

Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3), 60min (T4) and 120min (T5) after infusion.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 70
* American Society of Anesthesiologists physical status I to II
* liver and kidney function is normal
* preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/L

Exclusion Criteria:

* history or presence of congestive heart failure (New York Heart Association class III to IV)
* history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion)
* intraoperative blood transfusion
Implant Placement With Simultaneous Gum Grafting

This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.


Eligibility Criteria:
Inclusion Criteria:

* One edentulous site bordered by 2 teeth needing a dental implant

Exclusion Criteria:

* Systemic diseases that affect the periodontium
* Previous head and neck radiation
* Smoking more that 1/2 pack per day
* Requires prophylactic antibiotics
* Allergy to meds used in study
* Previous chemotherapy
* Pregnancy
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.


Eligibility Criteria:
Inclusion Criteria:

1. Aortic insufficiency 2+
2. Ascending aorta size more than 5 cm
3. Ascending aorta size more than 4,5 cm (Marfan syndrome)
4. Good conditions of aortic cusps

Exclusion Criteria:

1. Aortic annulus more than 30 mm
2. Aortic cusps destruction
3. Critical aortic cusps elongation
4. Aortic root dissection
The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing

HELI is a multicenter, randomised controlled trial in two Dutch research centres (Donders Centre for Cognitive Neuroimaging, Nijmegen, and the department of Human Nutrition \& Health at Wageningen University) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Age between 60-75 years (at pre-screening);
* Fluency in Dutch (speaking, reading and writing);
* Lives near study centres in Nijmegen and Wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden);
* Presence of ≥2 self-reported risk factors for cognitive decline (BMI of 30 or higher, physical inactivity according to World Health Organization guidelines, hypertension \[not using hypertensive drugs counts as an additional risk factor\], hypercholesterolemia, diabetes type-II, non-symptomatic cardiovascular disease).

Exclusion Criteria:

* Concurrent participation in other intervention trials;
* Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.);
* No internet access from home;
* Clinical diagnosis of ≥1 of the following: vascular event (CVA), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, Parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment;
* Unable to undergo MRI (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic);
* Cognitive impairment as determined by the Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.
Psychological and Enterostomal Therapy Care

In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

The aim of the study is to asses the benefit of an optimal and specific care concerning the temporary stoma in patients operated for rectal cancer surgery in term of psychological and enterostomal therapy effect.

This study is a monocentric and randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y
* Rectal adenocarcinoma (tumor height \< 15 cm from the anal verge) with or without pre operative radiochemotherapy.
* Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis.
* Temporary stoma.
* Patient consent
* Patient with national health affiliation

Exclusion Criteria:

* Stage IV disease with synchronous hepatic or pulmonary metastases
* Colonic cancer \> 16 cm
* Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy)
* Abdominal perineal resection
* Associated comorbidity
* Emergency surgery
* Psychological care refusal
Effect of IV Lidocaine Infusions on Pain

Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. Our study will incorporate pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.

Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. Plasma concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of the medical team. This will be conducted according to standard medical practice for the infusion and the study procedures will not affect the infusion paradigm. Total infusion time is approximately 1-2 hours. During the course of the study, the primary outcome measure was changed from blood oxygenation level dependent (BOLD) signal to pain intensity.

Eligibility Criteria:
Inclusion Criteria:- subjects between the ages of 18 and 100 years for clinical component; subjects between the ages of 18 and 70 for the MRI component

* meets the study criteria of chronic pain of either peripheral or central origin
* male or a non-pregnant, non-lactating female. If females are of reproductive potential (i.e., not surgically sterilized and/or not post menopausal), they must be practicing an accepted method of birth control, agree to a urine pregnancy test at the start of each study session (for patient scheduled through the clinic, this has already been addressed by the recommending physician)
* is not currently on a sodium channel blocking agent, anticonvulsant, or tricyclic antidepressant,
* must be able to comply with any other study requirements and complete experimental tasks
* have no reported substance abuse within the past six months; Exclusion Criteria:- subject is lactating or pregnant;
* subject suffers from clinically significant cardiac, pulmonary, renal or liver disease;
* subject allergic to lidocaine.
* MRI Component: any metal objects (especially surgical clips), devices, or implants or any other MRI contraindication
Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome

OSAS is a disease characterized by repeated interruptions and restarts of breathing during sleep. Respiratory muscle sarcopenia is a condition in which the muscle strength of the diaphragm and other respiratory auxiliary muscles decreases, resulting in a decrease in breathing effort. Decreased respiratory effort is an important indicator of OSAS. Age, presence of chronic disease, and obesity increase the presence and severity of respiratory sarcopenia. If OSAS is left untreated, it leads to cardiovascular diseases, dementia, Alzheimer's and even death in early adulthood. In recent years, studies have shown that continuous positive airway pressure (CPAP), as well as healthy behavior development, preventive health and exercise measures, are important in the management of these diseases. There is no research in the literature on the evaluation of respiratory muscle sarcopenia in OSAS patients.

This study aims to evaluate respiratory muscle sarcopenia in OSAS based on a concrete value reflecting respiratory muscle strength and/or volume.

In the study, respiratory muscle sarcopenia will be evaluated in OSAS patients. It will be evaluated whether the expiratory pressure value, peek flow meter value and 6-minute walking distance are predictors of respiratory sarcopenia for OSAS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with normal-mild-medium-severe OSAS
* 18 years and above
* Turkish speaking patients will be included.

Exclusion Criteria:

* Pregnancy,

  * Latent autoimmune diabetes,
  * Chronic renal failure,
  * Active or serious infections,
  * Liver failure,
  * Recent major cardiovascular events,
  * Unstable angina, heart failure (NYHA III-IV),
  * Patients with neurological or musculoskeletal disorders that create limitations in walking and performing tests
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment

Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3).

Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor.

Methods:

Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily.

We are investigating in prospective ongoing non-randomized case study effects of addition of dapsone 100-200 mg daily in addition to standardized recommended treatment versus a a cohort of patient admitted at our institution since October 2020 versus a group that only received standardized treatment. Our primary out comes are decrease in FIO2 requirement leading to discharge from hospital and decrease in over all mortality between group treated with only standardized recommended treat versus group with addition of dapsone and cimetadine.

An objective criteria of improvement, was used for effectiveness of therapy.

A. a reduction in the FIO2 requirement and

B. a decrease in the progression of hypoxia. We treated the patients with standard COVID-19 ARDS treatment with dapsone 100 mg to target NLRP3 inflammasomes.

Eligibility Criteria:
Inclusion Criteria:

1. All, PCR confirmed cases of COVID-19

Exclusion Criteria:

1. Only consenting consenting patients

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