cyrilzakka/clinical-trials huggingface dataset:
Healthier Hearts and Brains in Treating Smoking: The HABITS Study

80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if eligible, enrolled and randomized to one of two four-week treatments for smoking cessation. The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate elements of widely-used tools for smoking cessation including managing craving and strong emotions, problem solving, tips on healthy eating and keeping active, and exercises based on cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a relaxation therapy) into standard therapy. Participants complete questionnaires and undergo an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of standard therapy or MBAT). During each scan, participants will complete a validated smoking-related cue paradigm and a validated affect labeling paradigm.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be considered eligible for enrollment if they are between 18-65 years old, smoke at least ½ pack cigarettes per day, desire to quit smoking (self-reported 75+ out of a possible 100), and have no contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

Exclusion Criteria:

* Participants will not be considered eligible for enrollment if they are not between 18-65 years old, smoke less than ½ pack cigarettes per day, do not desire to quit smoking (self-reported -75 out of a possible 100), or have contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).
Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis

Hemodialysis patients have a high prevalence of pain, mainly musculoskeletal and intra dialytic pain. A high prevalence of pain was also observed in the upper and lower limbs and the trunk. In addition, severe functional interference of pain in the ability to walk was associated with pain in the upper Limb. These results indicate that pain in hemodialysis patients is limiting and disabling (Dos Santos et al., 2021).

Acupressure increases relaxation, relieves pain, and reduces anxiety and depression, especially in the elderly. It is relatively inexpensive, safe, non-invasive, and easy to use and is performed by hands, elbows. by applying pressure to specific areas of the body so muscle spasms are relieved, blood circulation and vital energy are improved (Bastani et al.,2022).

Strong non-painful TENS within or close to the site of pain produces clinically important reductions in the intensity of pain during or immediately after treatment. With no reports of serious adverse events. TENS as an adjunct to core treatment or immediate short-term relief of pain, irrespective of diagnosis. Patients should be advised to tailor TENS Treatment according to their individual needs (Johnson et al., 2022).

Sixty patients will be randomly assigned into two equal groups (n=30):

1. Group A (30 patients) will receive Acupressure three times per week for eight weeks.
2. Group B (30 patients) will receive TENS three times per week for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Sixty patients with renal failure stage 5 undergoing hemodialysis sessions at least six months ago up to 2 years.

  * Participants with lower limb pain and brief pain inventory (BPI) pain score between 7 and 10 points.
  * Body mass index ranges from 25 to 29.9.
  * Their ages range from 50-60 years old.
  * All patients will be under full medical control.
  * Patients will be free from lower limb dialysis grafting.
  * Hemoglobin level more than 10 mg\\dl.

Exclusion Criteria:

* Skin disease such as dermatitis, stitches and wound.
* Active infection, autoimmune diseases and malignancy.
* Severe cardiac diseases.
* Severe chest diseases.
* Patients with cardiac pacemaker.
* Epilepsy.
* Using another integrative treatment method during the study.
* Uncontrolled diabetes.
* Deep vein thrombosis.
* Lumber disc prolapses affect lower limb.
Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Sleep-disordered breathing at night is a common medical problem. It leads to daytime fatigue, impairment in concentration and daily activities, and a higher risk of cardiovascular disease and life-threatening events. A particularly common form is obstructive sleep apnea (OSA), and it is usually treatable with a high rate of patient satisfaction and improved quality of life using a continuous positive airway pressure (CPAP) device.

Treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the upper airways. Research shows that in cancer, sleep disordered breathing is frequent. Low oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. This study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung tumors, and thus serve to ultimately block tumor growth.

Participants of this study will undergo sleep study and receive CPAP therapy as a part of routine care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lung cancer in one of 2 sub-types:

  1. newly diagnosed early-stage tumor
  2. advanced-stage lung tumor undergoing serial contrast-CT imaging according to standard of care
* Diagnosis of a metastatic carcinomatous mass in the lung
* Positive study for sleep-disordered breathing (SDB) with intermittent hypoxia (IH) and clinical recommendation for CPAP
* Ability and willingness to undergo baseline and repeat perfusion-CT imaging following 3- to 4 weeks of CPAP therapy for SDB (regardless of CPAP compliance).

Note: Participants will undergo sleep study and receive CPAP therapy as a part of routine care.

Exclusion Criteria:

* Lung cancer with a negative sleep study (i.e., no SDB)
* History of radio-contrast allergy
* At excessive risk for contrast nephropathy (following standard radiology renal-risk criteria)
* Pregnancy
Biomarkers of Meats and Potatoes Intake

This cross-over meal study is a four-way intervention with 12 volunteers randomized at the same time to four meals with fried meats (beef, pork, chicken and amino-acid matched non-meat control) and to four meals with potato products (boiled, chips, fries, and a control with boiled white rice) to search for biomarkers of intake.

In a two-dimensional, cross-over meal study, 12 healthy volunteers consumed in a randomized sequence four test meals: chicken, pork, beef, and a control made of egg white and pea. At the same time they were independently randomized to four starchy foods to be consumed together with the meats: boiled potatoes, fried potatoes, potato crisps or boiled white rice. Fasting and postprandial urine samples were collected to cover 48 h after each meal and samples were profiled by untargeted LC-ESI-qTOF-MS metabolomics. The profiles following the meal challenges were explored by univariate and multivariate analyses and single and combined markers of intake identified chemically by MS/MS fragmentation experiments and statistically by ROC curves and error rates as well as FDR statistics.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills
The Effect of Body Mass Index on Taste Perception,Salivary Hormones and Oral Health Status

the goal of the study is to test the effect of body mass index on adolesent Iraqi student girls by measuring salivary hormones (ghrelin,leptin,resistin)and measuring oral health by plague index score() and taste perception score () 90 female subject will be enrolled in this study between 16-17 years old,30 subjects with normal body weight ,30 subject overweight ,and 30 subject with obeiece group catogerize by body mass index according to age.

the methed of the study is by taking Saliva sample from the subject , taste perception score and oral health measure.


Eligibility Criteria:
Inclusion Criteria:

* female
* 16-17 years old
* subject with no systemic diseas.

Exclusion Criteria:

* medically compressed patient
* patient with systemic disease
Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
* Patients with erosive OLP patients who will agree to take supplied medications.
* Ability to complete this trial.

Exclusion Criteria:

* OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
* Pregnant and breast-feeding females.
* Patients suffering from systemic diseases.
* Patients with lesions showing any dysplastic changes in the biopsy specimen.
* Patients who are smoking and tobacco users in any form, will not be included.
* Patients with both lichenoid contact reaction and lichenoid drug reactions.
* Patients with cutaneous lichen planus lesions
Virtual Reality - A New Vision on Pain

The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.

The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.

VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.


Eligibility Criteria:
Inclusion Criteria:

* pain duration \> 3 moths
* Master Norwegian spoken language

Exclusion Criteria:

* History of malignant disease
* pain duration \< 3 Months
* Does not master Norwegian spoken language
* Epilepsy
Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis

OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal cystine accumulation.

II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00 unit when treated with this regimen.

PROTOCOL OUTLINE: This is a randomized, multicenter study Patients are randomized to receive the current formulation of cysteamine hydrochloride as drops in one eye and the new formulation of cysteamine hydrochloride as drops in the other eye.

Patients receive the two formulations of cysteamine hydrochloride in their assigned eyes every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy study).

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of cystinosis with more than 2 nmole half-cystine/mg protein in leukocytes OR presence of corneal crystals consistent with cystinosis and distributed in corneal stroma observed by slit lamp biomicroscopy
* Clinical history consistent with cystinosis
* Safety study: History of adherence with current eye drop and follow-up schedule on protocol #86-El-0062 Any crystal density score, including zero, on photographs, that has been stable or improved over the past year
* Efficacy study: Crystal density score at least 1.00 on photographs Concurrently on cysteamine for at least the past 6 months

--Prior/Concurrent Therapy--

* No prior cysteamine drops (efficacy study)

--Patient Characteristics--

* Age: 1 to 50 (safety study) 2 to 12 (efficacy study)
* Other: Willingness and ability to tolerate corneal photographs
Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.

The main questions it aims to answer are:

* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?

Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.

They will be supervised during their cath lab period as first operators by senior interventional cardiologists.

During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Specializing doctors who are about to start dedicated training in the interventional cardiology room
* Patients who must undergo coronary angiography examination.

Exclusion Criteria:

Specializing doctors:

* No interest in performing interventional cardiology procedures as first supervised operator (classical training)
* Experience as first supervised operator in interventional cardiology procedures
* Absence of informed consent

Patients:

* Acute Coronary Syndrome
* Severe left ventricular dysfunction with ejection fraction less than 30%
* Severe chronic renal failure (with glomerular filtration rate less than 30 ml/min)
* Absence of informed consent
Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.

Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.

Eligibility Criteria:
Inclusion Criteria:

* patients with age-related cataracts

Exclusion Criteria:

* any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.
Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight

Effect of massage on hormone levels in puerperal women

Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.

Eligibility Criteria:
Inclusion Criteria:

* puerperal women within 4 hours of normal delivery and they are primiparous

Exclusion Criteria:

* nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery
The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer

The purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (NOSES) and totally laparoscopic right hemicolectomy (TLRH). The hypothesis is that NOSES could achieve good short-term and oncological outcomes for right colon cancer patients.

This study is a retrospective clinical study. We reviewed collected data from all patients who underwent laparoscopic curative resection for stage I-III right-sided colon cancer between January 2018 and January 2023. A total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the NOSES group. To establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (TLRH) during the same period were selected. The purpose of this study is to investigate the short-term and long-term outcomes between NOSES and TLRH. The hypothesis is that NOSES could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with TLRH.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven colon carcinoma;
2. Imaging diagnosis of T1-3 colon cancer;
3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
4. Written informed consent;

Exclusion Criteria:

1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;
Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure

Evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Adults with hypertension (treated or not), without known cardiovascular or renal disease.
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism

The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of congenital hyperinsulinism
* Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
* Can safely washout of background medications used to treat hyperinsulinism.

Exclusion Criteria:

* Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
* Body Mass Index ≥ 35 kg/m2
* Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
* Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.
Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
2. Ability to understand and provide written authorization for use and disclosure of personal health information.
3. Subject who are able and willing to comply with the study protocol and follow-up visit.
4. Must be 18 years or older to participate.
5. Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments,
6. Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll.
7. Must be a minimum 2 year (24 months) post-surgery on the knee.
8. The UKA operation must have been performed by the Investigator.
9. Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and imaging studies.

Exclusion Criteria:

1. Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
2. Women who are pregnant.
Influence of Intracranial Lesions on Bispectral Index

The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
* Control group: Neurosurgical patients without intracranial pathology.

Exclusion Criteria:

* Patient refusal
* Significantly increased intracranial pressure
* Uncontrolled arterial hypertension
* Significant coronary artery disease
* Anticipated difficult airway
* Decreased level of consciousness
* Existing motor weakness dominant arm/hand
* Impaired hearing
* Nausea, vomiting
Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* Patients: stable coronary artery disease with accordingly endothelial dysfunction

Exclusion Criteria:

* acute inflammation (CRP\>0,5 mg/dl, leucocyte \>11000/dl)
* malignant diseases
* acute or terminated kidney disease
* relevant heart failure (NYHA III-IV)