cyrilzakka/clinical-trials huggingface dataset:
The Effect of Motivational Interviewing on the Level of Self-Efficacy and Addiction in Smoking Cessation

This study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students.

This study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students. The study was planned as a single-blind randomized controlled experimental study. The population of the research will be composed of students studying in the 1st, 2nd and 3rd years of Ordu University and Giresun University Faculty of Health Sciences Nursing Department and who meet the research criteria, and the sample will be 90 students determined by power analysis. In the study, 30 students from Ordu University Faculty of Health Sciences Nursing Department will be in the experimental group and 30 students in the I. control group. 30 students from Giresun University Faculty of Health Sciences Nursing Department will be in the second control group. Students in the experimental group will be given a motivational interview on quitting smoking for 40-50 minutes on average once a month for 6 months. No intervention will be applied to the students in the control groups during the research process, but a motivational interview will be applied once at the end of the research in terms of ethics. The data of the research will be collected with Personal Information Form, Fagerström Nicotine Addiction Test, Self-Efficacy Scale and Stage of Change Evaluation Form. In the study, repeated measurements will be made in the 1st month, 3rd month and 6th month. Necessary institutional permission and ethics committee approval will be obtained for the research. The analysis of the data will be done by an expert statistician in a computer environment.

Eligibility Criteria:
Inclusion Criteria:

* Being a 1st, 2nd, and 3rd year student of the Nursing Department,
* Continuing active education and training,
* Smoker at least one cigarette a day,
* Open to communication and cooperation, and
* Students who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Fourth grade,
* Having a serious psychiatric diagnosis (schizophrenia, bipolar disorder, psychotic disorder, etc.),
* Receiving professional support for smoking cessation,
* Changing schools during the research process and
* Students who do not want to continue the research will be excluded from the research.
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.

OBJECTIVES:

* Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed acute lymphoblastic or acute myeloid leukemia

  * M3 bone marrow relapse required
* Refractory to conventional chemotherapy
* No extramedullary disease at relapse

PATIENT CHARACTERISTICS:

Age:

* 21 and under at time of initial diagnosis

Performance status:

* ECOG 0-2

Life expectancy:

* At least 2 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 1.5 times normal
* Alkaline phosphatase no greater than 2.5 times normal

Renal:

* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 7 days since prior biologic therapy and recovered
* At least 6 months since prior allogeneic stem cell transplantation
* No concurrent immunomodulating agents during first 2 courses of therapy
* No concurrent routine filgrastim (G-CSF)

Chemotherapy:

* See Disease Characteristics
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* No prior paclitaxel or docetaxel
* No other concurrent chemotherapy during first 2 courses of therapy

Endocrine therapy:

* No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to treat allergic reactions, or treatment for adrenal crisis

Radiotherapy:

* Recovered from prior radiotherapy
* At least 2 weeks since prior palliative local radiotherapy
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of the pelvis
* At least 6 weeks since prior substantial bone marrow radiotherapy
* No concurrent radiotherapy

Surgery:

* Not specified
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Cirrhotic patients complaining of frequent muscle cramps (\>3 per week) for at least a month

Exclusion Criteria:

1. Patients with allergy to study drugs
2. Renal impairment
3. Peripheral vascular disease
4. Peripheral neuropathy
5. Glaucoma
6. Prostatic enlargement
7. Pregnancy and lactation
8. Patients taking calcium channel blockers, and conjugated estrogens
9. Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
10. Patients with alcoholic cirrhosis
Plasma Hydrogen Sulfide as a Biomarker for Alzheimer's Disease and Related Dementias

Hydrogen sulfide is a signaling molecule that is important for vascular health. Because vascular factors such as hypertension and high cholesterol are risk factors for Alzheimer's disease and related dementias, we hypothesize that hydrogen sulfide plays an important role in brain health as well. We will compare blood levels of hydrogen sulfide across groups of people with and without dementia. We will also look at the relationship between hydrogen sulfide, cognitive dysfunction and measures of brain microvascular disease examine the contribution of hydrogen sulfide to cognitive decline. Our goal is to identify a biomarker of vascular dysfunction in dementia.

We have described hydrogen sulfide (H2S), a signaling molecule important in vascular homeostasis, as a biomarker of cardiovascular disease. There is accumulating evidence that vascular factors such as hypertension, hypercholesterolemia, and type 2 diabetes are associated with increased risk of Alzheimer's disease and related dementias (ADRD). Furthermore, in the brain, H2S acts as a neurotransmitter/second messenger produced following nerve excitation. It also modulates N-methyl-D-aspartate (NMDA) receptors during long term potentiation for memory consolidation. Three biochemical forms of reactive sulfur pools exist: free H2S, acid-labile (e.g. iron-sulfur clusters) and bound sulfide (e.g. persulfides, polysulfides). We hypothesize that H2S becomes dysregulated in ADRD, where vascular and cognitive functions are linked. We will use analytical biochemical methods to measure plasma H2S and its metabolites, and 3T MRI to evaluate indicators of microvascular disease in ADRD. We will compare H2S levels in people with and without cognitive dysfunction consistent with ADRD, and determine the specificity and sensitivity of H2S indistinguishing people with and without cognitive dysfunction. In addition, because previous studies report differences in the incidence and prevalence of ADRD by race and sex, we will compare outcomes across these groups as well. Finally, we will examine the potentially mediating role of H2S in the relationship between cognitive function and microvascular disease.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be aged \>55 years with English as the 1⁰ language, with stable permitted medications for \<4 weeks, geriatric depression scale score \<6, visual and auditory acuity adequate to perform tests, and history of education excluding developmental cognitive abnormalities.

Exclusion Criteria:

* Exclusion criteria are history of significant neurologic disease or mental illness, unstable medical conditions that could interfere with completion of study, substance abuse within 2 years, contraindications to MRI, abnormal findings on MRI, history of chronic kidney disease, and investigational agents within 1 month of participation.
Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer

RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

OBJECTIVES:

Primary

* Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.

Secondary

* Assess changes in HER1 and HER2 expression during treatment.

OUTLINE: This is a multicenter study.

Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.

Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.

After completion of study treatment, patients are followed every 6 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast

  * Metastatic disease
* No inflammatory breast cancer
* Measurable disease according to RECIST criteria
* Hormone receptor status:

  * Estrogen receptor- and/or progesterone receptor-negative by IHC

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Liver transaminases ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy to xylocaine
* No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency

PRIOR CONCURRENT THERAPY:

* No prior first-line treatment for metastatic disease
Feasibility of the Blended Care Pirate Group

Rationale: In 2010 Aarts developed the pirate group in which children received constrained induced movement therapy (constrained with a sling) followed by bilateral therapy. During this pirate group children were dressed as a pirate to increase motivation and to make the sling more meaningful. This pirate group had a duration of eight weeks with three times three hour training sessions each week. However, due to COVID-19 therapists were introduced to home-based rehabilitation. Therefore they developed the blended care pirate group, which is in principle the same as the pirate group of Aarts, however one training session each week is replaced by a home-based training session. It is however not yet clear how this blended care pirate group is perceived by parents and therapists.

Objective: The aim of the current study is to investigate the feasibility and effectiveness of the blended care pirate group.

Study population: Children with unilateral cerebral palsy between 2.5 and 8 years old will participate. These children will participate in the blended care pirate group and are asked to participate in the study as well.

Intervention: The total duration of one blended care pirate group is eight weeks with two times three hour training sessions at the rehabilitation centre and additional training sessions at home. The training sessions on-site will be the same as the conventional pirate group. For the training sessions at home parents will receive instructions and material from the therapists. This intervention is developed and already planned by therapists without direct influence of the research department and can therefore be considered as standard treatment.

Main study parameters/endpoints: The primary outcome are the total training hours performed by parents at home. Additionally after the blended care pirate group parents and therapists will participate in an interview about how they perceived the blended care pirate group. Secondary outcomes are improvements in arm function during the blended care pirate group.


Eligibility Criteria:
Inclusion Criteria:

* Receiving treatment at the Sint Maartenskliniek. Care demand of parents that requires a more and better use of the affected arm and hand.
* Children with unilateral cerebral palsy
* A Manual Ability Classification System (MACS) score of I, II or III

Exclusion Criteria:

* Cognitive developmental age below 2
* Child is not able to walk independently without a walking tool
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate to severe chronic posterior blepharitis
* if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* had ocular surface surgery (LASIK, refractive, etc.) within the past year
* unwilling to discontinue use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of lid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-term study for the indication of MDD, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.
* Sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug.

Exclusion Criteria:

* Clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. Any exception must be discussed with and granted by the sponsor.
* Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
* Presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurologic disorder, acute illness, neoplastic disorder).
The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

Eligibility Criteria:
Inclusion Criteria:

* making a request for the phlebotomy
* being in the 7-12 age group
* having the consent of the parent
* willing to participate in the research
* with the history of invasive procedure
* not using any medication with analgesic effect in the last 12 hours
* without any communication barriers of either child or the parent
* with a normal level of consciousness during the process
* without the history of passing out during the phlebotomy

Exclusion Criteria:

* not being in the 7-12 age group
* not having the consent of the parent
* not willing to participate in the research
* without the history of invasive procedure
* had medication with analgesic effect in the last 12 hours
* with communication barriers of either child or the parent
* with an abnormal level of consciousness during the process
* with the history of passing out during the phlebotomy
Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence.

OBJECTIVE: To compare a new ultra-modified internal sphincterotomy technique to the closed lateral sphincterotomy for treating chronic anal fissures, based on internal anal sphincter function and postoperative complications.

DESIGN: Prospective, randomized, controlled trial (block randomization method) SETTING: Pamukkale University hospital in Denizli-Turkey PARTICIPANTS: 200 patients with chronic anal fissures INTERVENTION: Patients were randomly assigned to receive either Sungurtekin technique (n = 100; ultra-modified group), or the closed lateral internal sphincterotomy (n = 100; closed-lateral group). Follow-up was 2 years.

MAIN OUTCOME MEASURES: The primary outcome was chronic anal fissure healing. The secondary outcomes were complications, visual analog scale pain scores, sphincter pressures, and incontinence scores.

Although the lateral internal sphincterotomy is the treatment of choice for CAF, it has several drawbacks. First, the lower portion of the internal sphincter is nested in the lowermost part of the anus. Thus, an incision from the fissure base up to the dentate line removes support to the inner sphincter structure on the incision site. In our opinion; this is the main cause of different levels of incontinence developing in the postoperative period. Second, the internal sphincter muscle is shorter in women than in men. Therefore, women are at higher risk of postoperative anal incontinence than men. Third, because the lateral internal sphincterotomy is not standardized, the length of the internal sphincter incision varies, depending on the surgeon's discretion and competency. Fourth, an incision that is too short increases in the risk of recurrence.

The investigators believe that this observation could be explained by the fact that the length of the incision required for a lateral internal sphincterotomy procedure has not been standardized

Eligibility Criteria:
Inclusion Criteria:

Patients with CAFs that had failed conservative therapy and required surgical treatment

-

Exclusion Criteria:

* Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg)
* Recurrent anal fissure
* Fissure location other than the posterior anal canal
* Fissure due to inflammatory bowel or infectious disease
* Acute anal fissure,
* Fissure due to chronic diarrhea or anal stenosis
* Anorectal malignancy
* Patients undergone pelvic radiotherapy
* Pregnancy
* Patients with history of diabetes, neurological disease and spinal cord lesions
* Previous episiotomy history
* Painless fissures
First-in-Human Study of Orally Administered GS-441524 for COVID-19

This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.

Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Negative pregnancy test at screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

* Use of other investigational drugs within 28 days of dosing
* Positive pregnancy test
* Abuse of alcohol or drugs
* Other clinically significant medical conditions or laboratory abnormalities