cyrilzakka/clinical-trials huggingface dataset:
Disclosure Intervention for People in Recovery From Opioid Use Disorder

Many people with substance use disorders struggle with decisions regarding whether to disclose to others that they have a history of substance use and/or are in recovery. Yet, these decisions are important because disclosures can lead to reactions from others that harm or help recovery. For example, stigmatizing responses can harm the mental health of people in recovery whereas supportive responses can strengthen people's commitment to their sobriety. We have developed a brief intervention to help people decide whether and how to tell others about their recovery as well as build skills for disclosure. The purpose of this study is to pilot test this intervention and test its acceptability and feasibility as well as determine if it shows preliminary signs of efficacy in comparison to a control condition. We hypothesize that: (1) participants exposed to the intervention condition will agree that the intervention is acceptable and feasible, and (2) participants in the intervention condition will report higher quality decision making in comparison to participants in the control condition.

Data will be collected from participants at two time points, spaced one month apart. All participants will be recruited from the waiting room at a local treatment center. The research assistant will screen interested individuals for eligibility in person and schedule study appointments, which may be coordinated with treatment appointments. All study screening and appointments will be conducted in private spaces at the treatment center. At the first study appointment, the research assistant will introduce the study, check for questions, and obtain consent for the study procedures, medical record review, and follow up procedures. Participants will be randomly assigned to receive either the disclosure intervention or a control intervention (i.e., an evidence-based mindfulness intervention). Following the intervention, participants will complete measures of acceptability, feasibility, and decision quality. At the second study appointment, participants will again be asked to respond to survey and interview questions designed to further evaluate the preliminary efficacy of the intervention. In particular, we will investigate whether participants who completed our disclosure intervention report better relationship outcomes than participants who completed the control condition.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* currently receiving outpatient treatment at the recruitment site
* are considering disclosing their recovery status to at least one person in the next month
* have access to a phone that can receive text messages and phone calls

Exclusion Criteria:

* current diagnosis of severe mental illness
Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)

The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied.

Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.

Study Drug Administration:

If you are found to be eligible to take part in this study, on Days 1-4 of every cycle, you will receive azacitidine by vein over 15-30 minutes.

You may receive drugs to help prevent nausea and vomiting before you receive your dose of azacitidine.

On Days 5-7 of every cycle, you will receive GM-CSF by vein over about 15 minutes or by injection.

Each study cycle will be about 4-6 weeks, depending on the study doctor's decision.

Study Visits:

One (1) time each week during every cycle, blood (about 2-3 teaspoons) will be drawn for routine tests.

At any time, if your doctor thinks it is needed, you will have a bone marrow aspirate to check the status of the disease.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your follow-up visits will be per standard of care for the disease.

This is an investigational study. Both azacitidine and GM-CSF are FDA approved and commercially available for the treatment of MDS. The study drug combination to treat MDS is considered investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with low- or intermediate-1-risk MDS according to the International Prognostic Scoring System (IPSS) classification
2. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UT MD Anderson Cancer Center.
3. Age \>/= 18 years old.
4. Prior therapy with growth factor support, lenalidomide, or other investigational agents is allowed.
5. Previously untreated patients are eligible for this study.

Exclusion Criteria:

1. Any previous adverse reaction (\>/= Common Terminology Criteria for Adverse Events (CTCAE) grade 2) to GM-CSF.
2. Prior treatment with azacytidine or decitabine.
3. Unresolved diarrhea \>/= CTCAE grade 2.
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy partial seizure subjects.
* Currently taking 1 to 3 antiepileptic drugs.

Exclusion Criteria:

* Pre-existing eye diseases (glaucoma).
* Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.
Supportive Care During Childbirth and Well-being

The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at birth on some parameters of maternal psychological well-being.

This is a single-blind randomized controlled trial. Data were collected from 80 women who gave birth in the obstetrics clinic of a state hospital in the south of Turkey between December 2020 and June 2021. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

Eligibility Criteria:
Inclusion Criteria:

* The ages of 18-40 women,
* At least primary school graduate,
* Mother tongue Turkish,
* Single fetus,
* Term,
* Spontaneous birth,
* Cervical dilatation between 0-6 cm (latent phase) and without a condition that could prevent vaginal delivery.
* Primiparous and multiparous women
* Not have any disease or complication and agreed to participate in the study were included.

Exclusion Criteria:

* Women who developed a complication with the fetus or themselves during delivery,
* Underwent emergency cesarean section,
* Not be reached during follow-ups by telephone,
* Wanted to withdraw from the study
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an infection consistent with complicated skin and skin structure infections.

Exclusion Criteria:

* Known or suspected hypersensitivity to any study medication
* Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
* Previous enrollment in this study
* Treatment with any investigational drug within 30 days before enrollment.
Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm

Healthy subjects will be invited to fill out a questionnaire regarding falls and balance skills followed by normal walking trials on a treadmill at 9 different speeds (0.28-1.4 m/s). Key gait parameters for the normative database will be collected. During the perturbation trials, the subjects will walk at a constant speed (1.2 m/s). The treadmill belts are ac, - or decelerated during the perturbations according to three different perturbation algorithms with varying perturbation onset. Movements will be analyzed by 3D motion capture, force plates, surface electromyography and IMU sensors. All methods are non-invasive and commonly used in the field of biomechanics.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18-40 years and 60-80 years
* Ability to walk at minimum 30 minutes at a regular pace without assistance or breaks
* Written informed consent as documented by signature (see informed consent form)

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Current neurological problems affecting walking function and balance
* Current orthopedic problems affecting upper and lower extremity movements
* History of alcohol abuse or the intake of psychotropic drugs
* History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
* History of major pulmonary condition (e.g., chronic obstructive pulmonary disease (GOLD II-IV))
* Current major depression or psychosis
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
* Fever of unknown origin
Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia

Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide


Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression

Exclusion Criteria:

* Relapsed or refractory APL
Emotional Support and Stress Management in Patients Diagnosed With COVID-19

The aim of the study is to identify the knowledge that CCSPT nurses have in relation to care aimed at addressing anxiety, fear or loneliness and the use they have made of it in the recent crisis. The design of the research/action will also enable the training of the participating professionals to improve nursing care in these areas in the future

This is a cross-sectional descriptive study with a research/action design to be carried out at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The aim of this study is to identify the knowledge that CCSPT nurses have in relation to care aimed at coping with anxiety, fear or loneliness and the use that they have made of it in the recent crisis. By its design, the research/action will allow the training of these nurses to improve nursing care of these aspects in the future. This is a population-based study, in which all CCSPT nurses who have carried out care work during the COVID-19 crisis period will be invited to participate. The variables collected will be age, sex, academic level, usual work shift, care given to reduce anxiety, fear, loneliness, coping style and self-pity. Quantitative variables will be described by their mean and standard deviation, while qualitative variables will be described in absolute and relative frequencies. A linear or non-parametric correlation will be made between the score on the self-pity and coping scales and the number of actions identified and/or performed referred to by the nurses and the calculation of the Pearson or Spearman correlation coefficient, as appropriate. Comparison of the number of actions between high activity and low activity (70% cut) coping nurses using the Mann-Whitney U test

Eligibility Criteria:
Inclusion Criteria:

* Nurses from any unit of the Consortium Parc Taulí Corporation who have been in direct care of patients diagnosed with COVID 19 between March 9, 2020 and May 15, 2020

Exclusion Criteria:

-
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥19 to 80 years
* ECOG performance status 0-3
* Life expectancy \>3 months
* Patients with malignant gastric outlet obstruction (distal part of stomach, pyloric ring or duodenal bulb obstruction) caused by gastric cancer
* Patients who are not eligible for radical operation due to local progression of gastric cancer, distant metastasis or his/her general condition.
* Patients with GOOSS score 0-2
* Patients with symptoms consistent with gastric outlet obstruction including persistent nausea and vomiting
* Patients with findings consistent with malignant gastric outlet obstruction on imaging studies including upper GI endoscopy, upper GIseries or abdominal computed tomography (CT)
* Patients who are eligible to undergo both gastroduodenal stent placement and gastrojejunostomy (eligibility will be determined by agreement by at least one gastroenterological surgeon and at least one radiologist)
* Patients who have been provided with an explanation of the procedures of the clinical trial, voluntarily decided participation and signed the informed consent form

Exclusion Criteria:

* Pregnant or lactating women
* Women of childbearing potential with positive pregnancy test at baseline. Post-menopausal women should have at least 12 months of amenorrhea to be considered not of childbearing potential.
* Patients who have previously undergone balloon dilatation or stent placement for malignant gastric outlet obstruction
* Patients with past history of palliative bypass surgery or gastrectomy
* Patients with peritoneal metastasis or multiple intestinal obstruction caused by other cause on imaging scan including abdominal CT or small bowel series
* Patients who have been treated for intestinal adhesion caused by previous abdominal surgery
* Patients who are not eligible for general anesthesia due to poor general condition
* Patients with clinical evidence of intestinal perforation or peritonitis
* Patients who are determined to be not eligible for stent placement or gastrojejunostomy due to other cause
Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.


Eligibility Criteria:
Inclusion Criteria:

* Both sex
* ASA physical activity I, II
* Age 4-12 years
* Admitted for elective hip surgery.

Exclusion Criteria:

* Parents refusal
* Children with severe systemic disease
* ASA III or IV
* Children with previous neurological or spinal anomaly, coagulation disorders
* History of premature birth
* Infection at the block injection site
* History of allergy to local anesthetics
* Bilateral hip surgery.
Development of a Comprehensive ADL Scale for Stroke Patients

our research team will develop a new CADL scale for stroke patients over the next three years.

In the first year, we had established a CADL item bank of 50 items. The investigators will administer the 50 items on 300 patients with stroke living in the community. Then we will select 10 to 15 items from the item bank for the CADL scale based on the International Classification of Functioning, Disability and Health (ICF), the opinions of an expert panel, and Rasch analysis. It is anticipated that the CADL scale will have unidimensionality, an interval level of measurement, soundly psychometric characteristics, a reduced number of items, and ease of administration.

In the second and third years, we will compare the psychometric properties of the CADL scale and the combined BI and FAI scale. The psychometric properties investigated will include reliability (e.g. inter-rater reliability, intra-rater reliability, and internal consistency), validity (e.g. concurrent validity, convergent validity, predictive validity and discriminant validity), and responsiveness. A total of 150 patients will be recruited. Both the CADL scale and the combined BI and FAI scale will be used on patients from the initial stage (within one month) to six months after hospital discharge. The results will be useful for researchers and clinicians to determine whether the CADL scale is better than the combined BI and FAI scale in stroke patients.

our research team will develop a new CADL scale for stroke patients over the next three years.

In the first year (an ongoing project: NSC 93-2314-B-002-284), we had established a CADL item bank of 50 items. The investigators will administer the 50 items on 300 patients with stroke living in the community. Then we will select 10 to 15 items from the item bank for the CADL scale based on the International Classification of Functioning, Disability and Health (ICF), the opinions of an expert panel, and Rasch analysis. It is anticipated that the CADL scale will have unidimensionality, an interval level of measurement, soundly psychometric characteristics, a reduced number of items, and ease of administration.

In the second and third years, we will compare the psychometric properties of the CADL scale and the combined BI and FAI scale. The psychometric properties investigated will include reliability (e.g. inter-rater reliability, intra-rater reliability, and internal consistency), validity (e.g. concurrent validity, convergent validity, predictive validity and discriminant validity), and responsiveness. A total of 150 patients will be recruited. Both the CADL scale and the combined BI and FAI scale will be used on patients from the initial stage (within one month) to six months after hospital discharge. The results will be useful for researchers and clinicians to determine whether the CADL scale is better than the combined BI and FAI scale in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of stroke

Exclusion Criteria:

with other major diseases (e.g., cancer)
Use of Inertial Sensors to Characterize the Fatigability of Post-stroke Hemiplegic Patients

This is an experimental, observational, prospective study designed to develop medical knowledge.

The main objective of the study was to identify clinically significant, easily interpretable, quantitative indices of fatigue-related gait pattern changes in post-stroke hemiplegic patients.

This study is part of a usual framework of management of post-stroke hemiplegic patients with additional data collection, via the use of inertial measurement units, considered here as non-interventional.

To achieve this identification, 2 6-minute walk tests will be performed for each patient at the beginning and end of the same day. Patient-perceived fatigue will be recorded by the Borg scale every minute during the 6-minute test. The level of activity during the rehabilitation day is also part of the data collected (number of hours of physical and non-physical activity). At the end of the second 6-minute test, the patient's participation in the study ends.

In addition to the inertial measurement, two scores will be collected to assess the correlation between fatigability and the level of anxiety/depression and stroke severity :

* National Institutes of Health Stroke Scale (NIHSS)
* Hospital Anxiety and Depression Scale (HAD)


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security plan
* Patient who has received informed information about the study and who has given his/her consent
* Post-stroke patients (subacute or chronic)
* 1 single unilateral ischemic or hemorrhagic stroke (supratentorial or subtentorial) confirmed by CT or IRM with consecutive hemiparesis
* No lower extremity surgery
* Ability to walk for 6 minutes without human assistance
* Ability to understand instructions in French

Non inclusion Criteria:

* Patients with cognitive problems that prevent them from understanding instructions
* Patent under guardianship or curatorship
* Post-stroke hemiplegic patient (acute = \< 6 months)
* Cardiorespiratory pathology incompatible with CT6
* Chronic decompensated pathology
* Neurological pathology
* Orthopedic pathology of the lower limbs or rheumatic conditions that may affect the ability to walk
Abo Follow-up Study

The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls.

The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls. Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices? Additionally, the research would attempt to answer the question, is there any way to predict problems or complications? This study will help to determine if excessive resources and time are being expended on follow-up phone method to detect complications.

This study will consist of a retrospective chart review identifying the outcome of follow-up phone calls after an induced abortion.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive-aged women
* women who have had an induced abortion, and are contacted by a clinical nurse for a follow-up phone call.

Exclusion Criteria:

-