cyrilzakka/clinical-trials huggingface dataset:
Non-surgical Alternatives to Treatment of Failed Medical Abortion

The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.

This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies \<= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours.

The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.

Eligibility Criteria:
Inclusion Criteria:

* Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) \<= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy
* Agree to comply with study procedures
* Able to consent to study participation

Exclusion Criteria:

* Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site
* Are \< 18 years old in US and Canadian sites
* Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac
* Are unable to provide contact information for follow-up purposes
The Use of Metaverse in Nursing Education

This study will be conducted as a randomized controlled experimental study in order to determine the effect of nursing process teaching in the metaverse environment on the instructional materials motivation and academic achievement of nursing students. this study will be conducted from March 2023 to April 2023 in the nursing department of a university. The sample consisted of 42 students who volunteered to participate in the research and met the inclusion criteria.

This study will be conducted as a randomized controlled experimental study to determine the effect of nursing process teaching in the metaverse environment on the instructional materials motivation and academic achievement of nursing students. The nursing process course will be conducted in a metaverse environment. A virtual classroom is designed in the metaverse space for the execution of this course. This study will be conducted from March 2023 to April 2023 in the nursing department of a university. The sample consisted of 42 students who volunteered to participate in the research and met the inclusion criteria. Scales and Forms to be used in the Study; Personal Information Form, The Instructional Materials Motivation Scale, and Academic Success Assessment (Quiz). With the simple randomization method, students will be assigned to the experimental and control groups. But students will not know which group is the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Having volunteered to participate in the study
* Being a first-year nursing student
* Taking the course nursing process
* Students with unlimited access to the internet and computer

Exclusion Criteria:

* Not having volunteered to participate in the study
* Students who do not taking and continuing in the nursing process course
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically confirmed Stage III B/IV NSCLC
* Adequate hematological, hepatic, and renal function
* Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days

Exclusion Criteria:

* Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
* Congestive heart failure
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Previous exposure to Pralatrexate
* Pregnant or breast-feeding women
* Major surgery within 14 days of enrollment
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
Vitamine d Dosage and Constipation

Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function.

It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.

Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.

Eligibility Criteria:
Inclusion Criteria:

* slow transit time constipation

Exclusion Criteria:

* drugs assumption comorbidity
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serum antibody to HIV with or without evidence of HIV.
* Antigenemia.
* Anticipated survival of at least 6 months.
* Allowed:
* Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malignancy other than Kaposi's sarcoma.
* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
* Primary hematologic or infectious disorders unrelated to AIDS virus infection.
* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Patients with the following are excluded:

* History of malignancy other than Kaposi's sarcoma.
* Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.

Prior Medication:

Excluded within 3 weeks of study entry:

* Marrow suppressive medication.
* Excluded within 4 weeks of study entry:
* Any investigational drug.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Systemic cytotoxic chemotherapy.
* Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

* Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.
Family Foundations Coparenting Pilot Trial

This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?


Eligibility Criteria:
Inclusion Criteria:

* Expecting first child
* Couple living together and planning to raise child together
* 18 years or older

Exclusion Criteria:

* Not first child
Study Of Oral Elagolix Tablets To Assess the Tolerability and Change in Disease Symptoms in Adult Female Participants With Moderate to Severe Endometriosis-associated Pain

Endometriosis is an abnormal, estrogen-dependent growth of endometrial tissue outside the uterus that frequently results in dysmenorrhea and pelvic pain and often causes infertility. Endometriosis is a significant burden on the quality of life of women. This study will assess the tolerability and how effective elagolix is in changing the disease symptoms in adult female participants with endometriosis.

Elagolix is an approved drug for treatment of endometriosis. Adult female participants with a diagnosis of endometriosis, who are prescribed elagolix by their physicians, in accordance with local clinical practice and label will be observed for up to 24 months. Around 80 female participants will be enrolled in the study in Israel.

Participants will receive Elagolix as prescribed by their physicians.

There may be a higher burden for participants in this study compared to standard of care. Patients report outcomes, in the form of questionnaires will be collected up to 24 months prospectively to assess the impact of elagolix on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
* Naïve to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to study enrollment.
* Prescribed elagolix as part of standard treatment for endometriosis, according to the local label.

Exclusion Criteria:

* Contraindication to the use of elagolix.
* Post-menopausal (naturally or surgically).
* Participation in a concurrent interventional clinical trial.
Phonak Behind-The-Ear Quality Evaluation

Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
* 18+ years old
* Good written and spoken English language skills
* Able to fill in a questionnaire conscientiously
* Experienced hearing aid user
* Able to produce a reliable hearing test result
* Able to describe listening impressions/experiences and the use of the hearing aids

Exclusion Criteria:

* Not willing to test the hearing aids
* Has auricle deformities that prevents secure placement of the hearing aids
* Has limited mobility and is not able to attend the appointments
* Not willing to wear the hearing aids for at least 8 hours per day
* Known hypersensitivity or allergy with synthetic materials
* Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
* Hints of psychological problems
* Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)
Metabolic Tracking and Weight Gain During Pregnancy

In this study, the investigators aimed to have pregnant women use a hand-held device to track increases in daily caloric needs during pregnancy. Weight gain was assessed over time with the goal of reducing excessive gestational weight gain relative to a group of pregnant women who received standard prenatal care.

Specific Aims

The investigators pursued the following specific aims:

1. Evaluate the impact of a mobile, real-time metabolism tracking device on gestational weight gain (GWG) (i.e. total weight gain and rate of weight gain) in pregnant women. The investigators postulated that the metabolism tracking (Breezing) group would have a higher proportion of women who gain the appropriate amount of weight per IOM recommendations. Further, the investigators expected the women in the Breezing group to gain a mean weight within +/- 3 lbs of their recommended GWG range per IOM guidelines, compared to standard care-receiving controls.
2. Assess changes in resting energy expenditure during pregnancy in relation to self-reported dietary intake (at baseline, 4 weeks, 8 weeks, and 12 weeks). The investigators hypothesized that energy requirements would change across the second trimester and that self-reported caloric intakes would correlate with resting energy expenditure (REE)-corrected values (from Breezing) for women in the Breezing group.

Exploratory Aims

1. Evaluate the associations among objective and self-reported sleep parameters (actigraphic total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; sleep diary total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; insomnia symptoms; and sleep disordered breathing risk) and GWG within the Breezing and control groups.

Eligibility Criteria:
Inclusion Criteria:

* All English and Spanish-speaking, pregnant women
* Gestational age \< 17 weeks at time of recruitment
* Aged 18 years or older

Exclusion Criteria:

* High-risk pregnancies that include the following diseases or conditions: fetal growth problems, medical history of hypertension, gastrointestinal disorders, malabsorptive diseases, hyper or hypo-parathyroid conditions, HIV, diabetes (Types 1 and 2 or gestational diabetes), asthma/lung disease, cardiac disease or conditions, current smoker (i.e. women who have smoked 100 cigarettes in their lifetime and now smoke every day or some days) history of eating disorder, or other metabolic conditions known to affect maternal health and fetal development
* Women pregnant with multiple gestations
Hypertonic Saline Dextran in Pediatric Cardiac Surgery

The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.

After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.

Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
* Age below 17 weeks

Exclusion Criteria:

* Preoperative: organ failure (other than heart), serum sodium \> 155 mmol/l, central venous pressure \> 12 mmHg
* Perioperative: core temperature \< 25 ºC on CPB, re-heparinization, re-operation
Comparative Study Between Three Different Methods for Stuttering Therapy in Children

The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment


Eligibility Criteria:
Inclusion Criteria:

* Children from 5 to 15 years old with IQ above 80

Exclusion Criteria:

* 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.
Addiction Among Mental Health Professionals

Our goal is to determine the representations of addiction among caregivers working in the field of mental health. We hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Health professional with more than 5 years of professional experience in the field of management of mental illnesses
* Health professional having accepted to participate in the study

Exclusion Criteria:

- Refusal to participate in the stud
The Effect of Motivational Interviewing on Nursing Students

Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety.

Nursing as a social profession needs more social interaction. Nurses should be able to develop therapeutic interaction with patients. This can only be possible when they are confident in themselves and worry about others and get rid of anxiety disorders. Social anxiety symptoms have been associated with increased risk of depression, other anxiety disorders and substance misuse, as well as difficulties in making healthy social connections and adjusting to the academic environment. Motivational interviewing (MI) has been found to provide symptom reduction in individuals with generalized anxiety disorder and to improve treatment outcome in individuals with SAD. A meta-analysis by Kirby et al. (2017) concluded that existing self-compassion-based interventions are moderately successful in enhancing compassion and reducing suffering (e.g. depression, anxiety, distress). While moderate effects are very important and encouraging, they indicate that interventions can be improved. It is suggested that including PD as a prelude to compassion-based interventions may provide similar benefits for program participation, initiation, adherence, and behavior change.It has also been shown that PD may increase sensitivity to dating violence interventions. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Have moderate and severe social anxiety (55 and above LSCQ)
* Volunteering to participate in the research
* Being in the pre-intention and intention stage according to the stage of change assessment form

Exclusion Criteria:

* Have to no or low level of social anxiety (below of 55 on the LSCQ)
* Have to any psychiatric diagnosis
* Have received psychotherapy for social anxiety before
* Attend to a psychotherapy or counseling program
Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain

As many as 75% of people with diabetes report chronic pain. While cognitive behavioral therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. The investigators tested the hypothesis that a CBT-based program delivered by community health workers (CHW) can improve quality of life in individuals with diabetes and chronic pain.

Diabetes mellitus (DM) is a growing chronic disease, affecting 20% of the population of Alabama. However, type 2 DM (90-95% of all DM) rarely occurs in isolation; 25% of all Americans report chronic pain, rising to 58-70% of community-dwellers over age 65. The National Center for Health Statistics reported in 2006 that chronic pain affected 76.2 million Americans, more than cancer, heart disease, stroke and DM combined. Despite the high prevalence of chronic pain, evidence suggests that under treatment is common. In one study, 68% of primary care physicians estimated that chronic pain was inadequately managed in their patients, and 60% thought improving physician education could help. Indeed, 40% of people with moderate to severe pain report not getting adequate relief.

Chronic pain is a significant barrier to successful DM self-care; patients with chronic pain have lower medication adherence and are less likely to exercise. Fully 60-80% of DM patients report chronic pain, and in our ENCOURAGE pilot study (Safford, PI), all but one participant did so. About 20-25% of pain may stem from neuropathy, but at least 1/3 stems from OA (osteoarthritis), and coexistence of multiple causes is common. Over half of patients \>65 and 60% of women of any age report OA, demonstrating the very high prevalence of OA in this demographic group. Pain management dominated 20% of primary care visits for diabetic patients in one study, and decreased the likelihood of DM risk factor management. Not surprisingly, depressive symptoms are common in individuals with OA and chronic pain, and are also associated with non adherence to DM self-care behavior. Pain is therefore a barrier to not only quality of life, but to successful DM self-care.

While cognitive behavioral therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. The investigators tested the hypothesis that a CBT-based program delivered by community health workers (CHW) can improve quality of life in individuals with diabetes and chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* 19 or older in age
* diagnosed with diabetes
* under the care of a doctor
* experienced chronic pain in the past month

Exclusion Criteria:

* not community dwelling
* less than 19 years old
* pregnant
* end-stage medical conditions with limited life expectancy
* no access to telephone
* does not speak english,