cyrilzakka/clinical-trials huggingface dataset:
Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting

Gender diverse (e.g. trans or non-binary) young people are at higher risk of self-harm and may be more likely to access support through gender-diverse-specific 3rd sector charities. Dialectical behavioural therapy (DBT) is a transdiagnostic intervention targeting emotion dysregulation, self-harm and suicidality and is recommended by best-practice clinical guidelines; There is developing evidence that DBT skills training can be offered as an effective stand-alone intervention.The current study, therefore, aims to evaluate the feasibility, acceptability and early indicators of effectiveness of a DBT-informed skills group intervention in a gender diverse charity setting. The intervention will be co-facilitated with a gender-diverse support worker from the charity to develop the therapeutic skills of the charity staff working with the young people, whilst they provide specialist knowledge and valuable lived experience.

Research questions

1. Is the intervention feasible to deliver in a charity setting?
2. Is the intervention acceptable to participants and charity facilitators?

Participants will attend a 16-week group intervention. They will complete questionnaire to assess acceptability at the end of the intervention. Attrition rates, training time, and questionnaires will be used to assess feasibility. Outcome measures will also be completed by the participants every three weeks to indicate possible effectiveness of the intervention. The outcomes will include emotion dysregulation, coping skills, anxiety, depression and suicidal behaviours.


Eligibility Criteria:
Inclusion Criteria:

* Age 16-25 years old
* Identify as gender diverse
* Receiving support from Gendered Intelligence
* Support worker identified and self-report emotion regulation difficulties.

Exclusion Criteria:

* In acute crisis at point of recruitment and start of the intervention such as active suicidal ideation with active plans, or severe self-harm requiring intensive interventions such as inpatient or crisis care.
Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait

This is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.

This is a prospective, exploratory, short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients. All patients who enroll have already agreed to undergo the bariatric procedure with their respective surgeon; the study team will simply follow specific outcome measures in addition to their normal clinical care at two time points after the surgery (week 4 and month 3).

Eligibility Criteria:
Inclusion Criteria:

* no urgent need for bariatric procedure
* 21-65 years of age
* body mass index (BMI) 35 kg/m2 or greater, defined as morbid obesity
* waist circumference of \< 66 inches
* able to walk independently

Exclusion Criteria:

* \< 21 or \> 65 years of age
* pregnancy; psychiatric conditions; binge eating patterns; Prader-Willi syndrome; drug dependency; dementia or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
* uncontrolled diabetes (not using meds)
* waist circumference of \> 66 inches
* orthopedic conditions that prevent ambulation (severe painful osteoarthritis of the hip or knee)
* patient is wheelchair bound
The Effect of Touchpoint Method on Clinical Learning; Experience With Nursing Students

This research aims to evaluate the effect of Touchpoint experience as a clinical learning method on clinical learning. The research is a quasi-experimental research with experimental-control groups. Students will be divided into experimental and control groups with the "simple randomization" method. A pre-test will be taken with data collection tools before the study for both groups. Students in the control group will continue their routine practice experiences. A post-test will be applied with data collection tools at the end of the 8-week internship period. TouchPoint is planned as a 2-session experience over a semester: Session 1 focuses on patient-centered care, Session 2 focuses on teamwork and collaboration. The method of both sessions will be conducted by 2 researchers with a small clinical group of 8 to 10 students. Sessions will last from 1.5 hours to 2 hours depending on the number of students and the degree of discussion. Sessions will be conducted face-to-face in a classroom.

Outcome Measures:

Clinical Learning Climate Scale: This measurement tool used in the study was developed by Demiral Yılmaz (2010). This scale consists of 36 items (Demir Yılmaz, 2010). The scale is scored using a 5-point Likert scale (I completely disagree: 1 - I completely agree: 5). Three dimensions are defined in the factor analysis of the scale. These dimensions are; clinical environment, emotional climate and motivation.

Student Satisfaction Scale-Short Form: SSS-SF is the shortened and revised version of the "Student Satisfaction Scale" developed by Baykal et al. to determine the satisfaction of students studying at nursing schools, by Baykal et al. in 2011. In the evaluation of the 53 items in the scale, a five-point Likert-type measurement is used, including "5-Strongly agree, 4- Agree, 3-Undecided, 2-Disagree, 1-Strongly disagree". As the average score approaches 1 in the scale as a whole and in the sub-dimensions, the student is considered to be dissatisfied, and as the score approaches 5, the student is considered to be satisfied. The scale was found to be highly reliable, with a Cronbach's alpha coefficient of 0.97 in total. The scale has 5 sub-dimensions, namely, faculty members, school administration, participation in decisions, scientific, social and technical opportunities, and quality of education. The highest score that can be obtained from the scale is 265 and the lowest score is 53. As the average score on the scale as a whole and in the sub-dimensions approaches 1, the student is considered to be insatiable, and as the score approaches 5, the student is considered to be satisfied.

Eligibility Criteria: Being a 2nd year student at the Faculty of Nursing, Agreeing to participate in the research

Eligibility Criteria:
Inclusion Criteria:

* Being a 2nd year student at the Faculty of Nursing,
* Agreeing to participate in the research

Exclusion Criteria:

* Not being a 2nd year student at the Faculty of Nursing,
* Not agreeing to participate in the research
Biomechanical Gait Analysis in Patients Post-Stroke

Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.

Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.

The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).

Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.

The procedure for gait analysis is as follows:

1. Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel.
2. The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection.
3. The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.

Eligibility Criteria:
Inclusion Criteria:

* Current in-patient in acute care for Cerebrovascular accident (CVA),
* Unilateral CVA affecting at least the lower limb, and
* Medically stable as determined by the rehabilitation physician.

Exclusion Criteria:

* Previous (more than 1) CVA with residual lower limb deficit, and
* Any lower extremity pathology on the affected side other than the effects of the CVA.
Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.

In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3 months following cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Gender- All
* Race- All
* Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis)
* \>250 microns central foveal thickness
* Able and willing to provide informed consent

Exclusion Criteria:

* Significant renal disease
* A condition that in the opinion of the investigator would preclude participation
* Participation in another investigational trial within 30 days of randomization
* Application of focal macular laser within 120 days of enrollment
* Administration of Iluvien implant within 3 years of enrollment
* Administration of intravitreal triamcinolone within 3 months of enrollment
* Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment
* Known hypersensitivity to any of the investigational products
* Blood pressure \>180/110
* Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization
* Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals
* Individual is planning on moving within 6 months of study enrollment
* Macular edema secondary to cause other than diabetic macular edema
* Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.)
* Evidence of ocular infections
* Evidence of uncontrolled glaucoma
* Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex
Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

Eligibility Criteria:
Inclusion Criteria:

Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;

Exclusion Criteria:

Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.

The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio \< 25%(O/E LHR \< 25%).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women age 18 years and older, who are able to consent
* Singleton pregnancy

Fetal

* Normal Karyotype
* Fetal Diagnosis of Isolated Left CDH with liver up
* Gestation at enrollment prior to 29 wks plus 6 days
* SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%

Exclusion Criteria:

* Pregnant women \<18 years of age.
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* Technical limitations precluding fetoscopic surgery
* Rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Psychosocial ineligibility, precluding consent
* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones. It will be studied in people with high amounts of urine calcium.

The investigators study is designed as a pilot study to study the effect of STS on urine chemistries in stone formers and normal controls. It is expected to continue for a duration of 1 year and will have two groups: 20 normal controls, who are healthy subjects without known kidney disease or nephrolithiasis, and 20 subjects with documented recurrent nephrolithiasis and hypercalciuria. Patients will be recruited from Dr Goldfgarb's stone clinic at VA Hospital and controls would be voluntary participants from NYU School of Medicine. Subjects who are pregnant or nursing, taking alcohol or drugs, have known CKD or are unable to give consent would be excluded from the study. Any diuretics or citrate containing drugs would be held for a period of 2 weeks during the study period to achieve washout of the effects of those drugs on urine chemistries. Oral STS 10mmol (10ml of 25% STS) BID will be administered to both groups for 7 days; four 24 hour urine collections, 2 prior and 2 at the end of the study, would be done with all participants. A diet diary would be maintained by subjects concomitantly during the study periods. The investigators then plan to compare the two groups in terms of urine chemistries to detect any changes in these parameters with thiosulfate administration. Based on prior animal experiments and human studies with STS the investigators anticipate that it would have a favorable effect on the supersaturation of Ca oxalate/phosphate and therefore its long term use would be helpful in preventing nephrolithiasis.

Eligibility Criteria:
Inclusion Criteria:

Control arm: no longer recruiting

Hypercalciuria arm:

* Age 18-80 years old
* history of calcium-containing kidney stones
* no history of liver, heart or kidney disease (other than kidney stones)
* Non-pregnant, non-lactating
* Able to stop diuretics for a period of 1 week

Exclusion Criteria:

* Not able to sign consent
* Not satisfying any of the above criteria
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.

To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of \>3 months
* Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
* Age greater than or equal to 18 years
* ECOG performance status of 0-1
* Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
* Have failed or unable to tolerate previous treatment regimen
* Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)

Exclusion Criteria:

* Metastatic lesions that are not accessible to biopsy
* Symptomatic CNS metastasis
* Previous history of another malignancy within 5 years of study entry
* Uncontrolled concurrent illness
* Known HIV, HBB, and/or HCV infection
* Pregnant or breast feeding or childbearing potential and not using adequate birth control
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant
Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.

OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck.

OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not specified), brachytherapy alone (using permanent or removable radiation sources), or both; plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410.

PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasopharynx Unknown primary origin with positive head and neck nodes TNM Stages I-IV or recurrent disease with no distant metastases, i.e.: T1 N0 M0 T1 N1-3 M0 T2-4 any N M0 T0 N1-3 M0 No carcinoma of the true vocal cord or other condition with greater than 90% probability of cure

PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 25% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 2 mg/dl OR BUN less than 40 mg/dl Other: No other serious, life-threatening illness No second malignancy within 5 years except nonmelanomatous skin cancer outside the planned radiotherapy field

PRIOR CONCURRENT THERAPY: At least 3 years since chemotherapy No prior radiotherapy to areas of current disease
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein \> 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms

Exclusion Criteria:

* pregnancy and breastfeeding
* hypersensitivity to Spironolactone
* hypersensitivity to Bromhexine
* Known liver failure
* Glomerular filtration rate \<20 ml/ min
* physician judgment that the patient will need mechanical ventilation in 24 hours
* other indications for Spironolactone
* Active cancer