cyrilzakka/clinical-trials huggingface dataset:
Assessment of Emotion Regulation Strategies Used When Suicidal

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include:

1. Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1.
2. Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1.
3. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation.
4. Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies.
5. (Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Currently serving in any Branch or Component of the U.S. military
* \>18 years old;
* Score ≥ 5 on the Scale for Suicidal Ideation and/or endorse a suicide attempt, aborted attempt, or interrupted attempt within the past month on the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
* Ability and willingness to complete research-related activities remotely
* Regular access to an Android or Apple smartphone that is compatible with the ecological momentary assessment application

Exclusion Criteria:

* Engagement in mental health treatment within the past year (including taking psychotropic medications)
* A psychiatric or medical condition that preventing providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication); or - Expecting to separate from the military within 90 days
Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

To determine if combined \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC).

Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.

Patients with locally advanced, N2 and N3 head and neck squamous cell carcinoma (HNSCC) will be recruited. All subjects receiving induction chemotherapy will undergo a baseline integrated \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan before the start of concurrent chemoradiation. This baseline assessment is optional in patients not receiving neo-adjuvant treatment.

All patients will undergo a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly control visits will be performed complemented with additional imaging as required. All patients will undergo PET/CT 1 year after completing chemoradiation unless recurrent/residual disease was already proven pathologically. Patients with a PET/CT suspected for residual nodal disease must have pathological proof of nodal involvement (fine needle aspiration in non-operable patients or neck dissection in the others) before salvage chemotherapy is started.

In a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation, an additional FDG PET/CT scan will be performed at baseline and after 1 cycle of chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).

Eligibility Criteria:
Inclusion Criteria:

* Patients with locoregionally advanced HNSCC (clinically and/or radiological N2 or N3 disease, any T stage) with no evidence of distant metastases, scheduled for concurrent chemoradiation and being potential candidates for a subsequent neck dissection.
* Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.

Exclusion Criteria:

* Other head and neck cancer histologies
* Upfront inoperable patients in the neck (eg. carotid invasion)
* Presence of distant metastases
* A history of another primary malignancy, except when disease-free for at least 5 years after radical treatment, or except for treated basaloid skin cancer or in situ carcinoma of the cervix
An Online Trial of Five Well-being Programs

Participants complete an 8-week program and complete assessment measures to track their outcomes over time.

Participants will be randomly assigned between five different well-being programs, each 8-weeks long and taking place on a simplified research version of the Happify platform. They will be asked to complete questionnaires before and after the 8-week program, as well as 1-month, 3-month, and 6-month follow-up questionnaires after the program is complete, at which point study participation will end.

Eligibility Criteria:
Inclusion Criteria:

* No prior experience on the Happify platform (new user registration)

Exclusion Criteria:

* None
Effects of Partial Sleep Deprivation on Cognitive Function of Anesthesiologists

The purpose of this study was to evaluate differences in cognitive functions at baseline and following night shift at a trauma center among faculty anesthesiologists.

Anesthesiology is one of the few health-care professions that often demands split-second decisions. This is especially true in a trauma setting where the situation in the operating room can change drastically in a few seconds. Anesthesiologists who cover trauma calls overnight are subject to long work shifts and demanding schedules that may adversely affect their performance. In combination with the disruption of circadian rhythm that can occur with night shift work, decline in performance from the long work shifts can lead to errors in judgment.

An anonymous questionnaire included two groups of different items were used. Items of the first group are about the personal data i.e. age, sex, marital status and parenting status, consumption behavior (tea, coffee, carbonated drinks, tobacco, anxiolytics, antidepressants, psychotropic agents and sport), and professional activity (number of extended worked shifts per month, number of weekends worked per month).

Items of the second group are related to the night shift itself i.e. number of cases, and the rest hours during the shift.

Psychomotor Vigilance Task, Karolinska Sleepiness Scale, Epworth Sleepiness Scale and Trail Making Test before and after the shift were performed.

Eligibility Criteria:
Inclusion Criteria:

* Full-time faculty anesthesiologists employed at Kasr El- Ainy Hospital.
* Both genders
* Ages of 25-28 years.
* Varying levels of experience.

Exclusion Criteria:

* History of chronic neurological disease.
* History of psychiatric disorders such as:

  * Episode of major depression within the past 2 years.
  * Lifetime history of schizophrenia.
  * Other psychotic illness or bipolar illness.
Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods

Rationale: Undernutrition risk among community-dwelling older adults in developed countries is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well as efficacious to reduce undernutrition in community-dwelling older adults. A promising strategy to increase protein intake among older adults, is to offer dietary solutions with normal foods that fit their current daily eating patterns. For this reason, home-delivered protein-rich readymade meals and protein-rich dairy products will be studied in this research.

Objective: The primary objective is to study the effectiveness of commercially available protein-rich readymade meals and protein-rich dairy products in increasing protein intake of older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary objectives include: studying effects of these meals and dairy products on total daily energy intake. Further, studying the acceptance of and compliance to the meals and dairy products.

Study design: The study will be performed as a single-blind randomized, controlled, four-week trial in a real-life setting: in community-dwelling older adults' own homes.

Study population: The target group of this study are community-dwelling older adults who use a meal-delivery service.

Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will also receive dairy products to freely consume during the intervention period. The intervention groups receives protein-rich meals and protein-rich dairy products, the control receives standard meals and food products.

Main study parameters/endpoints: Difference in daily protein intake between intervention and control group. Secondary parameters: energy intake and acceptance (liking).


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or over
* Living at home
* Be a client of maaltijdservice.nl
* Being able to eat by themselves
* Have a microwave to heat meals
* Live in Nijmegen or Den Bosch area
* Being able to understand, read and speak Dutch
* Having signed informed consent.

Exclusion Criteria:

* Legally incapacitated
* Mini Mental State Examination (MMSE) score \< 24
* Following a diet with protein restriction or a vegetarian diet
* Allergies or intolerances prohibiting the use of dairy products
* Only using texture modified foods (liquid diet)
* Diagnosed by doctor with renal insufficiency
* Suffering from a terminal illness
BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
* Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
* Known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and

  * Part A: 60 mL/min/1.73 m\*2 \</= eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m\*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
  * Part B: 30 mL/min/1.73 m\*2 \</= eGFR \<= 60 mL/min/1.73 m\*2 (MDRD) at the screening visit
* Serum potassium \</= 4.8 mmol/L at the screening visit
* Systolic blood pressure \>/= 90 mmHg without signs or symptoms of hypotension at the screening visit

Exclusion Criteria:

* Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
* Subjects with anuria, acute renal failure, or Addison's disease
* Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
* Valvular heart disease requiring surgical intervention during the course of the study
* History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
Increasing Patient Experience Survey Responses

This project aims to evaluate the effect of thank you cards on patient experience survey response rate.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have been discharged from the designated hospital units during the study period

Exclusion Criteria:

* N/A
Dedinje FFR/QFR Registry

Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains.

The primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients \>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)

Exclusion Criteria:

* Declines to participate in the registry and provide informed consent
Computer-Based Treatment for Social Anxiety Disorder

The present study is an open trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)

This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 60
* Current primary diagnosis of SAD
* Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
* Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
* Current severe depression
* Suicidal ideation or behavior
* Current diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
* Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
* Current unstable or untreated medical illness
* Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed)
* Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
* Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months
* Pregnancy, or plans to become pregnant during the period of the study - will be assessed by urine
* Contraindication to MRI scanning:
* Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
* Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Open-label Study of the Effects of Montelukast in Patients With Chronic Cough

Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of chronic cough and this could be made objective by measuring cough threshold before and after two weeks of treatment.

Chronic cough is typically defined as cough that persists for longer than 8 weeks and is the most common presenting symptom in adults who seek medical treatment in an ambulatory setting. Prospective studies have shown that three conditions account for the etiologic cause of chronic cough in the largest part of immunocompetent, nonsmoking patients with normal chest radiograph findings. In order of frequency, they are upper airway cough syndrome (UACS), previously referred to as postnasal drip syndrome (PNDS), asthma and gastroesophageal reflux disease (GERD). UACS comprises many different conditions including PNDS, acute sinusitis, allergic rhinitis, non-allergic rhinitis (postinfectious rhinitis, rhinitis medicamentosa, vasomotor rhinitis, rhinitis due to physical or chemical irritants). Cough occurs in all asthmatics, and in a subset of patients with cough-variant asthma (CVA), it is the only presenting symptom. In these cases it is well controlled with inhaled corticosteroids and beta-2 agonists. GERD is another cause that should be contemplated when anti-tussive or anti-inflammatory/anti-allergic treatment do not render results and when there are presenting symptoms suggestive of it. Moreover, factors like smoking and use of ACE-inhibitors should also be taken into account.

Leukotrienes are very important agents in the inflammatory response. It is known that they are contributing significantly to the pathological processes in asthma. Montelukast is a leukotriene receptor antagonist which blocks the bonding of leukotrienes to their receptors thus inhibiting their inflammatory, bronchoconstrictive and mucosecretory effects. Multiple clinical trials have demonstrated the ability of the leukotriene antagonists to improve symptoms, pulmonary function and bronchial hyperresponsiveness in patients with asthma. However, not much is known about their effects in people with chronic cough. Studies have been carried out in an attempt to find out the effects of montelukast in some forms of chronic cough. Nevertheless, the impact of montelukast on objective parameters such as cough reflex threshold, has not been explored. The investigators also reckon that montelukast will affect exhaled breath temperature - a novel surrogate marker of airway inflammation recognized lately

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic cough: cough persisting for more than 8 consecutive weeks

Exclusion Criteria:

* Current use of ACE-inhibitors
* Use of systemic steroids in the last 4 weeks
* COPD
* Pregnancy
* Concomitant severe disease
* Smoking
the Effect of Different Modialites of Varicocelectomy on Semen Parameters in Patient With Normal Semen Analysis

to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen parameter for patients complaining of varicocele with normal semen parameter (pain is the main complaint)

the varicocele is defined as dilated and incompetent veins within the pampiniform plexus of spermatic cord. varicocele has been described as the most common surgically correctable cause of male subinfertility.this is a disease that devolops during puberty when both endocrine and exocrine function of the testicle dramatically increases, along with testicular blood flow. varicocele only rarely detected in boys less than 10 years. left sided varicocle found in 15% of healthy young men.incontrast, the incidence in sub fertile men approaches 40% bilateral varicocele is uncommon in healthy men (less than 10%) but palpated in 20% in sub fertile men. in-general varicocele don't spontaneously regress. an accurate physical examination remain the corner stone of varicocele diagnosis.

several anatomic features contribute to the predominance of left sided varicocele is the left intrnal spermatic vein longer than the right and it typically joins the left renal vein at a right angle.as result of this character higher venous pressures fair transmited to the left spermatic vein and result in reterograde reflux of blood.

varicocle are associated with testicular atrophhy and varicocle correction can reverse atrophy in adolececnt. there is strong evidence affect semen quality it can cause abnormalties in concentration, motility and morphology.main defect is the motility.

indication of varicocelectomy:

1. Large varicoceles in adolescents
2. Childhood varicocele with testicular atrophy
3. Varicoceles with elevated FSH values, or low testosterone levels
4. Varicoceles with scrotal pain
5. Cosmetic indication
6. Male infertility with pathological semen analysis and varicocele

Eligibility Criteria:
Inclusion Criteria:

* age more than 19 years old
* primary varicocele

Exclusion Criteria:

* secondary varicocele recurrent varicocele age less than 19 years
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference.

The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Capable and of age
* Diagnosed with acromegaly
* Sufficient treated for at least 6 months prior to enrollment

Exclusion Criteria:

* Pregnancy or nursing
* Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator