cyrilzakka/clinical-trials huggingface dataset:
Pilot Comparison of N-of-1 Trials of Light Therapy

This study compares the effect of two N-of-1 trials on study compliance with an N-of-1 protocol and on satisfaction with participation in an N-of-1 trial. Using within-person analyses, the study also compares the effect of different types of light therapy on mood, fatigue, sleep, physical activity, and side effects within a mild to moderately depressed cancer survivor population. Ten participants will be randomized to the bright white versus dim red light therapy N-of-1 trial, while the remaining 5 participants will be randomized to a dim white versus dim red light comparator N-of-1 trial.

Fatigue or low energy levels, trouble sleeping and feeling down are symptoms that represent some of the most important concerns in cancer survivors, across a range of cancer types. Despite the impact of these symptoms on quality of life, previous studies have shown that few cancer survivors are receiving adequate treatment for these symptoms.

Light therapy involves the use of a light box (a box that lights up) in close proximity for a specified amount of time each day. There can be big differences in the way light therapy affects individual patients. Patients can learn whether this therapy is helpful to them by engaging in an N-of-1 trial. An N-of-1 trial is an experiment conducted with one individual (N refers to "number of individuals in the trial"). In an N-of-1 trial of light therapy, a patient can try light therapy to learn whether it is beneficial to them. All participants will receive two light boxes. The boxes will be labeled "A" and "B." Each light box will emit a different intensity of light. An app will send reminder notifications to participants' smartphones each morning to remind them which light box they should be using, depending on the week. They will be asked to use Box A or Box B each morning for 30 minutes per day for 12 weeks

The purpose of this study is to empower cancer survivors with symptoms of fatigue, trouble sleeping or who are feeling down to learn whether light therapy is helpful for them.

Eligibility Criteria:
Inclusion Criteria:

* History of cancer (not including basal cell or squamous cell carcinoma, or carcinoma in situ)
* Current mild to moderate severity depressive symptoms (PHQ-8 score 5 to 19)
* iPhone user

Exclusion Criteria:

* Has not completed primary cancer treatment including initial chemotherapy, surgical resection, or radiation therapy
* Non-English speaking
* Severe depression (PHQ-8 score \>=20) or active suicidal ideations
* Other severe mental illness that would preclude participation in a study that requires extensive self-monitoring, including depression with psychotic features, other psychotic disorder, bipolar disorder, severe personality disorder
* \<6 months life expectancy due to cancer or other severe medical illness
* Other severe medical illness that would preclude ability to do daily self-tracking
* Unavailable for follow-up over the course of the 3 month trial
Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU

The main objective of this study is to determine if the systemic (intravenous) administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 40 years
2. Strongly suspected or documented COPD, defined by the presence of the following criterias:

   * Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
   * History of exposure to a risk factor such as tobacco smoke
   * If available, pulmonary function tests showing airflow limitation not fully reversible (post-bronchodilator ratio of FEV1/ FVC ratio \< 0.7)
3. ACRF, defined by the presence of the two following criteria:

   * COPD exacerbation defined by a change in the patient baseline respiratory symptoms at least 24 hours and requiring a change in regular respiratory medication
   * Acute respiratory failure \<24h (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
4. Admission to an ICU, a step-up unit or a respiratory care unit
5. Inform consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent.
6. Affiliation to (or benefit from) French health insurance system

Exclusion Criteria:

* Previous diagnostic of asthma, according to "GINA" international guidelines (40)
* Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
* Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
* Pneumothorax at randomization
* Extracorporeal life support (ECMO or ECCO2R) at inclusion
* Moribund patient life expectancy \< 3 months
* Pregnancy
* Patients protected by law
* Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
* Previous inclusion in the present study
Evaluatıon of the Effıcıency of Stress Management Traınıng Applıed to Nursıng Students (Happy Nursıng Student)

This research was conducted to determine the effect of stress management education on the perceived stress levels, coping styles, self-esteem, happiness and general health of nursing students. It was conducted in a mixed method as a randomized controlled intervention study.

The research was carried out at Ankara Yıldırım Beyazıt University in the 2021-2022 academic year. 20 nursing students were assigned to the experimental group and 20 to the control group. Stress management training was applied to the experimental group selected in the research for eight weeks in 60-90-minute sessions once a week. No action was taken on the students in the control group. Quantitative data, Socio-demographic data form, Perceived Stress Scale (PSS), Scale of Stress-Coping Styles (SCSS), Rosenberg Self-Esteem Scale (RSES), Oxford Happiness Scale-Short Form (OHQ-SF) and General Health Questionnaire-12 (GHQ-12). Qualitative data were collected through a semi-structured focus group interview form with the experimental group after the training. The analysis of the data was made using the IBM SPSS 25.0 statistical package program.

Eligibility Criteria:
Inclusion Criteria:

* Having completed the age of 18
* Being a registered (ongoing) Nursing Program student at Ankara Yıldırım Beyazıt University
* Having no problem attending school
* Being open to communication and cooperation
* Not having been diagnosed with any mental illness
* No diagnosis of mental illness in first degree relatives
* Not having a situation that would prevent them from participating in the trainings (Students will be included in the study after being evaluated within the scope of the SCL90-R test results).

Exclusion Criteria:

-
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.


Eligibility Criteria:
Inclusion Criteria:

1. Documentation of informed consent and authorization.
2. Full term and late preterm newborns (EGA 35-44 weeks)
3. On room air
4. Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
5. Parents agree to follow-up contact post discharge

Exclusion Criteria:

1. On supplemental oxygen
2. Admitted to the Neonatal Intensive Care Unit
3. Parents do not agree to follow-up
4. Greater than 30 days of age
A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis

Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,

In order to evaluate the efficacy and safety of the 4-month test gatifloxacin-containing regimen, comparison will be made with a standard 6-month regimen, recommended by WHO. Patients will be treated with one of the two regimens that will be randomly allocated. A total of 2070 patients will ne recruited in the trial and followed-up for a duration of 2 years. The trial is multicentre, and conducted in 5 countries in Africa.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Aged 18 to 65 years
* Currently suffering from recently diagnosed microscopically proven pulmonary tuberculosis and providing informed consent for inclusion in the study.

Exclusion Criteria:

* Patients with history of tuberculosis treatment within the last 3 years
* History of diabetes mellitus or non insulin dependent diabetes mellitus requiring treatment
* Concomitant infection requiring additional anti-infective treatment (especially anti-retroviral therapy)
* HIV infected patients with WHO stage 3 infection - except those presenting with only the "loss of weight\>10% body weight" criterion - and all HIV infected patients at WHO stage 4.
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥ 50 kg
* Diagnosis of Heterozygous Familial Hypercholesterolemia.
* Females must be non-pregnant and non-lactating.
* On stable lipid lowering therapy for at least 4 weeks.
* Lipid levels meet the pre-specified criteria.

Exclusion Criteria:

* Subject had heart problems in the prior 6 months.
* Subject has elevated ALT, AST, or CPK.
* History of renal disease, liver disease, or malignancy.
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.
To Explore the Related Factors of Cough After Thoracoscopic Pneumonectomy

To explore the related factors of cough after Uniport video-assisted thoracoscopic surgery pneumonectomy, and to provide theoretical basis and social accumulation of new knowledge for the diagnosis and treatment of cough after pneumonectomy in the future.

Intractable cough after thoracoscopic pneumonectomy is one of the common complications after pneumonectomy. The incidence of cough can reach 25% ≤ 50%. Cough after operation can aggravate the pain of incision, prolong the hospitalization time, increase the cost of hospitalization, affect the conversation and even sleep of the patients, increase the psychological burden of the patients, and reduce the quality of life of the patients accordingly. Therefore, through this study, the investigators hope to understand the related factors of cough after thoracoscopic pneumonectomy and whether there are predictable risk factors, so as to provide theoretical basis for reducing the occurrence of cough after pneumonectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, male and female
* Uniport video-assisted thoracoscopic surgery
* No cough symptoms within two weeks before operation
* Informed consent form was signed before operation

Exclusion Criteria:

* Diabetes , heart, brain, liver and kidney diseases
* Chest radiographs / CT in recent months indicate pneumonia
* Pulmonary function cannot tolerate lobectomy / segmental / cuneiform resection
* Distant metastasis patients
* Before operation, there were internal causes of cough (including respiratory tract infectious diseases, pharyngitis, allergic rhinitis, posterior nasal drip syndrome, etc.)
Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).


Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear custom made Hearing aids
* Informed Consent as documented by signature
* Benefit with TFG tool at least on one ear

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Limited dexterity (not able to change a 10size Hearing aid battery)
* no Benefit of the TFG tool on both ears
* Known psychological problems
* Central hearing disorders
Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion

The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.

BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.

Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.

AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.

DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. AF patients over 18 years old
2. Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT
3. Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score ≥3

Exclusion Criteria:

1. Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis≥75%)
2. Absolute contraindications to OAC
3. Absolute contraindications to anti-platelet therapy
4. Contraindications to MR or unwilling to receiving MR
5. Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion
Interrupting Prolonged Sitting With Periodic Interval Exercise: Effect on Postprandial Lipemia

Investigating the effects of interrupting various lengths of prolonged sitting with bike sprints on post prandial lipemia the next day. We will conduct three trials, one control, one with two-hour sitting intervals (total of 4 bouts of bike sprints) and one with 6-hour sitting intervals I total of two bouts of bike sprints). A milkshake high fat tolerance test will be conducted the next day and whole body fat oxidation as well as triglyceride area under the curve will be measured every hour for the duration of the 6-hour test.


Eligibility Criteria:
Inclusion Criteria:

* Inactive or recreational healthy adults aged 18-65 years old.

Exclusion Criteria:

* Lactose intolerance, cardiovascular or metabolic diagnoses, medications for cardiovascular or metabolic diagnoses, orthopedic issues barring cycling.
Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome

The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).

The study was carried out on 150 patients with PCOS. Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.Statistical methods Distribution of characteristics in patients is presented as the mean ± SD. We used the Mann-Whitney U test for exploratory comparison of initial parameters between responders and nonresponders. The univariate and multivariate relation with response to CC was assessed using logistic regression analysis. Backward stepwise elimination was used for the multivariate logistic analysis of prediction of patients being CRA, and P \< 0.10 was used as a cut-off level for elimination of non-significant predictors from the prognostic model. The area under the receiver operating characteristics (ROC) curve (AUC) was used to assess the discriminative ability of the logistic models. SPSS with statistical package version 17 (SPSS Inc., Chicago, IL) and MedCalc Software version 12.4, (Ostend, Belgium) were employed for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* The study included 150 infertile women(age from 18 to 40 years) with PCOS diagnosed by the presence of at least two of the following \[15\]:

  1. Clinical hyperandrogenism: Hirsutism or acne vulgaris and/or biochemical hyperandrogenism (total testosterone \>88 ng/dl or DHEAS \>275 ug/dL)\[16\]. (2) Menstrual and/or ovulatory disturbances, mainly oligomenorrhea (interval between vaginal bleeding \>35 days and \< 6 months) or amenorrhea (bleeding interval \>6 months). (3) Polycystic ovaries as visualized by transvaginal ultrasound (either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume \>10 cm3).

Exclusion Criteria:

* Patients having one or more of these criteria were excluded; Age \<18 years or \>40 years, body mass index (BMI) \<18.5 kg/m2 or \>35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.
OKS for the Treatment of Hemispatial Neglect

Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.


Eligibility Criteria:
Inclusion Criteria:

* Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test

Exclusion Criteria:

* Reduced vision
* Documented vestibular disorder
Pediatric Heart Transplantation: Transitioning to Adult Care

The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.


Eligibility Criteria:
Inclusion Criteria:

* Have received a heart transplant at a children's hospital and are ready to transition, as determined by the pediatric heart transplant cardiologist, to the adult heart transplant center with whom a collaborative relationship has been established;
* 18 years or older;
* Able to speak, read at a fifth grade level or above, and write English;
* Physically able to participate.

Exclusion Criteria:

* History of psychiatric hospitalization within the last 3 months, assessed on a case-by-case basis with exclusion only if patients could not potentially benefit from the intervention.
Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.

The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence.

In the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.


Eligibility Criteria:
Inclusion Criteria:

* patients post laryngectomy with primary insertion of voice prosthesis

Exclusion Criteria:

* patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap