cyrilzakka/clinical-trials huggingface dataset:
The Effect of Telehealth Applications on the Level of Anxiety in the Treatment of Infertility

It is expected that 84% natural pregnancy will occur at the end of the first 12 months of sexual intercourse without the use of contraceptive methods.The lack of natural fertility is under the influence of multiple factors. These factors can be summarized as age, past infections, genetic factors, anatomical structural disorders, environmental toxins, occupational exposure, lifestyle and sexually transmitted infections.Severe psychological stress, anxiety and depression are encountered in the diagnosis, treatment method and management of the related process in couples who are faced with the diagnosis of infertility.

With the telehealth service that came to the fore in the world in the 1950s, nurses use it in the management of many treatment processes such as infertility treatment, with the roles of managing the information collection process, making decisions with the information they receive, and transmitting information on patients who are far away and need constant follow-up.

Assisted reproductive technologies, which are the current treatment method of infertility, have been used effectively for thirty years. Anxiety control is important in the success of treatment in the treatment process, which is both costly and stressful. Providing 24/7 hours of counseling by using telehealth methods contributes to the reduction of this anxiety.

Ethics committee and hospital approval were obtained in order to conduct the study. The sample of the study consists of people who applied to the IVF clinic of Süleyman Demirel University Research and Practice Hospital. The work is planned to be completed between April 2021 and March 2022. In the first meeting with the participants, it is carried out by taking precautions to protect against the COVID 19 pandemic, in cases where it is met face to face. Participants will be divided into groups with 1 to 1 method in randomization. Participants assigned to the intervention group will be given a personal information form and beck anxiety scale before treatment, followed by telehealth service throughout the treatment protocol, and the beck anxiety scale will be repeated at the end of the treatment. In the control group, a personal information form and Beck anxiety scale will be applied before the treatment and will be repeated after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages 20-45
* Female
* Having been diagnosed with infertility
* Should be able to use a smart phone
* Open to communication

Exclusion Criteria:

* Not between the ages of 20-45
* Individuals who do not want to be inherited
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.


Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of superficial transitional cell carcinoma of the bladder
* Males or females at least 18 years of age
* Karnofsky Performance Status greater than or equal to 70%
* Patient compliance and geographic proximity that allow adequate follow-up
* Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
* Signed informed consent.

Exclusion Criteria:

* Clinical evidence of muscle-invasive or locally advanced bladder cancer
* Clinical evidence of upper urinary tract tumor
* Distant metastases
* Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
* Severe concomitant psychiatric disease
* Febrile, active infection
* Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
Effects of Exercise on Abdominal Obesity and Risk Factors for Cardiovascular Disease

The investigators will randomize abdominally obese men and women at increased health risk to one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high intensity exercise (LVHI).

The primary aim of the trial is to determine the effects of varying exercise dose (energy expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist circumference and glucose tolerance. The investigators will test the following hypotheses: 1) That the reduction in waist circumference and improvement in glucose tolerance in response to all treatments will be greater than controls. 2) That reduction in waist circumference and improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That hypotheses 1 and 2 are true independent of gender.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 40 and 60 years of age. The lower age range for men and women is selected to help ensure recruitment of a sample with metabolic syndrome as prevalence of metabolic syndrome is significantly related to age. The selection of 60 years for the upper age range reflects concerns we have randomizing older adults to the high intensity exercise group wherein exercise at 75-80% of maximum may be difficult to achieve, and likely to be associated with increase orthopaedic injury and thus, poor compliance. We also considered lowering the lower age range from 40 to 35 years, but decided against doing so to increase the cost-effectiveness of recruitment (e.g., ensure a higher yield of those with metabolic syndrome).
* Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively) and NCEP-ATPIII defined Metabolic Syndrome. Abdominal obesity for non-Caucasians will be determined using values suggested by the International Diabetes Federation.
* Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
* Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
* BMI less than 40 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI less than 40 kg/m2).

Exclusion Criteria:

* Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia.
* Diabetes.
* Current smokers.
* Alcohol consumption \> 21 drinks per week.
* Plans to move from the area.
* Participating in another research study.
* Clinically judged to be unsuitable for participation or adherence as determined by the participants physician.
* Inability or unwillingness to provide informed consent.
* For women, planned pregnancy in the next year.
A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia (MK-8189-019)

The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg MK-8189 on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily doses of MK-8189 in participants with schizophrenia. The effects of 3 treatment sequences 1) MK-8189 (48 mg \[Day 1\] and 80 mg \[Day2\]); 2) standard image placebo (Day 1) and moxifloxacin 400 mg (Day 2); and 3) MK-8189 placebo (Day 1 and Day 2) were assessed with 5-day washout intervening sequence. Participants received all treatments in a counter-balanced order according to 1 of 6 possible treatment sequences.

The primary hypothesis is that the administration of an 80 mg MK-8189 dose on Day 2 does not prolong the QTc interval to a clinically significant degree. Specifically, the true mean difference (MK-8189 - placebo) in QTc change from baseline is less than 10 milliseconds (msec).


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
* Is in the non-acute phase of their illness.
* Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia.
* Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other medical conditions could be considered if their condition is stable.

Exclusion Criteria:

* History of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria.
* History of intellectual disability, borderline personality disorder, anxiety disorder, or organic brain syndrome.
* History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia (TD).
* History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
* History of cancer.
* History or presence of sick sinus syndrome, atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QTc interval, or conduction abnormalities.
* History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome).
* History of frequent syncope, vasovagal episodes, or epileptic seizures.
* Family history of sudden cardiac death.
* Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
* Had major surgery, donated, or lost 1 unit of blood within 4 weeks prior to the pre-study visit.
Recovery After Stress Toolkit (RESET) Study

This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.

As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.

Eligibility Criteria:
Inclusion Criteria:

* 8 years to 17 years at enrollment
* Treated for an injury in the ED or hospitalized
* Abbreviated Injury Scale (AIS) score 2 or greater
* Parent and child English speaking
* Broad band internet availability at home
* Residing with parent or legal guardian

Exclusion Criteria:

* Moderate or severe traumatic brain injury (GCS less than 13)
* Diagnosed with moderate or severe intellectual disability
* Pre-existing psychiatric disorder that required hospitalization
* Abuse or interpersonal injury as mechanism of injury
* Currently receiving psychotherapy
* Hospitalized for injury over 30 ays
* Death of a family member or friend at time of injury
The Effect of Epidural Fentanyl on Immune Function

Background: For cancer to grow and metastasize, inflammatory and immunologic conditions in the host must be favorable. The perioperative period provides inflammatory and immunologic changes that may be pro-malignant. Anesthetic medications, including the use of opioid medication, may contribute to these changes.

Hypothesis: The investigators hypothesize that perioperative immunologic changes in patients undergoing resection of hepatic colorectal cancer recurrence, as measured by natural killer cell function and cytokine levels, will undergo less alterations in those who receive only epidural bupivacaine, as compared to those who receive epidural bupivacaine and fentanyl.

Methods: In this double blind control trial patients with no extra-hepatic evidence of cancer, undergoing a planned curative resection of hepatic recurrence of colorectal cancer, will be randomized to receive an epidural with bupivacaine and fentanyl, or bupivacaine alone. No other perioperative opioid medication will be given, and post-operative analgesia will be supplemented with acetaminophen and gabapentin. Blood samples and pain ratings using a verbal analogue scale will be obtained preoperatively, immediately and 6 hours postoperatively, and then daily until removal of the epidural catheter. Samples will be analyzed for levels of interleukin 2, 6, 8, 10, 12, 16, 17,TNF-α, TGF α and β, MCP-1, CRP, and NK cell activity. Cytokines will be measured using a suspension bead array immunoassay kit, and NK activity will be measured using flow cytometry of isolated peripheral blood mononuclear cells exposed to the K562 cell line and treated with fluorescent antibodies to intracellular markers of activation. Data will be compared between groups using t-tests, or Mann-Whitney tests as appropriate. To demonstrate a 50% smaller decrease of NK cell activity in the bupivacaine group as compared to the bupivacaine and fentanyl group the investigators will need to randomize a total of 30 patients.


Eligibility Criteria:
Inclusion Criteria:

We will consider for inclusion any adult patient undergoing a planned curative hepatic resection of a colorectal carcinoma liver recurrence.

Exclusion Criteria:

E 3. Patients Excluded Any patient unable to communicate in English or French. Any patient with evidence of extra-hepatic metastasis. Any patient with contra-indications to epidural anesthesia, or any of the medications used in the study.

Any patient with evidence of coronary artery disease or congestive heart failure, either previously or currently.

Any patient with insulin treated diabetes. Any patient with a BMI greater than 40. Any patient who has received steroids in the past 2 months. Any patient who has taken any pain medication the week before surgery. Any pregnant or breast feeding patient. Any patient with a chronic inflammatory disease, including but not limited to Lupus, rheumatoid arthritis, and inflammatory bowel disease.
PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus

Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.

The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 20 to 40 patients over a 12-month enrolment period.

Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.

After discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection criteria:

Inclusion criteria:

1. Written informed consent
2. Degenerative mitral valve disease
3. \> 18 years old

Exclusion Criteria:

Main exclusion criteria:

1. Presence of structural or organic tricuspid valve disease
2. urgent operation
3. presence of pacemaker leads through the tricuspid annulus
4. acute endocarditis or other organic valve diseases
5. previous surgical procedure
6. Severe TR
7. Associated cardiac procedure
8. NYHA class IV
9. Severe COPD (GOLD class 3,4)
Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial

The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes (PPROM).

Bed rest at home or in the hospital has been widely advised for many complications of pregnancy, including preterm premature rupture of membranes (PPROM) - a problem in which the water breaks prematurely and is not accompanied by labor. For most patients, bed rest represents a significant change in lifestyle, including having to stop work, and/or not being able to do household duties or take care of their children. In pregnancies, complicated by PPROM, patients are usually hospitalized and placed on bed rest throughout the stay.

Despite its widespread use, there are no good published studies evaluating the effect of bed rest on common complications of pregnancy. There are, on the other hand, several other studies that indicate that bed rest may actually be harmful. Bed rest has been shown to increase a patient's risk for developing blood clots in their legs or in their lungs. Bed rest may also have myriad other deleterious effects such as muscle and bone atrophy. Furthermore, bed rest has been shown to be emotionally distressing both to the patient and her family.

Once the amniotic membranes are broken, amniotic fluid will generally continue to leak for the remainder of the pregnancy, and a fetus in otherwise good health will continue to make more amniotic fluid by urination. In patients hospitalized with PPROM, an objective assessment that can be obtained is an ultrasound amniotic fluid index (AFI), which measures how much amniotic fluid remains despite the water having broken. It is thought that a greater amount of amniotic fluid may be indicative of a longer duration/continuation of pregnancy and fewer adverse interim effects such as cord compression. Remaining on bed rest was thought to perhaps affect the AFI in a positive way. It is unclear whether retaining the ability to ambulate would affect the AFI, because amniotic fluid continues to leak even while on bed rest; the benefits of ambulation may be well worthwhile. Twice weekly ultrasound amniotic fluid measurement will be checked to assess the effects of ambulation verses bed rest in pregnancies complicated by PPROM, and secondarily look at the overall outcome of the pregnancy.

The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria
* Pregnant women
* Clinical diagnosis of PPROM (made by sterile speculum examination)
* Singleton pregnancy
* Vertex or frank breech presentation
* 18-55 years old
* Gestational age \< 34 weeks

Exclusion Criteria:

* Multiple gestations
* Gestational age \> 34 weeks
* Current treatment with MgSO4 for preterm labor
* Footling breech presentation
* Any maternal or fetal indication for immediate delivery
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients

The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
* Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA \<400 copies/mL and have CD4 count \>200 cells/mm³
Photobiomodulation Therapy in a Field Test With High-level Rugby Players

Background/Aim: While growing evidence supports the use of photobiomodulation therapy (PBMT) for performance and recovery enhancement, there have only been laboratory-controlled studies. Therefore, the aim of this study was to analyze the effects of PBMT in performance and recovery of high-level rugby players during an anaerobic field test.

Methods: It is a randomized, crossover, double-blinded, placebo-controlled trial. Twelve male high-level rugby athletes were recruited in this study. No intervention was performed before the Bangsbo Sprint Test (BST) at familiarization phase (week 1). At weeks 2 and 3, pre-exercise PBMT or placebo were randomly applied to each athlete. PBMT/placebo irradiation was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser diodes of 905nm, 4 LED diodes of 875nm, and 4 LED diodes of 640nm, 30J per site - manufactured by Multi Radiance Medical™). Average time of sprints, best time of sprints, and fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at 3, 10, 30 and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a questionnaire.

All exercise tests were conducted in an enclosed soccer/rugby field. The three test phases, administered one week apart, were performed on the same day of the week (Tuesday) and time (1-5pm). The average temperature inside the building during the trials ranged from 26°C to 28°C. At first stage (exercise test 1) all athletes performed the Bangsbo Sprint Test (BST) to familiarization with the procedure. No interventions or comparators were applied before this test. However, at the second and third stages (exercise tests 2 and 3, respectively) either a placebo or active PBMT was applied according to randomization. Blood samples were collected from the athlete's fingertips prior to stretching and warming-up (baseline), and at 3, 10, 30 and 60 minutes after BST at each of the three study stages/phase (exercise tests). After blood sample collection (to establish baseline), a warm-up comprised of low-intensity activities such as dynamic stretches and low-intensity short running were performed by each athlete. Following the warm-up and cool down period, either the active or placebo comparator was applied to the athlete according to the randomization procedure for the second test. For the third test, the other comparator was utilized to complete the cross over design. A quick perception of fatigue survey was administered following each test.

Eligibility Criteria:
Inclusion Criteria:

* high-level athletes from São José Rugby Club (Brazil)

Exclusion Criteria:

* Athlete would be excluded if the participant presented any skeletal muscle injury
* if athlete took any nutritional supplement or pharmacological agent
* if the athlete presented signs and symptoms of any disease (i.e., neurological, inflammatory, pulmonary, metabolic, oncologic), and
* if the athlete had history of cardiac arrest that could limit performance of high-intensity exercises