cyrilzakka/clinical-trials huggingface dataset:
Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.

The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART (highly active antiretroviral therapy) for the first time. Patients who are eligible to be initiated on HAART at the UW/Coptic Hope Center for Infectious Diseases will be referred for enrollment. Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent.

Study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. Participants will be followed in the study for 1 ½ years after enrollment and randomization. Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. During follow-up visits, blood will be drawn and stored for CD4 counts and HIV-1 viral analyses.

Within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.

Eligibility Criteria:
Inclusion Criteria:

* Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
* Must be above 18 years of age
* Must be HAART treatment-naïve
* Must agree to home visits, and plan to live in Kenya for at least two years.

Exclusion Criteria:

* Individuals who are mentally incompetent or are pregnant are excluded from the study.
Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea, but the innervation of these muscles by the ansa cervicalis is variable. The investigators propose a study examining the anatomic variation of the ansa cervicalis and the effect of neurostimulation on muscle recruitment.

This is a single-arm physiology study. Consenting patients undergoing neck dissection (ND) for cervical lymphadenectomy of level IV will undergo dissection of the ansa cervicalis nerves to the infrahyoid strap muscles. Per routine care, a large incision is made across the neck to provide surgeons access to the cervical lymph nodes for extirpation. During this dissection, the branch(es) of the ansa cervicalis nerve plexus descending from the loop of the plexus and innervating the infrahyoid strap muscles (the "common trunk") are dissected uni- or bilaterally. For this study, measurements and photos/videos of the common trunks will be taken. An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old).
* Scheduled for uni- or bilateral neck dissection (BND) for cervical lymphadenectomy of level IV and other indicated procedures for management of head and neck cancer.

Exclusion Criteria:

* Unable to consent for research due to a pre-existing neurologic condition as determined by PI.
* Unable to consent for research due to language barriers.
* History of prior neck surgery with transection of the infrahyoid strap muscles as determined by clinical history.
Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin

This study supplements patients' current medications with Pravastatin, a cholesterol-lowering medication, to try to improve residual symptoms of schizophrenia, and also to improve cognitive functioning.

This study supplements patients' current medications with Pravastatin, a cholesterol-lowering medication, to try to improve residual symptoms and also to improve cognitive functioning. It consists of 15 total study visits over a 28-week period of time, one visit every 2 weeks.

Blood draws will be done once every 4 weeks throughout the study to monitor lipid levels, C-Reactive protein, AST, ALT, and CPK Total. Cognitive testing will be completed at the beginning of the study and at the end of the study. During the study visits, the staff will be monitoring vitals signs (weight, height, blood pressure, pulse, waist/hip ratio), possible side effects, positive and negative symptoms, mood symptoms, and overall functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Male and female subjects; age 18-65 years inclusive
* Ability to provide informed consent
* No psychiatric hospitalization in the last 30 days prior to randomization
* PANSS score at study entry between 80 and 120 inclusive, OR those who continue to experience some residual positive and/or negative symptoms and are not at their baseline level of functioning.
* Current psychiatric medications stable for at least 30 days
* Currently receiving only one antipsychotic medication
* Female subjects of child-bearing age must use an acceptable method of birth control

Exclusion Criteria:

* Active, uncontrolled, or chronic liver disease
* Heart failure
* Current alcohol abuse or dependence
* Female subjects who are pregnant, lactating or plan to become pregnant during the study period
* History of allergic reaction with any statin in the past
* Kidney disorder or other evidence of renal dysfunction
* Uncontrolled diabetes
* Untreated hyperlipidemia
* Concurrently receiving treatment with cyclosporine, gemfibrozil, clofibrate, fenofibrate, niacin, macrolide antibiotics, erythromycin, HIV protease inhibitors, nefazodone, or verapamil
Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)

This study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and results will be collected through self-assessment questionnaires and clinical pelvic examination. Effectiveness outcomes will be tracked over the duration of the trial and measured against historical symptoms.

The objective of the study is to test the device with women who are experiencing symptoms of pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation problems, to assess the changes in pelvic floor muscle strength, before and after the intervention.

The study device is a pelvic floor exercise device that provides biofeedback and exercise guidance.

Women who meet the inclusion criteria will be recruited from the regular patients at the investigation site and given the device to use at home daily for 12 weeks. Subjects will submit information regarding their experience with the device and self-assessed improvements in their symptoms. A pelvic examination will be conducted at the start and conclusion of the study to measure a pelvic floor muscle strength reading.

The research hypothesis is that strength level, subjective assessment of vaginal tightness and sexual sensations will be greater at the end of the study than at the baseline and the mean value of frequency and volume of bladder leaks will be less than at the baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
2. Experience urinary incontinence and/or vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more.

Exclusion Criteria:

1. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
2. Has had prior surgery for incontinence, prolapse or vaginal tightening
3. Has been diagnosed with pelvic organ prolapse more severe than grade 2
4. Suffers from vaginal penetration difficulties
5. Has had more than 3 urinary tract infections in the past 12 months
6. Has any conditions of the bladder that effect continence
7. Suffer from vaginal/vulvar/pelvic pain
8. Is currently taking any medication for incontinence
9. Is pregnant or trying to become pregnant
10. Has given birth less than 6 weeks prior to enrollment
11. Has been diagnosed obese - BMI \> 30
12. Is a heavy smoker - \> 20 cigarettes per day
13. Has a history of neurological conditions - Parkinson's, multiple sclerosis and other
14. Suffers from chronic constipation
Validation of Peptest™ for the Detection of Reflux in Cough

Chronic cough is a common presenting problem which has a significant impact on quality of life. Gastro-oesophageal reflux (GOR) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. Clinical history in patients with suspected reflux can aid in the diagnosis but traditional investigations for GOR including 24hr oesophageal pH monitoring or endoscopy are not reliable diagnostic tools since the reflux may be non acidic.

The detection of pepsin in the sputum, saliva or bronchial biopsy has been found to be an accurate marker of reflux into the airways. Pepsin is solely produced by parietal cells in the stomach. The presence of pepsin in the upper airways therefore indicates reflux. Studies have demonstrated that pepsin was frequently found in laryngeal biopsies and sputum of patients with signs and symptoms of airways reflux and that Nissen fundoplication resulted in a decrease in pepsin detection alongside an improvement in symptoms. The Peptest™ lateral flow device has been shown to be effective in the detection of pepsin in sputum and saliva of patients with chronic cough and gastro-oesophageal reflux. The investigators have detected pepsin in expectorated saliva during episodes of cough, apparently supporting a diagnosis of airways reflux. Critics, however, have suggested that the act coughing itself is responsible for the reflux.

This study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.


Eligibility Criteria:
Inclusion Criteria:

* A negative score for airway reflux (HARQ score \<13).
* Provision of informed consent.

Exclusion Criteria:

* Participants with a positive score for airway reflux (HARQ score \>13).
* Chronic respiratory disease.
* Acute gastro-respiratory illness at the time of the study.
* Participants who will be physically unable to undergo sputum collection or cough induction.
* Those who are unwilling to undergo cough challenge and induction of cough.
* Smoking or consumption of food, caffeinated or carbonated beverages for 30 minutes prior to sample collection.
Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety

Employing imaginary pills could offer a new way of investigating underlying mechanisms of open label placebo (OLP) treatment by eliminating the physical treatment constituent (i.e., the pill itself). This can reveal the power of the purely psychological component of a placebo and gives insights into underlying mechanisms of placebo effects. The aim of the project is to assess possible effects of an imaginary pill in comparison to no treatment, and open label placebo treatment in subjects with test anxiety.

Interventions (seven to three weeks before the exam) will be held online using a video Chat application such as zoom (https://zoom.us/) or skype (https://www.skype.com/de/) or will take place at the division of Clinical Psychology and Psychotherapy, University of Basel (Missionsstrasse 62, 4055 Basel).


Eligibility Criteria:
Inclusion Criteria:

* Having an exam at the end of the semester, that is still at least four weeks ahead
* Self-reported fear of the exam (i.e., not clinical)
* Healthy by self-report statement (i.e., no known current or chronic somatic diseases or psychiatric disorders)
* Willing to participate in study

Exclusion Criteria:

* Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
* Current medications (psychoactive medication, narcotics, intake of analgesics)
* Any psychiatric disorders or being currently in psychological or psychiatric treatment
* Insufficient German language skills to understand the instructions
* Daily consumption of more than three alcoholic standard beverages (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
* Current or regular drug consumption
* Being a master student in Psychology
* Allergy of one of the ingredients of the placebo pills (P-Dragees blue Lichtenstein)
* Problems to swallow pills
Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age.

The incidence of arterial hypotension under general anesthesia using sevoflurane is particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the initial mean blood pressure (mBP) is the definition of significant arterial hypotension in adults and children. In adults, intraoperative arterial hypotension is associated with an increase of intraoperative mortality and a certain neurological morbidity. In infants under 6 months of age, neurological disorders have been reported following general anesthesia. Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial hypotension.

Current management of hypotension uses vascular filling with crystalloids and vasopressive amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be used. Ephedrine is particularly interesting because of its action on both α and β receptors and its mode of administration: one dose and peripheral access.

Only one study is available in children from birth to adulthood; it demonstrates a lower hemodynamic response in infants than in adults, when administered a low dose of Ephedrine (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and the use of higher doses than those recommended.

The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine associated with a difference of proportion of newborns/infants in therapeutic success of 55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative arterial hypotension.

Secondary objectives:

* Return to a mBP superior to 38mmHg post Ephedrine administration.
* To assess occurrence of hypoxemic events during anesthesia.
* To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6 months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Newborns or infants \< 6 months of age,
* boys and girls,
* premature or not,
* requiring general anesthesia induced by sevoflurane
* who presents during anesthesia a decrease of blood pressure superior to 20% of the basal mBP (measured prior to surgery) despite of vascular filling with sodium chloride 0.9% (10mL/kg during 10 min).
* Written, informed consent obtained from the 2 parents

Exclusion Criteria:

* Allergy to Ephedrine.
* Emergency surgery.
* Patient having previously received other vasopressive amines.
* Use of other indirect sympathomimetic drug such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate.
* Premedication with clonidine
* Congenital heart disease
* IV-induced anesthesia.
Artificial Intelligence - SARS-CoV-2 (COVID-19) Risk Evaluation

The management of COVID-19 patients in overwhelmed hospital facing the pandemic is a clinical challenge.

The improvement of decision making may allow a better allocation of available resources and a better treatment of patients at higher risk.

Chest CT has been widely adopted for COVID-19 pneumonia diagnosis. Several experiences documented the capability of Artificial Intelligence to improve and fasten COVID-19 pneumonia detection, mainly using chest X-ray.

Aim of the present study was to develop and validate an Artificial Intelligence approach integrating clinical and imaging data (automatically extracted through the adoption of dedicated neural networks) for the creation of a cloud platform capable of performing automatic patients risk stratification. Such an approach could be used for triage of COVID-19 patients in the emergency department, with the aim to improve healthcare personnel decision-making and allocation of resources during health emergencies.


Eligibility Criteria:
Inclusion Criteria:

* confirmed SARS-CoV-2 infection with RT-PCR
* non contrast chest CT scan performed within 72 hours after admission to the emergency department

Exclusion Criteria:

* age \< 18 ys
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.

Eligibility Criteria:
Inclusion Criteria:

Head MRI confirmed RI lesions. Sign the informed consent.

Exclusion Criteria:

With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients with pathologically positive lymph nodes who have been treated with resection alone. The investigators have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence occurred 34.6% in mediastinal lymph nodes，13.3% in supraclavicular lymph nodes，10% in abdominal lymph nodes. Distant metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients. Chen reported that the 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (P=0.03). Based on the investigators' studies, treatment failure occurred in 8% patients because of celiac metastases. Small radiation field by omitting celiac axis lymph node basin may ensure 5-6 cycles of concurrent chemotherapy for lower toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. KPS≥70
2. Diagnosis of pathologically positive lymph node thoracic esophageal cancer
3. Complete resection
4. Adequate organ function:

Hematopoietic Absolute granulocyte count at least 1,500/mm\^3 Platelet count at least 150,000/mm\^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

Exclusion Criteria:

1. Uncontrolled diabetes
2. Interval between surgery and adjuvant therapy more than 3 months
3. Sign of recurrence on CT scan or ultrasound or PET-CT No palpable supraclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
4. With Weight loss greater than 10% from baseline
5. With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
6. Be pregnant
The Beijing Adult Dry Eye Cohort Study

To investigate the prevalence of dry eye in adults in Beijing, and explore the extremely dangerous factors of dry eye in adults in Beijing through two years follow-up, and establish a prediction model of dry eye; On this basis, the prevention and treatment strategy of dry eye disease suitable for Chinese people is put forward, and its actual effect is verified.

Specifically, it is planned to carry out cluster random sampling in Jianguomen community, Yongdingmenwai community, and Jiaodaokou community in Dongcheng District, Beijing, and select adults over the age of 18 to enter the queue for observation; In order to ensure the accuracy of the prevalence survey, people with mobility difficulties or mental problems are not excluded. The subjects will be examined by ophthalmology and OSDI questionnaire to determine whether these people have dry eyes. Then the prevalence of dry eye would be expolored. Then through one-year and two-year follow-up, the incidence would be explored.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above, resident population of sample community, able to complete dry eye examination, informed consent signed

Exclusion Criteria:

* Mental illness, mobility difficulties, can not participate in follow-up
Does Vitamin D Improve Glycemic Control in Type II DM?

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetics living in Riyadh area who consume no more than one serving of milk/day
* Do not take vitamin supplement
* Habitually have less than 10 hour of sun exposure per week
* Don't suffer from granulomatous conditions, liver disease, or kidney disease
* Don't take anticonvulsants, barbiturates, or steroids.
* Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
* Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.