cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)

Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.


Eligibility Criteria:
Inclusion Criteria:

i. Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)

ii. Online informed consent of participation in the study should be provided

iii. Willing to comply with the requirements of the study protocol

iv. The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)

v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period

vi. Having access to a smartphone and consistent internet access for their smartphone

vii. Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention

Exclusion Criteria:

i. A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome

ii. A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder

iii. Presence of serious suicidality as evidenced by ideation with a plan or an attempt

iv. Receiving any pharmacological treatment (including sleep promoting agents)

v. Receiving any structured psychotherapy

vi. Having shiftwork and trans-meridian travel in the past 3 months and during the intervention
The Accuracy of s-CAIS Compared With c-LIS

To compare the static computer-aided implant surgery (s-CAIS) and conventional laboratory-guided implant surgery (c-LIS) in terms of accuracy for single tooth replacement in posterior areas.

There was still a lack of evidence in randomized clinical studies about the accuracy measurement comparing digital and laboratory workflows with tooth-supported templates for single implant cases in the posterior regions. Therefore, this present study's primary investigation was to perform accuracy measurement comparing digital and laboratory workflows with tooth-supported templates for single implant cases in the posterior regions. The secondary investigation was to find the effect of several factors on the accuracy of implant placement in these areas.

Eligibility Criteria:
Inclusion Criteria:

* Patients had a partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonistic contacts
* Patients had healthy periodontal status and adequate keratinized gingiva at the edentulous space

Exclusion Criteria:

* - Patients have any local and systemic diseases considered as contraindications for dental implant treatment.
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction
* Subjects must be habitual wearers of toric soft contact lenses.

Exclusion Criteria:

* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus

The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* able to sign informed consent
* able to arrange transportation to and from study site
* without acute stroke, concussion or traumatic brain injury
* without acute medical issues at the time of participation
* At least 12 weeks post Kidney transplant surgery

Exclusion Criteria:

* are claustrophobic or have other contra-indication for magnetic resonance imaging (MRI)
* have hearing or visual impairment
* are unable to read, write, speak or understand English
* have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
* taking Envarsus at the time of recruitment
Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure

Thirty (30) orthopaedic surgeons from the University of Florida Department of Orthopaedics and Rehabilitation will be recruited and enrolled in the study to determine whether having a laser pointed on a fluoroscopy machine can significantly decrease the amount of radiation exposure as measured while obtaining multiple views during surgery as well as decrease radiation exposure and time to accomplish the goals of surgery.

The subject be asked to participate in one test session at the UF Psychomotor and Surgical Skills Lab located in the UF Orthopaedics \& Sports Medicine Institute. During this test session the patient will be asked to wear a 0.5mm thick lead wrap-around apron and thyroid shield for maximal protection from radiation. The patient will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves.

The patient will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer.

A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.

The patient will attempt to achieve the perfect views using the fluoroscopy unit with and without the laser pointer. The use of the laser pointer will be randomized by a randomization table that is prepared prior to testing. The patient's total fluoroscopy time and the number of shots you take for each task recorded. The investigators will also record the number of years training the patient has as an orthopaedic surgeon.

Female Participants: Because the radiation exposure from the fluoroscopy machine in this study might affect an unborn baby, the patient will not be allowed to participate in the study if they are pregnant. All women of childbearing potential must take a pregnancy test prior to participating in this study.

Eligibility Criteria:
Inclusion Criteria:

orthopaedic surgeons (Attendings, Fellows, and Residents) from the Department of Orthopaedics and Rehabilitation

Exclusion Criteria:

non-orthopaedic surgeons (Attendings, Fellows, and Residents) from the Department of Orthopaedics and Rehabilitation
Study Evaluating Bifeprunox in Bipolar Depression

The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age, inclusive.
* Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.

Exclusion Criteria:

* This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan

This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20.


Eligibility Criteria:
Inclusion Criteria:

* Adult Chinese subjects, at age 18-65, diagnosed with Type 2 diabetic nephropathy (Stage II-IV) who meet the WHO diagnostic standards of diabetes in 1999. The international Mogensen staging standard for diabetic nephropathy is used. Specifically, in Stage II (normal albuminuria stage), the UAER is normal (\<20μg /min or\<30mg/24h). In Stage III (early diabetic nephropathy stage), the UAER is 20-200μg /min or 30-300 mg/24h. In Stage IV (clinical or overt diabetic nephropathy stage), the UAER is \>200μg/min or urine protein quantitation is \>500mg /24h.

Exclusion Criteria:

* Renal damage caused by other causes;
* Uncontrolled hypertension (blood pressure constantly greater than 140/ 90mmHg);
* Type 1 Diabetes
* Any acute and chronic infections;
* Glycosylated hemoglobin (HbA1c)\>7.5%;
* 24h urinary protein quantity\>3g, serum albumin\<25g /L and estimated glomerular filtration rate (eGFR)\<60 ml/min;
* Patients who suffered from malignant tumors or any illness that endanger life, such as liver, kidney, heart and lung function insufficiency over the past 5 years;
* People who have received the gastrointestinal operation, which may affect absorption of Vitamin D;
* People who have taken such drugs as angiotensin receptor blocker, calcium, and angiotensin converting enzyme inhibitor that affect excretion of urine protein, and who have been allergic to Vitamin D;
* Pregnant or lactating women;
* Other candidates that are deemed not suitable by investigators.
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
* Patient has a documented clinical diagnosis of schizophrenia
* Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Patients with a known intolerance or lack of response to previous treatment with quetiapine
* Patients who have previously participated in this study
Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.

This is a randomized study that sought to analyze the diagnostic accuracy of the telemedicine consultation of patients suspected of respiratory tract infections during COVID-19 pandemic in comparison with the face-to-face evaluation at the emergency department.

Unicentric, prospective and randomized study performed between September and November 2020 with adult patients who sought care at emergency department. The inclusion criterion was the exhibition of any tract respiratory symptom. Patients older than 65 years, with chronic heart or lung diseases or immunosuppressed were excluded. Eligible patients were randomized 1:1 for a brief telemedicine consultation, blinded to subsequent face-to-face evaluation or direct face-to-face evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one acute symptom compatible with RTI (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) in presence or absence of symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) that motivated spontaneously face-to-face evaluation at the ED.

Exclusion Criteria:

* Patients with diagnosis of chronic respiratory diseases (chronic obstructive pulmonary disease, asthma and interstitial lung disease)
* Patients with previous diagnosis of congestive heart failure,
* Patients with HIV / AIDS
* Patients with active cancer
* Patients with type I diabetes mellitus
* Patients in use of any immunosuppressant
* Patients with chronic cough
* Patiets that referral to emergency room after nursing triage.
The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery

The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 20 and 75 who were diagnosed with as having osteoarthritis or osteonecrosis of the femoral head
* Scheduled for an elective primary total hip arthroplasty
* Those who were willing and able to return for follow-up over at least a 6-month postoperative period

Exclusion Criteria:

* Acute coronary syndrome \< 6 months
* Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium \< 3.0 mmol, alcohol abuse, premenopausal women
* Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors
* Patients with history of thromboembolic disease, bleeding disorder
* Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation ) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
* Allergy to TXA
Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer

A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients with Advanced Colorectal Cancer and Liver Metastases.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal adenocarcinoma (stage IV) with at least 1 measurable hepatic lesion of 20 mm or more on MRI and for whom no standard therapy is available.
* WHO Performance status 0 - 2.
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry and stable without steroid treatment for 10 days or greater.
* Last dose of prior chemotherapy must be discontinued at least 4 weeks before the start of study treatment.
* Last dose of radiotherapy received within 4 weeks before the start of study treatment excluding palliative radiotherapy.
* Prior treatment with VEGFR TKIs
* Serum bilirubin . 1.5 x the upper limit of reference range.
* Serum creatinine \>1.5 x ULRR or Creatinine clearance (as determined by the Cockcroft - Gault method) less than or equal to 50 mL/min.
* ALT or AST \>5 x ULRR
* ALP \>5 x ULRR
* Evidence of severe or uncontrolled systemic disease or any concurrent conditions which in the investigators opinion make it undesirable for the patient to participate in the study or would jeopardize compliance with the protocol.
* Any unresolved toxicity greater than CTCAE Grade 2 for previous anti-cancer therapy.
* Significant cardiovascular event within 3 months before entry, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
* History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled by medication is not excluded.
* Congenital long QT syndrome or 1st degree relative with sudden unexplained death under of 40 years of age.
* Presence of Left Bundle Branch Block.
* QTc with Bazett's correction unmeasurable or greater than or equal to 480 msec or greater of screening ECG.
* Potassium \<4.0 mmol/L despite supplementation, serum calcium (ionized or adjusted for albumin), or magnesium out of normal range despite supplementation.
* Women who are pregnant or breast feeding.
* Any concomitant medications that may cause QTc prolongation or induce or induce Torsades de Pointes or induce CTP3A4 function.
* Hypotension not controlled by medical therapy.
* Participation in a clinical study of any investigational pharmaceutical agent within 30 days prior to commencing study treatment.
* Major surgery within 4 weeks or incompletely healed surgical incision.
* Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or Squamous cell carcinoma of the skin.
* Any contraindications to MRI scans.
* Involvement in the planning or conduct of the study.
* Previous enrollment or randomization of treatment in the present study.
Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.

Liraglutide and Orlistat improve glycemic control by increasing glucagon-like-peptide-1 (GLP-1) response and fat malabsorption, respectively but do not reverse type 2 diabetes. Roux-en-y gastric bypass (RYGB) surgery reverses type 2 diabetes 84% of the time while the less invasive, reversible laparoscopic adjustable gastric banding (LAGB) procedure reverses type 2 diabetes 48% of the time.

Decreased caloric intake occurs after RYGB and LAGB but increased post-prandial GLP-1 response and fat malabsorption only occur after RYGB. Since FDA-approved agents Liraglutide and Orlistat increase GLP-1 response and fat malabsorption, respectively, it is of significant clinical interest to determine if addition of Liraglutide and/or Orlistat can improve type 2 diabetes remission rates in the 52% of patients who have not achieved diabetes reversal after gastric banding.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible if they meet the following criteria:

* male or female,
* age 25-70 years,
* BMI 26-65,
* type 2 diabetic,
* weight stable for 3 months,
* status post laparoscopic adjustable gastric banding (LAGB) for at least 1 year,
* hemoglobin a1c 7-10%;
* on any diabetic regimen including insulin except for thiazolidinedione use in the past 6 months.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* prior history of pancreatitis,
* prior history of gastroparesis,
* glomerular filtration rate (GFR) \< 50,
* history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer,
* history of cholelithiasis,
* history of hyperoxaluria or calcium oxalate nephrolithiasis,
* abnormal AST,
* ALT elevation,
* current or past history of liver disease,
* history of Roux-en-y gastric bypass or gastric sleeve or any other bariatric procedure other than LAGB,
* type 1 diabetes,
* any gastrointestinal disease causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue),
* prior history of Orlistat or incretin therapy use in past 3 months,
* unwilling or unable to complete scheduled testing,
* thiazolidinedione use within past 6 months,
* any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study.

Patients who have had organ transplantation are on chronic anticoagulation, pregnant or have A1C values \> 10% will also be excluded.
Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length

A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.

This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.

Eligibility Criteria:
Inclusion Criteria:

* all twin pregnancies
* cervical length less than 30mm

Exclusion Criteria:

* Twin to twin transfusion syndrome
* Stillbirth
* congenital anomaly in one of the fetuses
* previous cervical trauma or surgery
* cervical cerclage in current pregnancy
* premature labour with or without rupture of membranes
* severe vaginal discharge
* acute vaginitis or cervicitis
An Assessment of the Occurrence of Hormone Deficiency in Patients With Empty Sella

The goal of this prospective study is to analyse the hormonal components in the blood of patients that were diagnosed with empty sella. Hereby we only take the hormones into consideration that are produced by the pituitary gland and/or are influenced by it due to positive/negative feedback. These are GH, ACTH, TSH, FSH, LH, PRL, oxytocine, ADH but also IGF-1, estradiol, testosteron, F4 and cortisol. The purpose is to see if abnormalities of the blook levels can be explained by the absence/shrinking of the pituitary gland. During this study, there will be a blood draw twice. The reason is to avoid wrong positive and negative results. Together with the second blood draw, there will be an insuline tolerance test in all patients. MRI will only be done if the last taken image is more than two years old or if the MRI was not taken with main focus on the pituitary gland.


Eligibility Criteria:
Inclusion Criteria:

* Patients that were diagnosed with an (partial) empty sella detected by MRI or CT of the brain have been included in this study. Whenever the MRI or CT scan was performed more than two years ago, a new MRI scan was required.

Exclusion Criteria:

* Children (patients less than 18 years) and patients with earlier diagnosed carcinomas of the brain as well as patients with secondary empty sella (antecedents of radiation, pharmacological treatment of pituitary adenomas, traumatic head injury and surgery of the pituitary gland as well as the central nervous system) were not included.
The Impact of Tai Chi Combined With Music Therapy Intervention on Depression and Anxiety Among College Students

This study aims to investigate the effects of Tai Chi combined with music therapy on alleviating depression and anxiety among college students. Depression and anxiety are prevalent among college students and have a significant impact on their lives and academic performance. Therefore, exploring effective interventions is crucial for promoting the mental health of college students.


Eligibility Criteria:
Inclusion Criteria:

* This study were being enrolled as a student at Tianjin University of Sport
* aged between 18 and 25 years
* proficient in reading and communicating in Chinese.

Exclusion Criteria:

* Students with visual impairments
* Students with auditory
* Students with other impairments