cyrilzakka/clinical-trials huggingface dataset:
Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery

The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.

The participants who will undergo third molar surgery divided into study and control groups. Study group divided further into three groups according to multiple intellegence test. Ultimately four groups created as follows;

1. Control: The group with standard (written and verbal) information without multiple intelligence test
2. Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document.
3. Verbal/Linguistic: The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document
4. Bodily/Kinesthetic: The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document To evaluate anxiety; participants will asked to complete MDAS questionnairre before and after consent, and after operation. Also, saliva samples will obtained to evaluate the salivary cortisol before and after consent, and after operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth
* Patients who maintain their normal sleep patterns,
* Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification.

Exclusion Criteria:

* Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure,
* Habits of Smoking and alcohol
* Patients who are pregnant or in the lactation period,
* Patients unable to cooperate,
* Patients having a psychiatric illness,
* Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response)
* Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids.
* Patients with pericoronitis
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.

All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:

Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).

Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).

Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
2. Participants age is 18 years or older.
3. Stage IV disease that is clearly progressive since last therapy
4. ECOG performance status of 0 or 1.

Exclusion Criteria:

1. Patients with uveal melanoma.
2. Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
3. Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
4. More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
5. Women of child bearing potential who are pregnant

Note: This is only a partial list of eligibility criteria.
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

Determine the consequences of COVID-19 pandemic on routine targeted surgeries.

Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation.

The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.


Eligibility Criteria:
Inclusion Criteria:

* hospitalizations with at least one act of cataract surgey hip arthroplasty knee arthroplasty coronary angioplasty definitive cardiac stimulation (pacemaker)
* between January 1, 2019, and June 30, 2021

Exclusion Criteria:

-hospitalizations for personal identifier problems in the database
A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)

The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors (NETs) as a potential new way to help diagnose NETs.

Up to 63 participants will be recruited in this study and who are confirmed or suspected to have NETs based on biochemical evidence or that of conventional anatomical or molecular imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent;
2. Age at enrolment ≥ 18 years;
3. Life expectancy ≥ 12 weeks;
4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET;
5. Adequate recovery from acute toxic effects of any prior therapy;
6. Adequate renal function (eGFR \>30 ml/min);
7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;

Exclusion Criteria:

1. Female participant who are pregnant or lactating;
2. Male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. Abstinence is considered acceptable;
3. Participant has received any treatment (including experimental treatment) for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan;
4. Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
5. History of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study).
6. Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment);
7. Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan;
8. Participants with extensive marrow/skeletal involvement (\>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.
Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

this study was aimed to evaluation of antiangial effect of a new fda drug approval on angina in diabetic patient with refractory angina

This was a prospective, double-blind, randomized pilot trial in which a total of 75 subjects were enrolled with T2DM and refractory angina, despite using conventional anti-anginal agents; and were randomly assigned to group A(Empagliflozin group) or B(placebo group) by blinded envelopes method. the study was conducted in two tertiary centers in Isfahan, Iran. The protocol of the study was revised and approved by the institutional ethics committee of Isfahan University of Medical Sciences; and each patient provided an informed consent before participating in the study. The primary aim of the trial was to examine the efficacy of Empagliflozin versus placebo on angina frequency in subjects with T2DM, CAD, and chronic stable angina who remain symptomatic, despite treatment with either one or two anti-anginal agents.The secondary outcome of this study was the evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ andeffects o Empaglofolzine vs placebo on treadmill exercise duration, times to angina onset and to 1mm ST segment depression and mean of heart rate recovery(HRR) prior to randomization and after 6 weeks of treatment at peak drug level.

Eligibility Criteria:
Inclusion Criteria:

1- T2DM patients over 18 years of age with CAD, who have had minimum 3-month refractory Angina Pectoris (AP) in spite of using full medical treatment , and were not suitable candidates for revascularization or CABG and reproducible angina, ischemic ST-segment depression of at least 1 mm and limited exercise capacity on treadmill testing (3-9 minutes on a modified Bruce protocol) while receiving full medical treatment .

Exclusion Criteria:

1- New York Heart Association functional class III to IV heart failure symptoms, 2- acute coronary syndrome in the past 2 months, 3-any coronary revascularization during the study period, 4- stroke or transient ischemic attack 5- hepatic or renal impairment, 6-prior treatment with Empagliflozin 7- any relative or absolute contraindication to exercise test or specific condition that preclude accurate interpretation of the electrocardiogram(eg,Left bundle branch block(LBBB),resting ST depression more than 1 mm, pre-excitation or digoxin use).

-
GI Symptoms in Infants Fed Goat Milk-based Infant Formula

A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media. Gastrointestinal symptoms after introduction of Goat milk-based infant formula (GMF) were questioned using the validated Cow's Milk-Related Symptom Score (CoMiSS®; scoring 0-33), lower scores indicate fewer symptoms. Occurrence of crying, gassiness, eczema, respiratory symptoms and stool consistency were asked retrospectively before and ≥14 days after introduction of GMF.

A cross-sectional observational online anonymous survey on GI symptoms in infants aged 0-24 months fed GMF has been developed and conducted in Brazil, Mexico, Russia, and The Netherlands. The GMF of interest was commercially available Kabrita® stage 1 or 2 (Ausnutria, B.V., the Netherlands). Participants who had purchased Kabrita® were asked to complete a voluntary survey regarding their experience and observation on their infant's GI complaints. No inclusion criteria were set at the time point of sending out the survey. The survey consisted of 30 questions and was online from June 2021 until November 2022. The survey and associated data collection do not meet the criteria for human subject research and therefore approval by an institutional and/or licensing committee is not needed, and participant consent is not required. Participation in the survey was anonymized and completely voluntary.

Eligibility Criteria:
Inclusion Criteria:

* infants aged 0-24 months
* fed at least once with goat milk-based infants formula

Exclusion Criteria:

* infants aged \>24 months
* taking medication for functional GI disorders
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.

New treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.

Participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years old
* Current major depressive episode
* Habitual TIB of 7 to \< 10 hours
* No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)
* Score of at least 18 on the Hamilton Rating Scale of Depression

Exclusion Criteria:

* Alcohol or substance abuse/dependence in past 6 months
* Current posttraumatic stress disorder or bulimia nervosa (past 6 months)
* Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa
* Trials of fluoxetine in the past 6 months
* Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of \> 5 minutes; history of seizures
* Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder
* Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)
* Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).
* Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.
* Known allergy, hypersensitivity or contraindication to study medication
* Females: pregnant or nursing
Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

Apatinib dose titration in Advanced or Metastatic Gastric Cancer


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 and ≤ 70 years of age
2. Histological confirmed advanced or metastatic adenocarcinoma of the stomach
3. Have failed for at least 2 lines of chemotherapy
4. Life expectancy of at least 12 weeks
5. Eastern Cooperative Oncology Group Performance Status of 0 or 1
6. At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
8. More than 4 weeks for operation or radiotherapy or cytotoxic agents
9. Adequate hepatic, renal, heart, and hematologic functions

Exclusion Criteria:

1. Pregnant or lactating women
2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
3. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
4. Any factors that influence the usage of oral administration
5. Evidence of central nerves system metastasis
6. Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure
7. proteinuria ≥ (+)
8. International Normalized Ratio \> 1.5 and activated partial thromboplastin time \> 1.5 × Upper limit of normal（ULN）
9. Certain possibility of gastric or intestine hemorrhage
10. Less than 4 weeks from the last clinical trial
11. Prior VEGFR inhibitor treatment
12. Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
* Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent
* Patient is able to understand the nature of the study and provide written informed consent
* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
* Patient accepts Home Monitoring® concept
* Patient age is greater than or equal to 18 years at time of consent

Exclusion Criteria:

* Patient meets a standard contraindication for pacemaker system implant
* Patient is currently implanted with a pacemaker or ICD device
* Patient has had a previous unsuccessful attempt to place a lead in the LBBA
* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
* Patient is expected to receive a heart transplant within 12 months
* Patient life expectancy less than 12 months
* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patient reports pregnancy at the time of enrollment
* Patient is enrolled in any other investigational cardiac clinical study during the course of the study
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear.

Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients.

Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study.
* Only patients above 18 years will be included.
Evaluation of Control Chart Impact on Surgical Outcomes

This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.


Eligibility Criteria:
Inclusion Criteria:

- All adults needing a digestive surgery who are hospitalized in one of the 40 departments

Exclusion Criteria:

* Age \< 18 years old
* Hospitalization \<24 hours
* Absence of surgical procedure
* Ambulatory care
* Palliative care
* Organ transplantation
Lung Cancer Patients' Attitudes to a Second Course of Radiotherapy

Patients with lung cancer are often treated with high dose x-ray treatment (radical radiotherapy) to control the disease. After one course of radiotherapy, after a period of time, there is a risk that the cancer can come back in either the same place or nearby in the lungs. This happens to about 700 patients in the UK every year. There is no strong evidence to suggest what the best treatment is in this situation.

One possible treatment is a second course of radiotherapy (re-irradiation). Early studies show that a re-irradiation may cause significant side effects like breathlessness or problems swallowing, but may control the cancer for a long period of time. We want to do a clinical trial to investigate if re-irradiation improves cancer control compared to other treatments to help guide treatment for patients with recurrent disease.

Before we can go ahead with the trial, we would like to talk to patients who are have completed radiotherapy to find out what are their feelings about having a second course of radiotherapy if needed, and how the side effects from the initial course of radiotherapy or the projected side-effects from the second course would affect that decision.

This information is vitally important to help develop a trial about re-irradiation in lung cancer as it will demonstrate if patients would accept a second course of radiotherapy, and, by accounting for patient concerns in the trial design, will make it more likely to recruit well.

This study will perform telephone interviews with patients five weeks after completing a course of radical radiotherapy for lung cancer at the Beatson Cancer Centre. We expect to interview 16-30 patients. This study will run over the course of 1 year. This research is funded by the Beatson Cancer Charity and The University of Glasgow.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or above
* Pathological or radiological diagnosis of non-small cell lung cancer
* Undergoing radical radiotherapy to the thorax using the following fractionations (55 Gray in 20 fractions, 54 Gray in 36 fractions or any Stereotactic Ablative Body Radiotherapy (SABR) fractionation that delivers a biological effective dose of greater than 100Gy10) as part of their primary lung cancer treatment at time of study enrolment
* Patients receiving concurrent and/or adjuvant systemic therapies are permitted
* Radiotherapy is delivered in the Beatson West of Scotland Cancer Centre
* Signed, written informed consent
* Willing and able to complete study processes

Exclusion Criteria:

* Not fluent in English