cyrilzakka/clinical-trials huggingface dataset:
ECT in Ultra-resistant Schizophrenia

The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with URS: patients who continue to experience persistent positive psychotic symptoms: item score of 4 (moderate) on at least two of four positive symptoms on the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current presence of at least moderately severe illness on the total BPRS-18 (45) and a score of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6 weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previous treatment trials with conventional or atypical antipsychotic drugs from two distinct families at a dose 600 mg of chlorpromazine equivalents.
* Age: from 18 to 55
* Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizers and antidepressants).
* Participants who gave their informed, written consents and agreement of their guardian for the patients under guardianship
* Patients deprived of liberty if they gave their informed, written consents

Exclusion Criteria:

* Current affective episode according to DSM-5 criteria;
* ECT within (the last) 6 months;
* Unstable epilepsy ; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than late dyskinesia or neuroleptic-induced parkinsonism);
* Severe substance use disorders (other than nicotine or caffeine) according to DSM-5 criteria.
* Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
* Women of childbearing age with no adequate contraception, pregnant or lactating women;
* Patients having contraindications to etomidate or any of its excipients;
* Patients having contraindications to neuromuscular blocking agents;
* Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy

The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.

A total of 20 patients were recruited according to the inclusion and exclusion criteria. The patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to participated and signed the informed consent form and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and recording the RPP preoperatively and postoperatively, the mean values of the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative white blood cell (WBC) count.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with acute or chronic cholecystitis
2. Patient hospitalized for cholecystectomy
3. Patients who were voluntarily involved in this study

Exclusion Criteria:

1. Patients who could not cooperate with pulse diagnosis
2. Patients with underlying systemic diseases such as cancer, chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
EXIBIT: Oxaliplatin in Biliary Tract Cancer

The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.

Secondary objectives are : Progression free survival, overall survival and safety.


Eligibility Criteria:
* Histologically proven, locally advanced or metastatic carcinoma of the biliary tract (gallbladder, intrahepatic bile ducts, extrahepatic bile ducts, ampula of Vater)
* For intrahepatic bile ducts, if the diagnosis of biliary tract origin is not evident by imaging or surgical exploration, and so equivalent to liver metastasis with unknown primary site, inclusion is possible if:

  * unknown primary after an exhaustive search for the primary site (chest radiography- , thoracic and abdomino pelvic CT scan, colonoscopy, oesogastroduodenal endoscopy, PSA determination for men or mammography for women, and PET scan if possible).
  * histological examination compatible with adenocarcinoma of bile ducts with the immunostaining expression of cytokeratin : 7+, 20- and 19 +. (Shimonishi, 2000 \^22)
* No prior chemotherapy for advanced disease (first line)
* No radiation therapy within 4 weeks prior to the first gemcitabine administration.
* Unidimensionally measurable disease.
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No known allergy to one of the study drugs
* No prior malignancy
* No CNS metastases
* No peripheral neuropathy \> grade 2
* ECOG PS \<=2
* ANC \> 1.5 X 10\^9 /L
* Platelets \> 100 X 10\^9 /L
* Creatinine \< 1.5 x ULN
* SGPT (ALT) \< 5 x ULN
* Bilirubin \< 2.5 x ULN (patients with jaundice or evidence of bile duct obstruction and in whom the biliary tree can be decompressed by endoscopic percutaneous endoprothesis, with subsequent reduction in bilirubin \< 2.5 x ULN will be eligible for the study).
Continuous Glucose Monitoring Following Hospital Discharge

In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Basal insulin use \>10 units per day
* Hemoglobin A1c \>8.0%
* Smartphone compatible with Clarity App
* Age ≥18 years

Exclusion Criteria:

* Type 1 DM
* Inability to consent
* Pregnancy
* Prisoners
* Discharge to skilled nursing facility
Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia

The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN).

The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN). A total of 45 patients with mean age of 46.09 years (26 female, 19 male) were randomly divided into three groups. The first group received PBM therapy with a new generation diode laser (NGD laser). In the second group, low-level Nd:YAG laser was applied along the affected nerve line and the placebo group received the same protocol with Nd:YAG laser without the device switched on. The scores were recorded before and after the treatment using the Brief Pain Inventory-facial (BPI-facial) scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic trigeminal neuralgia as defined by the International Headache Society (2).
* Patients diagnosed with idiopathic trigeminal neuralgia and receiving medical treatment (carbamazepine, etc.)
* Patients with unilateral, severe, sudden onset of facial pain along the branches of the trigeminal nerve.
* Patients who have not previously received any interventional treatment for TN.
* Patients recently diagnosed and started on a first dose of carbamazepine and its derivatives

Exclusion Criteria:

* • Patients diagnosed with type 2 (atypical, symptomatic) trigeminal neuralgia as defined by the International Headache Society (2).

  * Patients with etiologies such as tumour, multiple sclerosis or neurovascular compression on radiography.
  * Pregnant women
  * Patients with systemic diseases such as diabetes, cardiovascular disease, hypertension, etc.
  * Patients who have been previously diagnosed and treated with any type of TN therapy.
Effects of Comedy Therapy on Anxiety and Vital Signs in Transplant Recipients

This study was conducted to investigate the effects of watching excerpts from classical Turkish comedy films on pre-transplant anxiety levels and vital signs in liver transplant recipients.

H1-0: Watching classical Turkish comedy films has no effect on preoperative anxiety in liver transplant recipients.

H1-1: Watching classical Turkish comedy films reduces preoperative anxiety in liver transplant recipients.

H2-0: Watching classical Turkish comedy films has no effect on preoperative vital signs in liver transplant recipients.

H2-1: Watching classical Turkish comedy films has a positive effect on preoperative vital signs in liver transplant recipients.

Intervention Group:

A patient introduction form and a state anxiety scale will be applied as a pre-test before transplant surgery, and vital signs will be checked. Patients will be shown 10-minute Turkish comedy films prepared by researchers before transplant surgery. After the intervention, vital signs will be checked as a post-test and a state anxiety scale will be applied. A quiet and calm environment will be provided in the patient room while patients are shown the comedy films.

Control Group:

A patient introduction form and a state anxiety scale will be applied as a pre-test before transplant surgery, and vital signs will be checked. No intervention will be made to the control group patients outside of the clinical protocol. After a certain waiting period (average of 30 minutes), the patients' vital signs will be checked and the state anxiety scale will be applied again.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Being a liver transplant recipient,
* Data obtained before transplantation,
* Not having any visual or auditory problems.

Exclusion Criteria:

* Being under 18 years of age,
* Having any visual/auditory problems,
* Not accepting to participate in the study/wanting to leave,
* Not providing hemodynamic instability (sudden change in vital signs, etc.)
Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation

RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.

PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are undergoing peripheral stem cell transplantation.

OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to inclusion of total body irradiation in the conditioning regimen (yes vs no). Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the day of admission for the stem cell transplant and continuing for 28 days or until hospital discharge, whichever is first.

PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Undergoing allogeneic or autologous stem cell transplant (including bone marrow, cord blood, or peripheral blood stem cells) Conditioning regimen must have at least 50% risk of grade III or IV mucositis No grade III or IV hepatic toxicity

PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No grade III or IV toxicity at admission for stem cell transplant No altered mental status

PRIOR CONCURRENT THERAPY: No concurrent vancomycin paste or nonabsorbable antibiotics
Automated Quantification of Dental Plaque

The study generates data that contribute to the development and validation of an automated approach to full-mouth quantification of dental plaque, based on fluorescence images and intraoral scans of teeth with disclosed and undisclosed plaque.


Eligibility Criteria:
Inclusion Criteria:

Males and females ≥ 18 years old Presence of at least one tooth Anatomically possible to perform intraoral imaging Subjects need to be able to understand and follow instructions, as well as to read and sign the informed consent form

Exclusion Criteria:

History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions
68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer

This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution, and tumor uptake of 68Ga-FAPI-FS.

This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.

Eligibility Criteria:
Inclusion Criteria:

1. Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Written informed consent provided for participation in the trial
5. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. Pregnancy or breastfeeding.
2. Severe claustrophobia.
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
* The subject has a HbA1c of 7.0% to 11.0% at Screening.
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than or equal to (\>=) 18 years of age
* Metastatic colorectal cancer

Exclusion Criteria:

* Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
* Central nervous system and bone metastases
* Moderate or severe renal impairment
* Clinically significant cardiac disease
* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
* Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain

The aim of the study is to find out the benefit of echocardiography, which is performed by a physican without a cardiological or radiological specialty. In this case the echocardiography is used in the first contact with a patient with chest pain of unclear etiology. Possible benefit is rapid risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.

Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.

Step one - Education in Cardiac ultrasound. All physicians involved in ENDEMIC study have to undergo education program of heart ultrasonography. This curriculum fulfills BSE level one requirements. Candidates of this program have to make a defined number of ECHOcardiography studies under supervisor control. Every curriculum is finished by exam.

Step two - FOCUS in clinical practise Patients with chest pain are randomized into two groups by the even-odd rule.

Inclusion Criteria:

Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG ) Higher age than 18

Exclusion Criteria:

STEMI Pacemaker / ICD Pregnancy Performance status 4 ( Zubrod scale ) Informed Consent unsigned Prisoners

Step Three - Evaluation

Aims.:

Compare time to make a decision in these groups Compare time of stay at emergency department in these groups Compare time to invasive coronary angiography and revascularization (if available) Compare time to hospital dimission Occurrence of MACE in following 30 days

Eligibility Criteria:
Inclusion Criteria:

* Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
* Higher age than 18

Exclusion Criteria:

* STEMI
* Pacemaker / ICD
* Pregnancy
* Performance status 4 ( Zubrod scale )
* Informed Consent unsigned
* Prisoners
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is:

Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment?

Participants will:

* Be given daily random assignments to avoid or not to avoid alcohol
* Wear an adhesive electrocardiographic (ECG) heart monitor
* Wear a wrist-worn fitness tracker
* Wear an anklet transdermal alcohol monitor
* Wear an adhesive glucose monitor
* Complete morning and evening surveys daily

Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria

* Comfortable reading and writing in English
* Have a smartphone and willing and able to use the Eureka mobile application
* Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
* At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
* Drank alcohol at least 1 day/week on average in the past month
* Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
* Willing and able to provide written informed consent

Exclusion Criteria

* Only post-operative AFib
* Greater than 40% ventricular pacing
* History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
* Intolerance to alcohol
* History of liver disease
* Currently incarcerated
* Currently pregnant or trying to get pregnant
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. older than 60 years of age.
* 2. meeting the indications for coronary intervention.
* 3. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm);
* 4. Target lesion vessel diameter \> 2.5 mm

Exclusion Criteria:

* 1. inability to provide written informed consent.
* 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
* 3. the subject is participating in another uncompleted clinical trial
* 4. life expectancy \<1 year.
* 5. non-in situ vascular lesions.
* 6. cardiogenic shock.
* 7. Patients with hemodynamic instability