cyrilzakka/clinical-trials huggingface dataset:
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

This is a prospective exploratory study using narrative therapy in group format, over 20 sessions, 2 hours per session, weekly, to determine whether this modality can provide any benefit to OCD symptoms, mood, sense of social connectedness, sense of identity, and/or quality of life in individuals living with treatment-resistant OCD. NOTE: an amendment is now in place so that the group can occur virtually given the COVID pandemic; Zoom will be used as our platform.

Many patients referred to the Thompson Centre at Sunnybrook have severe OCD, and have significant and disabling symptoms even after completing our treatment protocols, including our intensive and residential programs. These patients have already undergone traditional cognitive behavioural therapy (CBT) and exposure and response prevention (ERP), as well as pharmacotherapy. Patients voice distress at their poor quality of life and high symptom burden, and can feel hopeless, if they have exhausted numerous evidence-based treatment options without significant improvement. Narrative therapy is a unique approach, based on the premise that language reflects a social construction of reality. Individuals with severe mental illness hold within themselves life narratives that reinforce their painful beliefs about themselves, the world, and others. Evidence indicates that narrative therapy can help to create a more cohesive identity and a more flexible view of the self and the future.

Our primary goal is to determine whether narrative therapy could improve OCD symptom burden and quality of life in a highly treatment-resistant population. Domains such as mood, identity, and interpersonal connectedness are secondary measures. The research questions are: could narrative therapy lead to symptomatic improvement in treatment-resistant OCD? And could narrative therapy improve the domains of mood, interpersonal connectedness, and/or identity in patients with treatment-resistant OCD?

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and write fluently in English.
* Patients who have participated in the intensive/residential program or group programs and/or have received pharmacotherapy with a psychiatrist at the Frederick W. Thomspon Anxiety Disorder Centre
* Patients between the ages of 18-65
* Only patients who have treatment-resistant OCD are eligible. For the purposes of this study we are defining this as: failure to achieve remission after having tried 1) At least two first-line SSRI's AND either clomipramine or atypical antipsychotic augmentation, and 2) at least one full course of exposure and response prevention (ERP), or our intensive/residential program.

Exclusion Criteria:

* those with active substance abuse/dependence within three months
* suspected organic pathology
* recent suicide attempt/active suicidality
* current self-injurious behaviour
* active bipolar or psychotic disorder
* history of aggression
Management of Obese Patients With Gastroesophageal Reflux Disease .

The aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms.

All patients underwent a preoperative work-up including history and physical examination, routine laboratory investigations, ECG, chest radiography, pulmonary function tests, abdominal ultrasonography, and barium swallow, upper GIT endos¬copy, 24 hours PH monitoring, nutritional, and psychiat¬ric evaluation. Further exams and/or consultations were performed when indicated. The study design was a pro¬spective randomized controlled study that received ap¬proval from the ethics committee in relevant hospitals. All the patients gave an informed written consent All patients had a written informed consent of the two types laparoscopic procedures of obesity, Prophylactic anticoagulant medications will be given to all patients in the form of subcutaneous Clexane 0.5 unit/Kg/24. An Intensive care unit (ICU) bed will be reserved for all patients the night of operation with the decision of transfer left to the postoperative recovery assessment.

According to the patient selection, all patients will be divided into two groups as follows:

Group (A): Patients will do Laparoscopic sleeve gastrectomy with crural repair. Under a general anesthesia, the patient was placed in the split-leg position with the surgeon standing between the legs and the assistant on the left-hand side of the pa¬tient. A veress needle was used to create the pneumoperi-toneum. Three 12-mm trocars were inserted in the upper abdomen (one on the right, two on the left side) and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpel (Ethicon Endo-Surgery Inc., Cincinnati, OH) to get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years.
* Both sexes.
* BMI ≥ 40 or ≥ 35 with co-morbidity.with reflux symptoms .
* Failure of non-surgical treatment.
* Patients with hiatus hernia .
* Absence of endocrinal or psychological disorders.
* Failure of non surgical treatment
* Non sweat eaters
* Patients with no previous upper GIT surgeries

Exclusion Criteria:

* Presence of endocrinal or psychological disorders.
* Morbidly obese patients with no reflux symptoms
* sweat eaters
* Patients with barrett,s oesophagus ,
* Patient with bad general condition
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform

All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0

Eligibility Criteria:
Inclusion Criteria:

1. Age: older than 19
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
3. Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
4. Patients who are currently administering EGFR TKI or EGFR mAb

Exclusion Criteria:

1. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
2. Patients with a history of topical medication

   * Steroids within 3 days prior to baseline visit
   * Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit
   * Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit
Field Usability Study of Eclipse Mask

The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.


Eligibility Criteria:
Inclusion Criteria:

•Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.

Exclusion Criteria:

* Diagnosis of any medical or behavioral conditions that would compromise subject safety.
* Under the age of 18: target for this current version of the platform is the adult population.
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube

The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
2. Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team
3. Endotracheal tube size 7.0 mm to 8.5 mm in diameter

Exclusion Criteria:

1. Patients with active hemoptysis
2. Patients with known tracheal or bronchial masses prior to endotracheal intubation
3. Patients with known tracheal or bronchial abnormalities requiring surgical repair
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

The duration of treatment is 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Any known allergy to the study drugs
Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy

In this explorative study, the feasibility of therapeutic fasting to reduce limitations in physical well-being and quality of life of patients undergoing endocrine therapy with aromatase inhibitors will be investigated. In addition, the application of the StudyU app, which is currently under development, will be monitored and the app adapted if necessary. In addition, in preparation for a larger multicenter main study, it will be examined whether the muscle and joint complaints frequently experienced by patients undergoing endocrine therapy with aromatase inhibitors (AI) can be alleviated by a 7-day guided therapeutic fasting intervention (prolonged fasting / PF) can be improved.

After baseline (t0), all patients will receive the following intervention:

7 days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).

Following the study intervention, at t1, patients will be offered a for a potential effect as sustainable as possible in addition to a dietary change.

According to the following criteria:

* As plant-based as possible
* Rich in nutritive prebiotics
* In addition, this group should include intermittent fasting/time restricted eating (16/8h) into their dietary habits (at least 6d/week).

All patients will be interviewed on a regular basis and anthropometric data will be collected accordingly at following time points:

* t1 (at the end of the fasting intervention).
* t2 (3 months after t0)

Eligibility Criteria:
Inclusion Criteria:

* Patients with curatively treated hormone receptor positive breast cancer who have been on aromatase inhibitors (AI) therapy for at least 3 months and have significant Pain (NRS\>4).
* Informed consent.

Exclusion Criteria:

* Eating disorders.
* Permanent medication other than endocrine therapy, which would constitute an absolute or relative contraindication to outpatient fasting, such as Marcumar, lithium, Antiepileptic drugs, etc.
* Patients with diabetes mellitus type 1 or 2
* Uncontrolled cerebral seizure disorder.
* Participation in another diet/fasting study.
* Lack of willingness to store and share personal medical data within the framework of the protocol.
* Insufficient knowledge of the German language.
Survivorship Promotion In Reducing IGF-1 Trial

This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors


Eligibility Criteria:
Inclusion Criteria:

* Women and men ages 18 or older
* Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
* Have a BMI of 25 kg/m\^2 or greater and weight \<=400 lbs.
* Willingness to accept randomization to each of the three arms
* Willingness to change diet, physical activity, and weight
* Regular access to computer with a reliable Internet connection
* Ability to send and receive emails
* Ability to complete online forms
* Access to phone
* Willingness to provide written informed consent

Exclusion Criteria:

* Women who are breastfeeding, pregnant, or planning pregnancy within the next year
* Medication-treated diabetes
* Fasting blood glucose \>=200 mg/dL, or fasting blood glucose \>=126 and \<200 mg/dL and HbA1C \>=7%
* Current or prior regular use of metformin within the past 3 months
* Uncontrolled concurrent medical condition likely to limit compliance with the study interventions
* Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date
* Have a prior history of lactic acidosis by self-report
* Prior or planned bariatric surgery
* Have significant renal disease or dysfunction defined as Estimated glomerular filtration rate (eGFR)\<45
* Have significant hepatic dysfunction \[Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (ULN) or reported liver disease\]
* Self-reported average consumption of \> 14 alcoholic drink per week
* Currently enrolled or planned to enroll in weight loss program
* Hemoglobin \<9 g/dl
* Platelet count \<100
* White blood cell count (WBC) \<2.5
* Plans to relocate from the area within one years
* Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.
Calprotectin I Serum as a Diagnostic Marker

Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).


Eligibility Criteria:
Inclusion Criteria:

* clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (AECOPD)
* COPD diagnosis previously confirmed by spirometry according to the GOLD criteria.

Exclusion Criteria:

* known malignant disease
* bronchiectasis
* chronic bacterial colonisation of the airways
* treatment with an immunosuppressive drug or long-term treatment with antibiotics.
* not examined with a chest X-ray at admission
Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.

Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction and additional risk factors on plaque morphology and plaque burden in patients with diabetes mellitus.

Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as patients with a prior (MI) without diabetes. In addition to macrovascular complications, and traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting several organs. The dynamics between microvascular dysfunction, known cardiac risk factors and coronary atherosclerosis in diabetic disease is not well characterized.

In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type 1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in diabetes will be compared to a historical cohort of patients with acute myocardial infarction (AMI).

All study participant will undergo the following examinations at baseline:

* CCTA
* CAC-score
* Transthoracic echocardiography
* 12-lead ECG
* Blood pressure and pulse frequency
* Height, weight, waist to hip-ratio
* Blood samples and urin samples
* Medical history

After 12 months all of the above examinations will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Type 1 or 2 diabetes mellitus
* Ability to provide informed conscent

Exclusion Criteria:

* History of CAD
* Symtoms of CAD (angina)
* Any tachyarrhythmias making CCTA impossible
* Glumerular filtration rate (GFR)\< 45 ml/min
* Allergy to iodine contrast
* Critical illness with life expectancy less than 1 year
* Documented heart failure
Safety and Effectiveness Study of rhGAA in Patients With Advanced Late-Onset Pompe Disease Receiving Respiratory Support

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety and efficacy of rhGAA in patients with advanced Late-onset Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged greater than or equal to 18 years
* patient's legally authorized guardian(s) must provide signed, informed consent prior to initiation of study; patient's signature required if patient understands informed consent
* patient must have a documented deficit in acid alpha-glucosidase (GAA) activity , corresponding to the diagnosis of Pompe disease confirmed by documented genotyping
* patient presents with advanced documented symptoms of the disease defined as follows: patient is in a wheel chair and presents diaphragmatic dysfunction and requires invasive ventilation or non invasive ventilation (12 or more hours daily)

Exclusion Criteria:

* patient has received enzyme replacement therapy with GAA from any source
* patient has taken an experimental drug in the 30 days prior to study enrollment, or is currently included in another study involving clinical evaluations; If this is the case, inclusion of the patient in the present study will be subject to prior agreement by Genzyme
* major congenital anomaly
* clinically important organic disease (except for symptoms related to Pompe disease) or any other medical condition, serious intercurrent illness, or other extenuating circumstance that, in the physician's opinion should preclude the patient's participation in the study or may reduce survival
* pregnancy and breastfeeding (women of childbearing age must use a medically accepted method of contraception throughout the entire duration of the trial. Male patients must use a medically accepted birth control method throughout the entire duration of the study)
Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis

Patients with unexplained atherosclerosis (severe atherosclerosis not explained by traditional risk factors) will receive fecal microbial transplants (FMT) from patients with a Protected phenotype (patients who have high levels of risk factors but little or no carotid atherosclerosis). The objective is to determine what changes in the intestinal microbiome are associated with a decline in plasma levels of toxic metabolites of the itnestinal microbiome such as trimethylamine N-oxide (TMAO) and p-cresylsulfate. The intention is to develop an ecosystem therapeutic of cultured bacteria to treat atherosclerosis.

100 patients with Unexplained Atherosclerosis, and 5 donors with the protected phenotype will be recruited; there will be extensive microbial, viral and parasitic screening of the donors. Recipients will be randomized to receive capsules of stool from the donors, or cellulose placebo. Recipients will take cloxacillin 500 mg 4 times daily for 5 days before the FMT, and will undergo purging with an electrolyte solution, (PegLyte) the day before the FMT. Metagenomic analysis of the recipient stool will be performed before FMT, 6 weeks later and after 12 months.Plasma levels of toxic intestinal metabolites will be measured before FMT, at 6 weeks and 12 months after FMT; the levels to be measured will be TMAO, P-cresylsulfate, Hippuric acid. Indoxyl sulfate, P-cresyl glucuronide. Phenyl acetyl glutamine, and Phenyl sulfate.

The investigators will analyze the metagenomic changes in the intestinal microbiome of recipients that are associated with decline in the plasma levels of the metabolic products of the intestinal microbiome to identify candidate bacteria for an "ecosystem therapeutic for atherosclerosis. Based on previous experience of designing such a therapeutic for clostridium difficile, it is anticipated that \~ 40 bacterial species would be needed.

Eligibility Criteria:
Inclusion Criteria:

* Severe atherosclerosis, with total plaque area in the top quartile (\>119 mm2), not explained by traditional risk factors in linear regression (residual score \>= 2)

Exclusion Criteria:

* Excluded will be patients unwilling/unable to provide informed consent, unwilling to ingest the stool capsules at baseline, patients with moderate to severe renal failure (eGFR\<50), immunosuppressed patients, and patients with cancer, unstable angina, planned carotid revascularization or other conditions that might be expected to reduce their survival to \< 1 year (including age \>80).