cyrilzakka/clinical-trials huggingface dataset:
Improve: Integrating Emotion Focused Components Into Psychological Therapy

The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on differential effects. Moreover, the mechanisms of change of both conditions are investigated.

Background:

"General Psychotherapy" postulates an ongoing process of including all interventions and concepts relevant for a domain, be they from other approaches to psychotherapy or concepts from basic science. "Psychological Therapy" (PT) is a therapeutic approach largely corresponding to the ideas of General Psychotherapy. It draws mainly on empirically validated interventions from Cognitive Behavior Therapy (CBT) and is based on concepts with a strong basis in academic psychology and neighboring fields. PT is based on explicit individual case conceptualization, reference to general therapeutic factors, and an explicit prescriptive concept for building and maintaining the therapeutic relationship. However the range of emotion-related interventions commonly used in PT is limited when compared with an approach like Emotion Focused Therapy (EFT). EFT appears thus as a suitable complement and enrichment to PT as commonly practiced. However, effects of integrating EFT-based interventions in a way that is close to common integrative practice have not yet been studied.

Objective:

To compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of EFT components and TAU with focus on self-regulation (SR).

Methods:

In Switzerland, a randomized-controlled trail will be carried out in secondary care, comparing the efficacy of TAU - EFT and TAU - SR for adults with major depressive disorder, anxiety disorder or adjustment disorder. Respondents will be followed until 36 months after end of therapy (measures will be taken at baseline, after 8 and after 16 weeks, at the end of therapy after 25 weeks, 6 months, 12 months and 36 months follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder, Anxiety Disorder or Adjustment Disorder according to DSM-IV as main diagnosis
* Minimum age of 18 years
* Mastery of the German language for being able to undergo a psychotherapy in German
* Written informed consent to participate voluntary in the study

Exclusion Criteria:

* Acute suicidality or immediate threats of self-harm
* Diagnosis or history of a psychotic disorder
* Mood incongruent psychotic symptoms
* Bipolar disorder
* Comorbid chronic organic disorder
* Substance use disorder as a main diagnosis
* Indication for a residential treatment
Investigation of Glass Carbomer Performance

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

In this study, total of 100 (46 class I, 54 class II) restorations were performed in 36 patients. All cavities were prepared conventionally. Half of the restorations were restored with nano composite resin (Tokuyama Estelite, Tokuyama Dental, Japan) and the other half were restored with glass carbomer material (GCP Dental, The Netherlands). Rubber-dam was used for isolation. Before the replacement of composite restorations, enamel edges were etched according to selective etching method. Then universal adhesive system was applied. Composite resin was applied to the cavity in 2 mm layers by incramental technique. Glass carbomer was placed with bulk technique by applying finger pressure with surface covering. Composite restorations were polymerized with LED light curing unit. Glass carbomer restorations were cured its own special curing unit. Restorations were evaluated with modified USPHS criteria at the end of the first week, 6 months and 12 months. Data were analyzed using Fisher's Exact Chi-Square test, Fisher Freeman Halton Test and Continuity (Yates) Correction. Wilcoxon sign test was used for intra-group comparisons of the parameters. Statistically significance was evaluated at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. 20-25 years of age
2. No systemic diseases
3. Presence of molar / premolar teeth with occlusal and / or interface caries
4. Lack of parafunctional habits such as clenching and grinding of teeth
5. Lack of cooperation problems
6. Accepted regular visits -

Exclusion Criteria:

* 1-Any endodontic treatment or withdrawal indications (abscess, swelling and fistula complaints, palpation and percussion pain, spontaneous or night pain) 2- Teeth with congenital developmental defect 3- Teeth with pathological mobility 4- Teeth which do not have normal occlusion due to skeletal or pathological reasons 5- Lack of contact or opposite teeth
Studying Lipids as Potential Biomarkers in Patients With Fabry Disease

Compare levels of lipids between well characterised enzymatically-genetically-phenotypically patients with Fabry disease and healthy controls (with no Fabry disease).

Correlate levels of lipids in patients with Fabry disease to clinical outcomes/manifestations of the disease.

The hypothesis is that Sphingosine-1 Phosphate (S1P) or any other related sphingoid bases and/or other lipid class could be a marker of the severity of cardiovascular remodelling in Fabry disease.

The overall approach is, by minimising possible pre-analytical and analytical biases, to study by lipidomics in well characterised enzymatically, genetically and phenotypically patients with Fabry disease, if S1P or any other lipid (including other glycosphingolipids) is shown to be a biomarker for the diagnosis, monitoring of disease activity and prognosis (including cardiovascular outcomes).

Eligibility Criteria:
Inclusion criteria for cases:

* Adult men and women
* Well characterized Fabry disease in terms of i. alpha-Gal A enzyme activity, ii. mutation in alpha-Gal A (GLA) gene, and iii. disease manifestations
* Followed at one of the 3 centers for patients with Fabry disease in Sweden (Karolinska in Stockholm, Sahlgrenska in Gothenburg, Akademiska in Uppsala)

Signed informed consent prior to sample collection is mandatory for inclusion to the study.

Inclusion criteria for controls:

* Adult men and women
* Followed/treated at the endocrinology or nephrology in- or out-patient clinic at Sahlgrenska University Hospital in Gothenburg
* Matched for age, sex, estimated Glomerular filtration rate (eGFR) with the cases with Fabry disease

Exclusion criteria for controls:

* Fabry disease
* Liver disease with elevated transaminases
* Ongoing infection
Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.

In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-75 years old, male or female;
* Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
* No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
* ASA grade 1-3;
* Patients without contraindications to surgery;
* Patients and their families voluntarily signing the informed consent form and participating in the study;

Exclusion Criteria:

* Patients diagnosed with primary tumors or distant metastasis;
* Patients whose tumor is located in the greater curvature side of the stomach;
* Patients with coagulation dysfunction which could not be corrected;
* Patients who were diagnosed with viral hepatitis and cirrhosis;
* Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
* Patients with organ failure such as heart, lung, liver, brain, kidney failure;
* Patients with ascites or cachexia preoperatively in poor general conditions;
* Patients diagnosed with immunodeficiency, immunosuppression or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
* Patients refusing to sign the informed consent of the study;
A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension.

The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.


Eligibility Criteria:
Inclusion Criteria:

* Celiac patients assessed through positive serology and histology
* functional patients according IBS Roma III criteria
* subjects with VAS\>5

Exclusion Criteria:

* refractory celiac disease
* disaccharide intolerance (fructose an lactose breath test)
* abdominal surgery
* comorbidity
* patients recruited in other clinical trials
* positive patients at lactulose breath test (SIBO)
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.

This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
4. Patients are technical and anatomical eligible for interventions.

Exclusion Criteria:

1. In the judgment of the investigator, subjects are not anatomical eligible for interventions.
2. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
3. Active endocarditis or active rheumatic heart disease.
4. History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
5. Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
6. Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls

Aims:

1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity?
2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin?
3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril?

We set out to pursue the following Aims:

1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals.
2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? No studies were performed
3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? No studies were performed

The intent of the current project is to efficiently and at low cost generate preliminary data along each of these lines of questioning, studying the minimum number of subjects required to assess the viability of the question using the current measurement approaches.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normotensive (BP\<140/95 mmHg)
* lean and obese
* 18 and 55 years
* women must be premenopausal

Exclusion Criteria:

* use of pharmacologic agents or recreational drugs, with the exception of occasional use of non-narcotic pain medications
* blood pressure (\>140/90 mmHg)
* elevated cholesterol (LDL \>130 mg/dL)
* diabetes mellitus (by ADA criteria)
* evidence of coronary and/or peripheral vascular disease by history and physical exam
* \>5 kg change in weight in the preceding 3 months
* chronic systemic illness with recognized metabolic effects
* hepatitis C and HIV
* recognized systemic inflammatory or autoimmune processes such as rheumatoid arthritis or systemic lupus erythematosis
* Raynaud's phenomenon or other abnormalities of hand or finger perfusion
* regular participation in endurance or high-performance athletic activity
* history of aspirin or salsalate sensitivity including aspirin-induced asthma
* prior treatment with salsalate, pentoxyfilline, or monoclonal anti-TNFalpha antibodies
* pregnancy
* liver transaminase levels \>3 times the upper limit of normal
* creatinine \>1.5 mg/dL
* history of a cellular immunodeficiency-related opportunistic infections, such as an endemic mycosis (eg. histoplasmosis) or mycobacterial infection (eg tuberculosis)
* reactive tuberculin skin test
* history of malignancy except for basal cell carcinoma of the skin
Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
* Foveal thickness \<= 300 um (measured by OCT center point thickness).
* Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy \& neovascularization) of \<= 12 disc areas, of which at least 50% must be active CNV.

Exclusion Criteria:

* Previous subfoveal thermal laser therapy.
* Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy.
* Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment
Botulinum Toxin in Burning Mouth Syndrome

The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. Pain severity will be measured by the visual analog scale (VAS) indicating average week pain before injection. Each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. In order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated after 4 weeks with incobotulinumA with the same dose reported above.


Eligibility Criteria:
Inclusion Criteria:

* burning mouth syndrome

Exclusion Criteria:

* any other mouth disorder
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* No contraindications to medical abortion and study procedures, according to provider
* Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
* Willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* \> 5 parity
* Signs and symptoms of infection
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Optimization of Intestinal Preparation in Older Patients

Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.

The participants in control group take 2L PEG the day before the examination, fast at dinner (participants without diabetes) and eat without residue (participants with diabetes). Participants take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 50y
* Colonoscopy is planned
* Willing to participate

Exclusion Criteria:

* Age\<50y
* Unwilling to participate
* Missing data
BeijngFH Health Cohort Study

Metabolic associated fatty liver disease(MEFLD) is a major chronic liver disease that can lead to various adverse events, such as liver cancer, cardiovascular disease, and chronic kidney disease. The present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, Beijing Friendship Hospital. Investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, imageological examination, and so on. Follow-up surveys are conducted annually and the information collected is the same as the baseline. The outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, are obtained by linking to the hospital discharge database and death registration system of Beijing. The primary aim of the study is to build a risk-stratified evaluation system for MAFLD through the cohort.

The present community-based cohort study enrolls subjects who take physical health examinations at the sub-center outpatient department, Beijing Friendship Hospital. After signing the informed consent, Their previous health physical examination results, which were recorded in the Hospital Information System (HIS) are collected retrospectively. Then, Investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, image logical examination, and so on. Additionally, follow-up surveys will be conducted annually and the information collected is the same as the baseline. The outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, is obtained from the hospital discharge database and death registration system in Beijing. The study's primary aim is to build a risk-stratified evaluation system for MAFLD through a community population cohort with long-term stable follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Permanent residents in Beijing
* Signing informed consent

Exclusion Criteria:

* No