cyrilzakka/clinical-trials huggingface dataset:
Spirituality Teaching Program for Depressed Adults

Major depression is a widely spread health problem in Canada. Recent research suggests a potential role for religion/spirituality in the prevention of and recovery from depression in adults. The purpose this study was to assess the efficacy of a home-based Spirituality Teaching Program for adults in the treatment of major depression. The objectives of the study were to determine:

1. whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults,
2. whether efficacy is maintained long term (over a 16 week period).

Major depression is a widely spread health problem in Canada with a life time prevalence of 11% in men and 16% in women. A recent avenue of research suggests a role for religion/spirituality in the prevention of and recovery from depression. It has been hypothesized that religion/spirituality acts as a coping resource in distressing life situations including illness and loss and may address the struggles of depressed patients of feeling separated from their surrounding world, as well as from their inner self. Majority of the research conducted to date on this topic has been observational and focused on the religious denomination, primarily the Christian and Muslim faiths. However, given the distinction between spirituality and religion and since a growing portion of the Canadian population identifies themselves as nonreligious but spiritual (10), it is pertinent to explore whether there is a role for a nondenominational spiritual intervention as a mental health resource. Considering the burden of depression on an individual and social level and need for effective and accessible treatment options, evaluation of spirituality based approaches is highly relevant. This study aims to assess whether nurturing spiritual coping resources in a non-faith based way may play a therapeutic role in recovery from major depression in adults.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy the DSM-IV criteria for unipolar major depression with a depression score of 18-22 on the Hamilton Depression Scale (mild to moderate severity),
* Are at least 18 years of age,
* Have the competence to understand the study requirements and the ability to comply with the study intervention,
* Have provided written informed consent.

Exclusion Criteria:

* History of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose
* History of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o)
* History of multiple suicide attempts
* Acute psychiatric condition other than unipolar depression
* Regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills
* Uncontrolled medical conditions in the last 3 months
* DSM-IV diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months
* High suicide risk
Effect of Iron-fortified Pea Powder on Exercise Performance

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study assesses the impact of an pea protein supplement with high iron bio-availability on iron status and exercise performance.

Female endurance athletes are susceptible to iron deficiency due to poor iron intake from diets or possibly because of destruction of red blood cells during foot-strike hemolysis. This study will evaluate the impact of 8-weeks of iron supplementation through consumption of a pea-protein power that has high iron bio-availability due to low phytate levels. This will be compared to consumption of regular iron protein powder and maltodextrin placebo by randomizing participants to three groups. Participants will be assessed at baseline and after 8 weeks of supplementation for exercise performance (maximal aerobic capacity and a 5 km time trial running test), blood levels of ferritin and hemoglobin, and body composition (fat mass and lean tissue mass).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Regularly participate in aerobic endurance training

Exclusion Criteria:

* Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"
Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4

The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the kidneys, brain, liver, pancreas, and skin.

Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in adults who are usually not involved in typical E. coli O157H7 HUS.

The aim of the present study is to gain knowledge on these different aspects of the HUS, including response to therapy.


Eligibility Criteria:
Inclusion Criteria:

* All patients with HUS concomitant to the outbreak linked to E. coli O104:H4

Exclusion Criteria:

* Patient not willing to participate or to sign informed consent
A Post Market Surveillance Study About the MONOCER Cup

Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.

All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
2. Patients who have signed the informed consent to participate in the study

Exclusion Criteria:

1. Minor patients, patients over 75 years of age at the time of primary surgery;
2. Any patient who is unable or unwilling to give informed consent to participate in the study.
Gas Exchange for Predicting Hospital Heart Failure Readmissions

To determine whether, and if so, which gas exchange parameters measured on the Shape-HF Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects discharged from hospitalization for an episode of acute decompensated heart failure.

This is a prospective, single-specialty clinical study. This study is intended to evaluate the select gas exchange parameters during a short, sub-max bout of exercise using a simple stationary step on day of discharge to predict the subjects' readmission for acute decompensated heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 Years and older
* Subject is hospitalized for acute decompensated heart failure (ADHF)

  1. Systolic OR
  2. Diastolic
* Subject is Stage C:Class II/III/IV heart failure
* Subject is willing and to provide appropriate informed consent
* Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule
* Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System

Exclusion Criteria:

* The subject is pregnant (verified in a manner consistent with institution's standard of care)
* Subject is currently participating in another investigational device or drug trial
* Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
* Subject is unwilling or unable to return for the required follow-up after test
* Subject has Left Ventricular Assist Device (LVAD)
* Subject is listed for transplant
* Subject has a clinical diagnosis of acute myocardial infarction (AMI) on admission (Note: If troponin measurements have been collected and are elevated but not due to an MI subject is still eligible for study)
* Subject has a pulmonary embolism (PE) on admission
* Subject is dialysis dependent
* Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study
* Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent
* Subject has severe hypertension \> 180 millimeter of mercury (mmHg) resting systolic at time of test
* Subject has severe heart failure with renal insufficiency (with Creatinine clearance rate (CrCL) of 30 or less) and/or on IV Inotropic therapy and/or enrolling in hospice
The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics

In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

Eligibility Criteria:
Inclusion Criteria:

* volleyball, basketball of handball players
* male

Exclusion Criteria:

* history or surgery of the lower extremities
* history of fractures of the lower extremities
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.

Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption
Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

To compare the below things between PEIT group and TACE group

1. Survival

   1. 5 year overall survival rate
   2. Disease free survival rate
2. Recurrence a. recurrence rate

Eligibility Criteria:
Inclusion Criteria:

* The evidences of HBV(+) \&/or HCV(+) infection or liver cirrhosis
* Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
* The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
* 1) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
* It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion Criteria:

* In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study

This study aims to investigate the effect of suture materials with different absorption times on istmocel.


Eligibility Criteria:
Inclusion Criteria:

* primary cesarean section
* single pregnancy
* 18-45 age

Exclusion Criteria:

* Diabetes mellitus disease
* inflammatory bowel disease
* systemic lupus erythematosus disease
* rheumatoid arthritis disease
* previous uterine surgery
Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease

This is a registry of the patients that are admitted to CICU and treated by the Scientific Staff of the 2nd Department of Cardiology, due to an acute cardiovascular disease (acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, cardiac tamponade etc) in order to investigate the clinical characteristics of the patients, their outcome, identify the factors that could predict the in-hospital mortality and compare the results with the predicted by established risk scores. Furthermore, the study will investigate the one-year mortality and also the major adverse cardiac events (MACE - acute myocardial infarction, stroke, or cardiovascular death) will be measured.

For every patient that will be enrolled to the study, information from the medical record will be collected, as long as he/she has provided a signed consent form after being fully informed of the study and its objectives. In case the patient cannot decide on his/her own, e.g. intubated patients, an informed consent form must be acquired by a relative or legal representative. Only the data that will be considered necessary for scientific reasons will be acquired: general and demographic information, medical information like the personal and family history, the diagnostic tests performed and the treatments or interventions that took place. The patients will not have to do anything further or undergo any additional visits or medical exams apart from those indicated; they will not receive any extra treatment (because of their participation to the study) beyond what they would receive for their condition according to the established practice so far. Furthermore, the doctor will not change or withdraw any treatment that the patients would normally receive. The patients' medical care will continue normally under the CICU doctors' supervision.

The participants will be monitored during their hospitalization in the CICU, during their hospitalization in the 2nd Department of Cardiology of the UHI after their discharge from CICU, as well as for the next 1-year in the Outpatients Clinic; if the latter is not feasible (in case of disability or distance) they will be contacted through telephone interviews.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Cardiac Intensive Care Unit (CICU) through the Emergency Department of the UHI
* All patients transferred to the CICU from other hospital departments or other regional secondary hospitals
* Patients with an acute cardiovascular disease that requires treatment in a CICU
* Patients who are under scientific supervision of the 2nd Department of Cardiology
* Patients (or their relative/legal representatives) that have signed the informed consent form

Exclusion Criteria: None
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery.

Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis.

It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old
* ECOG performance status: 0-2
* Histologically confirmed adenocarcinoma of the rectum
* Distal border of the tumor located ≤ 12 cm from the anal verge
* Primary stage T3-4 or any node-positive disease
* Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy
* Conventional fractionated radiotherapy of at least 45 Gy
* Resectable disease after neoadjuvant chemoradiotherapy
* No evidence of distant metastasis
* Amenable to sphincter-preserving surgery
* Tolerable to general anesthesia
* Provision of written informed consent

Exclusion Criteria:

* Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
* Synchronous colon cancer
* History of colorectal resection except appendectomy
* Acute intestinal obstruction or perforation
* Multiple visceral resection
* Abdominoperineal resection
* American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
* Pregnant or nursing, fertile patients do not use effective contraception
* Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
* Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
SeQuent Please Neo Multicenter Registry

The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.

The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.

Eligibility Criteria:
Inclusion Criteria:

* ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the stented segment of \<25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm

Exclusion Criteria:

* There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.
A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma

This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 20 weeks and follow-up period of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
* 2. Female and male aged 18 to 75 years.
* 3. Diagnosed with asthma for ≥12 months that meet GINA.
* 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
* 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
* 6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

Exclusion Criteria:

* 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
* 2. Severe asthma exacerbation within 4 weeks prior to randomization.
* 3. Subjects with any eosinophilic diseases other than asthma.
* 4. Known, pre-existing severe or clinically significant cardiovascular disease.
* 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
* 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
* 7. Subjects with allergy/intolerance to a monoclonal antibody.