cyrilzakka/clinical-trials huggingface dataset:
Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient status.
* A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
* Depressive symptoms for at least 90 days in single episode and for at least 28 days in recurrent episode before the screening visit.
* A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS total score at baseline is not over 25% from the screening visit.
* A QIDS16-J-SR score ≥16 at the screening and baseline visits.
* A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline visits.

Exclusion Criteria:

* Subjects who concurrently have Axis II personality disorder or mental retardation according to DSM-IV diagnostic criteria.
* Subjects who meet DSM-IV criteria for current or past history of Schizophrenia, Paranoid Disorders, or any other Psychotic Disorders.
* Subjects who meet DSM-IV criteria for current or past history of Dementia.
* Subjects who meet DSM-IV criteria for current or past history of bipolar disorder, Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).
* Subjects who meet DSM-IV criteria for current (within 12 months before the screening visit) generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
* Subjects with a first degree relative with bipolar disorder.
* Subjects who are actively suicidal.
* History of non-responsive to 2 antidepressant treatment (at least 6-week usage for each) for the past or current episodes.
* History of Electroconvulsive therapy (ECT) at any time in the past.
* History of chronic treatment with benzodiazepines for longer than 6 months before the screening visit (Excluding subjects who have taken PRN benzodiazepine use, \< 3 times/week).
* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study.
* Known presence of raised intraocular pressure or history or presence of narrow angle glaucoma.
* Myocardial infarction within 180 days of the screening visit.
* Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG) or laboratory tests.
* Use of prohibited treatments
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.

Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or more including following conditions

  * Family history of gastric cancer
  * Post endoscopic resection status for early gastric cancer or adenoma
  * Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
  * Chronic gastritis
  * Non-ulcer dyspepsia
  * Healthy adults who want to receive H. pylori treatment
* H. pylori positive by urea breath test, histology, or rapid urease test

Exclusion Criteria:

* History of H. pylori eradication therapy
* History of stomach operation
* Other organ cancer within 5 years
* Liver cirrhosis or Hepatic insufficiency
* Renal insufficiency
* Current treatment for serious medical condition which may hinder participation
* Contraindication or allergy history for H. pylori treatment regimens
* Mental incompetence to understand and sign informed consent
* Incompatible conditions to be included into the trial by investigators' decision
* Inability to provide an informed consent
* History of treatment for peptic ulcer disease
Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature \<35 weeks of gestation.

In Egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm \[1\] (UNICEF, 2001). In a study that Campbell et al. (2004) conducted in Egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). A substantial proportion (29%) could not be classified \[2\]. In developing countries, prematurity was the main cause of early neonatal deaths (62%)\[3\] Autologous cord blood transfusion will be safe, and cheap. The preterm neonates need transfusion of whole blood or any of its components at a time during NICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates less than 34 weeks of gestation.
* Low birth weight less than 1500 grams

Exclusion Criteria:

* Congenital malformations.
* Suspected inborn error of metabolism.
* Suspected inherited neurologic disease.
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. The current study is designed to investigate the effects of SFA versus MUFA versus CARB on insulinemic response and lipid metabolism in healthy individuals with central obesity.

Study design: A randomized, crossover, single blind design study was carried out. The subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (C18:1).

Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation


Eligibility Criteria:
Inclusion Criteria:

1. Abdominally obese males and females (waist circumference \> 90 cm for male, \> 80 cm for female),
2. Age 20-60 years

Exclusion Criteria:

* a medical history of cardiovascular disease, diabetes, dyslipidemia;
* current use of antihypertensive or lipid lowering medication;
* plasma cholesterol \> 6.5 mmol/L, TAG \> 4.5 mmol/L;
* alcohol intake exceeding a moderate intake (\> 28 units per week);
* pregnancy,
* smoker and
* breastfeeding.
Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease

EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not known whether there are some pre- or per-operative anatomic or pathophysiological findings which may influence outcome.

The aim of this trial is to study a series of parameters acquired during the pre-therapeutic work-up or during the procedure and their influence on the outcome of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients being considered for EsophyX treatment of GERD
Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction

The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Subject needing to undergo extraction of one impacted mandibular third molar
* For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle.
* Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)

Exclusion Criteria:

* Existence or history of parotid gland disorders
* Acute or history of recent acute pericoronitis at any tooth
* Extraction of more than 1 third molar in the same surgical procedure
* Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease)
* Coagulation or haemostatic disorder or use of anticoagulants
* Hypersensitivity to chlorhexidine or any of the excipients;
* Hypersensitivity to any anesthetic agent;
* Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief
* Intake of systemic vasodilator or vasoconstrictor
* Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study;
* Use of any antiseptic mouthwash within 7 days before Day -1
* Regular heavy smokers (more than 20 cigarettes per day)
* Is pregnant or in post-partum period or a nursing mother
Bilevel Positive Airway Pressure in Cardiac Surgery

The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria.

This randomized controlled trial aimed to evaluate the effects of Bilevel Positive Airway Pressure (BiPAP) in patients undergoing heart surgery of valve replacement and coronary artery bypass graft on the variables clinics, cardiorespiratory and physical functional.These individuals were randomized to compose the control group (GC) and the BiPAP group (GBiPAP). The routine physical therapy was performed in both groups and in the BiPAPG two daily sessions of 20 minutes were applied with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: the 6-minute walk test (6MWT), the heart rate variability, the manovacuometry, and cirtometry in the axillary line, umbilical line and the xiphoid appendix.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients in preoperative for coronary artery bypass or valve replacement.

Exclusion Criteria:

* Inability to understand or sign a free and informed consent form
* Chronic obstructive pulmonary disease (COPD)
* Cerebrovascular disease
* Musculoskeletal disease
* Chronic infectious disease
* Unstable angina
* Treatment with steroids, hormones or chemotherapy for cancer
* Prolonged mechanical ventilation
* Unable of maintaining airway patency
* Severe hemodynamic instability
* Abdominal distension or vomiting.
Two-piece Zirconia Implants With Two Various Platforms

24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Single missing maxillary premolar
* Occlusal stability
* Good oral hygiene
* Good general health

Exclusion Criteria:

* Oral mucosa pathology
* Dental caries
* Active periodontitis (non-treated)
* Systemic diseases and conditions that affect healing or immune capacity
A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size.

The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.


Eligibility Criteria:
Inclusion Criteria:

* Clear corneal media
* Patients must be at least 18 years of age.

Exclusion Criteria:

* On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5 dioptres. (exclusion criterium for Group A only)
* The maximum K- value may not exceed 60 D, the minimal value may not be smaller than 37 D. (exclusion criterium for Group A only)
* Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. (exclusion criterium for Group A only)
* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Known sensitivity to planned concomitant medications.
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Keratoconus
* Patients with woundhealing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
* Abnormal examination results from slit lamp, Fundus, IOL Master
* Abnormal examination results from Orbscan (exclusion criterium for Group A only)
* Patients with an autoimmune disease, collagenosis or clinically significant atopy.
* Patients who are pregnant or nursing.
* Patients who do not give informed consent.
* ACD \< 2.4 mm or ACD \> 4.5 mm as measured by ultrasonic examination (exclusion criterium for Group A only)
Sildenafil For Meniere's Disease

Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its vasodilatory activity. The purpose of this study is to assess the safety and efficacy of sildenafil (Viagra) compared with placebo on symptoms during one acute attack.


Eligibility Criteria:
Inclusion Criteria:

* Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis

Exclusion Criteria:

* Pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods
* severe Meniere's diseased (more than 8 attacks per month)
* previous ear surgery
* intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for Viagra (eg. nitrates)
* with medical conditions that make Viagra contraindicated
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

The purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (OxyVu) to Ankle Brachial Indices (ABI), toe pressures (TBP), and transcutaneous oxygen monitoring (TCOM) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
* Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
Effects of Oxytocin and Vasopressin on Moral Decision Making

To determine whether the neuropeptide oxytocin (OXT) and vassopressin (AVP) influence moral decision making

In a double-blind, between- subject placebo (PLC) controlled design, subjects will first complete a series of questionnaires in terms of mood, clinical symptoms, and traits. After that their moral judgment and emotion towards both verbal descriptions of moral dilemma scenarios and pictures of specific interpersonal ones will be assessed and the effect of intranasal OXT and AVP between both male and female healthy subjects will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* pregnancy
Femoral Block With or Without Ropivacaine for Analgesia After Total Knee Replacement (TKR)

Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks.

The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.


Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacement
* Age \> 18 years old
* Accept the study

Exclusion Criteria:

* Revision surgery
* Use of anticoagulants drugs
* Neurologic disorder
* Unable to sign consent form
Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.

100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.

The Attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. One of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients are expected to experience improved function, better stability and less pain during activity. So far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as control.

100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes. Patients can only participate with one knee.

Surgical procedure: The operations will be done according to our routines without use of bloodless field. Local analgesia will be infiltrated periarticulary during the operation. Cemented fixation will be used in all cases. So-called "fast-track"principles will be applied in both Groups.

Patients will be followed for five years.

Eligibility Criteria:
Patients with degenerative joint disease of the knee on our waiting list for a total knee replacement will be asked to participate in this study

Inclusion Criteria:

* Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
* Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees
* BMI \<35
* ASA 1-3.
* Coming from independent living in own home
* Written informed consent

Exclusion Criteria:

* Cortisone treatment during the last 6 months before operation
* Neurological diseases with symptoms, stroke with sequel
* Endocrine diseases with symptoms
* OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
* BMI \>=35
* OA of the hip with symptoms. (Patients operated with total hip arthroplasty are accepted)
* Ongoing infection
* Unable or unwilling to participate in the follow-up.