cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

Subjects who have completed study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged \>18 years at the time of the Screening Visit.
2. Completion of study 4975-MN-202.
3. Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period:

   1. Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration.
   2. Total abstinence from sexual intercourse since the last menses before IP administration.
   3. Intrauterine device.
   4. Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream).
4. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and weekly IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
5. Signed an Informed Consent Form approved by the Institutional Review Board.
6. Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening.

Exclusion Criteria:

1. Other chronic pain anywhere in the body that is severe in intensity or would interfere with the subject's ability to evaluate foot pain from intermetatarsal neuroma.
2. Signs of arterial insufficiency in the feet, including clinically meaningful edema.
3. Raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot.
4. Daily use of opioids for any condition.
5. Corticosteroid injection in the affected foot within 30 days of Screening.
6. Presence of any medical condition (or taking any medication) or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
7. Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
8. Has a positive pregnancy test at the Screening Visit.
Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.

Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.

Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Attending from ninth grade to eleventh grade in the eight participating schools.
* Informed consent and informed assent.
* Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.

Exclusion Criteria:

* High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
* Current treatment with antidepressant drugs.
* Current treatment with psychotherapy.
Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients

The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with a progressive or terminal disease.

Cancer patients in an advanced phase or who are terminally ill generally present with depression, pain, drowsiness, alterations of cognition, anorexia and other symptoms due to the progressive disease. The objective of the medical team of support and palliative care is to control these effects to maintain a quality of life. Particularly, the cancer patient in an advanced phase of the disease presents with important asthenia. In some patients, this asthenia is characterized by drowsiness or apathy. It always leads to ill-being and a sensation of bad adaptation. When an etiologic treatment is possible (correction of the anaemia, of the metabolic disorders, of the undernutrition, of the anorexia, of the insomnia, of the stubborn pain, of the psychological suffering), the asthenia can be fought. But, when it appears in patients not really in the end of life (life expectancy more than 1 month) and when no etiologic treatments are possible, other solutions must be considered, and all the more when the complaint is important with repeated requests for relief.

Methylphenidate is an amphetamine first indicated for deficient attention disorders with hyperactivity in children more than 6 years old. Several studies have been realized to evaluate its effect in cancer patients in palliative care. Some studies showed, in particular, its effectiveness on asthenia because of a stimulant and an antidepressant action. The methylphenidate could have an anti-analgesic effect or co-analgesic effect. All these studies are observational and not randomized. So they have a small level of proof and they have not been realized in a population of asthenic patients in palliative care. So a randomized controlled clinical trial in this specific population needs to be experimented.

Eligibility Criteria:
Inclusion Criteria:

* Advanced phase of neoplasm without any treatment available.
* Life expectancy of more than 1 month
* Karnofsky index more than 50%
* Chemotherapy IV or immunotherapy SC stopped more than 3 weeks before the end of the study
* Asthenia more than 5/10 on the visual analogical scale
* Informed consent form signed
* Affiliation to social security

Exclusion Criteria:

* Patients who can receive chemotherapy IV or immunotherapy SC in the month following the study
* Patients in whom disease can respond to chemotherapy
* Corticotherapy started less than 7 days before the study or potentially within the first week of the study
* Asthenia which can be easily corrected
* Contraindications to the amphetamines
* HADS score of anxiety and/or depression more than or egal to 17/21
* Potential surgery with general anesthesia in the first 7 days of the study
* Inability to quantify the sensation of asthenia on the visual analogical scale
* Pregnancy or feeding
* Guardianship
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin

The purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.


Eligibility Criteria:
Inclusion Criteria:

* Youths with metabolic syndrome (BMI above 95%)
* Youths with BMI below 3%

Exclusion Criteria:

-
A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women aged 19 to 75 years of age at the time of registration.
2. A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
3. A person who voluntarily agrees to participate in this observation study and signed the informed consent form.

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

   * Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
   * Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
   * Pregnant and lactating women
   * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
2. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).

This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.

Comparison: External cardioversion vs. catheter ablation

Eligibility Criteria:
Inclusion Criteria:

* Age \>20 years and \<75 years
* documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
* documented sufficient anticoagulation for at least 4 weeks before inclusion

Exclusion Criteria:

* Paroxysmal atrial fibrillation
* NYHA IV (if recompensation is not possible)
* Contraindication for warfarin
* Disturbance of blood coagulation
* Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
* Reversible causes of atrial fibrillation (i.e. hyperthyroidism)
* Pregnancy
* LA-diameter \> 55mm
* LV-function \< 30% EF
* Aortic or mitral stenosis or regurgitation III°-IV°
* Prosthetic valves
Alcohol Drinking as a Vital Sign

The purpose of this study is to determine whether Alcohol Screening, Brief Intervention, and Referral to Specialty Chemical Dependency Treatment (as appropriate) by Non-Physicians versus Primary Care Providers (versus control group) is more likely to be implemented and more effective at reducing unsafe drinking.

This health services implementation study is a clustered, randomized trial. We propose to randomize primary care clinics to three arms-a control condition and two alternative modes of delivery of the NIAAA Clinician's Guide to Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) in primary care settings. In the Primary Care Physician or "PCP" arm, PCPs will be trained on the SBIRT protocols outlined in the NIAAA Clinicians' Guide and conduct brief intervention and referrals as needed. In the Non-Physician Provider or "NPP" arm, Medical Assistants will be trained to use the NIAAA screener and enter the results in the Electronic Medical Record, and NPPs (e.g., Behavioral Medicine Specialists, Clinical Nurses and Health Educators) will conduct brief intervention and referral activities. The SBIRT content, based on the NIAAA Guide, is the same in both the NPP and PCP arms; we compare delivery by the two types of providers and versus the control condition, in which providers and staff will not receive any training on SBIRT protocols. We examine implementation outcomes: rates of screening, brief intervention, follow-up screening and brief intervention, referral to Chemical Dependency treatment, and alcohol use disorders medication rates. We also include, as secondary analyses, an effectiveness study examining patient outcomes by study arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients: All patients aged 18+ who receive primary care visits in the Kaiser Permanente clinics in Northern California.

Exclusion Criteria:

* Patients younger than 18.
Multicenter Myocardial Viability Trial

The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 21 years and \< 85 years
* Sinus rhythm
* Weight \< 120 kg
* LVEF \> 30%
* Wall motion abnormality on Echo. or LV-gram
* Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days

Exclusion Criteria:

* Resting heart rate \> 100 bpm
* Frequent atrial or ventricular ectopy
* Severe aortic stenosis or HOCM
* Unstable angina
* Myocardial infarction within 14 days
* Active congestive heart failure
* Pregnancy
* Known allergy to gadolinium
* Contraindication to MRI
Diagnostic Criteria for Septic Arthritis

Septic arthritis (SA) is a rare but highly disabling disease. The ideal diagnosis criteria is not well established. There is an urgent need to establish golden standard for diagnosis.

Septic arthritis (SA) is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9-1.3 per 100,000 \[1, 2\]. The treatment is challenging and the ideal diagnosis criteria is not well established. The specific tactics employed by relevant researches varied widely \[3-6\]. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss \[2\]. Therefore, there is an urgent need to establish golden standard for diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* admission to orthopaedics
* complete data

Exclusion Criteria:

* Accompanied with fracture
* Accompanied with other infections
* Accompanied with immune system diseases
Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study

Investigators previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery.

Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study.

Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* End-stage arthritis of the knee
* Failure of medical treatment or rehabilitation
* Hemoglobin \> 10g/dl
* No use of non-steroid anti-inflammatory agent one week before operation

Exclusion Criteria:

* Preoperative Hemoglobin ≦10 g/dl
* History of infection or intraarticular fracture of the affective knee
* Renal function deficiency (GFR \< 55 ml/min/1.73m2)which is relative contraindicated for venography
* Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant)
* History of deep vein thrombosis, ischemic heart disease or stroke
Acute Effects of a Non Excitatory Cardial Stimulation

Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity


Eligibility Criteria:
Inclusion Criteria:

* planned CCM Implantation
* systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
* implanted pacemaker, defibrillator or pacemaker during CS intubation
* written informed consent
* open entryways

Exclusion Criteria:

* anemia Hemoglobin (HB)\<8 mg/dl
* lying coronary sinus (CS) tube or CS being not able to intubate
* chronic atrial fibrillation or flutter
* mechanic tricuspid valve prothesis
* no access via subclavian vein
* patients with VVI pacemaker being stimulated 110%
* idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
* acute myocardial ischemia presented by angina pectoris or ECG changes under load
* patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances
* acute coronary syndrome should not be implanted for at least 3 month
* patients with mechanic aortic or tricuspid valve
* patients after heart transplantation
* patients with clinical significant ectopy, defined by \> 8.900 PVCs during 24 hours at beginning Holter monitoring
* patients after hypertensive crisis
* patients with acute renal failure
* Ejection Fraction (EF) \> 35
* patients after left ventricular pacemaker electrode
* pregnant or breast feeding women
* patients with heart failure after sepsis
Intervention in the Surgical Treatment of Obesity

The worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. In Brazil, estimated that one third of the population is overweight. Currently, bariatric surgery the fastest and most effective method to control the disease. However, most patients do not follow the postoperative follow-up protocol, causing weight regain. Intervention in the literature that goes beyond multidisciplinary and can prevent weight relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight relapse patients and bariatric surgery

The objective of this randomized clinical study is to compare the eating behavior of obese participants who underwent the dietary guide after bariatric surgery treatment. The main questions are:

* Can an interdisciplinary intervention through a dietary guide promote a change in eating behavior in participants undergoing surgical treatment for obesity?
* Participants will participate in consultations and receive a food guidance guide and lectures with guidance.
* Researchers will compare intervention and control groups to see if there will be changes in eating behavior

Eligibility Criteria:
Inclusion criteria:

Referred for bariatric surgery Having or not comorbidity associated with obesity.

Exclusion criteria:

not signing the informed consent form.
Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery

Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation

Exclusion Criteria:

* Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
* Polytrauma
* Prolonged hospitalization (\>10days)
* Pregnancy
* Known surgery cancellation within study period
Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.

Eligibility Criteria:
Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant