cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers

Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.

Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201, racemic isometheptene, or placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 and ≤ 55 years of age on the day of randomization. NOTE: At least 6 female subjects need to be randomized in each cohort.
2. Body mass index (BMI) ≥18.5 and ≤33.0
3. Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)

Exclusion Criteria:

1. Any clinically significant abnormality or clinically significant abnormal laboratory test results found at Screening or Day -1, or a positive test for HBsAg, HCAb, or HIV found at Screening
2. Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
3. Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
4. Positive serum pregnancy test at Screening or Day -1
5. Any reason, in the opinion of the Principal Investigator (PI) or the sponsor's Medical Monitor, to prevent the subject from participating in the study
6. Clinically significant ECG abnormalities
Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.

The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.

Exclusion Criteria:

* Inability to obtain consent
* known or suspected allergy to iodine or shellfish
* women with active herpes simplex virus infection
Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

There is a growing epidemic of the bacterial sexually transmitted infections (STIs) syphilis, chlamydia and gonorrhea worldwide; similarly concerning trends have been noted in Canada, where increases of over 160% have been seen in bacterial STIs over the last decade. In Canada, gay, bisexual, and other men who have sex with men (gbMSM) - including those living with HIV - are disproportionately impacted by bacterial STIs5,6These dramatic increases in bacterial STIs, the potential development of serious complications including AMR, and waning effectiveness of the promotion of conventional STI prevention tools (e.g. condoms), signals the need for novel STI prevention strategies and tools to mitigate STI-related complications. A rigorous randomized controlled trial will be conducted to compare STI PrEP vs. STI PEP and definitively assess the efficacy, safety, antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention.

With the rising rates of STIs among gbMSM populations in Canada, there is an urgent need for novel interventions to prevent significant sequelae (e.g. neurosyphilis) and onward transmission of untreated infections. Despite longstanding public health efforts to encourage conventional strategies of STI prevention, gbMSM continue to bear the burden of syphilis which poses synergistic effects in the transmission of HIV. This study will add to this field through providing the first methodologically rigorous, prospective multicentre, open-label randomized controlled trial (RCT) of doxycycline-based STI PrEP (daily 100mg doxycycline) versus STI PEP (200mg doxycycline after exposure event) for the prevention of bacterial STIs among gbMSM over 15 months (60 weeks) of follow-up with adequate power to address drug efficacy in the prevention of bacterial STIs. Beyond the determination of efficacy, our trial will provide insight to the unique challenges of medication adherence through assessing the acceptability, tolerability and safety of therapy with doxycycline. This study aims to provide health care providers one additional tool to address the burden of STIs in populations with an increased likelihood of infection.

Eligibility Criteria:
Inclusion Criteria:

1. Males, ≥ 18 years of age;
2. Any sexual activity (i.e. oral sex, insertive or receptive anal sex, with or without a condom) with more than one male partner in the preceding 12 months;
3. Intention to remain sexually active with more than one male partner in the next 12 months;
4. At least one prior episode of a previously diagnosed and adequately treated syphilis, gonorrhea or chlamydia infection within 12 months prior to screening.

Exclusion Criteria:

1. Known allergy to doxycycline or tetracyclines;
2. Existing chronic or intermittent tetracycline or doxycycline use (e.g. for chronic osteomyelitis, acne).
3. Use of medications which could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine.
4. Individuals currently using isotretinoin;
5. Any individual capable of becoming pregnant.
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Age of all studied subjects ≥ 18 years old
* All patients with hepatocellular carcinoma will be included in group I.
* Patients not treated with systemic TKIs

Exclusion Criteria:

* Patients presented with liver tumors other than HCC.
* Patients with Child-Pugh grade C for liver function.
* Patients with other malignancies.
* Patients with chronic inflammatory disorders.
* Patients with severe organ dysfunction such as heart, lung, and kidney.
* Patients who cannot tolerate or are allergic to sorafenib.
* Patients with severe coagulation dysfunction were uncorrectable.
* Age less than 18 years old.
PRF for Treating Maxillary Gingival Recession

This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Bilateral Miller class I + II recession in the upper jaw

Exclusion Criteria:

* Smokers
* Patients with systemic diseases that could interfere with the healing
* Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.
Rapid Detection of Staphylococcus Aureus in Burn Patients

The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.

Burn patients have lost their primary barrier to microorganism invasion and therefore are continually and chronically exposed to pathogens. Ninety-seven percent of patients with \>20% total body surface area (TBSA) burns develop septicemia; predominantly involving gram positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate sample volumes can impair detection by BC and results can take 3-4 days.

Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected in a growth-independent manner by targeting their genetic make-up. Quantitative determining of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect persistent infections during antimicrobial therapy when culture samples are inhibited.

The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2) to test the clinical application of PCR results with clinical outcomes of treatment of presumptive diagnosis of staphylococcal sepsis.

Eligibility Criteria:
Inclusion Criteria:

* 20% or \> TBSA burns at hospital admission
* will require BC during hospital stay
* Patient/surrogate able to sign consent

Exclusion Criteria:

* allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
* on antibiotic(s) prior to first BC
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms

The specific aims of this study are:

1. To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
2. To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
3. To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
4. To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.

Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Permanent termination of menstruation of natural cause.
* Cessation of menstrual cycles for more than 12 consecutive months.
* A score of the Chinese version of Beck Depression Inventory-II of greater than 10.
* Able to speak Mandarin or Taiwanese.
* Age from 45 to 64 years.

Exclusion Criteria:

* Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
* Subjects who received hormone replacement therapy prescribed by gynecological physicians.
* Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's lymphoma.

OBJECTIVES: I. Assess the response to CHOD (cyclophosphamide/doxorubicin/vincristine/ dexamethasone) and BVAM (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain radiotherapy in patients with primary central nervous system non-Hodgkin's lymphoma (PCNSL). II. Assess the toxic effects associated with this treatment. III. Assess the survival of patients with PCNSL receiving this treatment. IV. Investigate the frequency of systemic involvement at follow-up. V. Identify factors that appear to be associated with outcome.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Primary central nervous system non-Hodgkin's lymphoma (PCNSL) Clinically diagnosed intracranial space-occupying lesion Pathology consistent with non-Hodgkin's lymphoma and reviewed by NCCTG Biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, CSF, or both No occult systemic lymphoma or prior lymphoma No post-transplant lymphoproliferative disorder Disease measurable or evaluable on postoperative contrast-enhanced CT or MRI Postoperative therapy must start within 6 weeks of definitive diagnosis

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-3 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No heart failure No uncontrolled arrhythmia Pulmonary: No severe pulmonary failure Other: No serious uncontrolled infection No active bleeding No AIDS or HIV-positive serology No prior organ transplant No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan Radiotherapy: No prior radiotherapy Surgery: Not specified
Research Into Risk Factors for Hospitalization Following a Fall in Older Patients

Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. The risk factors for falls themselves are well identified, but not those that lead to hospitalizations in older people who all fall. Some risk factors, such as age, cannot be modified. With a view to preventing hospitalizations in older patients who fall, The investigators aimed to identify functional, and therefore modifiable, risk factors for hospitalizations in patients who fall, such as gait parameters. The investigators hope that the results of this study will lead to early identification of the risk of hospitalization in these patients and thus to appropriate rehabilitation as early as possible to limit this risk.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 65 years old
* Patient having had at least one fall
* Patient able to walk without human assistance
* Hospitalized at the geriatrics center or seen in fall consultation at the Strasbourg University Hospital during the period from 05/01/2023 to 01/31/2024

Exclusion Criteria:

- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug

An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.


Eligibility Criteria:
Patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven't obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months.

Inclusion criteria:

* Age ≥ 18 years;
* Patients with non progressive localization-related epilepsy;
* Patients who are able and willing to give written Informed Consent;
* Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide;
* 50% or greater seizure reduction\* as assessed after an at least three-month maintenance period with zonisamide.

  * = seizure frequency before starting zonisamide must be documented checking case histories.

Exclusion criteria:

* Patients contraindicated for zonisamide use (see SmPC);
* Patients with renal or hepatic impairment;
* Pregnant or lactating women;
* Women of childbearing age who are not willing to use any contraceptive method with established efficacy.
* Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation;
* Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency;
* Patients who have been on an investigational drug or device within 30 days prior to the initiation of the present study;
* Patients with a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.
Social Cognitive Training for Psychosis: Treatment Development

The primary aim of this proposal is to develop, refine, manualize and assess the feasibility and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for individuals with psychosis. The intervention will focus on helping individuals interpret social situations, specifically the intentions and feelings of others.

Study methods include preliminary treatment and manual development based on series of uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly developed intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or other psychotic disorder
* Age between 18 and 55
* Psychiatrically stable
* Clinician agrees to individual's participation in study
* English as primary language

Exclusion Criteria:

* current (past 30 days) symptoms of alcohol abuse/dependence
* developmental disability
* severe auditory/visual impairment or known neurological disorder
* participant has a legal conservator
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Subjects who participated in study 580299-007.
* Written informed consent obtained from the subject prior to enrollment.

Exclusion Criteria:

* Use or planned use of any investigational or non-registered product other than the study vaccine.
* Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator.
* Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.
Reward Effects on Cognition, Motor Skills, and Motivation in Children

This interventional study aimed to aimed to evaluate the effects of rewards on cognitive function, motor skills, and motivation in 8- to 10-year-old children with ADHD following 3- and 6-week interventions.

Research problem: children with Attention-Deficit/Hyperactivity Disorder (ADHD) are inattentive and distractible, which often makes it difficult for physiotherapists to keep them interested, as prolonged activity often causes boredom.

The aim of this study was to determine the effects of reward on cognitive function, motor skills and motivation in 8-10 year old children with ADHD after 3 and 6 week interventions.

Objectives of the study:

1. To compare the cognitive function of children receiving conventional physiotherapy with that of children receiving reward therapy. 2. To compare the motor skills of the children receiving conventional physiotherapy with those of the children receiving the reward. 3. To compare the motivation of children receiving conventional physiotherapy with that of children receiving rewards.

The hypothesis of the study is that exercise with rewards improves cognitive function, motor skills and motivation better than conventional physiotherapy in children aged 8 to 10 years with attention deficit disorder.

Research methods: the study included 60 boys diagnosed with ADHD. Age: 8-10 years. Subjects were randomly divided into reward and conventional physiotherapy groups. In both groups, subjects performed exercises for balance and coordination for 3 times per week for 45 min, but in one group subjects received a reward using virtual reality.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ADHD confirmed by a neurologist;
2. male gender;
3. age between 8 and 10 years.
4. ability to read and write;
5. patient's willingness to attend physiotherapy sessions;

Exclusion Criteria:

1. claustrophobia;
2. neurological disorders (e.g., autism spectrum disorder, depression, obsessive-compulsive disorder, Tourette's syndrome);
3. chronic medical conditions (e.g., cancer, diabetes, cardiovascular diseases);
4. previous treatment for ADHD (e.g., pharmacological therapy, cognitive behavioral therapy) within the last six months;
5. Medication use.