cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation

This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.

In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.

All patients will be randomized equally divided into four groups (30 patients each).

Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.

Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.

Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12

Eligibility Criteria:
Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

* Erectile dysfunction
* Diabetes mellitus
* chronic prostatitis
* Advanced renal or hepatic diseases
* Neurological diseases
Managing Epilepsy Well- WebEase Project

The purpose of this study is to test a computer program for people with epilepsy. The program was developed to help people with epilepsy improve their self-management skills for taking medications, reducing stress, and sleeping well.

WebEase is an internet self-management program for people with epilepsy. Our goal is to offer a program that supports the management of epilepsy by people with epilepsy. The program is based on proven techniques of motivational interviewing and stages of change. Before offering WebEase to the general public, we tested the program among volunteers with epilepsy. We recruited individuals with epilepsy who were willing to use the program.

The program was developed by a team of researchers and physicians who treat patients with epilepsy. The program offers information on three major topics: 1) medication taking, 2) stress and 3) sleep management as it relates to epilepsy. It includes quizzes, fact sheets, and links to other authoritative websites on epilepsy.

Before beginning the study, each participant completed a brief survey about medications, stress, and sleep. Then participants worked through the WebEase program. WebEase consists of three modules: medication, stress, and sleep. Each module lasts 2 weeks, and includes an interactive session geared specifically to each person's needs. During the study, each participant kept a diary of medications, stress, sleep, and seizures, which allowed them to see changes over time. After completing the WebEase program, participants completed two more brief surveys about six weeks apart. About half of the participants were asked to complete two surveys about 6 weeks apart before beginning the WebEase program. These individuals completed one survey after the end of the program.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Understand and speak English
* Have been diagnosed with epilepsy
* Have been on an antiepileptic medication (AED) for at least 3 months
* Have access to the internet
* Be willing to participate
* Have not participated in WebEase in the past

Exclusion Criteria:

* Under age 18
* Unable to understand and speak English
* Have NOT been diagnosed with epilepsy
* Have NOT been on an AED for at least 3 months
* Not willing to participate
* Have participated in WebEase in the past
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.

Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant
* Clinically or medically-induced non-functioning or surgically removed ovaries
* Clinical investigator believes patient would be eligible for oocyte donation

Exclusion Criteria:

* Any contraindication to progesterone or estrogen therapy
* Undiagnosed vaginal bleeding
* History of uterine fibroids or any other conditions that could adversely affect pregnancy success
* Hysterectomy
* Any contraindication to vaginal drug delivery systems
Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients

The goal of this study is to determine if robot aided rehabilitation therapy can be equivalent to or more effective than conventional rehabilitation therapy at promoting functional recovery of the paretic upper limb in acute and subacute stroke patients.

The study aims to test a robotic rehabilitation protocol which involves the use of a robotic device (NeReBot) as an alternative to the conventional rehabilitation treatment. NeReBot is a 3-degree-of-freedom robotic device, which can be programmed by the therapist to perform repetitive assistive movements (flexion and extension, adduction and abduction, pronation and supination, circular) of the upper limb (shoulder and elbow), combined with a visual and acoustic display. Acute and subacute stroke patients (≤20 days post-stroke) will be randomized into two groups with a procedure by a computer program: the experimental group (EG) and the control group (CG). Both groups will receive a total daily treatment time of 120 minutes for five days a week and for five weeks. The EG will perform the conventional functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational therapy for 80 minutes a day, while the proximal paretic arm will be treated by NeReBot for 40 minutes a day. For the CG, NeReBot therapy is substituted by 40 minutes of conventional mobilization of the proximal paretic arm by the therapist.

Eligibility Criteria:
Inclusion Criteria:

1. recent unilateral single stroke (ischemic or hemorrhagic) verified by brain CT or MRI;
2. sufficient cognitive and language skills to understand the instructions of the operator (assessed by Modified Mini-Mental State Examination \> 21);
3. patients with upper limb paralysis (Motor Power score between 8 and 12);
4. written informed consent signed by the patient (or an authorized representative).

Exclusion Criteria:

1. cardiovascular instability (severe uncontrolled hypertension, severe coronary artery disease, etc.) or orthopedic, or neurological conditions;
2. presence of multiple cerebrovascular lesions (usually the result of many ischemic episodes in the past);
3. early appearance of marked spasticity (≥ 3 according to Ashworth Scale);
4. joint pain or limited joint range of motion (ROM) of the upper limb that results in the inability to complete the protocol;
5. severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect), affecting the patient's ability to follow instructions;
Remediation of Auditory Recognition in Schizophrenia With tDCS

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.

This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Primary diagnosis of Schizophrenia or schizoaffective disorder
* English fluency
* Willing/capable to provide informed consent
* Auditory tone matching deficits
* Receiving stable doses of antipsychotic medication(s) for at least 2 weeks
* IQ\>75

Exclusion Criteria:

* Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.
* Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)
* Pregnancy or breastfeeding
* Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)
Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion

The purpose of this study is to compare the effect of a combination of separate therapies of Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear avoidance among low back patients over a 1-week period of time.

A convenience sample of 120 acute low back pain patients will be recruited from Sport and Spine Rehab at their initial appointment. Exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of low back surgery will be excluded. Patients will be recruited following their initial examination if they meet the inclusion criteria of reporting low back pain for less than 2 weeks and be \>18 years of age. Patients will complete the informed consent, demographics information questionnaire, Numeric Pain Rating Scale (NPRS), Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), Fear Avoidance Beliefs Questionnaire (FABQ). Following paper documents their lumbar range of motion and posture will be analyzed using the DorsaVi ViMove device \[http://us.dorsavi.com/vimove/\] (T1). After completing T1, patients will then be randomized into 1 of 4 at-home pain management groups (n=30 per group), to be followed for one week. Group 1 (Biofreeze® + Tape), Group 2 (Tape Only), Group 3 (Biofreeze Only), and Group 4 (Advice Alone). Treatment at the first office visit will be standardized to include manipulation only; no in-office therapy will be provided to either group at the first visit. Upon returning for their 2nd (T2), and 3rd (T3) office visits, all patients will rate their pain (NPRS). At one week (T4) patients will complete the paper and pencil instruments from the first visit, which assess the subjects' pain on the Numeric Pain Rating Scale (NPRS), low back disability on the Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), and fear on the Fear Avoidance Beliefs Questionnaire (FABQ). Lumbar range of motion and posture will also be reassessed. In addition,, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.

Eligibility Criteria:
Inclusion Criteria:

* low back pain for less than 2 weeks and 18 years of age or older

Exclusion Criteria:

* pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery
Memantine for Post-Operative Pain Control

Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain reliever's effects can develop in just a few hours. It is thought that activation of the N-methyl d-aspartate (NMDA) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA receptors in the brain and spinal cord. It has been used for years to help patients with Alzheimer's Disease. In this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).


Eligibility Criteria:
Inclusion Criteria:

* Surgery for total hip replacement, knee replacement OR lumbar spinal fusion
* Taking no opiate medication OR taking opiate medication for at least 6 weeks

Exclusion Criteria:

* History of alcohol or drug abuse
* Clinical diagnosis of Alzheimer's Disease
* Prior adverse reaction to memantine
* Severe renal impairment (creatinine clearance \<30 ml/min)
* Inability to give informed consent
Success Rates for Management of Separated Instruments

The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach

Teeth with Type II Vertucci root canal configuration are having more incidence of instruments separation due the presence of an S-type (Double curve). The aim of this study is to compare the outcome of minimally invasive approach (MIA), retaining the separated in one root canal, cleaning and shaping of portals of entry of the two canals and portal of exit of both canals through the other patent canal, in comparison to the outcome of retrieval of the broken instrument by ultrasonics retrieval techniques (URT)

Eligibility Criteria:
Inclusion Criteria:

* Presence of separated instrument in a root with a Vertucci's type II configuration (the level of the SI was evaluated using CBCT scans)
* Age range 35-55 years
* Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root

Exclusion Criteria:

* • Patients who refused to undergo radiographic follow-up.

  * Pregnant females.
  * Patients suffered from a systemic disease.
  * Teeth with lesions connected to adjacent teeth.
  * Teeth with root fractures or perforations.
  * Teeth with lesion communicating with the alveolar crest.
  * patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  * teeth with damaged or resorbed peri- apex
  * teeth that were treated with a fiber post and teeth with canal curvature more than 25 degrees
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia

This is a preliminary study to determine the safety and efficacy of intravenous immune globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in clinical measures of disease severity before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with SCA diagnosed by a movement disorder specialist.
2. Age 10 years to 80 years.
3. Able to ambulate with or without assistance for 30 feet.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).
6. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
7. Stable doses of all antidepressants and vitamins (including internet purchased idebenone) for 30 days prior to study entry and for the duration of the study. Throughout the study, all possible efforts should be made to maintain stable doses of all other medications.
8. Subject permission (informed consent).

Exclusion Criteria:

1. Any unstable illness that in the investigator's opinion precludes participation in this study.
2. Use of any investigational product within the past 30 days.
3. Presence of clinically significant cardiac disease (as determined by the investigator based on EKG and echocardiogram results within the past 6 months). Specifically, an ejection fraction \<40%, or a prolonged QT interval (\>50% of cycle duration) will be excluded. If the investigator notes clinically significant abnormalities on the EKG or echocardiogram, the subject will be eligible IF they provide clearance from a cardiologist.
4. Presence of diabetes (as determined by blood glucose labs within the past 6 months).
5. Dementia or other psychiatric illness that prevents the subject from giving informed consent (MMSE less than 25).
6. Legal incapacity or limited legal capacity.
7. Presence of severe renal disease (estimated creatinine clearance \<50 mL/min) or hepatic disease (AST or ALT\>2x times normal) (as evidenced by labs reported within the past 6 months).
8. Clinically significantly abnormal WBC, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
9. IgA deficiency (evidenced by screening lab evaluations)
Irritation and Sensitization Study of HP-5000 Topical System

This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.

This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent prior to entering the study or undergoing any study procedures;
* Subject is a generally healthy male or female 18 to 65 years of age;
* Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.

Exclusion Criteria:

* Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
* Subject has severe cardiac, renal or hepatic impairment;
* Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.
Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion

The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment in children with obstructive sleep apnea hypopnea syndrome (OSAHS) and malocclusion.

In this study, we hope to improve children's OSAH in function, three-dimensional shape and subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus orthodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as mild to moderate OSAHS
2. Tonsil and/or adenoid hypertrophy
3. Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5)
4. The guardian / child can understand the study and sign the informed consent

Exclusion Criteria:

1. Patients with nasal obstruction disease
2. The pathological obesity
3. Patients with systemic disease
4. Patient with central sleep apnea/hypopnea syndrome
Lyon PJI Retrospective Cohort Study

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs.

This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.


Eligibility Criteria:
Inclusion Criteria:

* patients having had a PJI between 2018 and 2020

Exclusion Criteria:

-
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels

The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate titer protection provided by TIG and TT given in combination will be assessed using a standardized administration regimen and standardized antibody assay procedure. This study may provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage for anyone with the potential of developing tetanus.

This is a prospective, open-label, single-center trial including a single group of subjects with no known primary immunization history with TT or \>10 years have passed since the last dose of tetanus containing vaccine was received. The study will enroll six subjects who would receive both dT and TIG concurrently on Day 1.

All dosed subjects will be followed for 40 days during which Day 1, 2, 3, 4, 5, 7, 14, 21, 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs. time curve, Cmax, Tmax, and duration of protective antibody levels.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 90 years.
* Signed a written informed consent prior to initiation of any study-related procedures.
* No known primary immunization history with TT/dT or \>10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
* Subjects must have documented tetanus antibody levels that are non-protective levels (\< 0.15 IU/ml).
* Subjects must be free of any presenting wound or wound infection

Exclusion Criteria:

* History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
* A history of selective IgA deficiency (serum level \<5.0 mg/dL) and known antibodies to IgA
* Congestive heart failure (New York Association stage greater than Class II)
* Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
* Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
* Subjects who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* TIG therapy within the previous six months
* Investigational drug therapy within the previous three months
* History of Thromboembolism