cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis

The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.

The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.

Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age range: 18 - 55 years of both sex.

Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult age from 18 to 55 years old
* Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Antipsychotic treatment for 12 months since clinical stabilization. Clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family.
* No changes in the antipsychotic doses in the last 4 months.
* No suicide attempts in the last 12 months.
* Patient who shows remission criteria.
* Signed informed consent form.

Exclusion Criteria:

* Patient who is not fluent in Spanish language
* Patient who takes mood stabilizers (Lithium, antiepileptic drugs...)
* Dependency on alcohol or other substances of abuse (cannabis, cocaine...)
* History of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders.
* Intelligence testing (IQ) less than 70.
* Suicide attempt from stabilization.
* Pregnancy or planning to become pregnant during the study.
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone

Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period. Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.Often, the donor site is reported to be more painful than the recipient site,affecting early mobilization, sleep, and need for analgesics postoperatively.

Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.

Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia. Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves.

American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.

Prolongation of analgesia after surgery under regional anaesthesia is a goal for clinicians. Many investigators have sought that the ideal analgesic adjuvant that would both prolongs pain relief and avoids side effects after a single-shot peripheral nerve block. Although many agents have failed this test (opioids, ketamine, clonidine, etc.), the perineural addition of dexamethasone to local anaesthetic has been shown in several studies to prolong the analgesic effect and its use has become common in clinical practice around the world. Not surprisingly, much research has been performed with the aim of providing Level 1 evidence via randomized controlled trials design and systematic review and meta-analysis. Despite this, there is still no adequate answer as to whether perineural dexamethasone is superior to systemic administration alone.

Eligibility Criteria:
Inclusion Criteria: • Age 2 -12 years.

* ASA I - II
* Scheduled for split thickness grafting.
* Availability and suitability of lateral and anterior aspects of the thigh as a donor site.

Exclusion Criteria:

* Patient's guardian refusal to participate in the study.
* Known allergy to local anesthetics
* Children known to be diabetic.
* Coagulopathy.
* Children with motor or sensory deficits in lower extremities.
* Children who are morbidly obese (BMI≥35) because ultrasound guided regional anesthesia could be technically difficult.
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women between the ages of 18 years and 85 years;
2. Acute fractures of the femoral shaft

Exclusion Criteria:

1. Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
2. Pathological fractures;
3. Open fractures;
4. Patients with additional injuries to the ipsilateral femur;
5. Surgical delay of greater than 7 days from the time of injury;
6. Retained hardware in the affected limb;
7. Previous infection in fractured limb;
8. Likely problems in the judgment of the investigators with maintaining follow-up;
9. Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
10. Hopeless diagnosis;
11. Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
12. Fractures requiring cephalomedullary nails
Management of Medium Sized Renal Stones

Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.

Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.

This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.

1. SWL All cases will be treated as day care procedures, under analgesia without any anesthesia. Dornier MedTech (Compact Delta II), an electromagnetic shock wave lithotripter will be used. Patients will be treated in supine position and the calculus will be localized by using X-ray or Ultrasound. All sessions will be performed by a single technician under the supervision of a urology consultant. Shock waves will be delivered at the rate of 60-80 per minute with a maximum of 2500 shocks per session of treatment. Session will be started with low energy waves and gradually increased according to patient tolerability. A maximum of 2 sessions spaced two weeks apart. All patients will be advised to drink lots of fluids and maintain active lifestyle and skipping exercises if possible. Prior to every sitting an X-ray KUB will be obtained to see for the state of clearance of stone.
2. Tubeless Super mini-PCNL (SMP) Modified technique will be performed in prone position using 14 Fr Amplatz sheath with the use of Karl Stroz semi rigid ureteroscope, Holmium Laser. Lithotripsy will be achieved by means of Holmium laser fiber 365 um.

   Ureteric catheter will be removed after 24 hours unless there is indications for JJ stent insertion ( eg. Only functioning kidney, perforation, etc)
3. F-URS A sensor guide wire was placed into the renal pelvis via rigid ureteroscope. A 11-13 Fr access sheath will be placed into the ureter, if possible. After ureteral access was obtained, a 8 Fr flexible ureteroscope will be used for the stone treatment. The stones disintegration by holmium laser fibers. At the end of the procedure, a ureteral stent (JJ stent or Ureteric catheter) will be inserted

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Single renal stones 10-20 mm in longest dimension

Exclusion Criteria:

* Previous upper urinary tract exploration in ipsilateral side.
* Patients with JJ stent in ipsilateral side.
* Absolute contraindications to SWL
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia

A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice hormonal contraception (injectable progestins or oral contraceptive pills) among HIV-infected, recently post-partum women in Lusaka, Zambia.

In the year 2000, there were over 37, 000 new acceptors of family planning in the Lusaka District Clinics. A variety of methods were prescribed, including combined oral contraceptive pills, injectable progestins, the intrauterine copper device, condoms, and others. The most recent sentinel survey of reproductive age women estimated that approximately 30% of reproductive age women in Lusaka are HIV-infected. Since voluntary HIV counseling and testing is not yet universally available in many of the district clinics, women receive all different types of contraception regardless of their HIV status.

There is some observational data published recently that suggests hormonal contraception may increase HIV viral load in the female genital tract and potentially increase HIV transmission to the male partner. By contrast, barrier methods have historically been very unpopular in stable couples and are not used consistently in many cases despite intensive counseling. The IUCD represents one of the most inexpensive and effective methods of birth control available in Lusaka. However, it has not been studied adequately to make policy recommendations regarding its use in HIV infected women. The purpose of this study will be to evaluate safety and acceptability of the IUCD versus hormonal methods of contraception in HIV-infected and uninfected women in Lusaka. Specifically, we will 1) compare the contraceptive effectiveness of the IUCD to the standard practices of user-chosen hormonal contraception, 2) compare the rates of pelvic infection between IUD and hormonal contraceptive users, and 3) compare rates of method discontinuation.

Patients who have a continuing second trimester pregnancy, serologically confirmed HIV infection, a desire for 24 months of contraception, and a willingness to be randomly assigned either an IUCD or hormonal contraception postpartum will be screened at 32 weeks in their pregnancies to receive either an IUCD or user chosen hormonal contraception postpartum. Women will then be seen at postpartum weeks 4-6 for method randomization and then at months 6, 12, 18 and 24 to monitor pregnancy, continuation of method, side effects and any other problems. Women will be encouraged to return for problems at any time. At least once yearly, women will have a complete physical exam. CD4 and HIV clinical status will be monitored regularly.

Eligibility Criteria:
Inclusion Criteria:

* desire for at least 2 years of continuous contraception
* two or fewer sexual partners in the prior year

Exclusion Criteria:

* advanced HIV disease (WHO Stage III or IV)
* history of a bleeding disorder
* history of PID within the prior five years
* less than 16 years of age (the "age of majority" in Zambia).
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

The purpose of this study is to see whether using the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to find out whether PET/MRI scans done after the injection of this investigational tracer are more accurate than the usual imaging scans used to locate deposits of prostate tumor cells. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that this tracer will be used in people who are undergoing surgery for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

Primary RP + PLND

* Age ≥18 years
* Patients meeting one of the following criteria:

  * Tumor clinical stage T3a or higher
  * Gleason score 8-10, or
  * PSA level \> 20 ng/mL
* Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
* Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) Salvage PLND
* Age ≥18 years
* Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node =\> 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
* Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
* Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)

Exclusion Criteria:

* Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
* Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
* Prior pelvic radiotherapy (N/A for Salvage PLND )
* Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer

  °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR \< 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
* Weight greater than the 400-lb weight limit of the PET scanner
* Unmanageable claustrophobia
* Inability to lie in the scanner for 30 min
Aging Brain Changes, Executive Dysfunction and Depression

The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.

Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
2. Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
3. Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).

Exclusion Criteria:

1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
2. High suicide risk, i.e. intent or plan to attempt suicide in near future.
3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
6. Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
7. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids.
8. Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.
9. Current involvement in psychotherapy.
10. History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
11. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
12. Inability to speak English.
13. Aphasia.
14. Residence outside a 45-minute drive from Cornell's clinical facilities.
15. Patients taking MAOI's and Fluoxetine will be excluded.
An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Nearly 90% of people with Parkinson's disease have speech and voice disorders that negatively impact their ability to communicate effectively in daily life. This study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with Parkinson's disease and speech impairment. This approach would offer an affordable way to continue to both instruct and encourage training by Veterans virtually indefinitely through the remote access technology. These findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and speech impairment.

Background/Rationale The great majority of individuals with Parkinson's disease (PD) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. Hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). Changes in speech may appear early in PD and progress in severity over time. Further, such changes in speech lead to significant declines in functional communication and quality of life. Pharmacological and surgical interventions that alleviate motor symptoms in PD are largely ineffective or sometimes even detrimental for speech.

Objectives Based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in PD to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. The investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program.

Methods A total of 104 community-dwelling Veterans with hypokinetic dysarthria in mild-to-moderate PD will be randomly assigned to the exercise intervention or to the health education control. The investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of idiopathic Parkinson's disease (PD)
* At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
* Response to dopaminergic medication
* Hypokinetic dysarthria

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction (MI) within 6 months
* History of ventricular dysrhythmia requiring current therapy
Effects of Muscle Flossing on Quadriceps Muscle Potentiation

Tissue flossing involves wrapping a thick rubber band around a joint or muscle, which can partially occlude blood flow. In practice, it is often used while concomitantly performing a range of motion exercises (ROM) for 1 to 3 minutes in duration. The mechanisms involved in tissue flossing with a floss band may be similar to those involved in ischemic preconditioning. Previous results would support the use of tissue flossing on ROM, while there are no clear conclusions on post-activation effects on sports-related performance and muscle contractile properties. This may be attributed to the different methodologies used in the studies. Therefore, the time course associated with tissue flossing benefits remains to be investigated.

Nowadays, various methods are used for acute performance enhancement. The most recent of these is tissue flossing, which is becoming increasingly popular for both performance enhancement and rehabilitation. However, the effects of flossing on athletic performance have not been clearly demonstrated, which could be due to differences in the methodology used. In particular, the rest periods between the end of the preconditioning activity and the performance of the criterion task or assessment tools varied considerably in the published literature. Therefore, the present study aimed to investigate the effects of applying tissue flossing to the thigh on bilateral countermovement jump performance and contractile properties of vastus lateralis (VL) muscle. Nineteen recreational athletes (11 males; aged 23.1 ± 2.7 years) were randomly assigned to days of flossing application (3 sets for 2 min of flossing with 2 min rest between sets) with preset experimental pressure (EXP = 95 ± 17.4 mmHg) or control condition (CON = 18.9 ± 3.5 mmHg). The first part of the measurements was performed before and after warm-up consisting of 5 min of cycling followed by dynamic stretching and specific jumping exercises, while the second part consisted of six measurement points after flossing application (0.5, 3, 6, 9, 12, 15 min).

Eligibility Criteria:
Inclusion Criteria:

* Healthy and physically active individuals
* without a history of lower limb injuries and/or surgeries at least 1 year prior to investigation.

Exclusion Criteria:

* neuromuscular and metabolic disorders;
* the presence of acute and/or chronic pain
* alcohol and drug consumption etc.