cyrilzakka/clinical-trials huggingface dataset:
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.

This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Third trimester
* Cesarean delivery under neuraxial anesthesia
* Healthy, clean skin
* 18 years or older

Exclusion Criteria:

* Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
* Unable to participate fully in all study procedures for any reason
* Cesarean delivery under general anesthesia
* History of hemophilia
* Pacemakers or implantable electronic devices
* History of psoriasis
A Safety, Tolerability, Pharmacokinetic and Efficacy Study of Azithromycin Plus Piperaquine as Presumptive Treatment in Pregnant PNG Women

Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by parasite resistance.

The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New Guinea women. The study will comprise of two sub-studies:

(i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* \>14 weeks and \<30 weeks gestation
* No signs of severe malaria by World Health Organisation criteria
* No significant concomitant disease (such as TB)
* No prior history of an adverse reaction to AZI or PQP
* No prior treatment with these drugs in the past 4 weeks
* Can attend all follow-up visits
* Provide informed consent

Exclusion Criteria:

* Have signs of severe malaria by WHO criteria
* Significant concomitant disease such as TB as assessed by the attending clinician
* A history/family history of sudden death or of congenital prolongation of the QTc interval
* Any clinical condition known to prolong the QTc interval
* A history of complicated pregnancies/deliveries
* A prior history of an adverse reaction to AZI or PQP
* Have taken these drugs in the past 4 weeks
* Cannot attend any of the follow-up visits
* Do not provide informed consent
Arimidex Bone Mass Index and Oral Bisphosphonates

To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score \<-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score \<-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* ER and or PgR positive breast cancer
* Completed Surgery and =/- chemotherapy

Exclusion Criteria:

* metastases
* history of fractures
* HRT or SERMs
* Liver or kidney disfunction
The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.

Success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. They increase the emotional stress of the staff and error probability. It is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia
* Age \>50 and \<85 years
* ASA (American Society of Anesthesiology Classification) II physical status
* Start of operation no later than 09:00
* Signed informed consent form

Exclusion Criteria:

* Age \<50 and \>85 yers
* BMI (Body Mass Index) \<20 and \>40 kg/m2
* ASA I and ASA\>II physical status
* History of a bleeding disorder
* Anemia before surgery Hb\<110 g/l
* Intravascular fluid infusion within 24 hours before study
* Diabetes mellitus
* Previous open hip surgery
* Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
* Alcohol intake 5 U daily
* Contraindication to spinal - epidural anesthesia
* Surgery not by project surgeon
* Start of operation later than 09:00
* Atrial fibrillation
* Narcotic addiction
* History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
* Participation in the other study
Maternal and Neonatal Outcome in Pregnant Women Before and After 1 Year Since Bariatric Operation

Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.

Ultrasound follow up for 9 months pregnancy in women who had laparoscopic adjustable gastric banding done within last 1 year or earlier.

Eligibility Criteria:
Inclusion Criteria:

* 1.Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier

Exclusion Criteria:

* medical disorders affecting pregnancy as diabetes, hypertension, SLE
Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder

Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more.

The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).


Eligibility Criteria:
Inclusion Criteria:

* patients Have been diagnosed in the University Hospital of Amiens-Picardie with a Developmental Language Disorder
* patients must be aged 12 or older,
* patients must be agreed answering the questionnaire

Exclusion Criteria:

* Children with a neurological pathology or handicap as epilepsy, cerebral palsy, sequelae of severe brain injury (traumatic or ischemic or inflammatory...)
* patients with a severe mental retardation
* patients with autism
* patients with bipolar illness
* patients with psychosis
Baseline Blood Indices and Prolonged Length of Hospital Stay

During a pandemic, length of hospital stay (LOS) is critical to managing high patient volumes and preserves access to care related to non-COVID-19 for maintaining the healthcare system. Moreover, identiﬁcation of prolonged hospital stay may allow physicians to reevaluate critical patients, focused delivery of specific interventions, and improve the efficiency of hospital care.

Furthermore, in previous recent studies, attention has been paid to patients with diabetes and COVID-19 infection may require a prolonged LOS. However, there is little evidence on prognostic factors associated with an extension of hospitalization in mild or moderate illness due to COVID-19 infection. Therefore, it is crucial to determine the most vulnerable patients with diabetes mellitus even if they have a non-severe COVID-19 infection during the pandemic.

We hypothesize that the clinically relevant inflammatory parameters may have an impact on LOS in older adults with diabetes and non-severe COVID-19 infection. Therefore, we aim to investigate whether baseline inflammatory parameters on admission hospitals as possible predictors of prolonged LOS in older adults with diabetes and non-severe COVID-19 infection during the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* We included all hospitalized Covid-19 patients with diabetes mellitus according to the any established diagnosis prior to admission or American Diabetes Association guidelines for diagnostic criteria

Exclusion Criteria:

* The patients with severe Covid-19 infection, secondary diabetes or type 1 diabetes mellitus were excluded.
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET

A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.


Eligibility Criteria:
Key Inclusion Criteria:

1. Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment
2. Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral
3. Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic
4. VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal to the highest VAS leg pain score
5. ODI ≥ 20 points
6. At least six (6) months of non-operative conservative management (Analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised exercise and/or physical therapy program-minimum of 12 sessions)
7. At least 22 years of age and skeletally mature

Key Exclusion Criteria:

1. Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded)
2. Osteoporosis or severe osteopenia
3. Lumbar fusion
4. Symptomatic spinal stenosis requiring surgical intervention
5. Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device
6. Disc herniation requiring surgical intervention
7. The subject has a Body Mass Index (BMI) of greater than 35
8. Planned elective surgery within 12 months
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.


Eligibility Criteria:
Inclusion Criteria:

* Post hip or knee surgery
* Fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery)

Exclusion Criteria:

* Social isolation
* Life threatening condition
* No GSM network
* No DSL network
Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue

The objective of this project is to assess the effects of a 2-month cardiopulmonary rehabilitation program on cardiorespiratory fitness in long COVID19 patients. Quality of life, functional capacity, functional respiratory capacity, inflammatory profile, coagulation markers, cognitive functions and brain O2 saturation will also be assessed before and after the exercise rehabilitation program.

Some symptoms such as breathlessness and fatigue appear to persist for several months after COVID-19 infection in about 50% of cases. Stress, anxiety, neurological and cognitive disorders have also been reported in the long-term side effects associated with the disease. Cardiopulmonary rehabilitation programs are recognized as an essential component of the management of people with chronic respiratory disease. These programs are based on exercise training with aerobic exercises, muscle strengthening, breathing exercises. Beyond the benefit on morbi-mortality, a marked improvement in symptoms, fitness and quality of life is observed in chronic respiratory diseases. Several hospital departments, research teams and scientific organizations as the WHO recommend the use of rehabilitation programs for COVID-19 patients.

The main objective is to assess the effects of a 2-month cardiopulmonary rehabilitation program on cardiorespiratory fitness in long COVID19 patients. Secondary objectives include: to characterize baseline and intervention-related changes in quality of life, functional capacity, functional respiratory capacity, inflammatory profile, coagulation markers, cognitive functions, neurovascular coupling and cortical pulsatility.

All participants will have signed a written consent form before taking part in the study.

40 patients who have had COVID-19 with persistent breathlessness and fatigue symptoms after at least 3 months after the diagnosis will be randomly assigned to one of the 2 following study arms : 1/ cardiopulmonary exercise training program; 2/ control group.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80
* Individuals infected by the SARS-COV2 virus, with positive PCR diagnosis
* Still having breathlessness and fatigue at least 3 months after the diagnosis of COVID-19 or patients presenting an increase of 1 point (compared to before infection) on the Modified Medical Research Council scale.
* Able to perform a maximal cardiopulmonary stress test and exercise training program in accordance with current guidelines on cardiopulmonary rehabilitation.
* Able to read, understand and sign the information and consent form.

Exclusion Criteria:

* pulmonary embolism diagnosed by scintigraphy
* Absolute and relative contraindication to exercise stress test and / or exercise training
* Recent cardiovascular events (cardiac decompensation or angioplasty or cardiac surgery, less than 1 month; valvular disease requiring surgical correction, active myopericarditis, severe ventricular arrhythmias not stabilized under treatment).
* Kidney failure requiring dialysis
* heart failure (NYHA III or IV)
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.

This study will conduct a randomized control double-blind clinical trial to evaluate an opioid versus a non-opioid pathway of gabapentin, ketorolac, and acetaminophen in treating postoperative pain following robot-assisted radical prostatectomy (RARP).

Eligibility Criteria:
Inclusion Criteria:

* All men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (RARP) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer

Exclusion Criteria:

* Allergies to any medication involved in the study
* T4 prostate cancer
* incarcerated persons
* chronic narcotic dependence
* any current prescription for narcotics
* any surgery in the past 6 months
Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care

This is a randomized controlled trial to assess the relative effectiveness of providing Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the Emergency Department (ED). Patients who are being discharged from the ED and have had a previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients who consent to enrollment will be randomized to discharge by usual care or discharge with ETOC as provided by the company BoardRounds.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 yrs and older) patients
* Have had a previous ED visit or hospital admission in the 90 days prior to the current ED visit (at Thomas Jefferson University Hospital or Methodist Hospital)
* Have just completed evaluation in the Thomas Jefferson University Hospital Emergency Department for any problem,
* Are ready for discharge from the Thomas Jefferson University Hospital ED, and
* Provide informed consent

Exclusion Criteria:

* Non-English speaking patients
* Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order
* Patients who live outside Philadelphia area (unable to seek follow-up care in Philadelphia) or other condition known to preclude follow-up (such as no reliable access to a telephone)
* Patients in police custody or currently incarcerated individuals
* Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database

Trauma-informed treatment will improve emotional regulation and behavior.

The proposed study is to request permission to continue federally mandated data collection to examine the clinical outcomes of children at the Family Center at Kennedy Krieger Institute who are enrolled in evidence-based and promising trauma-informed treatments as part of the National Child Traumatic Stress Network funded by the Substance Abuse and Mental Health Services Administration. The purpose of the National Child Traumatic Stress Initiative(NCTSNI) Evaluation is to determine the extent to which the NCTSI, through the National Child Traumatic Stress Network (NCTSN), has raised the standard of care and improved access to services for traumatized children. In addition, the evaluation assesses the extent to which the NCTSI has served as a national resource capable of improving children's access to high-quality, trauma-informed mental health services. This data, previously collected and managed by the Category I NCTSN Center at Duke will now be managed by ICF Macro in a data system entitled NICON.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in treatment at the Family Center and caregivers

Exclusion Criteria:

* Psychosis,
* Inability to comply with directions
Quality of Life in Normogonadotropic Anovulation

Among the causes of ovulation disorders (group II of anovulation according to the World Health Organization classification), the dominant one is polycystic ovary syndrome (PCOS), and the remaining cases are classified as Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown. To diagnose PCOS, the Rotterdam criteria must be met and other conditions that may cause hyperandrogenism or ovulation disorders must be excluded. PCOS is more often accompanied by other endocrine and metabolic disorders, such as obesity, dyslipidemia, hyperandrogenism, insulin resistance, diabetes, hyperprolactinemia and thyroid diseases, as well as infertility due to ovulation defect. These conditions not only significantly reduce quality of life (QoL), but also lead to an increased risk of cardiovascular disease, metabolic syndrome, adverse obstetric outcomes and an increased risk of endometrial cancer, further impairing QoL.

A prospective questionnaire study will be conducted regarding the quality of life among women undergoing hormonal diagnostics due to anovulation. The study will include women aged 18-45 with ovulation disorders: PCOS (arm 1) and HPOD (arm 2). The quality of life will be assessed using the self-assessment method using the SF-36 questionnaire (Short Form Health Survey). The questionnaire is intended for a subjective assessment of health status. It consists of 11 questions containing 36 statements that allow you to determine eight quality of life indicators, i.e.: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, health change.

The percentage score on a scale of 0-100% in each of the 8 life domains will be compared between both arms of the study.

Eligibility Criteria:
Inclusion Criteria:

* menstrual cycle length \<21 days or \>35 days
* age 18-45 years

Exclusion Criteria:

* previous ovarian surgery
Vitamin C and Septic Shock

This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.

This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.

Eligibility Criteria:
Inclusion Criteria:

* • Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.

  * Age ≥ 18 years
  * Septic shock as pragmatically defined as:

    o Order for intravenous antimicrobials with either procalcitonin \> 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
  * Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
  * Lactate \> 2 mmol/L 24 hr prior to enrollment AND
  * Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.

    * SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
    * qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.

Exclusion Criteria:

* • Unable to start infusion within 24 hours of septic shock identification

  * Currently pregnant or breastfeeding
  * Patient to receive comfort measures only
  * Cardiac Arrest
  * Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics \< 48 hours post-operation
  * Participation in another study involving an investigational product within 30 days of the baseline visit
  * Allergy to Vitamin C
  * History of nephrolithiasis
  * History of G6PD deficiency
  * ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
  * Clinical course that treating clinician decides would preclude safe participation