cyrilzakka/clinical-trials huggingface dataset:
The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia on Opioid Consumption in Gastric Sleeve Surgery

This is a unicentric, prospective randomised trial that aims to evaluate the role of intra-operative monitoring of nociception through SPI (Surgical Pleth Index) in guiding analgesia and reducing opioid consumption in obese patients undergoing bariatric surgery.

We aim to enrol 40 patients having laparoscopic gastric sleeve surgery in the Cluj-Napoca County Hospital. They will be randomised into two groups, one with opioid administration during surgery guided by SPI, and the other one guided by anesthetist experience. We will monitor opioid consumption, pain scores during the first 90 minutes post-operatively, hemodinamic events during surgery and the duration between reversal of neuromuscular block and extubation.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to laparoscopic gastric sleeve surgery in First Surgical Clinic, Cluj-Napoca County Hospital

Exclusion Criteria:

* drugs that affect the autonomic nervous system
* peripheral neuropathy
* altered renal/hepatic function
* chronic opioid use
* use of vaso-active drugs intra-operatively
Auditory Evoked Potential Monitoring on Bronchoscopy

To compare the difference of sedation monitoring for bronchoscopic examination monitoring by auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients with aged 18 or over and they needed bronchoscopic examination in the ICU were eligible for this study.

Exclusion Criteria:

* patients with pacemaker, neuromuscular blockades, propofol allergy or hearing impairment.
College Students Who Self-Harm

Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.

Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD with its associated high rate of self-harm and suicide. The investigator previously implemented a 4-mth condensed-DBT regimen with success in an adult clinical population. This study will evaluate an intensive 8 week intervention formulated for students to reduce the high prevalence of self-harm and dysfunctional behavior in this population and reduce the need for extended treatment in later years. It will include rigorous screening for collateral disorders, including Substance Use Disorders exacerbating BPD symptoms and suicide risk.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 27
* Currently enrolled in college
* Meet at least 4 of 9 Criteria of BPD (DSM-V) with one criterion being self-harm (e.g. cut, burn, or hit self)

Exclusion Criteria:

* have a current major psychiatric disorder diagnosis, or other gross cognitive impairment (as identified in the phone screen or the SCID I measure) or
* have undergone DBT or
* are suicidal and require full DBT and/or hospitalization or
* are currently in any other individual or group therapy
* unable to attend weekly visits over 8 weeks, starting March 24, 2014
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease

Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.
* Patients with both legs are affected, but the most severe leg does not exceed stage 5.

Exclusion Criteria:

* Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.
* Patients with limited amputation of the toes can participate.
* Insufficient understanding of the Dutch language.
* No physiotherapy insurance.
Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.

Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Different strategies aim to maximize the early impact of vaccination in a context where few doses are available.

In early January 2021, large-scale vaccination began in France, first for populations at risk of severe COVID-19, but also for healthcare workers over 50 years of age or with an underlying pathology, and then for all voluntary healthcare workers.

The question of vaccination of patients with a history of recent or late SARS-CoV-2 infection has rapidly become a major issue. Currently, French recommendations call for a single dose in the cohort that has been cured of COVID-19 for six months. In addition, the use of anti-SARS-Cov2 serology may be of interest because the presence of antibodies indicates recent or past contact with SARS-CoV-2. However, serological testing is not included in the vaccination decision strategy.

The goal of the investigators is to provide data on the immune response induced by SARS-CoV-2 vaccines in a real-world setting to support this choice. Given the absence of recommendations concerning the realization of the anti-SARS-CoV-2 serology, it will be proposed to all the nursing staff of the Groupe Hospitalier Paris Saint Joseph at the time of their vaccination, a serological screening.

The investigators will evaluate the dynamics of antibody production against the SARS-CoV-2 Spike protein after the first and second dose of vaccine (conventional prime-boost strategy recommended) in healthcare workers with or without a history of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Health care workers of the Paris Saint Joseph Hospital Group whose age ≥ 18 years
* French-speaking
* Health care workers who have received the BNT162b2 mRNA vaccine (COMIRNATY, Pfizer/BioNTech).

Exclusion Criteria:

* Health care workers under guardianship or curatorship
* Health care workers under court protection
* Health care workers who object to the use of their data for this research
Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex

The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)

The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.

Tuberous Sclerosis Complex (TSC)is a genetic disorder with a birth incidence of approximately one in six thousand. Five to twenty percent of patients with TSC will develop astrocytoma, a slowly progressive tumor. They grow and cause damage to surrounding brain tissue, blockage of spinal fluid (hydrocephalus), blindness, trouble walking, seizures, and brain damage. If untreated, they can be fatal. Standard treatment involves surgery to remove the tumor; however surgery may itself cause brain damage, bleeding, or infection, as well as other complications. Studies have shown that everolimus suppresses the chemicals that cause tumors to grow in tuberous sclerosis, and may cause them to shrink.

The primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with Tuberous Sclerosis who have been diagnosed with an astrocytoma

Eligibility Criteria:
Inclusion Criteria:

* Age three years and older
* If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. In the extension phase, all females of child bearing potential will be required to take monthly home pregnancy tests and record results on a provided diary card.
* Clinically definite diagnosis of tuberous sclerosis (modified Gomez criteria or positive genetic test)
* Presence of giant cell astrocytoma as defined by imaging characteristics and serial increase in size of lesion on 2 or more MRI scans
* Adequate renal function (creatinine \< 1.5 mg/dl)

Exclusion Criteria:

* Serious intercurrent medical illness or other uncontrolled medical disease which could compromise participation in the study
* Significant hematologic or hepatic abnormality
* Continuous requirement for supplemental oxygen
* Intercurrent infection at initiation of everolimus
* Embolization of angiomyolipoma within one month; any other recent surgery within 2 months of initiation of everolimus
* Pregnant or lactating women
* Use of an investigational drug within the last 30 days
* Must be adequately recovered from the acute toxicities of any prior therapy
* Clinical evidence of impending herniation or focal neurologic deficit related to the subject's astrocytoma
* Unwilling or unable to use highly effective contraception
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.

ii) Evaluate adverse events. iii) Evaluate viral resistance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for the study if they meet the following inclusion criteria:

  1. 18 years of age or older
  2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
  3. Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
  4. Detectable serum HCV-RNA
  5. No significant co-morbid conditions
  6. Liver biopsy is not necessary
  7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects)

Exclusion Criteria:

* Subjects will be excluded from participation in this study if the following conditions are present:

  1. Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
  2. Active substance abuse within the past 12 months
  3. Co-infection with hepatitis B or HIV
  4. Decompensated cirrhosis (Child-Pugh class B or C)
  5. Significant cytopenia - any of the following: platelets \<80 x 109/L, neutropenia \<1.2 x 103/L, Hb \<120 g/l for men or 110 g/l for women
  6. Lack of informed consent
  7. Previous null-responders (\<2 log10 decrease at week 12 with previous PR therapy)
PSMA-PET Guided Radiotherapy

PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). \[18F\]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
3. ECOG 0-1
4. Charlson Cormobidity Index ≤ 4
5. High-risk of distant metastases as defined by any of:

   1. Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.
   2. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
   3. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or\>0.2ng/ml-RP)
6. Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Exclusion Criteria:

1. Prior androgen deprivation therapy terminated \< 12 months prior to enrollment.
2. Prior or planned PET scan.
Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder

Selecting a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.

Purposive sampling method was used to select a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into age, gender, clinical typing, medication use, family proximity, Conners scores and SNAP-IV scores matching the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children clinically diagnosed with ADHD;
* 7-14 years old;
* Combined Raven's Test ≥ 80;
* Not participating in any treatment other than drug therapy;
* The body can participate in sports training;
* The type of family intimacy is intimate or above;
* Voluntarily participate and sign an informed consent form

Exclusion Criteria:

* Children with a history of epileptic seizures;
* Children with other mental or motor disorders;
* Children with visual impairments;
* Using other psychotropic drugs;
* Have other comorbidities;
* Merge other serious chronic diseases (such as severe heart, brain, kidney, lung, etc.), tumors, etc
Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects

This is an open-label, single-dose, study in healthy males. The primary objective is to assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose of radiolabeled BMS-986142 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

* History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
* Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
* History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
* Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis

Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.

The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal healthy women
2. Uncomplicated cystitis

Exclusion Criteria:

1. Postmenopausal women
2. Complicated UTI
3. Women with catheter
4. Women with recurrent UTI
5. Pregnancy
6. Diabetes Mellitus
Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer

Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .

The goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients.

Clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic MIBC. Based on Level I evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the American Urologic Association (AUA), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Association of Urology (EAU) . In the Southwest Oncology Group (SWOG) Intergroup study, RC alone was compared with three cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. This randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront RC alone.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )

Exclusion Criteria:

* Non muscle invasive bladder cancer (NMIBC)
* Metastatic patients
* Patients treated with surgery firstly
Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS) Damage

The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.


Eligibility Criteria:
Inclusion Criteria:

1. post-severe closed head injury (Glasgow Coma Scale \[GCS\] score at admission to emergency room of ≤8) \[Kathryn 2008\].
2. at least one year post trauma.
3. ages 7 to 13 years.
4. independent ambulation (foot orthoses permitted).

Exclusion Criteria:

1. had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
2. unable to follow simple instructions.
Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.

The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.

Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.

Eligibility Criteria:
Inclusion Criteria:

* Single or double rooted teeth indicated for extraction
* Presence of a buccal defect.
* Maxillary and Mandibular Arches

Exclusion Criteria:

* Systemic conditions/disease that contraindicated surgery.
* Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
* Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
* Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.