cyrilzakka/clinical-trials huggingface dataset:
Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.

The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above with informed consent

Exclusion Criteria:

* ECOG performance status ≥2
* ASA 4 or above
* History of bleeding disorder
* Any use of anti-coagulants
* Pregnancy
Finnish Spinal Cord Injury Study (FinSCI)

The purpose of the Finnish Spinal Cord Injury Study (FinSCI) is to identify factors related to the health and functioning of people with spinal cord injury (SCI), their challenges with accessibility and how such factors are interconnected. The International Classification of Functioning, Disability and Health (ICF) is used in the study as a structured framework. The study participants will be recruited from three SCI outpatient clinics, which together are responsible for the life-time care of the SCI population in Finland.

Mixed methods are used including a questionnaire and interviews. The survey will be formed from patient-reported instruments; SCI-specified Spinal Cord Injury Secondary Condition Scale, Spinal Cord Independence Measure, Nottwil Environmental Factors Inventory Short Form and selected items of the generic instruments of Patient-Reported Outcomes Measurement Information System and National study of health, well-being and service. The survey covers 51 ICF categories. The study results can help develop care and rehabilitation policies with SCI, the planning of training models and information provided to various parties involved.

The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.

Eligibility Criteria:
Inclusion Criteria:

* 16 years or over
* Traumatic or non-traumatic SCI
* ASIA-classification A,B,C tai D
* Time since onset of SCI over 6 months
* Client of HUS, Tays or Oys SCI outpatient clinic

Exclusion Criteria:

* Innate SCI
* Progressive new non-traumatic SCI
* Neurodegenerative disease
* Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care
Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy

Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque.


Eligibility Criteria:
Inclusion Criteria:

* Men or women between 30 and 85 years
* Affiliated to a social security scheme
* Informed consent signed
* Patients to get an endarterectomy carotid stenosis\> 70% asymptomatic is
* Women of childbearing potential (negative pregnancy test), effective contraception for the duration of the study

Exclusion Criteria:

* Inability to give informed information about the study (subject in emergencies, difficulty of understanding ...)
* Patient treated by OMACOR®
* Patients on oral anticoagulant (AVK, apixaban, dabigatran, rivaroxaban)
* Daily consumption of fish oil (medical food with fish oil (omega 3))
* Carotid Restenosis
* Pregnancy (positive pregnancy test) and lactation
* Hypersensitivity to fish
* Allergy to fish
* Subject under judicial protection
* Subjects under guardianship or curatorship
Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I)

This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene

Following the end of participation in Study RP-L201-0318, patients will be offered enrollment into this LTFU protocol. Patients will be followed for up to 15 years following the RP-L201 infusion in the parent study, until the patient dies, withdraws consent, or is lost to follow-up (whichever occurs first).

For all follow-up visits, remote evaluation facilitated by local health care providers (with blood sample shipment to relevant laboratory facilities) is permitted; however, annual visits to the study center are required during initial 3 years post- RP-L201 infusion. Visits where a bone marrow sample is being collected are required to be performed at the study center for the duration of the study. Peripheral Blood samples and bone marrow samples will be archived and tested when clinically or scientifically indicated, as in the event of development of a second malignancy.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the Phase I/II Study RP-L201-0318.
2. Received an autologous infusion of CD34+ hematopoietic stem cells modified with a lentiviral vector containing the ITGB2 gene, encoding for the human CD18 receptor in the parent Study RP-L201-0318.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Provided written informed consent and, as applicable, assent to participate in the current study.

Exclusion Criteria:

There are no criteria for exclusion in this study.
FiO2 Closed Loop Control Ventilation

A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous ventilator.

The trial will use a proportional-integral-derivative (PID) type controller for automatic adjustment of FiO2 to maintain the SpO2 within a target range, based on continuous use of pulse oximetry. Intubated subjects will be randomized to either manual control of FiO2 or closed-loop control of FiO2, during a 12-hour period. The PCLC is designed to respond to acute hypoxemia (SpO2 \<88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.

Eligibility Criteria:
Inclusion Criteria:

* The subject's legally authorized representative will provide signed and dated informed consent.
* Age 18 - 65, inclusive.
* Admission to a surgical or neurosurgical intensive care unit following traumatic injury or acute surgical illness
* Requirement for endotracheal intubation
* Requirement for mechanical ventilation
* Patient is currently receiving inspired oxygen concentration (FiO2) \>=40%

Exclusion Criteria:

* Age under 18 or over 65
* Isolated or severe head injury (Glasgow Coma Scale = 6 or less) with expected survival less than 24 hours
* Brain death
* Anticipated survival less than 48 hours
* Pregnant female
* Patient in whom a pulse oximeter cannot detect a reliable signal due to hypotension, hypothermia, or other injury
* Known carbon monoxide poisoning
* Uncontrolled diabetic
* Patient who is unable to maintain SpO2 level of 88% at an FiO2 of 100% due to their medical condition. (NOTE: Being in the trial would impose no additional risk to a patient who presents with this condition however, data from a patient presenting with this pathophysiology would not provide insight into the performance of the controller as it would simply maintain that patient on an FiO2 of 100%.)
* Patient with chronic hypercarbia.
* Patient where a physician believes that FiO2 PCLC could be detrimental to the management of the patient.
* Prisoner
* SpO2 to SaO2 difference \>4%
* Patient with core temperature \<35 C
Comparing Acceptance and Commitment Therapy (ACT) and Cognitive Therapy (CT) for Test Anxiety

This study proposes to compare the effectiveness of an acceptance-based intervention and a cognitive control-based intervention for coping with test anxiety in nursing students during the HESI (Health Education Systems, Inc.) examination.

Subjects will be randomized to receive either the CT or the ACT condition. In both conditions, subjects will receive an education on test anxiety to inform them about what test anxiety is and why it occurs. Then, the different conditions will receive the respective treatment of either CT or ACT. The study is considered minimum risk because the nursing students will only be exposed to an amount of anxiety that is typical of their testing experience. Both conditions will meet three times, with each session lasting approximately one and a half hours. The purpose of the treatment is to provide subjects with tools to help them cope with their test anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Nursing student subjects may only participate if they are currently enrolled as an undergraduate student at Drexel University.
* They must be nursing majors enrolled in Nursing 492 and intending to take the cumulative HESI examination.
* Psychology students must be enrolled in the courses where recruitment will occur.
* Pre-professional students must be currently enrolled at Drexel University, and planning to take a Standardized test within 6 months.
* All subjects must be at least 18 years of age or older.

Exclusion Criteria:

* Persons may not participate if they are unable to see/read words off of a computer screen.
High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa.

To assess the efficacy and safety of alternative magnesium sulfate regimens when used as single agent tocolytic therapy for prevention of preterm labour in patients with symptomatic placenta previa and subsequent changes in the cervical length .

Placenta previa is implantation of placenta on or near internal os .It is classified into major degree when lower edge of placenta lies within 2 cm from internal os , and minor degree if lower edge of placenta at lower uterine segment but more than 2 cm from internal os .

There are many risk factors for developing placenta previa including multi parity , multiple pregnancy , increased maternal age (\>35y ) , previous uterine surgery , history of placenta previa (4-8%) .

A significant degree of uterine contractility has been observed with symptomatic placenta previa. It is directly associated with vaginal bleeding. However, a large percentage of women who have placenta previa associated with haemorrhage will experience subclinical uterine contractions before the onset of overt vaginal bleeding. Therefore, the use of tocolytic agents in management of placenta previa seems reasonable .

Magnesium sulfate alters calcium up take, binding and distribution in smooth muscles of the uterus, so reduces the frequency of cell depolarization and inhibits myometrial contraction .

In addition to its tocolytic action magnesium sulfate also provide neuroprotection to preterm infant . .

At women Health Hospital, Assiut University, Egypt our policy is using magnesium sulfate as first line for tocolysis for placenta previa patients with preterm uterine contractions. By giving a loading dose of 4 g on 150 ml saline intravenous infusion over 20 minutes, and a maintenance dose of 6g/6h on 500 ml saline slow intra venous infusion

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age between 28 weeks to 37 weeks.
3. Patients presented to the hospital with per vaginal bleeding and in whom a clinical diagnosis of placenta previa is confirmed by trans vaginal ultrasound.
4. Placenta previa with preterm uterine contractions (\< 3 contractions in 10 minutes)
5. Ability to provide informed consent.

Exclusion Criteria:

1. Placental abruption .
2. Women with placenta previa and severe attack of bleeding need immediate termination
3. Clinical criteria of intra uterine infection.
4. intrauterine growth restriction .
5. Fetal anomalies.
6. Fetal distress.
7. intrauterine fetal death.
8. Preterm rupture of membrane
9. High order multiple pregnancies.
10. Treatment with any tocolytic agent before maternal transport.
11. Inability or refusal to provide informed consent.
12. Women with any contraindication for use of magnesium sulfate as patients with renal failure.
13. Patients with bleeding disorder or on anticoagulant therapy .
Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases

Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The study reports reconstruction of small to moderate defects of the fingers with the direct and reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap and joint motion.

At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) test. Active motion of the joints is measured using a standard hand goniometer. For the direct DDIF, total active motion is calculated as the sum of degrees of active flexion of the interphalangeal and the metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed DDIF, total active motion of the donor finger is calculated as the sum of degrees of active flexion of the proximal and distal interphalangeal joints subtracted from the degrees of extension deficit.

Eligibility Criteria:
Inclusion Criteria:

* a defect greater than or equal to 1.5 cm in length
* the defects on the dorsal and lateral aspects of the fingers
* the defects located between the distal 1/2 of the middle phalanx and the tip of the finger
* a patient between 15 and 60 years of age.

Exclusion Criteria:

* injuries involving the donor sites or the course of the vascular pedicle
* a defect less than 1.5 cm in length.
Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis

The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year


Eligibility Criteria:
Inclusion Criteria:

* Inverse Psoriasis or Sebopsoriasis lasting from at one year
* At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)

Exclusion Criteria:

* Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure
* Iodine allergy
* Women who are pregnant or planning to become pregnant during the study
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen

The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength.

IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane.
2. No major rheumatological disorders such as severe rheumatoid arthritis.
3. Patients must have provided informed consent for participation in this study.

Exclusion Criteria:

1. Concomitant endocrine therapy for breast cancer.
2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.
Sirolimus Conversions in African-American Renal Transplant Recipients

This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.

A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ. The regimens in kidney transplantation include tacrolimus, sirolimus, mycophenolate mofetil and steroids. This study will compare the effectiveness and safety of a regimen including Sirolimus, Prograf, and steroids compared to a regimen including Sirolimus, Cellcept and steroids. These regimens have already been researched in the Caucasian population, and both drug regimens are FDA approved. This study's focus is on the effectiveness and safety of these regimens in African-Americans.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and able to give informed consent
* African-American ethnicity
* Received a first or second non-ECD cadaveric or living donor renal transplant
* Transplant occurred during the past 6 to 24 weeks
* Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
* Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
* Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria:

* Biopsy proven acute rejection episode that occurred within the past 6 weeks
* Malignancy within the past 3 years, except for non-melanoma skin cancer
* Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
* Currently enrolled in an investigational trial
* Woman of child bearing potential not utilizing an effective form of birth control
* Patients with uncontrolled dyslipidemia, defined at serum fasting LDL \>200 mg/dL or serum fasting triglycerides \>500 mg/dL.
* Patients with a spot urine protein to creatinine ratio of \> 800 mg of protein per gram of creatinine.
* WBC \< 3,000 cells/mm3
* Platelets \< 100,000 cells/mm3
Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat

This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. The treatment sites are the right and left upper back fat areas. The right and left sides of the upper back fat will be randomly assigned (1:1) to receive cryolipolysis, while the contralateral side will receive ATX-101.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years old
2. Subjects are in good health as judged by the investigator.
3. Subjects with mild to moderate upper back fat.
4. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. History of hypertrophic scars or keloids
2. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder
3. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
4. Pregnant or breast feeding
5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
6. Subjects who are unable to understand the protocol or give informed consent.
Pneumothorax Drainage With Vacuum Bottle

The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Eligibility Criteria:
1. Inclusion criteria:

   · Clinical diagnosis of pneumothorax
2. Exclusion criteria

   * Bleeding tendency
   * Tension pneumothorax
   * Shock
Effect of Probiotics in the Atopic Dermatitis

This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.

Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.

Eligibility Criteria:
Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -

Exclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.

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