cyrilzakka/clinical-trials huggingface dataset:
CanGaroo® Registry Study

A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation

This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope.

Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses.

The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF.

Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.

Eligibility Criteria:
Inclusion Criteria:

1. Participants for whom this is their first CIED implantation at a particular anatomical site.

   Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.
2. Participants aged 18 years or older at time of enrollment.
3. Participant is able and agrees to provide written informed consent and use of PHI.

Exclusion Criteria:

1. Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
2. Participants under the age of 18 at time of enrollment.
Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy

The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC).
* Participates aged ≥18 years of age at diagnosis of PTCL.
* Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023.

Exclusion Criteria:

* Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March 2024.
* Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL.
* Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL.
* Participates judged to be inappropriate for enrollment in this study by the site investigator.
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial

To compare the laparoscopic Burch colposuspension with the midurethral slings (TVT, TOT) for treatment of female stress urinary incontinence as regard efficacy and safety.

Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as an involuntary loss of urine on physical exertion, sneezing, or coughing (1). It occurs primarily in multiparous women (2).

The prevalence of UI among Egyptian women is high (55%). Aging, low educational level, menopause, higher parity (\>3), vaginal delivery, and previous multiple abortions (\>3) are significant risk factors for UI(3) Mid-urethral slings (TVT and TOT) are now the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence(4) (5) Mid-Urethral Slings have a very high satisfaction rate (85-90 %) (4) (6), with durability of satisfaction recently demonstrated out to 5-years (79-85 %) as well as a modest 5-year treatment success (43-51 %) (4, 7) Burch colposuspension is a well-accepted technique for surgical management of stress urinary incontinence (SUI), especially when it is associated with urethral hypermobility. it first description in 1961 (8) (9) Originally performed as an open surgical procedure and then Over time, Burch colposuspension has been adapted for laparoscopy, it was long considered as the "gold standard" for the treatment of SUI before emergent of midurethral slings (9) The cure rates for laparoscopic colposuspention is as high as 68.9% to 88.0% whereas recurrence rates remain low, however, it has been reported that the cure rate of retropubic suspension techniques in general decreases steadily from 90% at 1 year to about70% by 10 years postoperatively. After a decline, it seems to reach a plateau at 65-70% at a 20 year follow-up (9) After the Food and Drug Administration (FDA) issued a warning about the use of transvaginal meshes for pelvic organ prolapse (POP) in 2011, there has been much debate about the use of mesh in the MUS continence procedures. Concern is increasing that the use of transvaginal mesh devices to treat SUI and POP have exposed women to avoidable harms following complications such as infection, tissue extrusion, mesh exposure ,mesh shrinkage, and side effects such as severe pain, sexual dysfunction, and repeat surgical interventions (5).

Eligibility Criteria:
Inclusion Criteria:

* 1- All Adult Female patients complaining of stress urinary incontinence attending the voiding dysfunction clinic at Asyut Urology and Nephrology hospital and willing to participate in the study.

Exclusion Criteria:

* 1- Recurrent SUI. 2- Significance Pelvic organ prolapse requiring surgical intervention. 3- Associated Neurologic disorders affecting the lower urinary tract e.g diabetes, spinal cord injury and others.
Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule

Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.

This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

* 1. Inclusion criteria:

  1. Aged 40-80;
  2. Lung nodules were detected by CT (≥5mm，≤3cm);
  3. Patients fully understand the informed consent and can sign the informed consent in person.

Exclusion Criteria:

* 2. Exclusion criteria:

  1. Patients diagnosed with malignant tumors in the past;
  2. This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
  3. Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
  4. Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
  5. The researchers concluded that there were other conditions that made it inappropriate to participate in this study
Pain Reduction Produced by Different Treatments in Carpal Tunnel Syndrome

Pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 3 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, kinesiophobia

  * Tumors
  * Cancer
  * Upper limb surgery or trauma
  * Pregnancy
  * Deformities of the (affected) upper limb
  * Recent skin injuries or infections (in the affected upper limb)
  * Autoimmune inflammatory conditions or flu type symptoms.
  * Allergy to gabapentin, ibuprofen or ibuprofen arginine
  * Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery

The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

As a result, the goal to reduce perioperative pain has taken on a multimodal approach.

Multimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities.

One method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of abdominal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* ASA status I, II, and III patients,
* aged 60-75 y,
* both male and female,
* undergoing inguinal hernia repair surgery.

Exclusion Criteria:

* morbid obesity (BMI \> 40),
* spine metastatic tumor, allergy to an amide LA, or magnesium sulfate,
* heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.
Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders.

The expected results are:

* to obtain two groups of subjects with differences in chewing abilities and saliva production
* the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition
* a sensory profile describing in-mouth comfort when food is eaten


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written consent
* Age \>= 65 years
* Persons living at home or in an old-people's home (Etablissement Hébergement Personnes Agées Dépendantes : EHPAD)
* Persons able to move around independently

Exclusion Criteria:

* Persons without national health insurance cover
* Persons in hospital
* Persons whose MMSE (Mini-Mental State Examination) is \< 24
* Persons requiring enteral or parenteral feeding
* Persons who in the last 12 months have received € 4500 by participating in clinical studies, including the present study
* Persons in a period of exclusion following a previous study
* Food allergies
* Adults under guardianship
Stress During Elective or Emergency Cesarean Operations

We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S.

Exclusion Criteria:

* patients with cardiopulmonary,
* renal,
* hepatic or
* psychiatric disease,
* obstetric-fetal anomaly and
* weighing ≥ 100 kg were excluded.
Effect of Carbohydrates From Nutritional Beverages in Children

This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.


Eligibility Criteria:
Inclusion Criteria:

* Children 33 months - 39 months
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
* Must not have visible erythema, blistering or peeling that would indicate recent sunburn
* Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
* Must not be taking any medication in which exposure to the sun is contraindicated
* Must be willing to obey all rules of the test facility
To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC

This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 75 (including 18 and 75), male or female;
2. Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC.
3. No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered.
4. Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening;
5. There must be at least one measurable lesion as a target (according to RECIST V1.1);
6. ECOG: 0\~1;
7. Life expectancy ≥24 weeks;
8. Major organs' function well.

Exclusion Criteria:

1. Patients with non-small cell lung cancer of other pathological tissue types;
2. Tumor histology or cytology confirmed positive ALK fusion gene;
3. Patients with imaging evidence of tumor invasion of large blood vessels;
4. Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage;
5. Patients with abdominal effusion;
6. During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia;
7. Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy;
8. Have heart disease or clinical symptoms that are not well controlled;
9. Patients with unhealed wounds, active gastric ulcers or fractures;
10. Patients diagnosed with esophagotracheal fistula;
11. People with known hereditary bleeding tendency or coagulation disorder;
12. Patients with known central nervous system metastases.
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery

This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.


Eligibility Criteria:
Inclusion criteria:

1. Patients presenting with cardiac disease requiring surgical operation
2. Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines.

   * significant three vessel disease
   * left main disease ± single, two or three vessel disease
   * two-vessel disease with proximal LAD stenosis
   * coronary artery disease requiring revascularization not amenable to percutaneous coronary intervention
   * Aortic valve disease requiring aortic valve surgery
   * Mitral valve disease requiring surgical mitral surgery
   * Combined surgery for revascularization and valve disease
   * surgery of ascending aorta
3. Have provided signed written informed consent

Exclusion Criteria:

1. Age \< 35 years
2. Patients requiring , emergency or salvage cardiac surgical operation
3. Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
4. Moribund patient not expected to survive surgery 12 months after surgery
5. Active malignant disease with a short life expectancy, not eligible for surgery
6. Hemoglobin levels \> 155 g/dL for women and \>167 g/dl for men (upper reference limits for TYKSlab)
7. Ferritin levels \>150 ug/l for women and \>400 ug/l for men.
8. Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR\<30ml/min).
9. Study treatment can't be infused during the required time window: minimum 48 hours and maximum 21 days before the operation.
10. Ongoing oral or parenteral iron medication at the time of randomization
11. Iron or haemoglobin metabolism or synthesis disorders
12. Primary or secondary hemochromatosis (in males and postmenopausal females, a serum ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum ferritin value of over 150\[17\] or 200\[18\] ng/mL (330 or 440 pmol/L) indicates iron overload).
13. Porphyria cutanea tarda.
14. Liver failure (Child-Pugh class B or C).
15. Pregnancy.
16. Body weight less than 50kg.
17. Ongoing antibiotic treatment other than prophylactic urine tract infection antibiotics.
Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers

The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days,
2. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
3. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
4. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
5. Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions)
6. Consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day

Exclusion Criteria:

1. Toddler with any positive food allergy test food allergy or intolerance to any foods
2. Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study
Paracetamol Treatment of the Borderline Significant PDA

The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs. The current investigation aims to study the effect of treatment on PDAs of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.

In the neonatal intensive care unit of the Shaare Zedek Medical Center, preterm babies \<30 wks. GA, are studied echocardiographically on day of life 3-4. Pending parental informed consent, those diagnosed with a PDA of borderline significance will be randomized to receive either paracetamol or placebo for three days, followed by a repeat echocardiogram. If the PDA remains of borderline significance, the treatment will be continued for an additional 4 days (1 week total). Paracetamol levels and liver functions will be assessed after the third day. Babies will be followed until discharge for subsequent PDA pathology; respiratory distress and chronic lung disease \[CLD\]; necrotizing enterocolitis \[NEC\]; retinopathy of prematurity \[ROP\].

The investigators' primary goal is to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease \[CLD\], as shown by decreased time on supplemental oxygen and assisted ventilation.

Secondary goals:

* To demonstrate a decrease in subsequently diagnosed hs PDA, including

  * Decrease in the need for subsequent therapy for PDA closure
  * Decrease in surgical PDA ligations
* To demonstrate a decrease in necrotizing enterocolitis (NEC) and/or ROP with treatment.
* To demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates \< 30 weeks' gestational age PDA of borderline significance

Exclusion Criteria:

* Infants not deemed likely to survive more than one week Infants with congenital heart malformations Infants with pulmonary hypertension and right to left ductal shunting