cyrilzakka/clinical-trials huggingface dataset:
A Comparison of the Sedation During Endoscopy in Children

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation \<90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

Eligibility Criteria:
Inclusion Criteria:

* All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion Criteria:

* Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM

A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.

Umbilical cord blood (UCB) is an alternative stem cell source for hematopoietic stem cell transplantations (HSCT) and can be used for the treatment of various life-threatening diseases, such as hematological malignancies or genetic blood disorders, in such cases where a matched related stem cell donor is not available. However, the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit (CBU), which was shown to be associated with inadequate hematopoietic reconstitution and high risk of transplant-related mortality. To improve outcomes and extend applicability of UCB transplantation, one potential solution is ex vivo expansion of UCB-derived stem and progenitor cells. NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord® is based on a novel technology for the ex vivo cell expansion of cord blood derived hematopoietic progenitor cells. By increasing the number of the short and long-term reconstitution progenitor cells transplanted, NiCord® has the potential to enable the broader application of UCB transplantation, and improve the clinical outcomes of UCB transplantation.

The study is designed as a multi center, single arm study, evaluating the safety and efficacy of the transplantation of NiCord® to patients with hematological malignancies following myeloablative therapy.

Total study duration is approximately 400 days from the signing of informed consent to the last visit one year following transplantation

The overall study objective is to evaluate the safety and efficacy of NiCord®: single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy as follows:

The main study objectives are to assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation and to assess the incidence of secondary graft failure at 180 days following transplantation of NiCord® Ten evaluable patients recruited for the study should be 12-65 years of age, up to a maximum of 15 treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Applicable disease and eligible for myeloablative SCT
* Patients must have two partially HLA-matched CBUs
* Back-up stem cell source
* Adequate Karnofsky Performance score or Lansky Play-Performance scale
* Sufficient physiological reserves
* Signed written informed consent

Exclusion Criteria:

* HLA-matched donor able to donate
* Prior allogeneic HSCT
* Other active malignancy
* Active or uncontrolled infection
* Active/symptoms of central nervous system (CNS) disease
* Pregnancy or lactation
Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on Plasma Zinc Concentration

This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21 days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days 1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after discontinuation of supplementation.

The study will be a double blind, randomized, placebo controlled trial conducted in men 19-65 years of age. Participants will receive daily zinc or placebo liquid supplements for 21 days. Supplemental zinc will be given as zinc sulfate; the lower dose zinc supplement will contain 10 mg/d elemental zinc, and the higher dose zinc supplement will contain 20 mg/d elemental zinc. The placebo will contain the same excipients expect for zinc sulfate.

Multiple blood draws will be performed throughout the course of the study, to determine the responsiveness of plasma zinc concentrations to zinc supplementation. Two baseline blood draws will occur prior to the start of supplementation (study days -7 and 0). Blood draws will be performed on days 1, 2, 5, 9, 14 and 21 of the 21 day supplementation period. Upon termination of supplementation (day 21), blood draws will be performed on days 1, 2, 5, 9, 14 and 21 post-supplementation (study days 22, 23, 26, 30, 35 and 42).

The major outcomes of interest are the magnitude and velocity of change in plasma zinc concentration. Other outcomes to be assessed are plasma concentrations of the acute phase proteins CRP and AGP, as well as reported morbidity, because of their potential roles as confounding variables. Anthropometric variables will be assessed at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Generally health men
* 19-65 years
* Non-anemic

Exclusion Criteria:

* Age \<19 or \>65
* Hemoglobin \<120 g/L
* Clinical evidence of illness
* Consumption of mineral supplements
* Recent blood donation (within 8 weeks)
Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

This study will be a Randomized controlled trial with a sample size of at least 100 individuals with carpal tunnel syndrome. Participants will be randomized to receive either thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment for 10 minutes, three times per week, for 4 weeks. Outcome measures will include pain intensity, functional status, and nerve conduction studies. Outcome measures will be assessed at baseline, 4 weeks, and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 30-60 years old
2. Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies, including:

   * Symptoms of pain, numbness, and tingling in the hand and/or fingers, particularly the thumb, index, and middle fingers
   * Positive Tinel's sign (tapping over the median nerve at the wrist elicits tingling or numbness in the hand)
   * Positive Phalen's maneuver (flexion of the wrist for 60 seconds elicits tingling or numbness in the hand)
   * Abnormal nerve conduction studies showing prolonged distal motor latency, and/or decreased amplitude of the median nerve

Exclusion Criteria:

1. Prior surgery for carpal tunnel syndrome
2. History of wrist or hand fracture in the past year
3. Pregnancy or planning to become pregnant during the study period
4. Active infection or skin condition in the treatment area
5. Known allergy to ultrasound gel or other components of the treatment
6. Use of corticosteroids or other medications that may affect nerve function within the past 3 months
7. Participation in another clinical trial within the past 30 days
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula

It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes and aged 20 years and above with high perianal fistula

Exclusion Criteria:

* Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma
Safety of Oral Thrombopoietin Receptor Agonist in Pediatric Chronic ITP

This study aimed to evaluate the response rate and safety of oral thrombopoietin receptor agonist (Eltrombopag drug) used for children with chronic immune thrombocytopenia in patients attending Assiut university children's hospital.

Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by decrease number of the platelets due to destruction of the platelets by antiplatelet antibodies. Also, platelet production can be reduced because the antiplatelet antibodies can also damage megakaryocytes . Its prevalence being approximately 8 per 100,000 children It is characterized by temporary or persistent reduction of the platelet number to less than 100 × 109/liter.

All new cases at diagnosis are defined as acute ITP. While, Persistent ITP is defined as ITP lasting between 3 and 12 months from diagnosis while chronic ITP is defined as the presence of ITP for more than one-year ITP Patients have an increased hazard of bleeding that may have no effect on patient's life or have life-threatening danger the goal of treatment in chronic ITP is to increase and then keep platelets in a sufficient number to prevent bleeding

. Meanwhile most life-threatening bleeding occurs with platelet number less than 30 × 109/liter.

New guideline recommend that treatment constricted on symptomatic patients with number lower than 30 × 109/liter (3,6) new Guidelines recommended that corticosteroids as first-line therapy and splenectomy considered as one of several second-line therapies. Other choices exist for ITP patients with insufficient response or who do not undergo to splenectomy including IVIg, IV anti-D, Rituximab, danazol, azathioprine, Vinca alkaloids and cyclophosphamide New consensus statements and guidelines recommend thrombopoietin-receptor (TPO-R) agonists as second and third line of treatment Eltrombopag consider the first oral, nonpeptide TPO-R agonist accepted for the treatment of chronic ITP in patients with insufficient response to at least one other therapy It rises platelet number by increase platelet production by binding to the transmembrane domain of the TPO-R. It does not compete with endogenous TPO in vitro and it enhance production and differentiation of BM progenitor cells in the megakaryocytic lineage

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 2 year and \<18 years of age in both sex
* Confirmed diagnosis of chronic ITP
* all patient received oral thrombopoietin receptor agonist (Eltrombopag) for 6 months or more

Exclusion Criteria:

* age of the patient \< 2years and \>18 years
* secondary thrombocytopenia
* Concurrent or past malignant disease, including myeloproliferative disorder
* patient with platelet agglutination abnormality that prevents reliable measurement of platelet counts
* patient with bone marrow aplasia
Validation of the NTX Wireless Patient Monitoring System

* Reduction in time to detection of Clinically Significant events
* Reduction of time to Intervention during Clinically Significant events
* Reduction in the number of admissions to Intensive Care

1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

Eligibility Criteria:
Inclusion Criteria:

* Ability to give written informed consent
* Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
* Patients must be ≥18 years of age

Exclusion Criteria:

* ICU patients
* Female subjects who are pregnant
* Patients \< 18 years of age
* Patients that have a contradiction for continuous Blood Pressure monitoring
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Are 20 years or older and considered to be candidates for systemic or phototherapy.

\[Moderate to Severe Plaque Psoriasis\]

* Diagnosed for at least 12 months.
* Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

\[Psoriatic Arthritis\]

* Diagnosed for at least 6 months.
* Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
* Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis
* Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
* any uncontrolled significant medical condition
Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.

To become eligible for therapy the following criteria must be fulfilled:

* No age or gender limit
* Patients with atypical malignant brain tumors.
* Must have a Karnofsky performance of at least 60%
* Hematologic studies and chemistry profiles will be within the parameters of the protocol
* Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
* Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
* Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
* patients with atypical malignant brain tumor will be eligible.
* Patients must have a Karnofsky performance score of at least 60%
* patients may be maintained on glucocorticoid therapy at the lowest possible dose.
* Baseline hematologic studies and chemistry profiles must meet the criteria.
* Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
* Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
* Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
* Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
* Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.

Exclusion Criteria:

* Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
* The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
* Patients with a known history of an autoimmune disorder.
* Inability to give informed consent.
* Pregnancy.
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm

The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.

The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks.

To meet this purpose, the following objectives will be addressed:

1. To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
2. To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the study, participants must meet the following inclusion criteria:

* born premature (\< 37 weeks' gestation),
* require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age.
* Primary parent must have a working mobile device.
* Participants must be English or Spanish speaking as primary language.

Exclusion criteria:

* primary parent does not having a working mobile device and
* Speaking a language other than English or Spanish.
* Unable to be placed in the prone position,
* Physiologically unstable for handling
* Orally intubated or have a tracheostomy
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke

The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.

This is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tDCS) paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. The investigators will examine changes in cognitive performance induced by tDCS + cognitive therapy compared to sham tDCS + cognitive therapy. This study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.

Eligibility Criteria:
Inclusion Criteria:

* Stroke that occurred within 4 weeks of the study
* Presence of cognitive impairment attributable to stroke
* Between the ages of 18 and 90
* Able to understand the nature of the study and give informed consent
* Able to follow simple commands as evidenced by NIHSS subtest 1C =0

Exclusion Criteria

* History of chronic, serious, or unstable neurologic illness other than stroke
* Current unstable medical illness(es)
* History of reoccurring seizures or epilepsy
* Current abuse of alcohol or drugs (prescription or otherwise)
* Active and severe psychiatric disorder
* Metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
* Pregnancy
Drug Use Investigation of Kovaltry in Hemophilia A Patients

The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.

This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.

Eligibility Criteria:
Inclusion Criteria:

* Male and female hemophilia A patients.
* Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A