cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.

Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control rate at 2 years will be recorded.

Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control rate at 2 years will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* resected well-differentiated throid cancer with at least one high risk feature for locoregional recurrence

Exclusion Criteria:

* medullary or anaplastic thyroid cancer, unresectable
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.

The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Eligibility Criteria:
Inclusion Criteria:

* 16 years of age and older
* Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

* Less than 16 years old
* Are pregnant
* Have skin cancer
* Currently taking immunosuppressive or steroids or photosensitizing drugs
* Current participation in any other investigational drug evaluation
* Concurrent use of known photosensitizing drugs
A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy adult males and females (age 18-45 years)
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening
* All females must have a negative serum human beta-chorionic gonadotropin test result or negative urine pregnancy test result at Screening and Baseline. Females of child-bearing potential must use a medically acceptable method of contraception throughout the entire study period and for 30 days after study drug discontinuation. Postmenopausal women and women who have been surgically sterilized or are proven sterile are exempt from this requirement. All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
* Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of child-bearing potential must use, or their partners must use, a highly effective,method of contraception starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug.
* Willing and able to comply with all aspects of the protocol
* Provide written informed consent

Exclusion Criteria:

* Standard selection criteria typically used in all protocols
* Clinically significant abnormal laboratory test results, including platelet count and electrolyte abnormalities at Screening and at each Baseline
Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth

Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. The aim of this study is to assess the regenerative potential of mature permanent teethwith necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic agitation of xp-endo finisher and conventionaltriple antibiotic paste


Eligibility Criteria:
Inclusion Criteria:

Patients with mature teeth. Patients with periapical periodontitis. Maxillary anterior teeth only will be involved. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.

Patients who will agree to the consent and will commit to follow up period.

Exclusion Criteria:

* Patients with immature roots. - Immuno-compromised patients, including patients who self-reportedto be a carrier of HIV, hepatitis, undergoing steroid therapy, thosewho self-reported with genetic or systemic diseases that could resultin a reduced immune response.- All patients who respond positive to allergic patch test \[tripleantibiotic paste\] and drugs.- Pregnant and lactating women.- Patients who could/would not participate in a 1-year follow-up.- Teeth with previous endodontic therapy performed. - Teeth with periodontal involvement. - Teeth with calcified canals.- Presence of external or internal root resorption.- Teeth with root fractures (checked with pre-operative radiographsusing horizontal and vertical angulations)
Intranasal TXA for Anterior Epistaxis in the Emergency Department

The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).

Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.

Informed consent will be obtained prior to patient enrollment.

Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.

Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.

Eligibility Criteria:
Inclusion criteria:

• Patients 18 years and older with anterior epistaxis

Exclusion criteria:

* Patients with inability to give consent
* Patients without a working telephone number
* Patients lacking the mental capacity to make their own decisions
* Patients with posterior epistaxis
* Epistaxis following major trauma
* Patients with known bleeding disorder like hemophilia and thrombocytopenia
* Prisoners
* Patients hemodynamically unstable
* Pregnant patients
* Patients with a known allergy to TXA
* Patients with a visibly bleeding vessel
* Those recently post-op nasal/sinus surgery (within ten days) will also be excluded
Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers

The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves.

A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.

Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been shown to improve the quality of decisions and reduce burden on the decision maker in multiple clinical settings, yet almost none have focused on life-sustaining treatments in acute critical illness such as stroke. This study proposes a comprehensive frame shift in how the health care team and surrogates collaborate on decisions regarding life-sustaining treatments for acute illness, by developing a tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.

The two project phases are: 1) Decision support intervention development; and 2) Pilot testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will be developed and incorporated into the tool.

The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient pairs in the intervention group, which equals a total of 100 subjects.

Eligibility Criteria:
Surrogates:

Inclusion Criteria:

* Self-identify as the surrogate decision maker for eligible patient
* Able to read and communicate in English without an interpreter
* Limited to one surrogate per patient

Exclusion Criteria:

* No prior relationship with patient
* Dementia or other cognitive or health condition that would impair their ability to participate

Patients:

Inclusion Criteria:

* Ischemic stroke or spontaneous intracerebral hemorrhage
* Impaired decisional capacity (per treating team)
* Enrolled on or before full hospital day 5
* Minimum illness severity (either):

  * National Institutes of Health Stroke Scale ≥ 10
  * Glasgow coma scale ≤12

Exclusion Criteria:

* No surrogate available for study procedures
* Already on comfort measures only
* Physician refuses to allow approach for consent
* Pregnancy
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.

Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.

BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
* Failure to have responded to one or more standard regimens for their disease.
* Performance status of \<=2 by Eastern Cooperative Oncology Group (ECOG) criteria
* All ages are eligible
* Life expectancy of at least 3 months
* Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits or normal \[ULN\])
* Adequate kidney function (calculated creatinine clearance \>50 mL/min)
* Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
* Signed informed consent/assent form (ICF) prior to start of any study specific procedures

Exclusion Criteria:

* Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
* Patients with known Hepatitis B and/or Hepatitis C active infection
* Patients with active CMV infection
* Tumor-related central nervous system (CNS) leukemia requiring active treatment
* Active serious infection not controlled by oral or IV antibiotics
* Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
* Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
* Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
* Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
* Pregnant and/or lactating women
Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment

The goal of this clinical trial is to measure the median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy. This clinical trial was divided into two groups based on age, Group I (Age \< 65 years old) and Group II (Age ≥65 years old). We used the sequential allocation designed by Dixon. The initial oxycodone dose was set to 0.1 mg/kg.A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point was included as the first case for ED50 estimation in each group.The study was conducted until 7 crossover points were collected


Eligibility Criteria:
Inclusion Criteria:

1. The first unilateral thoracoscopic lobectomy was performed under general anesthesia
2. age 18- 80 years old
3. American Society of Anesthesiologists (ASA) physical status I-III
4. Sign the informed consent of the patients

Exclusion Criteria:

1. Moderate to severe obesity (i.e., BMI \> 30kg/m2)
2. Allergic or hypersensitive reaction to oxycodon
3. A history of chronic pain
4. Patients with significant heart, pulmonary, liver or renal disease
Thinking Skills for Work in Severe Mental Illness

The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.

This randomized controlled trial is evaluating the effectiveness of a pilot-tested, manualized cognitive remediation intervention entitled the "Thinking Skills for Work Program" by comparing it to enhanced supported employment services in clients with severe mental illness (SMI) who are participants in high fidelity supported employment programs at the Greater Mental health Center of Manchester and Thresholds, Inc., Chicago, Il, but who have had difficulty getting or keeping jobs. Participants are randomized to either the Thinking Skills for Work (cognitive remediation +supported employment; CT+SE) or enhanced supported employment (E-SE), with cognitive, symptom, and quality of life assessments performed at baseline, 3 months (following the completion of the computerized cognitive training component of the Thinking Skills for Work program), 12 months, and 24 months, and employment data gathered over the full 2-year period. For the E-SE condition, supported employment services are enhanced by training provided to the employment specialists regarding to recognize cognitive problems related to work performance, and how employment specialists can teach clients coping strategies for managing these problems. Primary analyses will focus on testing the hypotheses that the Thinking Skills for Work Program (CT+SE) leads to better cognitive functioning and better competitive work outcomes over the 2-year follow-up period compared to the E-SE program.

Eligibility Criteria:
Inclusion Criteria:

* Chronic mental disorder
* Minimum age 18
* Unemployed
* Wants employment
* Must be a recipient of services at one of two participating agencies
* Fluent in English
* Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included

Exclusion Criteria:

* History of neurological conditions that impair cognition
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC.


Eligibility Criteria:
Inclusion Criteria:

* children between 3 years and 12 years 11 months at the time of consent
* diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
* at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,
* physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,
* medically stable,
* passes MR safety screening (e.g., no metal in the body).

Exclusion Criteria:

* presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),
* current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),
* presence of significant medical problems that would interfere with participation,
* the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,
* individuals taking antioxidant agents and glutathione prodrugs, or
* the inability/unwillingness to swallow an agent during the screening visit.
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure

To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have given written informed consent and comply with the requirements of the study protocol.
2. Must be aged 18 years or over.
3. Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation treatment.
4. Sufficiently fit to undergo an additional examination time of 30-90 minutes.
5. Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation procedure.

Exclusion Criteria:

1. Patients expected to require more than two injection positions for radioembolisation treatment.
2. Pregnancy or nursing.
3. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
4. Patients who are declared incompetent.
5. Previous enrollment in the present study
6. Claustrophobia
7. The last dose of prior chemotherapy has been received less than weeks prior to the planned 99mTc-MAA pre-treatment procedure.
8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 2 from previous anti-cancer treatment
11. Body weight over 250 kg (because of maximum table load)
12. Patient length over 1.90 m (to fit IXSI geometry)
13. Patient bust line over 135 cm (to fit IXSI geometry)
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis

A comparison study was performed between laparoscopic appendectomy and open appendectomy in acute setting in tertiary hospital to access the outcome of postoperative pain and hospital stay. As the popularity of laparoscopic appendectomy has failed in major tertiary hospital due to huge amount of patient load in which open appendectomy was performed.This study was performed to prove that outcome of laparoscopic appendectomy are far better than open appendectomy and to increase the use of laparoscopic surgery in acute settings

Introduction:

Open appendicectomy has been a safe and usually opted mode of operation for acute appendicitis for more than a century, but since last 10 years laparoscopic appendicectomy is gaining popularity, although still not as popular as laparoscopic cholecystectomy. Comparison of these two is studied in terms of pain outcome as patient perceives and length of hospital stay.

OBJECTIVES:

The objective of this study was to compare the outcome of open appendectomy and laparoscopic appendectomy in patients with acute appendicitis.

STUDY DESIGN: Randomized control trial

SETTING:

Surgical Unit I, Services Hospital, Lahore

DURATION OF STUDY:

Duration of my study was six months after the approval of synopsis i.e 21-02-2015 to 20-08-2015.

SAMPLE SIZE:

Was calculated using WHO method of calculating sample size.

SAMPLING TECHNIQUE:

Non probability consecutive sampling.

DATA COLLECTION PROCEDURE:

All patients fulfilled the inclusion criteria was admitted through the emergency after taking approval from hospital Ethical committee. A detailed history had been taken including demographic data (age, address). Patients was requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures was done by a single operating surgical team to control bias. All the data/variables was recorded on a specially designed Performa attached which are post-op pain at 12hrs and 24 hrs, post-Op stay and patient satisfaction score.

Eligibility Criteria:
Inclusion Criteria:

* with acute appendicitis confirmed clinically by pain in right iliac fossa accompanied by right iliac fossa tenderness, elevated leukocyte count (\>8\*109/ml) without a palpable mass and on radiological investigation admitted through emergency department were included in the study.

Exclusion Criteria:

* • Perforated appendix (had been assesses on abdominal ultrasound or per-operatively.

  * Palpable mass in the right lower quadrant as assessed by clinical exam.
  * History of Co-morbidities e.g. known diabetic, known hypertensive, cirrhosis as shown by ultrasonography and coagulation disorder (to be determined by low platelet count; \<140 \*109, deranged PT and APTT).(PT=13sec, APTT= 33 sec)
  * Patients unfit for surgery (ASA Grade III/IV).
  * Patient who did not give informed consent.