cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures

The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience.

Outcomes of hand surgery are greatly dependent on factors outside the operating theater as well. These include patient compliance to preoperative instructions that consist of proper surgical site care, proper positioning, and following occupational therapy protocols. Previous studies have shown that video-based information provide greater patient satisfaction than verbal instructions. Visual information was also reported to decrease patient anxiety regarding the procedure and increases patient education in terms of procedure risks and benefits(1-5). The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience. The secondary objective is to evaluate if VBI result in better outcomes than standard written instructions.

Eligibility Criteria:
Inclusion Criteria:

Please ensure that ALL items below are satisfied to be included in the study.

* Patient undergoing hand and/or upper extremity surgery with Dr. Thibaudeau
* Patient ≥ 18 years old
* Patient who comprehends instructions provided in English and/or French
* Patient who can navigate the internet to complete an online post-operative questionnaire

Exclusion Criteria:

Please ensure that NONE of the following items are selected to be included in the study.

* Patient presenting with intra-articular, open, or pathological fractures
* Patient presenting with associated tendon or nerve injuries
* Patient receiving definitive surgery ≥21 days after injury
* Patient with previous surgeries/deformity in the hand
* Patient with pre-existing severe joint disease (rheumatoid arthritis, finger joint stiffness, or non-union)
* Patient with medical contraindications to surgery
* Patient who is unable to comply with rehabilitation
* Patient who is unwilling to be followed up
* Patient with dementia
* Patient with significant mental illness
* Patient who is unable to provide informed consent
Acupressure and Training for Coping With PMS

The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life.

This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.

Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age.

Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms

Eligibility Criteria:
Inclusion Criteria:

Having regular menstruation (between 21-35 days),

not having any psychiatric diagnosis or any gynecological diseases

not using contraceptives,

not having tissue deformity in the extremities.

Exclusion Criteria:

having any psychiatric diagnosis having any gynecological diseases
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.


Eligibility Criteria:
Inclusion Criteria:

* Non smoking
* Ages 18 to 45 year, inclusive
* BMI between 18 and 30

Exclusion Criteria:

* subjects taking any prescription or OTC medications or vitamins or supplements
* pregnant females
* subjects with pulmonary disease or sleep apnea
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone

The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.

This 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Recreational use of prescription opioids at least once per month within the past year
2. No current major mood, psychotic, or anxiety disorder
3. Physically healthy
4. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) within normal limits
5. Able to perform study procedures 6.21-45 years of age

7.Blood glucose concentration between 70-145 mg/dl for men and 70-125 mg/dl for women (fasting) 8.Hb \> 13 for men and Hb \> 11 for women with no other evidence of medical disorder resulting in blood loss or anemia/hematological disease

Exclusion Criteria:

1. Physical dependence on any drugs, excluding nicotine and caffeine
2. Participants requesting treatment
3. Participants on parole or probation
4. Pregnancy or lactation: Female participants must agree to the use of a barrier control method of contraception (e.g. male and female condoms, diaphragms, cervical caps and contraceptive sponges used in combination with spermicide)
5. Current or recent history of significant violent behavior (within the past 6 months)
6. Current major Axis I psychopathology that might interfere with ability to participate in the study
7. Significant suicide risk
8. Current chronic pain
9. Current or history of congestive heart failure, edema, or diabetes mellitus
10. Sensitivity, allergy, or contraindication to opioids or pioglitazone
11. Unstable physical disorders that might make participation hazardous, such as end-stage AIDS, hypertension (blood pressure \> 140/90), or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist)
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years Old
* Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week)

Exclusion Criteria:

* Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
* Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
* Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
Immune Thrombocytopenia in Pregnancy

The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence of pregnancy on the evolution of ITP was never studied while this pathology affects firstly women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. The realization of a prospective study to answer these questions is necessary to allow us to inform better the patients affected by ITP and to define better in this context the strategy of supervision of the mother, the foetus and the newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications will indeed allow the implementation of prevention measures.

The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.


Eligibility Criteria:
1. Pregnant ITP women Inclusion Criteria

   * Women more than 18 years old
   * Primary ITP diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia \<100 G/L)
   * And pregnancy diagnosis after ITP diagnosis
   * Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
   * Secondary ITP (according to 2009 consensus conference)
   * Severe comorbidity making difficult women's following
2. Control ITP Women (Non pregnant) Inclusion Criteria

   * Women more than 18 years old
   * Primary ITP diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia \<100 G/L)
   * Non pregnant (\> 12 months of precedent pregnancy)
   * (Matched on age+/- 5 years old: suppress by amendment n°3 20170117), phase and status of ITP, and history of splenectomy
   * Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
   * Secondary ITP (according to 2009 consensus conference)
   * Severe comorbidity making difficult women's following
3. De novo ITP pregnant women Inclusion Criteria

   * Women more than 18 years old
   * Pregnant
   * With a newly diagnosed thrombocytopenia \<50G/L, after elimination of others thrombocytopenia etiologies during pregnancy: gestational thrombocytopenia, preeclampsia, HELLP syndrome, ....
   * Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
   * Secondary ITP (according to 2009 consensus conference)
   * Severe comorbidity making difficult women's following
   * Non confirmation of ITP diagnosis in post-partum
Household Influenza Transmission Study

The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.

HITS is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. Secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. The pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (Intervention 1), and hand washing and mask use (Intervention 2). Following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. This study is being conducted at Queen Sirikit Institute for Child Health in Bangkok.

Eligibility Criteria:
Inclusion Criteria:

* Child, 1 month through 15 years of age
* Resident of Bangkok Metropolitan Area
* Outpatient of Queen Sirikit National Institute of Child Health Children's
* Hospital seen during HITS' active study period
* Positive influenza rapid test result from patient presenting with influenza-like illness
* In addition to the index case, consent must be obtained from at least 2 household members ≥1 month of age who plan to sleep inside the house for a period of at least 21 days from the time of enrollment

Exclusion Criteria:

* Illness onset 48 hours or more before presentation and influenza testing at Queen Sirikit National Institute of Child Health Children's Hospital
* Treatment with influenza antiviral medications since it may decrease secondary attack rate
* Children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy)
* A history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain.
* Receipt of influenza vaccine by any household member during the preceding 12 months.
* Prior participation in HITS.
Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma

Glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss

Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian market. It contains the PG analog tafluprost. Better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index (OSDI) questionnaire, and able to provide informed consent form.

Exclusion Criteria:

* Unable to provide informed consent form
Radiosurgery for Glioblastoma Multiforme

Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.

To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status.

Secondary:

Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.

Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
2. Patient must recover from the effects of surgery, post-operative infection, or other complications.
3. Therapy should start within 5 weeks of surgery
4. Must have an estimated survival of \> 8 weeks.
5. KPS \< 70.
6. Age \> 65 years.
7. Must have a pre- and post operative contrast enhanced MRI scans
8. Laboratory values within the following limits: ANC (absolute neutrophil count) \>/= 1500 cell/ul Platelets \>/= 100x 10(3)/ul, Hemoglobin \>/= 9g/dl, Serum Creatinine ≤ 1.5mg/dl., Serum total Bilirubin \</= 1.5 x upper limit of normal (ULN), SGOT/SGPT \</= 2.5x ULN, Albumin \>/= 3g/dl.

   -

Exclusion Criteria:

1. Histology grade less than Anaplastic Glioma ( WHO Grade III).
2. Recurrent malignant glioma.
3. Tumor involving the Brain stem.
4. Any detected tumor foci beyond the cranial vault.
5. Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
6. Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \> 5 years.
7. Prior chemotherapy for the current disease.

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A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria (Cisplatin Treatment Group):

1. Males and females ≥ 18 years of age
2. Diagnosis of head \& neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

   * as single agent chemotherapy in conjunction with local radiotherapy course, or
   * as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent

Inclusion Criteria (Control Group):

1. Males and females ≥ 18 years of age
2. Diagnosis of head \& neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent

Exclusion Criteria (All Subjects):

1. Chronic kidney disease defined by eGFR \<60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (\>30 mcg/mg creatinine) will be excluded
2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
5. Use of creatine supplements within 7 days prior to hospitalization
6. Solid organ transplant recipients
7. Abnormal liver function (serum ALT, AST or total bilirubin \>2xULN)
8. Significant anemia (Hemoglobin \< 10 g/dL)
9. Pregnancy
10. Institutionalized individuals
Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node dissection (ALND) did not result in inferior survival. These patients, therefore, are unlikely to benefit from further surgery that results in a longer period of hospitalization, higher costs and higher postoperative morbidity. This result has been written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.

However, Limitations of Z0011, such as failure to achieve target accrual and possible randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand, further testing in different country are needed.

The investigators design and begin a prospective randomized multicenter phase III study of ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.

OBJECTIVES:

To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.

OUTLINE: This is a randomized multicenter study. Before randomization, all women were stratified according to age (≤50 years, \>50 years), tumor size(≤2cm, \>2cm) and research center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB). Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes.

Experimental: No surgery of axillary lymph node in this arm. All the patients were to receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.

Patients are followed up every 4 months for the first 2 years, every 6 months from the third year to the fifth year, and then annually for a total of 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Female;
* Patient aged 18 years and above;
* Patient with histological proven invasive breast cancer;
* Clinical T1-T2 disease with no distant metastasis;
* Patient with clinical N0 status;
* Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic;
* Patient with positive SLNs 1\~2;
* Signed consent to participate.

Exclusion Criteria:

* History of neoadjuvant chemotherapy or hormone therapy;
* History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
* History of any other invasive cancer;
* Initial metastatic disease known;
* Pregnant women or lactating women;
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.