cyrilzakka/clinical-trials huggingface dataset:
Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses

The purpose of this study is

1. to determine the correct dose for intramuscular administration
2. to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia

Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis.

PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.

There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.

The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.

The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.

Other side effects than antibodies will be registered during treatment with PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 1-17 years
* Newly diagnosed ALL (high intensive)
* Treated according to the NOPHO-2000 protocol
* Treated at one of the Nordic pediatric oncology centers

Exclusion Criteria:

* \<1 year and \>18 years
* Newly diagnosed ALL other than high intensive
* Not treated according to the NOPHO-2000 protocol
* Not treated at one of the Nordic pediatric oncology centers
* Allergy to the contents
* Pancreatitis (Active or earlier)
Norethindrone for the Delay of Menstruation

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Many women ask the OBGYN for help in delaying a poorly timed period in order to participate in events that menstruation would normally interfere with. While most OBGYNs prescribe combined oral contraceptives for this purpose, this method often results in unpredictable spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist, inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation, enhancing glandular secretion, and maintaining endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used it for this purpose in women who desire to remain fertile. The intention of our study was to compare norethindrone to birth control pills in order to determine the effectiveness at suppressing bleeding and spotting, compare side effect profiles and to find a method allowing women to freely and comfortably participate in their life events.

OBJECTIVES:

1. Determine if norethindrone can delay menstruation without breakthrough bleeding
2. Compare norethindrone with oral contraceptive pills for delaying menstruation
3. Compare patient satisfaction of each method
4. Compare side effect profiles of each method

Eligibility Criteria:
Inclusion Criteria:

* female, age 18-45, regular periods, desires to postpone menstrual period,

Exclusion Criteria:

* fibroids, irregular menstrual cycle, endometrial polyps, BMI\>30
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Rising PSA, as defined by increasing levels on at least two consecutive assessments
2. ECOG performance status 0 or 1
3. Adequate hematologic function
4. Adequate liver and renal function
5. Able to swallow and retain oral medication.

Exclusion Criteria:

1. Received prior chemotherapy for HRPC.
2. Concurrent therapy for the treatment of prostate cancer.
3. Clinical signs or symptoms of CNS metastases
4. Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
5. Active secondary malignancy or history of other malignancy within the last 5 years.
6. Failure to recover from toxicities related to prior therapy.
7. Uncontrolled concurrent illness.
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures

Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed.

Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer).

Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation).

Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.


Eligibility Criteria:
Inclusion Criteria:

* distal radius fracture
* age \> 18

Exclusion Criteria:

* intellectual or mental impairment
* \< 18 years of age
Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients

Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy

Gastrointestinal endoscopy is performed as standard for the diagnosis of many gastrointestinal diseases. During gastrointestinal endoscopy, sedoanalgesia is applied to relieve patients' pain and increase patient comfort. Anesthetic drugs used for sedoanalgesia may cause respiratory depression and hypoxia in patients. Hypoxia resulting from hypoventilation in patients is responsible for many events, including coronary ischemia. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia. The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. Our study will show us which method is more beneficial in preventing hypoxia and other side effects, providing comfort for the doctor performing the procedure and for the patient undergoing the procedure. This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing gastrointestinal endoscopy
* ASA Physical Status 1-2
* Body mass index 18.5 - 35 kg/m2

Exclusion Criteria:

* High risk of pulmonary aspiration

  * Pregnancy
  * Anesthesic drug allergies
  * Difficult airway or facial deformities
  * Height \<155 cm
  * Alcohol or narcotic drug usage
  * Restrictive or obstructive pulmonary diseases
  * Hepatic cardiac or renal failure
  * Neurologic or cognitive deficiencies.
  * Previous cervical surgery or cervical radiotherapy
  * Previous esophagus surgery
  * Psychotic problems
Study of the Effects of Carbohydrate Counting

The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Diabetes duration at least 12 months
* MDI therapy
* HbA1c 8-10,5% (both included)

Exclusion Criteria:

* Gastroparesis
* Present or former practice of carbohydrate counting
* Pregnancy or nursing
Endometrial Cancer Lymphadenectomy Trial

The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma
2. a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)
3. absence of bulky lymph nodes
4. performance status ECOG 0-1
5. age 18 - 75 years
6. written informed consent
7. adequate compliance

Exclusion Criteria:

1. stage pT1a, G1 or G2 tumors of type 1 histology
2. sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
3. EC of FIGO stages III or IV (except for microscopical lymph node metastases)
4. evidence of extrauterine disease by visual inspection
5. recurrent EC
6. preceding chemo-, radio, or endocrine therapy for EC
7. any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
8. any medical history indicating excessive peri-operative risk
9. any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
10. any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
11. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
12. known HIV-infection or AIDS
13. simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)
Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia

This work is part of a broader research with women with fibromyalgia. The aim of this study is to establish the effectiveness of implementation intentions to manage the preference for avoiding pain and fatigue and stop walking exercise, versus to maintain the approximate behavior (walking), taking into account high and low pain catastrophizing conditions.

Fibromyalgia is a widespread and diffuse musculoskeletal chronic pain problem not associated with inflammatory or degenerative changes, often accompanied by fatigue and sleep problems, in addition to anxiety, depression and cognitive dysfunction. Its prevalence in Europe for adults is estimated at 2.5% with a higher proportion of women. The treatment incorporates physical activity and exercise as one of its therapeutic aims has shown positive effects on health outcomes.However, it has been reported that women with fibromyalgia are less active than others with similar socio-demographic characteristics.Theories of behavioral self-regulation that taking into account motivational and volitional processes (implementation intentions) provide a conceptual framework to work with the incorporation and maintenance of the exercise, helping these people to create strong goals and handle the different self-regulation problems that can arise. These include the ones related to the preference for avoidance goals (pain or fatigue avoidance) against performing or keep doing an activity (walking exercise). This work searches to help women with fibromyalgia to manage the above mentioned inhibitors to incorporate and maintain long-term physical exercise walking. We consider the heterogeneity of people with fibromyalgia in pain catastrophizing, which makes necessary to adapt interventions aimed to promote physical exercise.

We expect participants with high catastrophizing and implementation intentions to control the preference for avoiding pain or fatigue will walk more time than the other conditions.

Eligibility Criteria:
Inclusion Criteria:

* Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
* Within the age limits

Exclusion Criteria:

* Comorbidity that prevents walking
* Those related to the 6MWT application protocol
Implementation of the Nurse Navigation Program

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care. The patients were evaluated using the Patient Information Form, Stoma Complications Evaluation Form, Stoma-Related Problems Experienced Form, Ostomy Compliance Scale, and Stoma Quality of Life Scale at the first interview, at the third and sixth months.

Eligibility Criteria:
Inclusion Criteria:with intestinal stoma

* Having no mental handicap or perception problems and no communication difficulties
* No psychiatric disease
* 18 years old and over
* literate
* Capable of using a smartphone
* No vision and hearing problems
* Those who have the physical ability to change the stoma bag themselves.
* Patients with intestinal stoma for a maximum of two months were included in the study.

Exclusion Criteria:

* After agreeing to participate in the research, wanting to leave,

  * Those who died during the research process,
  * The stoma was closed during the research process,
  * Patients whose communication could not be maintained during the research process
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18
* Biopsy proven invasive carcinoma of the breast
* Clinical T1-T4 invasive carcinoma
* Cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon.
* Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to adequate contraception for the duration of study participation.
* Ability to understand and willingness to sign a written informed consent document
* Life expectancy \> 6 months
* Patient is to be treated at Stony Brook University Hospital

Exclusion Criteria:

* Women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Breast implant in the breast to be treated with SBRT
* Insufficient breast imaging to judge clinical stage
* Inability to receive study treatment planning and treatment secondary to body habitus
* Inability to understand or unwillingness to sign a written consent document
* Life expectancy \< 6 months
* Children (\< 18 years of age)
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements
Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery

The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

The current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. Also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. This condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy.

MPFF is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. More research has also shown the effects of MPFF on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. Since other anorectal surgery has similar complications. Therefor we conducted this randomized control trial to evaluate the benefits of MPFF after anal fistula surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo fistulectomy or fistulotomy are included.

Exclusion Criteria:

* Emergency operation
* Participants who had Trans-sphincteric anal fistula, Extra-sphincteric anal fistula
* Participants accompanied by severe liver cirrhosis
* Participants accompanied by coagulation disorders
* Participants taking anticoagulant
* Participants taking corticosteroids as long-term medication.
* Participants who had colorectal cancer
* Participants taking analgesic drugs (morphine or others) as long-term medication
* Participants bed-ridden
* Participants who had history of human immunodeficiency virus (HIV) infection
* Pregnant woman