cyrilzakka/clinical-trials huggingface dataset:
Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* Nulliparous patients
* patients with cervical pathology
* retroverted uterus (detected by transvaginal ultrasound)
* previous cervical surgery
* patients with severe vaginal bleeding
* allergy or contraindications to dinoprostone or INH therapy
Gender Differences in Familial Risk

To develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences.

DESIGN NARRATIVE:

Models were developed which allowed for sex difference in the expression of autosomal polygenes, differences in the impact of the paternal and maternal environment on male and female offspring, and for the complex consequences of assortative mating on the correlations among loci and between genes and environment. Computer simulations were used to decide which kinds of gender-dependent effects could be resolved with particular constellations of relatives, and to address problems of power and bias resulting from errors of model-specification. The methods developed were applied to data from extensive data already gathered from twins and their relatives to determine the importance of sex differences in genetic and environmental causes of variation in measured aspects of cardiovascular risk including weight, body-mass index, family history of CV disease, smoking, alcohol consumption, exercise, diet, psychosocial variables and lifestyle.

Eligibility Criteria:
No eligibility criteria
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances


Eligibility Criteria:
Inclusion Criteria:

Subjects must comply with the following criteria in order to participate in the investigation:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33 mm or less
6. Have experience leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant or breastfeeding
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation
Web-based International Register of Emergency Surgery and Trauma

The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by an acute surgical disease
* Patients with indication to be referred to the emergency surgeon attention
* Patients to be operated or to be treated with non-operative approach without surgical intervention

Exclusion Criteria:

* Patients not affected by an acute surgical disease
* Patients without indication to be referred to the emergency surgeon attention
Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition

Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 with a cancer diagnosis (any type).
* Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
* Having lost more than 5% of body weight in the last 6 months.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent.

Exclusion Criteria:

* Subjects who are participating in other clinical trials.
* Subjects with morbid obesity.
* Subjects who will undergo surgery or who will undergo.
* Subjects with cachexia
* Subjects with infection of a cause other than of the tumor
* Subjects with an infectious process
* Subjects with Diabetes Mellitus treated with insulin and/or not controlled
* Subjects with kidney, heart, respiratory or liver disease.
* Subjects with autoimmune diseases.
* Subjects with mental illness or decrease function cognitive.
* Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study.
* Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month.
* Patients who reject oral supplements.
* Pregnant or breastfeeding women.
* Allergic to any component of the formula
Facts-Up-Front Versus Traffic-Light Food Labels

The U.S. food and beverage industry recently released a new front-of-package nutrition labeling system called Facts Up Front that will be used on thousands of food products. The purpose of this study was to test consumer understanding of the Facts Up Front nutrition labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up Front displays grams/milligrams and % daily value information for various nutrients; Traffic Light uses an interpretive color-coded scheme to alert consumers to low, medium or high levels of certain nutrients. Participants in an Internet-based study were randomized to one of five front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light plus information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up Front plus information about "nutrients to encourage" (Facts Up Front+). Total percentage correct quiz scores were generated reflecting participants' ability to compare two foods on nutrient levels, based on their labels, and to estimate amounts of saturated fat, sugar, sodium, fiber and protein in foods. 703 adult participants recruited through an online database in May 2011 participated in this Internet-based study and data were analyzed in June 2011. The investigators hypothesized that the Traffic Light label groups would perform better than the Facts Up Front groups on all outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants in Survey Sampling International Panels

Exclusion Criteria:

* Younger than 18 years old
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum.

Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.

C. parvum is a significant opportunistic infection in much of the developing world, where children may not have access to highly active antiretroviral therapy. There is currently no established therapy for chronic cryptosporidiosis in HIV infected children. The FDA has approved NTZ for the treatment of cryptosporidiosis diarrhea; however, there are no data on the safety and effectiveness of NTZ in HIV infected children. The purpose of this study is to evaluate the safety of different doses of NTZ in HIV infected children with chronic diarrhea caused by C. parvum.

In Step 1, participants will receive one of four different doses of NTZ. Participants will take NTZ twice a day for 56 days in either a liquid or pill form. All participants will be closely monitored for drug toxicity. There will be seven study visits; they will occur at study entry, Weeks 1, 2, 4, 6, and 8, and Day 70. Study visits will include a physical exam and blood, urine, and stool collection. Pharmacokinetic (PK) sampling will be performed during four of the study visits. PK sampling requires the participants to take their morning NTZ doses while in the clinic; participants will undergo additional blood collection either before or after taking NTZ. At the end of the 56-day study period, participants who are experiencing a positive clinical benefit from NTZ and who have had no harmful side effects may choose to continue taking NTZ for an additional 24 weeks and enter Step 2. Participants who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks.

Eligibility Criteria:
Inclusion Criteria for Step 1:

* HIV infected
* Chronic diarrhea with 3 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry OR 2 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry if accompanied by dehydration
* Documented presence of C. parvum oocysts in stool
* Weight of 4.0 kg (8.8 lbs) or more AND less than or equal to the maximum weight for age group as specified in the study protocol
* Parent or guardian willing to provide informed consent, if applicable
* Willing to use acceptable forms of contraception

Exclusion Criteria for Step 1:

* Inability to take liquid or tablet form of medication
* Serum transaminase (ALT) and bilirubin greater than or equal to 5 times the upper limit of normal at study screening
* Active M. avium intracellulare or cytomegalovirus (CMV) colitis
* Active cancer
* Certain medications
* Pregnant or breastfeeding
Optimal Intensity of Reactive Balance Training for Healthy Older Adults

Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults (65-80 years old)

Exclusion Criteria:

* Unable to stand independently without upper-limb support for \>30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
* Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
* Score below normative values on the Montreal Cognitive Assessment;
* Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
* Have insufficient English language comprehension such that they cannot understand instructions;
* Have contraindications to reactive balance training such as severe osteoporosis; and/or
* Are currently attending physiotherapy or supervised exercise.
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age≥18;
2. Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
3. Prescribedand accept Rivaroxaban;
4. Sign thewritten informed consent.

Exclusion Criteria:

1. Renal impairment (CrCl\<15 ml/min) or severe hepatic impairment.
2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
3. Stroke or TIA caused by large artery atherosclerosis
4. Planned major surgery or invasive intervention
5. Active internal bleeding
6. Malignancy or other serious medical conditions with a life expectancy \<6 months
7. Allergery to Rivaroxaban
8. Pregnancy or breast-feeding
Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears

Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears


Eligibility Criteria:
Inclusion Criteria:

* Male or female 19 years of age and older
* Unilateral shoulder pain with a pain score of 4 or higher.
* patients with a symptom duration of at least three months who have not responded to conventional treatments, including analgesics.
* patients diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by computed tomography arthrography or magnetic resonance imaging.

Exclusion Criteria:

* patients diagnosed with small or medium full-thickness rotator cuff tears among study participants with full-thickness rotator cuff tears.
* patients who have received subacromial injection therapy in the affected shoulder within the past three months.
* patients who have undergone rotator cuff surgery on the affected shoulder within the past six months.
* patients exhibiting or suspected of having the following radiological findings: malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing.
* patients presenting with symptomatic cervical spine disorders.
* patients experiencing bilateral shoulder pain.
* patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
* patients with neurological deficits.
* Pregnant or breastfeeding patients
* patients unwilling to use effective contraception during the study period.
* patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result.
* patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies.
* patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders.
* Any other cases deemed inappropriate for study participation by the investigator.
A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a Phase 2 cohort.


Eligibility Criteria:
Key Inclusion Criteria:

1. Ages 18 to ≤ 50 years.
2. Ages ≥ 1 year to \< 18 years, after health authority approval.
3. T-ALL/T-LL that is CD7-positive (defined as at least 20% of blasts positive for CD7 by flow cytometry or immunohistochemistry based on assessment of the study site's CLIA \[Clinical Laboratory Improvement Amendments of 1988\] certified facility) in second or greater relapse, first relapse post-transplant relapse, or chemotherapy-refractory disease. Specifically:

   1. Second or greater relapse or post-transplant relapse, defined as:

      * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening after second documented CR; OR
      * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR
      * Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR
      * Biopsy confirmed evidence of relapsed T-LL on lymph node biopsy after second CR; OR
      * Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LL on lymph node biopsy
   2. Refractory disease, defined as:

      * Primary refractory T-ALL or T-LL, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-confirmed evidence of residual T-ALL or T-LL; OR
      * Relapsed, refractory disease, defined as \> 5% BM blasts or biopsy-confirmed evidence of residual TLL after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T-cell dominant phenotype may be enrolled if the aforementioned criteria are met.
4. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.

Key Exclusion Criteria:

1. CNS involvement meeting any of the following criteria: CNS-3 disease, progressive CNS involvement despite therapy, CNS parenchymal or cranial nerve lesions on imaging.
2. Clinically active CNS dysfunction or known history of irreversible neurological toxicity related to prior antileukemic therapy.
3. Receipt of prior CD7 targeted therapy.
4. Systemic antileukemic therapy intended to induce or maintain remission within 14 days prior to completion of screening.
Brace Versus Casting in Pediatric Radial Head Fractures

Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.

Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.

Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.

Eligibility Criteria:
Inclusion Criteria:

5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head

Exclusion Criteria:

The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.

All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.

Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.

Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.