cyrilzakka/clinical-trials huggingface dataset:
Intra-arterial Chemotherapy for Retinoblastoma

Children with retinoblastoma who may benefit from intra-arterial chemotherapy will receive up to 3 doses of melphalan and will be assessed for feasibility, toxicity, and response.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with retinoblastoma \>4 months of age16
* Patients whose other treatment options would require systemic chemotherapy, radiotherapy, or enucleation
* Patient or parent/legal guardian must sign a written informed consent
* One of a, b, or c:

  * Patients who have bilateral COG stage B, C, D, or E retinoblastoma (refer to Appendix A) who have undergone systemic chemotherapy without resolution (meaning either has not had CR or has progressed despite systemic chemotherapy) and would have the following treatment options remaining:

    * IAC
    * enucleation of one eye
    * local radiation
  * Patients with non-germline retinoblastoma with unilateral disease who have COG A, B, C, or D tumors (refer to Appendix A).
  * Other patients may be considered on a case by case basis after discussion with pediatric ophthalmology, hematology/oncology, and interventional neuroradiology.

Exclusion Criteria:

* Opaque or hazy media which precluded visualization of the fundus.
* New or recurrent retinoblastoma that can be controlled with other conservative measures such as cryotherapy, thermotherapy, or plaque radiotherapy.
* Unilateral COG group E retinoblastoma (refer to Appendix A) with very poor visual prognosis as defined by pediatric ophthalmologist.
* Patients who would benefit from systemic chemotherapy.
* Patients with clinical or radiological evidence suggestive of retinoblastoma invasion of the optic nerve, choroid, sclera, orbit or metastatic sites.
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

The goal of this study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated.

This study's protocol was designed to assess the efficacy of JGT (Jaeumgeonbi-Tang) for chronic subjective dizziness.

* This design of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
* Symptoms and quality of life of chronic subjective dizziness patients will be evaluated.
* Dizziness severity and quality of life of the patients will be evaluated using DHI (Dizziness Handicap Inventory) (1) before treatment (baseline), (2) after 2 weeks, and (3) after 4 weeks of JGT treatment.
* Blood samples of the patients will be gathered before and after JGT treatment for pathophysiological analysis.

Eligibility Criteria:
\[Inclusion Criteria\]

* Chronic subjective dizziness patients, aged from 20 to 65
* DHI (Dizziness Handicap Inventory) score ≥ 24
* Those who can fully comprehend the general protocol of this study and voluntarily agree to participate

\[Exclusion Criteria\]

* Inner ear disease (benign paroxysmal positional vertigo, vestibular neuritis, Meniere's disease, etc.)
* Dizziness secondary to specific diseases such as hypoglycemia, recent stroke (within the last 6 months), or heart disease.
* Use of medications that could influence the result of the study (anticonvulsants, sedatives, antidepressants, sleeping pills, prostate medicine, Parkinson's drug, dementia drug, etc.)
* Pregnancy, breastfeeding, or plans of becoming pregnant
* Functional dyspepsia (persistent, recurring abdominal pain, or discomfort)
* Other allergic diseases
* Ineligibility for other reasons in the opinion of the research clinician (when the physician determines that there are significant physical or mental defects that the patient cannot understand and follow the protocol)
Evaluation of the Impact of Stress on IVF Outcome

The purpose of this study is to determine if physiological measures of stress, measured by the non-invasive OTO device, are significantly correlated with IVF outcome.

The OTO device is a wearable device that utilizes multiple methods of electrophysiology to identify the impact of stress on humans. The device consists of the OTO sensor, a belt with two electrode pads worn around the chest, one electrode placed on the thenar of the dominant hand and one electrode placed on the forehead; the sensor pairs with the OTO App via Bluetooth. It tracks 54 physiological properties including temperature, HRV, amplitude frequency analysis (AFA) of ECG and DC potential. This data is analyzed by the proprietary OTO Expert System which creates the overall conclusions on levels of stress, functional reserves, adaptive capacity and level of readiness to additional stressors.

Physiological data will be collected from the study participant using the OTO device for the duration of one IVF and frozen embryo transfer (FET) cycle. Study participants will complete questionnaires online related to perceived stress at the beginning and the end of study participation. Study participant's IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device.

Eligibility Criteria:
Inclusion Criteria:

* Women age 25-40 years old
* Planning to undergo their first IVF cycle with frozen embryo transfer at one of the participating fertility clinics
* Have access to the internet and own a smartphone
* Ability and willingness to wear the OTO device for a few minutes each morning during their IVF and FET cycle
* Able to read and speak English

Exclusion Criteria:

* Medical history of cardiac arrhythmias
* History of cardiac surgery within a year of study enrollment
Comparison of Hands-on Versus Online Learning About Ocular Ultrasound

In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as coronavirus disease 19 (COVID19). As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.

Since the eye is an superficial organ, it has excellent access to ultrasound. Also, the eye has a liquid-filled structure (vitreous body), it is suitable for obtaining some important findings with bedside ultrasound. In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as COVID19. As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.

Eligibility Criteria:
Inclusion Criteria for doctors:

* Those who have received basic ultrasound education but have not received ocular ultrasound education
* Residents and interns working in the emergency room
* Those who voluntarily agree to participate in the research through the recruitment announcement

Inclusion Criteria for standard patients:

* Adults over 18 years of age without eye-related symptoms
* Those who do not have unusual findings in the eye when scanning by ultrasound
* Those who voluntarily agree to participate in the research through the recruitment announcement

Exclusion Criteria for standard patients:

* Those with a history of ophthalmic diseases
* Those who have a history of ophthalmic surgery such as lens implantation
Treatment of Young Permanent Teeth With Different Adjuvant Approaches

To determine microbiology assessment of infected root canal in young permanent teeth, as well as antimicrobial efficiency of different adjuvant treatment modalities including photodynamic therapy (PDT), high-power diode laser, and essential oils following mechanic-chemical treatment in the treatment of periapical periodontitis in these teeth.

To determine antimicrobial efficiency of adjuvant photodynamic therapy (PDT) and high-power diode laser, and essential oils in the treatment of chronic periapical periodontitis in young permanent teeth.

Material and Methods: Young permanent teeth with chronic periapical periodontitis were selected and randomly divided into tests and control groups. Adjuvant treatment approaches were randomly performed following standard mechanical-chemical endodontic treatment:

1. Experimental laser-device 1, PDT group: adjuvant PDT (n=10)
2. Experimental laser-device 2, Diode laser (940 nm, 1W) (n=10)
3. Experimental essential oil (n=10)
4. Experimental sodium hypochlorite (NaoCL) group (n= 10) solely mechanical instrumentation with 1.5 % of NaOCl irrigation was performed (positive control).

Afterwards, each root canal was filled with calcium hydroxide, and definitive obturation was done seven days respectively.

Microbiological analyses of root canals were assessed after accessing the canal (sample 1), following mechanical-chemical treatment (sample 2), and adjuvant treatment approaches (sample 3). The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay. To evaluate the efficiency of treatment modalities, radiography records were additionally used.

Eligibility Criteria:
Inclusion Criteria:

* Had signed informed consent by the parents or legal guardian ;
* Systemically healthy children;
* Had not been submitted to antibiotic therapy in the previous 3 months;
* Had a least one young permanent anterior tooth (incisor or canine) or the first premolar with pulp necrosis and presence of a chronic periapical lesion (CPP);
* Had no endodontic treatment of the selected tooth;
* Had no signs of an acute condition;

Exclusion Criteria:

* Presence of systemic diseases such as diabetes mellitus, asthma, chronic infections, immunosuppressive diseases or other that could compromise the patient immune system
* Use anti-inflammatory or immunosuppressive therapy in the last 6 months;
* Patients with antibiotic prophylactic requirements before dental treatment;
Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery

The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.


Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years
* American Society of Anesthesiology functional status I-III
* able to read and understand the information sheet and give informed consent

Exclusion Criteria:

none
Trial to Assess Vitamin D Requirements in Lactating Women

This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women and to ascertain whether vitamin D supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe the relationship between them. Information on maternal iPTH levels, anthropometry, diet and sun exposure will also be reported.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women intending to breast feed their infant for at least 12-weeks
* Pregnant women \>20 weeks gestation
* Pregnant women \>18 years of age
* Pregnant women in good general health

Exclusion Criteria:

* Consumption of a vitamin D-containing supplement(\>10µg/day) in the 3 months prior to commencing the trial
* Consumption of a vitamin D or calcium containing supplement during the 12- week trial
* Mothers taking a vacation to a sunny climate or using a solarium during the 12-week trial
* Mothers with pre-existing type 1 or type 2 diabetes
* Mothers with pre-existing hypertension
* Mothers with diagnosed hypercalcemia
* Mothers with diagnosed intestinal malabsorption conditions
* Mothers with multiple fetuses (e.g. twins)
* Consumption of medications known to interfere with vitamin D metabolism.
Myofascial Release and Sustained Stretching in Spastic CP Children

The aim of this research was to find and compare the effects of Myofascial Release Technique and Passive Sustained Stretching on Hamstrings Flexibility in Children with Spastic Cerebral Palsy.

Randomized Clinical Trials done at DHQ Sahiwal. 26 spastic CP children of age 6-12 years were taken by random sampling technique from DHQ Sahiwal. 13 were allocated to each group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique Group A received Passive Sustained Stretching along with conventional treatment. Whereas Group B received MFR along with conventional treatment. Both these groups received treatment for 6 weeks. The baseline and post treatment score of MAS, Goniometer (AKET to measure popliteal angle) and GMFCS -88 were evaluated. Data analysis was done by using the SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 6 to 12 years were included.
* Both genders were included.
* Ambulatory subjects with or without ambulatory aids.
* Diagnosed children with Spastic CP.
* CP patients with grade 3 on modified Ashworth scale for hamstrings were included

Exclusion Criteria:

* Children with visual or auditory defects.
* Children with cognitive dysfunction.
* Subjects who had severe limitations in passive range of motion at lower extremities specially hamstrings due to surgery or any other complication.
* Children with other types of Cerebral Palsy such as Ataxic CP, Dyskinetic CP etc.
Study To Assess Long Term Safety Of Pazopanib

This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.


Eligibility Criteria:
Key Inclusion Criteria:

* Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
* Able to understand and provide written informed consent
* Women and men agree to use protocol specific birth control measures

Key Exclusion Criteria:

* The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
* If you are pregnant or breast feeding
* Your doctor does not think you would be a good candidate for the study
* Poorly controlled high blood pressure
* Subject is unwilling or unable to follow the procedures outlined in the protocol.
Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers

The hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.

The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study.

Patients with reduced or severely reduced mobility, over 18 years of age, bedridden and requiring the use of a bedpan, estimated hospitalization equal to or greater than 2 days on the ward.

Eligibility Criteria:
Inclusion Criteria:

* Patient of legal age (age ≥ 18 years).
* Patient with reduced and very reduced mobility, bedridden requiring the use of a bedpan.
* Estimated length of hospital stay on the ward ≥ 2 days.
* Patient affiliated to a social security system.
* Patient able to understand the protocol.
* Patient having given oral non-opposition to participate.
* Patient who has received the study information note.
* Patient who had never had a pelvis placed by the evaluating caregiver prior to inclusion.
* Patient who had never participated in this study.

Exclusion Criteria:

* Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.
* Patients under guardianship, curatorship or safeguard of justice.
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)

To evaluate the efiicacy of TAI combine SBRT in unresectable HCC


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* cannot accepted hepatectomy;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent.

Exclusion Criteria:

* cannot tolerate TAI or SBRT;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy.
Stearoyl-CoA Desaturase and Energy Metabolism in Humans

The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.

In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.

The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.

This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy normal-weight (BMI 20-25 kg/m2)

Exclusion Criteria

* High physical activity
* Smoking
* High intake of fatty fish or cod liver oil
* Drugs
* Pregnancy or breastfeeding
* Chronic disease
Effect of Duration and Follicle Diameter During Oocyte Pick up on Embryological Parameters

Investigators aim to investigate if the time spent for smaller follicles worth to deal with. The difference between follicle groups are recorded for embryological parameters. Results will be analysed for yielding transfer embryo and pregnancy rates between groups.

There are papers about follicle dimensions and volumes studying their effect on embryologic parameters. But most of these studies are far from practical approach and are not easily applicable, such as 3D volumetric measurement is not feasible for most of the clinics. Also one of the points important for us it to evaluate the duration of the procedure and the possible positive effect of shortening the duration for better results. Investigators plan to measure the follicles just before puncture and arrange two groups. Group 1,follicles with diameter of 17 mm and more, and group 2 follicles between14-17 mm. Maturation, fertilization, cleavage characteristics are recorded. The source of chosen transfer embryo and crio-preserved embryos per cycle is also point of interest.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 year old women

Exclusion Criteria:

* History of recurrent implantation failure (RIF)
* Known chromosomal abnormality
* Severe male factor and azospermia
A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.

Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.

Colonoscopy is the current standard method for evaluation of the colon. It has an indispensable place in the diagnosis and treatment of colon diseases. Diagnostic accuracy and therapeutic safety of colonoscopy depends on the quality of the colonic cleansing or preparation. Good preparation of the bowel is necessary prior to colonoscopy, to allow clear visualization of the bowel wall and any pathology within. The proposed study is a post-marketing study in which the study device, the Angel of Water system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy, instead of standard preparation solution. The effectiveness of the hydrotherapy in comparison to the standard preparation will be defined by evaluating colon cleanliness, subject's attitude and the duration of colonoscopy procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>= 18 and ≤ 80 years old, referred to colonoscopy
2. Subject is able and agrees to sign the informed consent and follow the study requirements

Exclusion Criteria:

1. Myocardial infarction within the last 3 months
2. Symptomatic congestive heart failure
3. Established renal failure (serum creatinine \> 2.0 mg/dL)
4. Previous abdominal surgery, colectomy, or recent colon or rectal surgery
5. Abdominal hernia
6. Partial or complete intestinal obstruction
7. Acute exacerbation of inflammatory bowel disease
8. Intestinal perforation
9. Fissures or fistula
10. Grade III or IV hemorrhoids
11. Carcinoma of the rectum
12. Distal rectal anastomosis
13. Cirrhosis
14. Hypokalemia
15. Pregnancy
16. Subject's weight \> 400 lbs. /182 kg
17. Participation in another study that may affect the results of this study