linjc16/ctgov huggingface dataset:
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to ABC-108, A Phase IIA Study of ABC294640 in the Treatment of Patients With Advanced,Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma

Conditions
-----------------
Cholangiocarcinoma, Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Perihilar, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Intrahepatic

Intervention / Treatment
-----------------
* Drug: ABC294640


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cholangiocarcinoma Ineligible to participate in the ABC294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial. Judged by the treating oncologist to be medically suitable for treatment with ABC294640 Willing and able to provide written, signed informed consent Approval by RedHill of the treating oncologist's clinical trial experience for the purpose of making ABC294640 available Regulatory approval by the appropriate jurisdiction Exclusion Criteria: 1. Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABC294640|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Trial, Phase II, Multicenter Trials, Clinical Study, Clinical Trials, Non-Randomized, Oral capsule, Single arm, Anti-cancer, Anti-inflammatory, ABC294640, Expanded Access Program, Compassionate Use, Special Access Program, Yeliva ®, opaganib
Preoperative Survey to Evaluate Patient Allergy

Study Overview
=================
Brief Summary
-----------------
The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.

Official Title
-----------------
Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care

Conditions
-----------------
Allergy Drug, Allergic Reaction, Pediatric, Surgery

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia Exclusion Criteria: Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medication allergy<br>Patients who have a medication allergy listed in their electronic medical record. | Other: Survey<br>* Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Listed allergies vs actual allergies | The number of allergies listed in the patient's electronic medical record (EMR) compared to actual allergies as described by parent/guardian | Baseline |
Quantitative Evaluation of Bitter Taste in Obesity

Study Overview
=================
Brief Summary
-----------------
Although taste influences food choices and favours diseases like obesity, there is no consensus about the existence of correlations between bitterness and anthropometric variables. Also, an electronic-based method for data collection could provide a more appropriate way for the evaluation of taste perception and save time. The objective is to search for correlations between bitterness and anthropometric variables.

Detailed Description
-----------------
A cross-sectional study evaluating correlations between the bitterness rates given on a generalized Labeled Magnitude Scale, anthropometrics and other variables. Bitterness perceptions at the tip of the tongue (TOTp) and at the whole mouth (WMp) were recorded using a locally developed novel cloud-based software (Cloud-gLMS). The ANCOVA test was adjusted using TOTp and WMp as dependent variables and age, height, weight, BMI, gender, waist circumference, alcohol intake, comorbidities, and use of medications as independent variables.

Official Title
-----------------
Anthropometric Variables and Perception of Bitter Taste in Obese Adults or Not

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight limit of 150 kg and who are able to read the text with the guidelines on how to be punctuated the sensation of bitter in the generalized labeled scale. Exclusion Criteria: Being a relative of the first degree of a patient already included in the research, tobacco in the forms of cigarettes, pipes and cigars in the last 30 days, presence of coryza, nasal congestion or frequent sneezing, dental treatment on the same day of the research. Being a dementia sufferer, having an altered, drowsy level of consciousness. Show upper limb tremor visible.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Evaluation of bitter taste<br>Participants will be evaluated as to the intensity of bitter taste when performing watery mouthwash with quinine. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of bitter taste 1 | It will be gently applied at the end of the tongue, by means of a swab soaked in the quinine solution at room temperature, in continuous movements from left to right, and will point a note to the bitter level. | 1 time | 
| Sensitivity of bitter taste 2 | The volunteer will perform a mouthwash with the quinine solution, and will point a note to the bitter level. | 1 time |
Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

Study Overview
=================
Brief Summary
-----------------
A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.

Official Title
-----------------
Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Gynaecological examination and a supine stress test, questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients operated on with the TVT<br> | Other: Gynaecological examination and a supine stress test, questionnaires<br>* Gynaecological examination and a supine stress test, questionnaires<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective outcome of the TVT operation | Objective outcome was measured with negative stress test and no need for reoperation for stress urinary incontinence during the follow-up. | 13.5 years |
Ovarian Follicle Function in Patients With Primary Ovarian Failure

Study Overview
=================
Brief Summary
-----------------
No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with prematurem ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.

Detailed Description
-----------------
No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous primary ovarian insufficiency. We know that more than one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This protocol permitted baseline clinical evaluation of patients with primary ovarian insufficiency and ongoing observation of the natural history of the disorder. The protocol is now in the follow up and analysis phase and is not now recruiting new patients. Now a major aim of the protocol is to investigate large scale medical sequencing as a method by which to uncover mechanisms of primary ovarian insufficiency and to assist in the management of women with this condition. This will involve a community-based participatory research approach.

Official Title
-----------------
Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency

Conditions
-----------------
Amenorrhea, Hypoaldosteronism, Hypogonadism, Infertility, Premature Ovarian Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Women 18 to 42 years of age with primary ovarian insufficiency who meet the following requirements were candidates for recruitment to the study: 1) at least a four month history of oligo-amenorrhea not due to pregnancy, and 2) clearly elevated gonadotropins in the menopausal range on two separate occasions at least one month apart. EXCLUSION CRITERIA: Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Estrogen, Infertility, Ovulation, Amenorrhea, Hypergonadotropic Hypogonadism, Young Women, Gonadal Steroid Deficiency, Mineralocorticoid Deficiency, Premature Ovarian Failure, POF
Ovarian Stimulation: Inositol and Melatonin

Study Overview
=================
Brief Summary
-----------------
An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available. Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH). To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin. As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.

Official Title
-----------------
Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Recombinant FSH (rFSH)
* Dietary Supplement: rFSH + Inositol + Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female age 18-39 years BMI 18-30 kg/m2, Fewer than 3 prior oocyte retrievals, No fertility Problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recombinant FSH<br>225IU rFSH | Drug: Recombinant FSH (rFSH)<br>* 225IU<br>|
| Experimental: Recombinant FSH Inositol Melatonin<br>225IU rFSH, 4g Inositol and 3mg Melatonin | Dietary Supplement: rFSH + Inositol + Melatonin<br>* 225IU rFSH, 4g Inositol, 3mg Melatonin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total oocyte number |  | 2 weeks after pharmacological treatment | 
| Number of clinical pregnancies |  | 6 weeks after embryo transfer | 
| Live birth rate |  | 10 months after embryo transfer |
The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children

Study Overview
=================
Brief Summary
-----------------
Children suffer from Cerebral Palsy that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 2 month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins & De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 5 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition Gait analysis will be also examined.

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy BOTOX injection Exclusion Criteria: Not able to stand independently 60 seconds Not able to walk independently

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: botox<br>* botox injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDF parameters |  | before and 2 months after the BOTOX injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Balance, Gait
A Study of GC1111 in Hunter Syndrom Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Official Title
-----------------
Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

Conditions
-----------------
Hunter Syndrome

Intervention / Treatment
-----------------
* Combination Product: GC1111
* Combination Product: Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Hunter syndrome Male at the age of ≥ 5 Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator. Voluntarily signed written informed consent to participation in this study Consent to contraception Exclusion Criteria: Prior treatment with iduronate-2-sulfatase ERT History of bronchotomy, bone marrow trasplanation, or cord blood transplanation. Known hypersensitivity reactions to any of the components of the invetigational product Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study. Unable to perform 6-MWT. Female

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC1111<br>All subjects should receive the GC1111 for 52 weeks. | Combination Product: GC1111<br>* GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.<br>|
| Active Comparator: Comparator<br>All subjects should receive the comparator for 52 weeks. | Combination Product: Comparator<br>* Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-MWT |  | at Week 53 from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GC1111, Mucopolysaccharidosis II, MPS II, idursulfase-beta, IDS
Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity

Official Title
-----------------
Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children

Conditions
-----------------
OBESITY, Endothelial Dysfunction, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves. Exclusion Criteria: presence of renal, liver and/or cardiovascular diseases; hypertension; metabolic and/or endocrine disorders; genetic syndromes; histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean children<br> | |
| Overweight Children (OW)<br> | |
| Obese children (Ob)<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children |  | 12 months |