cyrilzakka/clinical-trials huggingface dataset:
Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation

The "Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation" study is open to a subset of patients with disorders of sex development (DSD) which is associated with the risk of malignancy and a high risk of infertility or sterility. For these patients, experimental gonadal tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility and/or restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy.

Unlike the oncology population, in which patients have inherently normal fertility potential and reproductive function, individuals with DSD may have infertility caused by 1) abnormal gonadal development, 2) gonadectomy performed for risk of malignancy, 3) abnormal hormone production or, 4) discordance, or difference, between gonadal type and gender identity. Fertility potential differs according to the specific DSD diagnosis and can also be influenced by age, genetic mosaicism, and/or risk of developing a gonadal malignancy.

Abnormal gonadal development can result in gonadal failure, either in infancy or progressively, such that individuals may not undergo spontaneous puberty, menarche or spermarche. Progressive germ cell loss may occur throughout childhood. In addition, abnormal gonadal development in certain cellular environments leads to an increased risk of germ cell cancer. Traditionally, it was recommended to perform gonadectomy at the time of diagnosis in all DSD conditions with a risk of gonadal tumor formation. The estimated tumor risk ranges from 2% in complete androgen insensitivity syndrome to 40% in partial androgen insensitivity syndrome. Advances in stratification of tumor risk have led to a more diagnosis-specific assessment of risk, but tumor risk remains a major concern.

Thus, the investigators are conducting a pilot study to assess the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility and/or restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy.

Eligibility Criteria:
Inclusion Criteria:

* \< 30 years of age
* Individuals diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue and will have their gonads removed for a clinical indication
* Individuals diagnosed with a disorder of sex development who are at risk of primary ovarian insufficiency (POI) due to an underlying genetic condition

Exclusion Criteria:

* Pregnancy
* Patients likely to retain inherent fertility and reproductive function
* Patients deemed high risk for perioperative complications
* Patients 7-17 years of age unable to provide assent (i.e. significant psychiatric problems/cognitive delay)
* Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)
The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption

The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Background: The use of microprocessor controlled (MIC) prostheses has increased in recent years, but the number of studies on gait pattern and energy consumption in above-the-knee amputee patients is very low.

Objective: The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Methods: This observational clinical study included 34 unilateral above-the-knee amputees, separated into two groups as Group 1 (n:17) using MIC prosthesis, and Group 2 (n:17) using non-MIC prosthesis. The patients were compared in terms of gait pattern, gait capacity, energy consumption, mobility, quality of life, and prosthesis satisfaction levels according to the type of prosthesis. 3D gait analysis, exercise tolerance test, Short Form 36 (SF-36) Health Survey Questionnaire, Locomotor Capabilities Index-5 (LCI-5), Satisfaction with Prosthesis Questionnaire (SAT-PRO) and six-minute walk test (6MWT) were used as evaluation criteria.

Eligibility Criteria:
Inclusion Criteria:

* as voluntary participation in the study
* age ≥18 years
* having a unilateral above-the-knee amputation
* the ability of independent ambulation in the community
* at least 6 months since the amputation
* use of the current prosthesis for at least 8 weeks

Exclusion Criteria:

* unwillingness to participate in the study
* age \<18 years
* limb length discrepancy of ≥2 cm
* the presence of contracture or deformity
* additional amputation
* neuromuscular disease or comorbidity that may interfere with the study follow-up period of \< 6 months since the amputation
* use of the current prosthesis for \< 8 weeks
* being uncooperative
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.


Eligibility Criteria:
Inclusion Criteria:

1. Experiencing heartburn at least 2 days per week over the past month.
2. Having heartburn that responds to heartburn medication.
3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
2. Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

Other protocol-defined inclusion or exclusion criteria may apply.
Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student

The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.

Learning and working memory are two of the key role for studying and work successful for student particular the high school student who study hard and preparing themselves for the graduate study. The consumption of brain booster product or functional food for improving memory has gained much attention. It has been reported that Bacopa Monnieri could improve learning and working memory in elderly subject by improving the N100 and P300 event related potential. Therefore, Bacopa Monnieri might be the potential product for improving the learning and working memory in student particular high school student.

Eligibility Criteria:
Inclusion Criteria:

* Healthy student subject aged between 15-18 years old who studying in the school within Khon Kaen province.
* Body mass index is between 18.5-24.9

Exclusion Criteria:

* Subjects who are diagnosed with one of the following: cardiovascular diseases, respiratory disease, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
* Subjects who take any medicine or nutraceuticals or hormone that effect on central nervous system are excluded.
* Alcohol addict or smoking addiction (more than 10 pieces/day)
* Athlete or subjects who have a regular exercise more than 3 times/week
* Subjects who don't follow the instruction during the trial
* Subjects who are participating the other project.
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy

Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.

The study will be carried out in a single study site located in Finland.

Eligibility Criteria:
Key Inclusion Criteria:

* Males or females, aged 18 to 65 years
* Good general health
* A documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 allergy seasons.
* Bet v 1 specific serum IgE ≥ 0.7 kU/L
* Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm
* Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m2.

Key Exclusion Criteria:

* History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
* Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening.
* History of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
* Forced Expiratory Volume in one second (FEV1) \< 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit.
* History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
Assessment of Visual and Refractive Results and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery

Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.

The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson \& Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.

No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.


Eligibility Criteria:
Inclusion criteria

* Aged ≥ 18 years
* Patients scheduled for bilateral cataract surgery
* For at least one eye :

  * Cataract surgery clinically indicated
  * Corneal astigmatism ≥ 1 D
  * Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens

Non inclusion criteria

* Pregnant or breast-feeding women
* In the eye with planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens:

  * Irregular astigmatism (keratoconus suspicion)
  * Corneal scaring in visual axis
  * Retinal impairment that may limit visual recovery (macular degeneration, history of retinal detachment, etc.)
  * Visually impaired eye since childhood that cannot be improved despite correction of the refractive disorder
  * Any other ophthalmic disease inducing visual impairment
Vessel-sparing Technique Versus Conventional Repair of PFUI: A Prospective Comparative Study

Pelvic fracture is associated with urethral injury in about 10% of patients . The common site of injury is at the bulbomembranous Junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury (PFUI) .

Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury, a maneuver that requires division of the bulbar arteries . Then, the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances .

When the distal blood supply to the urethra is compromised, either by congenital anomalies such a hypospadias, by previous surgery, or by the pre-existing pelvic fracture, the retrograde flow to the spongiosum is insufficient . In such cases, traditional anastomotic urethroplasty may result in ischemic bulbar necrosis, leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter, with subsequent retrograde urethrogram (RUG) showing a long bulbar urethral defect .

In 2007, Jordan et al described a modification to excision and primary anastomosis (EPA) in the proximal bulbar urethral strictures particularly post radical prostatectomy, which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained .

Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal. Consequently, they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow .

So that, we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study.


Eligibility Criteria:
Inclusion Criteria:

- Adult male patients ≥ 18 years old with PFUI

Exclusion Criteria:

* Recurrent cases. • History of concomitant bladder neck injury
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine.

The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.


Eligibility Criteria:
Inclusion Criteria:

* Study subjects must be 18-50 years old.
* Subjects must weigh at least 110 pounds.
* Subjects must be in good health as judged from medical history, physical examination, EKG and chest x-ray, complete blood count (CBC) with differential, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test, and be medically cleared for participation by an investigator. If any HIV or hepatitis testing is positive, the individual will be provided with counseling and referral for health care.
* Females of childbearing potential must have a negative pregnancy test on vaccination day before each dose and agree to not become pregnant or breastfeed for 3 months after the last dose of the vaccine and be willing to use a reliable form of contraception during the study.
* Study subjects must read and sign an approved informed consent.
* Study subjects must be willing to complete a subject diary card after each vaccination.
* Study subjects must be willing to return for all follow-up visits.
* Study subjects must agree to report any adverse event (AE) that may or may not be associated with administration of the investigational product through the 9-month follow-up visit. Study subjects will report all serious adverse events for the duration of the study.

Exclusion Criteria:

* Body weight less than 110 pounds.
* Acute or chronic medical conditions or immunodeficiency from a medical condition or medical treatment, medications, or dietary supplements that, in the investigator's opinion, would impair the subject's ability to respond to vaccination.
* Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or laryngospasm).
* History of asthma, chronic obstructive pulmonary disease, or other current/residual disease of the lungs.
* Clinically significant abnormal laboratory tests.
* Current smoker.
* Any known allergies to sodium succinate, Tween-20 (a detergent), aluminum hydroxide, or kanamycin.
* Previously received ricin toxin vaccine or has antibodies to ricin toxin proteins.
* Receipt of licensed vaccines within 30 days prior to the start of the study or plans to receive other vaccines during the initial 9 months of the study (the only exceptions are the inactivated influenza vaccine that can be received at least 30 days after RVEc Dose 3).
* Receipt of investigational drug/test product within 30 days prior to entry or within the initial 9 months of the study.
* Females: Pregnant or breastfeeding.
* Enrolled in another greater than minimal risk study.
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of \[14C\]-TD-1473. Subjects in cohort 2 will receive a single oral dose of \[14C\]-TD-1473 only.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
* Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
* Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
* Additional inclusion criteria apply

Exclusion Criteria:

* Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
* Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
* Subject regularly works with ionizing radiation or radioactive material
* Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
* Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol
* Additional exclusion criteria apply
Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care.

Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before undergoing any study-related activities
* Male or female, at least 18 years of age
* Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
* Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
* Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
* Measurable disease defined as one or more target lesions according to RECIST
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Pretreatment with regorafenib.
* Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
* Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
* Magnesium less than 0.9 milligram per deciliter (mg/dL)
* Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
* Other protocol defined exclusion criteria could apply
Thrive Initiative Parent-Education Programming Study

The purpose of this study is to evaluate the effectiveness of the Thrive Initiative's parent-education program delivery methods by comparing hybrid (i.e., a combination of online and group components) program delivery to online-only program delivery. The Thrive Initiative consists of four, universal parent-education programs that correpsond to specific child developmental periods. These programs inlcude: Take Root for parents/caregivers of 0-3-year-old children; Sprout for parents/caregivers of 3-5-year-old children; Grow for parents/caregivres of 5-10-year-old children; and Branch Out for parents/caregivers of 10-18-year-old children. The effectiveness of delivery method will be examined for each program. Eligible participants for this study will be United States Air Force service members or dependents who are caregivers of a child 0-18 years old. The study will involve randomization to condition meaning that participants will be assigned to the online-only or hybrid program delivery condition by chance.


Eligibility Criteria:
Inclusion Criteria:

* United States Air Force service member or dependent
* Parent/caregiver of a child 0-18 years old
* 18 years of age or older
* Willing to participate in the research study
* Has access to technology that will enable them to receive and respond to various technological aspects of the Thrive Initiative programs and research study
* Able to speak and understand English proficiently
* Able to understand and give consent

Exclusion Criteria:

* Not an United States Air Force service member or dependent
* Not a parent/caregiver of a child 0-18 years old
* 17 years of age or younger
* Unwilling to participate in the research study
* Does not have access to technology that will enable them to receive and respond to various technological aspects of the Thrive Initiative programs and research study
* Unable to speak and understand English proficiently
* Unable to understand and give consent