cyrilzakka/clinical-trials huggingface dataset:
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years
* Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
* Objective and radiologically confirmed progression of disease after prior first-line treatment
* Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
* At least one measurable lesion as per RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
* More than one line of prior treatment for advanced or metastatic disease
* Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
* Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
* Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
* Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \< 50%, Q-T interval corrected for heart rate (QTcF) \> 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
* Inadequately controlled hypertension
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
* Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
* Pregnant or nursing (lactating) woman

Other protocol-defined inclusion/exclusion criteria may apply
Photograph Quality Rating Scale Study ("PQRS Study")

Advances in smart phone-based photography (both quality and image transmission) offer the potential to greatly improve access to pediatric dermatologists. However, the accuracy of diagnoses reliant on parent-provided photographs has been neither measured nor compared to diagnoses based on in-person examinations. Therefore, the primary objective of this study was to assess the concordance between diagnoses based on photographs taken by parents (or legal guardians) and those based on in-person examinations. A secondary aim was to assess the effect of photography instructions on improving this concordance.

Each patient/parent dyad will be randomized into one of two approximately equally sized groups; half of the subjects will be provided with an instruction sheet on how best to take photographs of skin conditions with their mobile devices (study group) and half will not be provided this instruction sheet (control group). Photographs will be evaluated for image quality and to provide a diagnosis (See attached forms including Photograph Quality Rating Scale).

Eligibility Criteria:
Inclusion Criteria:

1. Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic
2. Patient must be under the age of 18.
3. Consenting parent or guardian must be present and able to speak English to participate.
4. Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll during the encounter.
5. Parent or legal guardian has a mobile phone with the capability to download the free MyChart app.
6. Parents have a data plan that allows them to download the MyChart app (if not already downloaded) and upload pictures, and are willing to accept any potential data charges incurred with these activities.
7. Patient has active skin lesion or rash that can be photographed during the clinic visit.

Exclusion Criteria:

1. Patient is over the age of 18.
2. Parent or guardian is not present or not able to speak English.
3. Parent or guardian is not able to enroll in MyCHOP (MyChart).
4. Parent or guardian does not have a mobile phone capable of downloading the MyChart app.
5. Photographs are not able to be taken (phone battery dies, phone/app does not work, patient is not cooperative, participant does not have time).
6. If there are no active skin lesions to photograph the patient/parent will not be enrolled (e.g. hives that are inactive, hyperhidrosis \[excessive sweating\], itching without a rash, resolved skin lesions \[e.g. warts, molluscum\]).
7. Patients presenting for a general full body skin exam will be excluded, as this would require full body photography, which is too time consuming. (Note: this does not include evaluation of one individual mole \[nevus\], which can be included in the study).
Beach Tennis And Hypertension Study

The purpose of the present study was to evaluate the effect of a beach tennis session on 24-hour ambulatory blood pressure in adults with hypertension. The main hypothesis is that a single session of beach tennis would decrease ambulatory blood pressure compared with a non-exercise control session.

In this randomized crossover trial, participants performed randomly assigned two experimental sessions: a beach tennis session and a non-exercise control session. The beach tennis session started with a standardized 5-minute warm-up consisting of basic techniques, followed by three 12-minute beach tennis matches with 2-minute intervals between them. Heart rate and rating of perceived exertion were continuously recorded during the beach tennis session, and enjoyment was measured after the beach tennis session. The control session was performed in seated rest. Both experimental sessions lasted 45 minutes. Ambulatory blood pressure was measured continuously for 24-hour after sessions.

Eligibility Criteria:
Inclusion Criteria:

* Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
* Non-engaged in structured exercise programs in the last 3 months before the beginning of this study;
* Able to perform the proposed exercises.

Exclusion Criteria:

* Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure;
* Diseases that reduce life expectancy;
* Smokers;
* BMI \>39.9 kg/m²;
* Diabetic proliferative retinopathy.
Uterocervical Angle and Preterm Labour

To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth

The uterocervical angle is the triangular segment measured between the lower uterine segment and the cervical canal, yielding a measurable angle. The first ray was placed from the internal os to the external os. The calipers were placed where the anterior and posterior walls of the cervix touch the internal and external os along the endocervical canal. If the cervix was curved, the first ray was also drawn from the internal os to the external os as a straight line. A second ray was then drawn to delineate the lower uterine segment. This ray was traced up the anterior uterine segment to a distance allowed by the preloaded image. Ideally, the second ray would reach 3cm up the lower uterine segment in order to establish an adequate measurement. The anterior angle in between the two rays was measured with a protractor. In the presence of funneling, the first ray was placed to measure the length of remaining cervix. The second caliper was placed from the innermost portion of measurable cervix and extended to the lower uterine segment. In the event that the lower uterine segment was found to be irregular, the second caliper was placed centrally along the segment. In the event of a retroverted uterus, the angle should be measured in a similar fashion with the first ray along the measurable cervix and the second ray traced along the lower uterine segment. Unlike in an anteverted or axial positioned uterus, however, the posterior side of the angle closer to the intrauterine contents should then be measured.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age (18_40).
* BMI (20_34).
* singleton gestations between (18 - 28) weeks.
* Multiparity.
* History of previous preterm deliveries or mid-trimesteric abortions.

Exclusion Criteria:

* Loss of follow up.
* Preterm premature rupture of membranes(PPROM).
* Placental abnormalities.
* Past history of cervical operations.
* Multifetal pregnancy.
* Polyhydramnios.
* Steroids intake .
* Medically or obstetric indicated pregnancy termination.
* Serious maternal or fetal problems.
* Cerclage during current pregnancy before the screening.
Effectiveness of CGA on QoL in Older Patients With Cancer Receiving Systemic Therapy

The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team.

The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team. The Medical Research Council (MRC) Framework, developed to test complex interventions, is used to design this study. A multicenter randomized controlled trial will be conducted in two academic hospitals (UZ Brussel - UZ Leuven) with a follow-up at 3, 6 and 12 months after the start of systemic therapy. Patients will be recruited in both academic hospitals in the period between the cancer diagnosis and the start of the systemic therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 70 years and older
* diagnosis of cancer (solid tumors)
* starting systemic therapy (chemotherapy, immunotherapy, targeted therapy or hormonal therapy)

  * curative intent (neo-adjuvant / adjuvant / concomitant / other)
  * palliative intent (first line / second line)
* patients must be able to comply with the study procedures
* physician-estimated life expectancy must be more than 6 months

Exclusion Criteria:

* patients with antihormonal monotherapy
* previous participation in geriatric intervention studies
* patients included in clinical trials with non-registered anticancer drugs
Rested & Ready to Learn: Pilot RCT

The goal of this pilot randomized controlled trial is to test the feasibility, acceptability, and preliminary signal of effect of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition.

This pilot randomized controlled study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. Classrooms will be randomized to either the intervention or waitlist control group. Intervention content will be delivered via text message to parents' phones and in the classroom. The primary aim of this study is to assess the feasibility and acceptability of the intervention. The secondary aim is to assess the preliminary signal of effect on children's sleep and classroom behavior. Findings from this study will inform any necessary intervention modifications prior to a fully powered randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Child between the ages of 4-6 years
* Currently enrolled in a participating school's 4-year-old kindergarten (4K) classroom
* Parent/guardian willing to complete questionnaires in English
* Parent/guardian must have access to a mobile phone with texting capability

Exclusion Criteria:

- Parent or child has a medical condition that impairs their ability to participate
Should I Have an Elective Induction?

The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation

60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant person
* Nulliparous
* Planned vaginal delivery
* No medical indication for induction of labor

Exclusion Criteria:

* Contraindication to vaginal delivery
* Prior delivery (vaginal or cesarean)
* Medical indication for induction of labor
Registry of the Patient Experience for Carpal Tunnel Release

Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).

Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).

Eligibility Criteria:
Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)\* 5. Confirmatory diagnostic testing in the target hand(s)\*:

1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
2. ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.

Exclusion Criteria:

1. Patient meets any of the contraindications per Instruction For Use (IFU)
2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
Cognitive and Blood Flow Effects of Mountain Tea

Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of 50-70 yr olds, both acutely and following 28 days of consumption.

The presence of polyphenols such as ferulic acid, chlorogenic acid and apigenin in Sideritis Scardica (SS or 'mountain tea') are likely responsible for the cognitive and mood effects of its consumption and this could be underpinned by the ability of such polyphenols to prevent monoamine neurotransmitter reuptake and to increase cerebral blood flow (CBF).

The current randomised, placebo controlled, parallel groups study extends on the abovementioned small amount of literature; assessing both cognitive and mood outcomes in a sample of older (50-70 yrs) adults, as well as blood pressure (BP) and CBF, in a sub-sample, utilizing near-infrared spectroscopy (NIRS). The above will be assessed acutely (pre-dose and 90- and 310-mins post dose) on day 1 and following 28 days consumption of either a placebo control, and active control of 240 mg ginkgo biloba, 475 mg SS or 950 mg SS.

Eligibility Criteria:
Inclusion Criteria:

* 50-70 yrs of age
* No underlying health problem which would prevent engagement with the study

Exclusion Criteria:

* BMI \< 18 or \> 35 kg/m2
* High blood pressure (defined as systolic \> 159 mmHg or diastolic \> 90 mmHg)
* Smoking
* Food allergies or insensitivities
* Pregnancy or breast feeding
* Currently taking any medication (use of contraceptives/hormone replacements was not excluded) or dietary supplements which would contraindicate with the study
* Sleep disturbances and/or taking sleep aid medication
* History of neurological, vascular or psychiatric illness
* Current diagnosis of anxiety or depression
* Migraines
* Recent history (within 12 months) of alcohol/substance abuse
* Disorder of the blood
* Heart disorder/history of vascular illness
* Respiratory disorder requiring regular medication
* Type I or II diabetes
* Renal disease, hepatic disease or severe disease of the gastrointestinal tract - Any health condition that would prevent the fulfilment of the study requirements
A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants

The main purpose of this study is to assess the effect of itraconazole and rifampin on how fast selpercatinib gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study is conducted in two parts and it will last up to 54 days (part 1) and 59 days (part 2), respectively, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2
Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase

40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave \<3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.

40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave \<3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC All patients were 35 years old ore more We exclude patient \>44ys ,AMH \<0.3ng/ml,FSH \>13, also patients of DM, endometriosis, general disease were excluded, any local uterine anomalies were excluded.

All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US were done to exclude any cyst or follicle \>10mm First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach \>12 mm, HCG was given only if we have at least 3 mature follicles \>14 mm and the leading one \>17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if \> 5miu/ML 28 day after ET, TVS was done to confirm ongoing pregnancy by visualization of IU sac.

Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF \>12mm, till day of HCG, HCG,OPU, ET were done by same method and under same criteria, luteal support and follow were the same.

Eligibility Criteria:
Inclusion Criteria:

1 Poor responders 2. Age \>35 years

Exclusion Criteria:

1. patient \>44ys ,
2. AMH \<0.3ng/ml,
3. FSH \>13, also
4. patients of DM ,endometriosis ,general disease were excluded,
5. any local uterine anomalies were excluded.
Efficacy and Safety Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, 30 to 60 years of age
* Bilateral lateral canthal lines rated as moderate or severe
* Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study
* Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders
* Muscle weakness or paralysis in the area receiving study treatment
* Active skin disease or irritation at the treatment areas
* Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
* Use of prescription retinoid products during the past 3 months prior to Screening
* Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
* Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
* Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
* Previous treatment with Botulinum Toxin Type A in the face area
* Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
* Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at Screening
* Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study
* Clinically significant laboratory values at Screening