cyrilzakka/clinical-trials huggingface dataset:
Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment

This clinical trial is the first-in-human study of BBT-176. The purpose of this trial is to investigate the safety and tolerability of BBT-176 (Part 1) and to evaluate the anti-tumor activity of BBT-176 (Part 2).


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated, written informed consent before any study specific procedures, sampling and analyses
* Histological or cytological confirmation of advanced and/or metastatic stage IIIB/IV NSCLC
* Radiological documentation of disease progression while on a previous continuous (at least 30 days) treatment with an EGFR TKI monotherapy (including, but not limited to, osimertinib, afatinib, gefitinib, or erlotinib)
* Patients must fulfill one of the following:

  * Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including, but not limited to, exon 19 deletion, L858R, or L861Q)
  * Documented partial or complete response or a significant and durable stable disease (at least 6 months), based on the RECIST or WHO criteria, after treatment of an EGFR TKI

Key Exclusion Criteria:

* Treatment with any of the following:

  * An EGFR TKI, including but not limited to osimertinib, afatinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
  * Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of advanced NSCLC, between prior EGFR TKI treatment and BBT-176 treatment
  * Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
  * Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment
  * Patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation within 6 weeks of the first dose of study treatment
* Any unresolved toxicities from prior therapy greater than NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2 neuropathy related to prior platinum-therapy
* Spinal cord compression or brain metastases, unless asymptomatic and stable
The Influences of Chokeberry Extract Supplementation on Handball Players

The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Standardized questionnaires conducted under the supervision of a trained nutritionist were used to collect general data, nutritional habits and use of dietary supplements. The athletes who used any dietary supplements at least a month before the study, were excluded. All participants (or their parents if they were under the age of 18) signed an informed consent document. The study was approved by the Ethical committee of The Military Medical Academy, Belgrade.

The study was conducted during regular competition season, and lasted for twelve weeks. All participants had the same training and nutritional regime, which excluded intake of berries. The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova Belgrade, Serbia. Process of extraction is performed under specific conditions which are subject of technical patent (producer EUHEM), for the purpose of production of extract with high concentration of polyphenols. The design of the product included few demands: sufficient daily dose of polyphenols to be dietary supplement, small volume which can be consumed as shot and acceptable taste for most consumers. Compliance was monitored by the trainers.


Eligibility Criteria:
Inclusion Criteria:

* healthy handball players of handball club "Novi Beograd" during competition phase.

Exclusion Criteria:

* active sports injuries,
* usage of any medications,
* smokers
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.

This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).

Eligibility Criteria:
Inclusion Criteria:

* Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.
* Subjects with non-myeloid malignancies
* Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.
* Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.
* Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =\<35%
* Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.
* Life expectancy of at least 6 months.
* Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.

Exclusion Criteria:

* Previous participation in a ferric carboxymaltose clinical trial.
* Known hypersensitivity reaction to any component of ferric carboxymaltose.
* Subjects with overt bleeding
* Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).
* Subjects on erythropoiesis-stimulating agents.
* Requiring dialysis for the treatment of chronic kidney disease.
* Any non-viral infection.
* Known positive hepatitis with evidence of active disease.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
* Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).
Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India

This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.

We will undertake a matched-cohort study among 84 villages in Ganjam district, Orissa, India to assess the health impact of a program that provides improved water supplies and sanitation to rural villages.

Eligibility Criteria:
Inclusion Criteria:

* Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion Criteria:

* None
A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.

This will be a Phase 1, open-label, 2-period, fixed-sequence, crossover study to investigate the effect of the strong CYP3A inhibitor itraconazole on PF-06463922 PK in approximately 16 healthy volunteers. The study will consist of potentially up to 6 treatments: single dose of PF-06463922 50, 75 or 100 mg and PF-06463922 50, 75 or 100 mg in combination with multiple dose itraconazole.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non childbearing potential and/or male subjects, who at the time of screening, are between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption.
* A positive urine drug test.
* History of HIV, Hep B or Hep C.
* History of regular alcohol consumption.
* Screening supine 12 lead ECG demonstrating PR interval \>180 msec, QTc \>450 msec or a QRS interval \>120 msec.
* Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: Use this criterion to describe any laboratory parameters that are not acceptable for the study. Examples included below:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>1.0 × upper limit of normal (ULN);
* Total bilirubin level \>1.0 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= ULN.
TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.

Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively, after 12 hours and 48 hrs postoperatively

TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.

GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h.

If (velocity time integral) VTI \<20, 250 mL colloid bolus administered. Dose repeated every 10 min until goal of VTI \>20 met. Norepinephrine titrated to maintain MAP(mean arterial pressure) \> 65 mm Hg. Blood transfused for haemoglobin \<8 g Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis at time of incision intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications, morbidity, mortality, duration of mechanical ventilation and ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1, 2 and 3
* Undergoing major abdominal oncosurgery

Exclusion Criteria:

* Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.
Effect of Virtual Reality on Balance in Autism

Children with ASD have poorer postural balance when compared to normal individuals. So, The aim of this study is to assess the effect of Virtual Reality on postural control in Autistic children

Autism spectrum disorders are a collection of persistent neurodevelopmental disorders characterized by difficulties in social interactions, communication, and repetitive, stereotyped, and restricting behaviors. Movement problems can occur throughout infancy and are one of the early indications of autism. Furthermore, movement impairments are the most often observed nonverbal deficits in autistic children.

Postural stability is described as the capacity to maintain an upright posture by keeping the body's center of gravity over its base of support with little swaying or maximal steadiness, and it is considered a fundamental skill required for normal motor development.

Virtual Reality has been used in the field of balance rehabilitation and training because of its relatively low cost and enjoyment. Therefore, the purpose of this study was to study the effect of VR on balance in children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Mild ASD

Exclusion Criteria:

* Taking medication affect motor
* Had a head injury, genetic disorder, blindness, fracture
IntraLase vs Hansatome Flaps in LASIK

This study compared the clinical outcomes between fellow eyes randomized to either IntraLase femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during wavefront-guided laser in situ keratomileusis.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were "T 6.00 D of spherical myopia, "T 3.00 D of refractive astigmatism, stable refraction (less than 0.50D per year of sphere or cylinder), corneal diameter less than 11.0 mm to allow for suction fixation ring, soft contact wearer with discontinuation of wear at least 7 days prior to preoperative evaluation, visual acuity correctable to at least 20/20 in both eyes, more than 21 years of age, ability to participate in follow-up examinations for 12 months after LASIK surgery. In order to fairly compare the visual outcomes of the two keratomes, patients were required to have closely matched eyes, in terms of refractive error. Exclusion Criteria:Exclusion criteria include rigid gas permeable contact lens wearer, severe dry eyes, severe blepharitis, anterior segment pathology (cataracts or corneal scarring or neovascularization within 1 mm of intended ablation zone), recurrent corneal erosion, severe basement membrane disease, progressive or unstable myopia or keratoconus, unstable corneal mires on central keratometry, corneal thickness in which LASIK procedure would result in less than 250 micros or remaining posterior corneal thickness below the flap postoperatively, baseline standard manifest refraction \> 0.75 D more minus in sphere power, or a difference of greater than 0.50D in cylinder power compared to baseline standard cycloplegic refraction, two eyes for which the baseline standard cycloplegic refraction differ from each other more than 0.75 in sphere, 0.50 D in cylinder, or have a different type of astigmatism (i.e. with-the-rule) when the cylinder is \> 0.50D, or preoperative assessment of ocular topography and/or aberrations indicates that either eye is not suitable candidate for LASIK vision correction procedure (ie forme fruste keratoconus, corneal warpage, or pellucid marginal degeneration), previous intraocular or corneal surgery, and history of herpes zoster or simplex keratitis, patients on systemic corticosteroid or immunosuppressive therapy, immunocompromised subjects or clinically significant atopic disease, connective tissue disease, or diabetes, steroid responder, macular pathology, pregnant or lactating patients, patients with sensitivity to planned study concomitant medications or patients participating in another ophthalmic drug or device clinical trial.
Study of Improving Gait Parameters When Using a Cane in "Light Touch" Condition in Elderly People With and Without Walking Difficulties

This project aims to study the effect of haptic sensory information delivered at the hand using a cane in "light touch" or "light support" condition on postural stability and spatial and temporal gait parameters of elderly subjects with and without walking difficulties


Eligibility Criteria:
Inclusion Criteria:

* presence of gait disturbance or balance disorders defined by a geriatric assessment and / or a walking speed test

Exclusion Criteria:

* presence of acute problems or central or peripheral neurological severe sequelae
* occurrence of a recent fracture of the lower limbs or spinal fracture
* cognitive disorders
* presence of comorbidities: blindness, heart or severe respiratory failure, disabling osteoarthritis of the hands or legs, severe malnutrition, muscle atrophy, untreated orthostatic hypotension
* patients using a cane to a mechanical support
Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults

Functional constipation in obese adults is a prevalent gastrointestinal issue characterized by infrequent bowel movements, difficulty during defecation, or a sensation of incomplete evacuation. Obesity is a significant risk factor for functional constipation due to several physiological and lifestyle-related factors. Excess body weight, particularly in the abdominal region, may exert pressure on the colon, leading to disrupted bowel function. Additionally, dietary habits common among obese individuals, such as low fiber intake and inadequate hydration, can worsen constipation. Sedentary lifestyles further contribute to reduced gastrointestinal motility. Addressing functional constipation in obese adults requires a multifaceted approach, including dietary modifications to increase fiber and fluid intake, regular physical activity, and, in some cases, medical interventions to alleviate symptoms and improve quality of life.

Visceral manipulation is a gentle manual therapy that focuses on the internal organs, particularly those within the gastrointestinal tract, to enhance their function and alleviate symptoms associated with various disorders. Practitioners of visceral manipulation use their hands to apply specific, subtle forces to the affected areas, aiming to improve the mobility and motility of the organs. This technique is based on the premise that the body's organs are interconnected by fascia and ligaments, and any restriction or imbalance in these connections can lead to dysfunction and disease. By restoring the natural movement of these organs, visceral manipulation is believed to improve blood circulation, enhance digestive function, and reduce pain and discomfort associated with gastrointestinal disorders.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with functional constipation according to Rome IV criteria
* Body mass index (BMI) ≥ 30 kg/m²
* Ability to provide informed consent

Exclusion Criteria:

* patients with organic gastrointestinal diseases, Pregnancy or lactation
* Participation in another clinical trial within the last 30 days, Endocrine and metabolic disorders (eg, hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus)
* Neurologic and psychiatric disorders (spina bifida, cerebral palsy, anorexia nervosa, known autism spectrum disorders)
* Secondary constipation to drug consumption, History of abdominal surgery
GM03 - Platelet RNA Signatures of Aspirin

This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible patients with diabetes will be enrolled into protocol A.

Protocol A This will be a randomized, cross-over design comparing low- and high-dose aspirin as well as a non-aspirin platelet inhibitor ticagrelor. This antiplatelet exposure study will be conducted at the DCRU using two separate cohorts: 1) healthy adult volunteers 2) patients with Type 2 diabetes. Subjects within each cohort will but in general will have platelet function testing and biospecimen collection before, four weeks, and eight weeks after low- or high-dose aspirin exposure. Subsequently there will be a period of aspirin washout and a four-week exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points peripheral blood RNA, purified platelets, DNA, serum, fecal samples and/or plasma will be collected.

Protocol B This will be a single arm study of the platelet inhibitor ticagrelor that is essentially the last two visits of Protocol A. This study will be conducted at the DCRU and will only be open to healthy adult volunteers and patients with Type 2 diabetes. Subjects who elect to participate in this protocol will follow the protocol outlined in Figure 2 and in general will have platelet function testing and biospecimen collection before and four weeks after exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points (see Figure 2 and Table 2) peripheral blood RNA, purified platelets, DNA, serum, and/ plasma will be collected. In order to align the visits with that of Protocol A, the two visits under this protocol will be labelled V4 and V5.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age ≥ 30 and ≤ 75
* Non-smoker
* The total number of enrolled females should not exceed 55% of the entire cohort. Therefore, the PI may include/exclude individuals on the basis of gender to achieve an equal balance between men and women.

Exclusion Criteria:

* History of bleeding disorder, gastrointestinal bleeding, intracranial bleeding or known prior gastric ulcer without documented resolution
* Current regular use of antiplatelet agents (aspirin, cilostazol, prasugrel, clopidogrel, dipyridamole, ticagrelor, or ticlopidine), nonsteroidal anti-inflammatory agents (NSAIDs), oral corticosteroids (i.e. prednisone), anticoagulants (warfarin, dabigatran, apixaban, rivaroxaban, enoxaparin)
* Known, severe hepatic impairment
* Surgery within the last 6 months, at the discretion of the PI
* Prior gastric bypass surgery (or equivalent) that interferes with absorbption at the discretion of the PI
* Aspirin allergy or known intolerance to aspirin or ticagrelor.
* Comorbid conditions:

  1. hypertension (requiring prescription medication).
  2. hyperlipidemia (requiring medications)
  3. Type 1 or 2 Diabetes