cyrilzakka/clinical-trials huggingface dataset:
A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants

The main purpose of this study is to compare two different formulations (mixtures) of pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will be collected. The study will last up to 65 days.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of non-childbearing potential.
* Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
* Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

Exclusion Criteria:

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  1. liver disease
  2. pancreatitis
  3. peptic ulcer disease
  4. intestinal malabsorption
  5. cholecystectomy
  6. gastric reduction surgery
  7. history or presence of clinically significant cardiovascular disease.
* Participants with out-of-range, at-rest vital signs.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to Day 1.
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to Day 1 and through end of trial.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
* Receipt of blood products within 2 months prior to Check-in (Day -1).
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis

This is a retrospective clinical study to analyze the clinical characteristics, complications, and effects of different treatment options on long-term prognosis in patients with central nervous system tuberculosis. All cases of central nervous system tuberculosis diagnosed between 2016 and 2021 were included in the electronic medical record system of one center, and data such as demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment plans, and outcomes were collected.


Eligibility Criteria:
Inclusion Criteria:

* The patient meets the following criteria 1) or 2) or 3):

  1. The discharge diagnosis is central nervous system tuberculosis, refer to the ICD-10 code related to central nervous system tuberculosis.
  2. The discharge diagnosis was tuberculous meningitis (ICD-10: A17.000), or tuberculous cerebrospinal meningitis (ICD-10: A17.001), or tuberculous meningoencephalitis (ICD-10: A17.803 ), or tuberculous encephalitis (ICD-10: A17.804), or tuberculous brain abscess (ICD-10: A17.805), or spinal tuberculosis (ICD-10: A17.806), or tuberculous encephalitis Water (ICD-10: A17.807).
  3. Tuberculous meningitis diagnosed according to the "Guidelines for Diagnosis and Treatment of Central Nervous System Tuberculosis in China (2019 Edition)"
* Age and gender are not limited.

Exclusion Criteria:

* Patients with no clear diagnosis at discharge.
* Patients judged by the investigator to be unsuitable for inclusion in this protocol.
Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery

The purpose of this study is to assess muscle function in women at least two years after being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group

Obesity is a public health problem globally. According to the World Health Organization (WHO) estimated are 600 million obese worldwide and according to National Health Survey 2010 in Chile 67% of the population suffers from some degree of overweight having approximately 300,000 morbidly obese.

The first-line treatment for obesity is diet, exercise and cognitive behavioral therapy, however, these interventions are not effective enough to control long-term obesity, and so bariatric surgery is currently the treatment of choice to control morbid obesity.

Overall, after bariatric surgery, most patients lose on average 60% of excess weight and improve their comorbidities during the first postoperative year, however, the long term effects of this weight reduction are not known in detail regarding body composition and muscle function.

The aim of this study is to assess muscle function measured by hand grip strength test in women at least 2 years after bariatric surgery (Roux-en-Y Gastric Bypass) and to compare with control group.

Eligibility Criteria:
Inclusion Criteria:

Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago

Exclusion Criteria:

* osteoarthritis of hands and knees, any osteoarticular, rheumatologic or neurological disease hindering the performance of the tests of muscle function; type 2 diabetes mellitus; acute infectious diseases; use of muscle relaxants; physical and intellectual disabilities and uncontrolled hypothyroidism.
Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (\>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.


Eligibility Criteria:
Inclusion criteria:

Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, ...) undergoing pulmonary rehabilitation (maintenance or inpatient)

Exclusion criteria:

Contraindication to exercise training
Casodex/Zoladex Hormonal therApy Study for assessMent of Correlation Between PSA & BAI in prOstate Cancer patieNts

This study is an observational study to see whether anxiety level can be correlated with PSA level under the current practice in the patients of prostate cancer taking hormonal therapy. For assessment of anxiety level BAI(Beck Anxiety Inventory) will be used. The target population for this study is the patients of prostate cancer diagnosed previously and who are taking hormonal therapy with regular follow-up and PSA test. The follow-up duration will be total 6 months with interim visit at 3 month and final visit at 6 month.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. Patients who take PSA test regularly
3. Observation suitable patients for PSA change according to hormonal treatment at least for 6months
4. Locally advanced or advanced prostate cancer patients who is suitable for hormonal therapy
5. Prostate Cancer Patients who has been taking one treatment among 3 hormonal therapies in below:

   * Bicalutamide Monotherapy : Bicalutamide 150mg/day
   * Goserelin 3.6mg/10.8mg
   * MAB(Maximal Androgen Blockade) :Bicalutamide 50mg + Goserelin 3.6/10.8mg

Exclusion Criteria:

1. Prohibition use under permitted indication
2. Previous inclusion in the present study
3. Participation in a clinical study during the last 30 days
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
* Must be willing to follow the study requirements and voluntarily give their informed consent.
* Subjects must be able to read and follow study instructions in English.
* Generally in good health as determined by the investigator, based on medical history interview.
* Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.

Exclusion Criteria:

* Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
* Sunburn within the last three weeks or use of tanning beds.
* History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
* History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
* Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
* History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study.
* Pregnancy or mothers who are breastfeeding or planning a pregnancy.
* Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.
Effects of an Exercise Program for Children With Asthma

exercise program in the pulmonary function and cardiorespiratory fitness in children with asthma and respiratory symptoms

This study aims to analyze the effects of an exercise program in the pulmonary function, cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle function, agility, and psychological health in a group of children with asthma and respiratory symptoms

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Asthma following the GEMA 2009 criteria (Spanish Guide for Asthma Management) at least 6 months prior to the study.
* Complete successfully both Cardiorespiratory and Functional Tests.

Exclusion Criteria:

* Diagnosed with other chronic respiratory disease or condition
* Diagnosed with any chronic disease including cardiovascular diseases.
* Reduced mobility
* Uncooperative
* Poor adherence to medication
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring

This is a prospective, monocentric diagnostic study aiming to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).

For some children, brain MRI is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. It can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. Impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. Procedural sedation with dexmedetomidine (DEX) can be administered intra-nasally. This technique offers good results and safety of use. Nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of DEX used (indicated doses vary from 2 to 4 μg/kg). This study aims to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).

Eligibility Criteria:
Inclusion Criteria:

* Indication of DEX sedation for brain NMRI at the CHR de Metz-Thionville

  * in a patient aged between 12 months and 5 years or
  * for a patient aged between 5 and 18 whose cooperation during the examination appears compromised (previous failure, autism spectrum disorders, etc.).
* Membership of a social security scheme
* Free and informed consent obtained from the patient's legal guardian(s).

Exclusion Criteria:

* Weight \< 10 kg
* Patients with contraindications to the use of DEX

  * Hypersensitivity to the active ingredient or to any of the excipients listed in the section on "Hypersensitivity".
  * Advanced heart block (level 2 or 3), unless pacemaker implanted
  * Uncontrolled hypotension
  * Acute cerebrovascular pathologies
* Patients with nasal obstruction
* Parental refusal of DEX administration
* Minors under guardianship
* Minors under judicial sanction
Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

Increasing experience has identified post-herniorraphy chronic pain as an under-recognized and important complication. Nerve entrapment and injury are recognized as causes of such pain. Operative treatment for selected patients with this condition includes surgical exploration of the affected groin, identification and removal of involved nerves, and removal of meshoma. This procedure has been highly effective in treatment of chronic pain. This study will attempt to subjectively and objectively evaluate the patient's chronic groin pain using quantitative sensory testing (QST) and validated pain scales and questionnaires. Quantitative sensory testing is a method used to assess damage to the small and large nerve fibers. It is used to diagnose and assess the severity of nerve damage, and can also help to determine if a neuropathy is responding to treatment. QST uses a computer testing system to measure how nerves react to vibration and changes in temperature. The procedure is non-invasive and the patient will feel minimal to no discomfort during testing. The hypothesis is that any decrease in subjective pain scores would be accompanied by improved QST results.

Background: Chronic postherniorrhaphy inguinal pain is a complex, major health problem. In the absence of recurrence or meshoma, laparoscopic retroperitoneal triple neurectomy has emerged as an effective surgical treatment of postherniorrhaphy inguinal pain. Methods: This prospective pilot study evaluated the neurophysiological and clinical effects of laparoscopic retroperitoneal triple neurectomy. Ten consecutive adult with chronic postherniorrhaphy inguinal pain and unilateral predominantly neuropathic inguinodynia underwent three comprehensive quantitative sensory testing assessments (preoperative, immediate postoperative, and late postoperative). Pain severity, health-related function, and sleep quality were assessed over the course of a 6-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* patient with chronic groin pain after inguinal hernia surgery and are candidates for triple neurectomy with mesh removal

Exclusion Criteria:

* non-English speaking patients
* significant psychiatric or medical disease
* bilateral groin pain
Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.

Patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. Tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. For patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. These biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.

Eligibility Criteria:
Inclusion Criteria:

* Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy
* Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
* Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

* History of autoimmune diseases
* History of immunotherapy
* History of pelvic radiotherapy
* Will receive immunotherapy during the course of treatment
* Contraindications for biopsy, such as high bleeding risk
The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults

The purpose of this study is to determine if an acute bout of removal of exercise reduces enothelial function and glycemic control in an active, older adult population; and whether a 3 day return to exercise restores this response. Glycemic control is the blood glucose response following the consumption of a meal. It is an indicator of insulin resistance (or type 2 diabetes) and impaired glycemic control has been suggested to lead to cardiovascular disease. Endothelial function has been shown to be improved by chronic or acute increases in physical activity. Both of these have been shown to be impaired to acute bouts of inactivity in young populations; however the impact of acute inactivity in older adults is less understood. In this proposal the investigators will examine 1)how quickly impairments in glycemic control occur to acute physical inactivity in older adults who exercise, 2) how quickly impairments in endothelial function occur to acute inactivity in older adults who exercise, and 3) whether 3 days of a return to exercise restores these responses.


Eligibility Criteria:
Inclusion Criteria:

1. 55 years and older, 18-40 years old
2. Healthy, physically active, performing at least 90 min/week of physical activity
3. Free of physical limitations that may interfere with alterations in daily physical activity levels

Exclusion Criteria:

1. Physician diagnosed HIV, hepatitis, or tuberculosis.
2. Body weight change of greater than 5% within the previous 2 months
3. Smoking within the previous 2 months.
4. Taking medications that alter blood glucose levels
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
* Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
* Life expectancy of at least 16 weeks.
* Ability to swallow whole capsules.

Exclusion Criteria:

* Use of or requirement for bisphosphonates within 8 weeks prior to screening.
* Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
* Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
* Recent or ongoing significant gastrointestinal disorder
Liquid Biopsies in Esophageal Cancer

Purpose of this study is to determine the value of liquid biopsies, e.g. testing of minimal residual disease (MRD) by using liquid biopsies to measure circulating tumour DNA (ctDNA) at diagnosis and during the multimodal and multidisciplinary curative-intent treatment of resectable esophageal cancer.

Multicentric, retrospective and prospective components.

Retrospective collection of leftover tissue from standard of care biopsies or resection specimens and prospective collection of additional blood samples for study-specific analyses at specific timepoints, at the same time as routine labs are foreseen. No additional venipunctures are expected.

Three distinct patient groups are defined, depending on the therapeutic scenario patients undertake:

Scenario 1: primary resection then follow-up - Study-specific liquid biopsies will be collected in 98 patients, at the time of routine labs. Samples will be acquired before resection, at 6-8 weeks, 6 and 12 months after resection.

Scenario 2: chemoradiation followed by resection and follow-up - Study-specific liquid biopsies will be collected in 50 patients. Samples will be acquired before the start of chemoradiation, before surgery, 6-8 weeks, 6 and 12 months after surgery. A subgroup of patients will undertake adjuvant immunotherapy and will constitute Group 3. Timing of sampling will be adjusted accordingly as per study flowcharts.

Scenario 3: chemoradiation followed by resection followed by adjuvant immunotherapy - Study-specific liquid biopsies will be collected in 100 patients. Samples will be acquired before the start of chemoradiation, before surgery, 6-8 weeks after surgery and during adjuvant immunotherapy every 3 months including a sample at the end of treatment.

Patient management is standard of care. No investigational medicinal product (IMP) is involved.

Specific clinicopathological variables will be collected in a RedCap electronic Case Report Form and analysed as per statistical analysis plan.

Eligibility Criteria:
Key inclusion criteria are:

1. Male or female, age \> 18 years
2. New diagnosis of esophageal cancer, pathologically confirmed squamous cell carcinoma (ESCC) or adenocarcinoma (EAC)
3. Clinically staged - cT1-4 N0-2 M0 (local or locally advanced, resectable)
4. Eligible for multidisciplinary treatment as assessed by MDT
5. Able to provide informed consent (ICF) according to Good Clinical Practice and national/European regulations

Key exclusion criteria are:

1. (Oligo)metastatic disease
2. Histologically or cytologically confirmed diagnosis other than squamous cell carcinoma or adenocarcinoma (eg. neuroendocrine carcinoma, lymphoma...)
3. Other active malignancies
4. Previous exposure to chemoradiation (prior to MDT)
5. Treatment plan after MDT: neoadjuvant chemotherapy with no radiation or chemoradiation with definitive intent (surgery is not planned)