cyrilzakka/clinical-trials huggingface dataset:
Study of Combined Oral Contraceptive Effects in Female Subjects

The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Written Informed Consent a) The signed informed consent form
2. Target population

   * a) Healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
   * b) Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive, at screening and Day -1. BMI = weight (kg)/\[height (m)\]2
   * c) Weight greater than or equal to 45 kg
   * d) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). If reenrolled, the subject must be reconsented
3. Age and Reproductive Status

   * a) Women, 18 to 40 years of age, inclusive
   * b) Women of childbearing potential (WOCBP) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of Ortho Cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing EE for at least two months prior to dosing on Day 1 of Cycle 1 and willing to switch to Ortho Cyclen for the total duration of the study (approximately 78 days)
   * c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on Day 1 of Cycle 1
   * d) Women must not be breastfeeding

Exclusion Criteria:

Medical History and Concurrent Diseases

* a) Any significant acute or chronic medical illness
* b) History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* c) Current or recent (within 3 months of dosing on Day 1 of Cycle 1) gastrointestinal disease
* d) Any major surgery within 4 weeks of dosing on Day 1 of Cycle 1
* e) Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
* f) Donation of \> 400 mL to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on Day 1 of Cycle 1
* g) Blood transfusion within 4 weeks of dosing on Day 1 of Cycle 1
* h) Inability to tolerate oral medication
* i) Inability to be venipunctured and/or tolerate venous access
* j) Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1 of Cycle 1)
* k) Recent (within 6 months of dosing on Day 1 of Cycle 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
* l) Any other sound medical, psychiatric, and/or social reason as determined by the investigator
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years
2. Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:

   * CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU)
   * Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), Taxane \[paclitaxel (Taxol) or docetaxel (Taxotere)\]) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
   * ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
   * FOLFIRI (irinotecan, 5-FU, leucovorin)
   * Any other 5-FU-based regimen (excluding FOLFOX)
3. Be willing and able to complete all study-related activities
4. Properly obtained written informed consent

Exclusion Criteria:

1. Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
2. Concurrent radiotherapy
3. Unable or unwilling to complete study assessments
4. Unable or unwilling to avoid using ice chips
5. Known allergy to silicone
6. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
7. Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
8. Chronic use of opioid analgesics
Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test

Compare the accuracy of two methods of ultrasound and air leakage test in positioning laryngeal mask. Validate the relationship between ultrasound scores, air leak levels, and bronchoscopic classification in positioning laryngeal mask


Eligibility Criteria:
Inclusion Criteria:

* patients selected for this study must meet all of the following criterion:

  1. Age is between 17 to 65 years old;
  2. ASA (Amecican Society of Anesthesiology ) scores I-II;
  3. Actual weight is between 30 to 100 kilogram;
  4. Patients undergo selective supine operations under general anesthesia (laryngeal mask);
  5. Patients agree to participate in our study and sign Informed Consent Form

Exclusion Criteria:

* Patients cannot participate in this study if they have any of the following conditions:

  1. Airway stenosis, history of airway masses etc, whicn may cause obstruction to ventilation;
  2. Swelling of the neck caused by huge mass in the neck and history of neck surgery etc, which doesn't contribute to ultrasound observation;
  3. Stomach fullness, intestinal obstruction, gastroesophageal reflux disease etc, which may cause reflux aspiration.
Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.

The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.

The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

Investigators will determine how molecules in human breath can define a "breath signature" that can be associated with neurological disorders like Parkinson's disease. The long-term goal of this study is to use blood inflammatory marker relationships and Breath Analytical Approach to identify individuals at risk for development of neurologic disorders and to monitor the effects of immune interventions on the rate of disease progression.

The study team will recruit a total of 100 participants: 50 early stage (defined by a Hohn \& Yahr Stages 1-2), non-smoking Parkinson's Disease patients from among the Emory Movement Disorders Clinic and 50 age and sex-matched healthy controls (HC). Investigators will recruit six to eight participants per month over an 18-month time period.

Eligibility Criteria:
Participants with Parkinson's Disease (PD)

Inclusion Criteria:

* Must be capable of providing written informed consent
* Non-smoking
* Clinical diagnosis of PD Hohn \& Yahr Stages 1 and 2

Exclusion Criteria:

* Cognitively impaired to the degree that they are not able to provide consent

Healthy Controls

Inclusion Criteria:

* Must be capable of providing written informed consent
* Age matched and a family member or healthy community control

Exclusion Criteria:

* Diagnosed with cancer and/or undergoing cancer treatment.
Closed-loop Control of Vasopressor Administration in Cardiac Surgery

Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients.

The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension.

After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller in three high risk patients undergoing cardiac surgery

The investigators have recently developed an automated closed-loop vasopressor (CLV) controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow range (±5mmHg of the chosen target).

The investigators published engineering, animal studies and recently described the feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac procedures. This initial cohort human study showed the controller was able to keep patients within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery represents unique challenges in MAP management as the manipulation of the heart itself, the use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease all increase the difficulty in maintaining a steady MAP throughout the surgical period.

In this case series the investigators describe three cardiac surgical procedures managed with the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and behavior in three high-risk patients before starting a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult high risk patients undergoing cardiac surgery (robotic, off-pump and on pump cardiac surgery)

Exclusion Criteria:

* Atrial fibrillation
Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women

Research; It is a planned, non-invasive, controlled study in obese female volunteers and non-obese female volunteers. The population of the study consists of voluntarily non-obese women and obese women. Sarcopenia assets of individuals will be measured with the sarc-f questionnaire, and then muscle strength, muscle mass and physical performance tests will be measured. Then, rectus femoris muscle thickness will be measured with USG, and then walking and balance will be measured with ZEBRIS.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old and female
* Volunteering and accepting to participate in the study
* BMI 30-39.9 kg/m2 in obese women (experimental group)
* BMI 18-27.9 kg/m2 in non-obese women (control group)
* Not having cardiorespiratory, neurological, orthopedic and metabolic disorders

Exclusion Criteria:

* Being under 18 years old and male
* Having a BMI of 40.0 kg/m2 and above in obese women (experimental group)
* BMI 28.0 kg/m2 and above in non-obese women (control group)
* Having cardiorespiratory, neurological, orthopedic and metabolic disorders
The Diagnostic Accuracy of the Clinical Examination

This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings

When patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. There are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating Orthopedic or Sports injuries. In these practices, surgery has become and remains the gold standard. However, in primary care, often imaging like Magnetic Resonance Imaging (MRI) has become the the criterion standard. This double blind study will compare the diagnosis reached by clinical exam to the results found on MRI. In addition, the examining clinician will report their recommended plan of care after the examination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-80 years old with musculoskeletal pain/dysfunction

Exclusion Criteria:

* Outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom MRI is contraindicated for example, with shrapnel in the body
Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B

This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.

There is a paucity of biomarkers to predict preeclampsia and for predicting the severity of preeclampsia. This study was designed to identify novel biomarkers for both the prediction of preeclampsia in previously normal pregnancies and for the prediction of the severity of preeclampsia in preeclamptic women. The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence and the investigators also plan testing for novel markers using various approaches such as proteomics, lipidomics and genomics. The targeted markers will include Aquaporin 4 (AQP4), soluble aquaporin fragments, chemokines, and halogenated fatty acids in the plasma and/or spinal fluid. Aquaporin fragments and AQP4 have been hypothesized to correlate with severe headaches which are complications of severe preeclampsia. The investigators found in their murine studies that there is a correlation between the presence of halogenated fatty acids in the plasma and elevated blood pressure in a murine model of preeclampsia. The approaches will complement the targeted analyses to identify novel markers that have not been predicted yet.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 20 years of age
* Greater than 24 weeks of gestation
* Obstetrics/Anesthesia Team had decided that Combined Spinal/Epidural (CSE) or Spinal Anesthesia will be performed

Exclusion Criteria:

* Pre-pregnancy comorbidities:
* hypertension, diabetes, or pulmonary hypertension
* use of steroids, beta blockers, Ca channel antagonist, anticoagulants
* cardiac or vascular conditions
* severe headaches or visual disturbances
* Inability to receive CSE or Spinal Anesthesia
* Chorioamnionitis, fever, bronchitis, pneumonia
Effects of Slow-Stroke Back Massage on CRF

Chemotherapy-related fatigue (CRF) is common in patients with breast cancer and it can be seen between 27% and 96% depending on the stage of cancer and treatment method. At the same time, CRF is reported as the most important symptom that reduces the functional capacity of patients with breast cancer and impairs their quality of life. For this reason, there is a need for an intervention that could decrease or prevent of CRF in breast cancer patients. In the literature, it is stated in the evidence-based guidelines that massage, which is one of the non-pharmacological methods, can be effective in CRF management.

This an assessor-blinded,parallel group randomized controlled trial aimed that investigating the effect of slow-stroke back massage on CRF in breast cancer patients.This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received Adriamycin-Cyclophosphamide (AC)/ Cyclophosphamide-Adriamycin-5 Fluoro-uracil (CAF) regimens every 21 days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer patients who had received at least 1 cycle of chemotherapy and were scheduled to receive 3 more cycles,
* Receiving one of the adriamycin-cyclophosphamide/cyclophosphamide-adriamycin-5-fluorouracil (AC/CAF) chemotherapy protocols,

Exclusion Criteria:

* With metastasis
* Having open wounds and edema on the upper limbs and back
* Using any complementary and alternative (CAM) treatment method to prevent fatigue during administration
Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.

Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* subacromial impingement syndrome
* without a complete tear of rotator cuff
* willingness to participate

Exclusion Criteria:

* had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors.
* had hypersensitivity to hyaluronate
* had participated in any other study within 6 months
* had received a subacromial injection within 8 weeks
* were pregnant or planned to become pregnant
* were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases

Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases.

The main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases.

The secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age\>18 years
* Informed consent signed by the patient
* Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis
* Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification \[1\], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).

Healthy controls :

* Age\>18 years
* Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants
* Informed consent signed by the patient
* Absence of known cutaneous or systemic inflammatory disease.

Exclusion Criteria:

* Under guardianship or curatorship
* Pregnant or breastfeeding woman
* Lack of affiliation with a social security system
* Systemic treatment in progress or received less than 3 months ago.
Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC

This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.


Eligibility Criteria:
Inclusion Criteria

1. Age: Patients aged 18 years or older;
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
3. Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
4. first-line loelaninab treatment fom Apr2023-Apr-2027.
5. Evidenoe of popression to first-line lorlztinib within 2 weekes.

Exclusion Criteria

1. Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
2. Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.