cyrilzakka/clinical-trials huggingface dataset:
REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need.

The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before)

* Patients with prior treatment with BTKi (full patient population) - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION
* Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CLL or small lymphocytic leukemia (SLL).
* ≥ 18 years of age the time of initial diagnosis.
* Venetoclax therapy in at least third line of treatment (LOT) during the period considered, following at least one LOT with BTKi
* Patients who received VEN during prior LOTs are eligible.
* Patient not opposed to data collection (including deceased patients)

Exclusion Criteria:

* Exposure to cellular therapy, including CAR T-cells / Allo-Stem Cell Transplantation.
* Richter's transformation.
Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.

A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.

Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.

Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of knee with Kellgren/Lawrence grade II or III

Exclusion Criteria:

* Who have implant in knee
* History of neurological deficit, such as stroke
A Home-based Breathing Training on Menopausal Symptoms

This is a prospective, triple-blinded and randomized controlled trial examining the effects of a home-based breathing training assisted with biofeedback on menopausal symptoms and autonomic functions among community menopausal women. We also examines whether the changes in autonomic functions would be mediators between slow breathing and menopausal symptoms. This study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms. Participants will be randomly assigned to either an intervention group (n = 80) or a waiting-list control group (n = 80). The intervention group will undergo the home-based breathing training 20 minutes twice daily and participants in the control condition will participate the same breathing training after a four-week waiting list period. The primary outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV). Measurements will be taken at baseline, week 4, and week 8.

Ditto

Eligibility Criteria:
Inclusion Criteria:

* aged from 45 to 64, reporting cessation of menstrual cycles with natural causes ≧ 12 consecutive months
* the Greene Climacteric Scale (GCS) Chinese version scores ≧ 1

Exclusion Criteria:

* clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis or mental deficiency
* received hormone replacement therapy prescribed by gynecological physicians
* took cardiac medications which may affect the autonomic functions, ex., β-blockers, etc.
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.

The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated
* Must be between 18-65 years of age
* Women of childbearing potential should use effective contraceptive measures
* Adequate hematologic, renal, and hepatic functions
* Karnofsky performance status above or equal to 80

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with comorbid condition which renders patients at high risk of treatment complication
* Patients with metastatic disease to CNS
* Patients with significant cardiac abnormalities
* History of seizure disorder in the past 5 years
* Patient has received any packed red blood cell transfusion within 2 weeks before study entry
* Prior surgery or radiation therapy within 2 weeks of study entry
* History of prior chemotherapy for sarcomas
* Iron deficiency
* Hypersensitivity to E.coli derived products
Preoperative Evaluation on Perioperative Complications

Failure to properly manage the perioperative period of patients is associated with increased morbidity and mortality. Preoperative evaluation in patients planned for surgery contributes to reviewing possible perioperative risks, optimizing the patient's functional and physiological status, and reducing the possibility of perioperative complications. Assessments made during the preoperative evaluation process can be used to educate the patient, organize resources for perioperative care, and formulate plans for intraoperative care, postoperative recovery, and perioperative pain management. However, the effect of preoperative evaluation on patient outcomes has not been clearly demonstrated. In this study, the effect of preoperative anesthesia evaluation on perioperative complications was investigated.

Not managing patients well before, during, and after surgery can lead to more health problems and deaths. In wealthy countries, 3-16% of patients face major issues during this time, and 0.4-0.8% of them might end up permanently disabled or dead. Checking patients before surgery helps identify risks, improves their health and fitness, and lowers the chances of problems during this period.

On another note, even though the right surgeries can save lives and prevent injuries, the growing cost of healthcare is a big issue worldwide. In the United States, the rising cost is a concern for everyone, including insurance companies and drug makers. It's believed that treatments that don't really help could be causing about 30% of these high costs.

No matter the surgery, patient's health, or anesthesia plan, checking patients before surgery is key to safe anesthesia for people of all ages. A thorough check before surgery helps manage patient care during this period, prevents surgery cancellations due to patient issues, and helps keep the surgery schedule efficient and cost-effective.

There's no agreed-upon definition for checking patients before anesthesia in medical literature. This check involves looking at the patient's medical history, interviews, physical exams, and test results. Anesthesiologists might also talk to other healthcare workers for more information or help with anesthesia care during this period. The information gathered can help educate the patient, plan for care during and after surgery, and manage pain.

However, it's not clear how much these pre-surgery checks actually improve patient outcomes. A recent study found that seeing a doctor before surgery didn't reduce, but actually increased, the chances of problems after surgery. This study looks at how well pre-surgery anesthesia checks at our center help prevent problems during this period

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* ASA ≤ 3 patients
* Patients over 18 years of age

Exclusion Criteria:

* Emergency surgeries
* ASA \> 3 patients
* Pregnant women
* Age \> 80
* Age \< 18
Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients

The intent of this study was to examine the health status of individuals who had been confirmed with COVID-19 in the year after their recovery. Parameters studied included serum levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acid test, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), lung function test, imaging data and airway microbiota data. In addition, we explored the systematic Immune \& Inflammation in some of the individuals recovering from COVID-19.

About 20% of COVID-19 developed into a critical illness and about 2% died. The global epidemic continues to develop, but some patients in China have entered the rehabilitation period, which is accompanied by a large number of respiratory symptoms and pulmonary fibrosis, bringing serious harm to the country. Therefore, early accurate detection and prediction of the development trend of patients in rehabilitation period and targeted treatment measures for corresponding patients are the key to the success of COVID-19 rehabilitation period. It will play a key role in the stratified management of the post-epidemic situation, which is crucial to improve the quality of life of COVID-19 patients. We aim to explore the clinical characteristics of rehabilitation patients by detecting some indicators of patients in rehabilitation period, including serum IgG and IgM antibody of SARS-CoV 2, SARS-CoV-2 nucleic acid, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary function, chest CT imaging, systematic Immune \& Inflammation states.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with laboratory test for SRARS-COV2 turning negative, or healthy volunteers without COVID-19.
2. The age range is 18-80 years.
3. Subjects or their family members agree to participate in the study and sign informed consent.
4. The previously diagnosed individuals have been cured for about 1 month.

Exclusion Criteria:

1. Woman who is breastfeeding, pregnant, or preparing to become pregnant.
2. Patients with cognitive impairment or poor compliance as determined by the investigator.
3. Participants in other clinical trials.
4. Subjects who were not suitable for clinical trials determined by the investigator.
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.

Exclusion Criteria:

1. Patients who are planned to undergo different surgery along with myomectomy
2. Those with a diagnosis and suspicion of malignancy
3. Those with a history of thromboembolic disease
4. Those with cardiac, hepatic or renal disease
5. Those with a body mass index of 30 and above
6. Patients with abnormal coagulation test results
7. Patients using anticoagulants
8. Those who use drugs or diseases that may affect coagulation (serum creatinine \> 1.5 mg/dL)
9. Those allergic to tranexamic acid
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema

Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility Criteria:
Inclusion Criteria:

* FEV1 \< 50%, RV\>150%, TLC\>100%
* emphysema confirmed by computed tomography
* pO2 \>60 mmHg (with supplemental oxygen), pCO2 \< 55 mmHg (room condition)
* no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
* no COPD exacerbation within the past 8 weeks
* daily use of \< 20 mg Prednisolon
* non-smoking for a minimum of 4 months prior to consent
* Patient has provided written informed consent

Exclusion Criteria:

* BMI \< 18 kg/m²
* clinically relevant bronchiectasis
* failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
* Prior lung resection (e.g. lobectomy)
Ultrasound Method to Measure Fibrosis of the Liver in Children

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.

Specific Aims:

To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.


Eligibility Criteria:
Inclusion criteria:

* Patients scheduled for random liver biopsy for routine staging of liver fibrosis
* Pediatric patients patients (ages 1-21)
* Girls or boys
* Suspected liver disease
* Consent to participate in the study

Exclusion criteria:

* Pregnancy
* Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound
* Patients that do not consent to ultrasound guided liver biopsy.
* Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)
Thermotherapy in Acute Nonspecific Neck Pain

Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with nonspecific neck pain by a doctor,
* To be between the ages of 18-65,
* Neck pain lasting for less than 1 month
* No previous neck or shoulder surgery,
* No shoulder pain due to any cause,
* A tumour or inflammatory disease underlying the neck pain not to be found,
* A clinically underlying stenosis or discogenic problem not to be present.
* Negative results from the following clinical examination tests;

Spurling test, Lhermitte test, Cervical distraction test, Adson test,

Exclusion Criteria:

* Not meeting the inclusion criteria,
* Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
* Systemic rheumatological or metabolic diseases or cancer
* Refusal to participate in the study,
* Failure to complete treatment,
* Having any neurological problem
* Severe psychological illnesses
Intramuscular Hydroxyprogesterone Caproate and Placenta Previa

Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide.

Placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries.

Many studies in literature proved the positive correlation between the Placenta previa and preterm uterine contractility and also reported that large proportion of women who have Placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding.

There are many tocolytic agents may have a role in conservative management of Placenta previa such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus 54.9%).


Eligibility Criteria:
Inclusion Criteria:

1. Estimated gestational age is ranging between 24 weeks and 26 week's gestation
2. Singleton pregnancy.
3. Placenta previa; either major or minor degrees.
4. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
5. For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
6. Accepting to participate in the study.

Exclusion Criteria:

1. Definite rupture of membranes.
2. Established preterm labor.
3. Severe attack of bleeding requiring an immediate intervention.
4. Fetal heart rates instability or non reassuring
5. Intrauterine fetal death or major fetal anomalies.
6. If associated with abruptio placentae
7. Patients with known bleeding disorders or on anticoagulant therapy
8. Patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment ...etc
9. The presence of reported side effects in the mother from 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.