cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Eligibility Criteria:
Key Inclusion Criteria:

* Premenopausal woman at screening.
* Body Mass Index ≥ 18 kg/m2.
* Menstrual cycles ≥ 21 days and ≤ 40 days.
* Presence of uterine fibroids.
* Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

Key Exclusion Criteria:

* The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
* History of uterus surgery that would interfere with the study.
* The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
* Undiagnosed abnormal uterine bleeding.
* Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance

To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC subtypes to reveal the mechanisms of immunotherapy resistance of SCLC

This retrospective observational study examines the predictive value of transcriptome-based molecular subtyping of extensive stage SCLC for PD-1/PD-L1 inhibitor efficacy and explores immune microenvironment differences between subtypes to uncover immunotherapy resistance mechanisms. Patients with extensive stage SCLC receiving first-line standard treatment are enrolled, and baseline tumor tissue and peripheral blood samples are collected for transcriptome sequencing and immunohistochemistry (IHC). Based on results, patients are classified into four molecular subtypes, and treatment efficacy and safety are recorded. The study compares the efficacy between SCLC subtypes to determine if molecular typing predicts immunotherapy efficacy and investigates immune microenvironment differences between subtypes to uncover resistance mechanisms. Treatment regimens follow first-line extensive stage SCLC guidelines, including cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitors, with options determined by the supervising physician.

Eligibility Criteria:
Inclusion Criteria:

* The enrolled subjects shall meet all the following conditions at the same time.

  1. Male or female, aged 18 to 100 years
  2. Patients with untreated advanced small cell lung cancer clearly diagnosed by histopathology
  3. Be able to provide tumor biopsy tissue sample for molecular analysis
  4. Eastern Cooperative oncology Group (ECOG) score: 0\~2
  5. Expected survival of more than 3 months.
  6. Has at least 1 measurable or evaluable tumor lesion with a longest diameter ≥ 10 mm at baseline (in case of lymph nodes, a shortest diameter ≥ 15 mm is required) according to RECIST v1.1
  7. Received first-line chemotherapy or chemotherapy＋PD-(L)1 inhibitor and be able to provide complete treatment information and efficacy evaluation results.
  8. Voluntary signed informed consent and expected good compliance.

Exclusion Criteria:

* Those meeting any of the following conditions may not be included.

  1. Patient unable to tolerate chemotherapy.
  2. Patients unable to provide tumor tissue samples for testing
  3. Patients with other malignant tumors or a history of other malignant tumors
  4. Patients have any other reason to be unfit to participate in this study.
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.

To determine whether the use of anti-adhesion barrier after thyroid surgery can prevent the voice changes after surgery, using objective voice-related indicators.

* Randomized controlled study
* Including 40 patients in each arm
* Treatment: anti-adhesion barrier apply on the thyroidectomy space
* Control: No use of anti-adhesion barrier
* Primary outcome: VHI-30 (Voice handicap index)
* Secondary outcome: findings from stroboscopy, CSL (Computerize Speech Lab)
* Outcome measurement: preoperative, post-operative 3 months, post-operative 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open thyroidectomy for thyroid cancer
* Patients whose tumor size is less than 4cm
* Patients who are not suspected of surrounding organ involvement (T4) or metastasis to central lymph nodes in preoperative imaging
* Patients with no history of voice-related diseases prior to surgery
* Patients with normal movement of both vocal cords in the preoperative vocal cord examination
* Patients who consented to the study and obtained consent for the study

Exclusion Criteria:

* Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc.
* History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.)
* Medical history of drug or substance disorder (alcohol, etc.)
* Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.)
* Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past.
* Patients with a history of keloid or hypertrophic scars
* Patients planning to perform lateral cervical lymph node dissection
* Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment
* Pregnant or lactating female patients
* Other patients who are in charge of clinical trials as unsuitable for participation in the study
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers

The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.

Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life.

Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate care in concordance with their goals of care.

2. To assess whether having conversations as per this model will improve patient Quality of Life (QOL) as per a validated scale.

3. To assess in patients with concordant care whether this model will improve patient QOL as per a validated scale 4. To assess provider opinions about end-of-life conversations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
* Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
* Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
* Patients with metastatic pancreatic adenocarcinoma.
* Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
* Patients with metastatic cholangiocarcinoma whose tumor has progressed through first-line chemotherapy of any type.
* Patients with metastatic hepatocellular carcinoma whose tumor has progressed through PD1 blockade.
* Patients with metastatic high-grade neuroendocrine tumor.
* A patient with a metastatic GIST that has progressed through first-line tyrosine kinase inhibitor.
* Expected life expectancy of at least one month

Exclusion Criteria:

* Any patient not meeting the above criteria
* Non-English speaking patients
Psychoeducation Based on Acceptance and Commitment Therapy

The aim of this study is to manage individual psychoeducation in acceptance and commitment therapy for problems with panic disorder and to evaluate the effect of this program on rumination and self-resilience.

Panic disorder; palpitations, sweating, tachycardia, fear of death, depersonalization, derealization, fear of going crazy, etc. It is a psychiatric disorder with symptoms. The most commonly used psychotherapy method for panic disorder patients is cognitive behavioral therapies. Acceptance and Commitment Therapy is a psychotherapy method originating from cognitive behavioral therapy. Acceptance and Commitment Therapy helps individuals act in the direction of their values by allowing them to contact their painful experiences rather than trying to escape or try to get rid of their difficult experiences, thoughts, and feelings. Acceptance and Commitment Therapy supports psychological well-being by providing psychological flexibility in the person. Rumination is mental rumination, which is used to keep thoughts spinning in the mind repetitively after an event.Self-compassion is a concept used to mean understanding oneself despite one's mistakes. This study aims to create psychoeducation based on acceptance and commitment therapy for patients with panic disorder and to evaluate the effect of this program on rumination and self-compassion. Psychoeducation, an evidence-based practice, is very important for the nursing profession. Although nurses have a significant impact on psychoeducational practices, this role is ignored and not implemented adequately. In addition, since there is no research examining the concepts of rumination and self-compassion together in people with panic disorder, it is thought that our study will be useful in new research.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Panic Disorder followed in Muğla Training and
* Research Hospital Psychiatry Polyclinics,
* Those between the ages of 18-65 who agree to participate in the research,
* Those who were in a euthymic mood during the interview, according to physician control,
* Those who speak Turkish,
* Those who are literate,
* Those who have a computer and internet access for the program to be conducted online if deemed necessary during the research process,
* Not having undergone such training within the last year is within the scope of the inclusion criteria.

Exclusion Criteria:

* Having a diagnosis of a psychiatric disease in addition to panic disorder,
* Having an attack period during the training period,
* Individuals with cognitive (diagnosed by a physician) and physical disability (hearing, speaking, etc.) are included in the exclusion criteria from the study.
Dual Task Training for Balance in Older Adults

Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study was to compare the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. The participants were divided into two groups; who received mCdtt (Group 1) and who received mMdtt (Group 2). The intervention program had lasted for 8 weeks.

Dual task training (DTT) have been showed that have satisfying effects on older adults. The aim of this study is comparing the effect of motor-cognitive DTT (mCdtt) and motor-motor DTT (mMdtt) on balance, fear of falling, walking functionality and muscle strength in older adults. A total of 50 participants aged 60 and over (mean age: 67.72±7.33 years), having a score ≥ 24 on the Mini-Mental State Exam (MMSE), being in category of walking ability ≥ 4 according to the Functional Ambulation Category (FAC), having no problem in visual ability and hearing were included for this study. The participants who received mCdtt (Group 1) counted back from the two-digit number and the participants who received mMdtt (Group 2) held half-filled glasses with 90o flexion elbow with both hand while performing exercises. The intervention program had lasted for 8 weeks. To assess balance, fear of falling, walking functionality and muscle strength of participants, Berg Balance Scale (BBS), Falls Efficacy Scale International (FES-I), Timed Up and Go (TUG) and Hand-held dynamometer were used, respectively.

Eligibility Criteria:
Inclusion Criteria:

* (1) age over 60 years old
* (2) score ≥ 24 on the Mini-Mental State Exam
* (3) category of walking ability ≥ 4 according to the Functional Ambulation Category
* (4) no problem in visual ability and hearing

Exclusion Criteria:

* (1) a history of specific balance problems (i.e., diagnosed neurological, musculoskeletal or vestibular disorder)
* (2) history of cerebrovascular occasion
* (3) history of hip-knee surgery
* (4) use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines.
Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 70 years, female
2. Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
4. Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
5. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
6. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
7. The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
8. Adequate organ function;
9. Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
10. The patient voluntarily signs an informed consent form.

Exclusion Criteria:

1. Participated in other clinical trials within 4 weeks;
2. Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
3. During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
4. Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
5. Evidence of central nervous system metastasis or leptomeningeal disease;
6. Individuals with a known history of allergies to the components of this medication regimen;
7. Pregnant or lactating women;
8. Left ventricular ejection fraction\<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
9. The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.
Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients

It is well recognized that patients with chronic kidney disease (CKD) have an increased risk for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in patients with CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database and their relationship to CVD.

Ninety eight subjects were sampling from Thai SEEK study database Traditional Traditional risk factors of CVD such as total cholesterol, triglyceride, age, sex, history of smoking and blood pressure levels were examined and recorded. Stored sera of these subjects were analyzed for the total homocysteine (tHcy) level. Analysis of variance was used to evaluate the different of mean tHcy among groups

Eligibility Criteria:
Inclusion Criteria:

* CKD stages 3-4 from Thai SEEK Study

Exclusion Criteria:

* CKD stage 5
Long-term Efficacy and Safety Study With Oralgen Grass Pollen

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.

Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.

Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.

Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
* Patients who have given their written consent to participate in this study.
* Patients who are willing to comply with the protocol and understand the information given.
* Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
* Negative urine pregnancy test if female at the end of the previous study.

Exclusion Criteria:

* Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
* Patients who were non-compliant during study AB0602.
* Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.

The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF)
* SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding
* Body weight must be less than 90 kg
* At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing
* Body mass index (BMI) 18 to 27 kg/m2
* Adequate hepatic and renal function

Exclusion Criteria:

* History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
* History of alcohol or drug abuse (within previous year)
* Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
* Clinically significant laboratory abnormalities at the time of randomization
* Previous use of teduglutide (ALX-0600)
* Prior use of native GLP-2 within 3 months of screening visit
* Hospital admission within 1 month prior to screening visit
* Pregnant or lactating women
* Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results.
* Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases