cyrilzakka/clinical-trials huggingface dataset:
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC

This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
* No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* At least one measurable lesion per RECIST v1.1
* ECOG Performance Status of 0 or 1
* Child-Pugh class of A5 to B7
* Adequate organ function

Exclusion Criteria:

* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
* History of hepatic encephalopathy
* Previous or current presence of metastasis to central nervous system
Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains

The purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle sprains

Supervised proprioceptive training has been recommended by recently published guidelines for the rehabilitation of ankle sprains. However, research evidence on the efficacy of this type of training is still weak, mainly owing to the methodological limitations of relevant studies. In addition, there is paucity of evidence concerning the effects of such training for the outcomes of functional performance, pain, ankle range of motion, and contradictory results have been reported for postural control.

This study aimed to substantiate the benefits of supervised training for the rehabilitation of ankle sprains, and elucidate the effects of two different proprioceptive protocols on the above-mentioned outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, Grade I-II

Exclusion Criteria:

* Individuals with lateral ankle sprains Grade III
* Individuals with ankle sprain to the medial ligaments
* Individuals with ankle sprain to the interosseous (syndesmotic) ligament
* Individuals with concurrent fracture
* Individuals with chronic ankle instability
* Individuals with history of surgery to the ankles
* Individuals with history of lower limb nerve injuries
* Individuals with history of further ankle injuries, after the sprain
* Individuals with any injuries that hindered training participation
The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: a Randomized Controlled Clinical Study

A variety of analgesic strategies are available following mixed hemorrhoids surgery, including pharmacological interventions (7), acupuncture, moxibustion, and electroacupuncture . Medications such as opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used but can be associated with side effects including nausea, vomiting, and gastrointestinal bleeding, with long-term use potentially leading to addiction (8). Complementary therapies require skilled administration and regular treatment sessions.

Methylene blue (MB), a cationic thiazine dye extensively utilized as a biological stain and chemical indicator, has been increasingly recognized for its potential analgesic properties (9). In the present study, methylene blue infiltrating injection (MBI) was administered to treat anal pain resulting from Milligan-Morgan surgery, with the aim of assessing its analgesic efficacy and safety profile.


Eligibility Criteria:
Inclusion Criteria:①Alignment with the diagnostic criteria for mixed hemorrhoids as outlined in the "American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids" ; ②Provision of informed consent following a thorough comprehension of the study's aims; ③An age bracket of 18 to 75 years; ④Satisfaction of surgical indications.

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Exclusion Criteria:①Presence of anal fistula, anal fissure, perianal abscess, enteritis, or other intestinal pathologies; ②Patients with known allergies; ③Impaired liver or kidney function; ④Pregnancy or lactation.

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Ketamine Safety and Tolerability in Psychiatric Inpatient Care (KetGD)

This observational registry aims to collect real-world data on ketamine use in psychiatric inpatients within a regional tertiary-reference center. The study evaluates the safety and tolerability of ketamine administration in individuals with treatment-resistant mental disorders, characterized by diverse comorbidities, heterogeneous disease courses, and variations in treatment responses based on illness stage and severity with a subset of patients with remitted-recurrent and treatment-resistant or chronic presentations.

The registry is designed to systematically document adverse events, side effects, and patient-reported outcomes, providing a comprehensive assessment of both the short- and long-term effects of ketamine in psychopharmacology. By generating real-world evidence, this study shall contribute to a more nuanced understanding of ketamine's risk-benefit profile in clinical practice, particularly in subpopulations that are underrepresented in clinical trials. The findings prioritize the support for the refinement of treatment protocols and enhance patient safety in psychiatric care.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis as provided by DSM-5 criteria:

* Major depressive disorder (MDD),
* Bipolar disorder (BD),
* Anxiety disorder,
* Obsessive-compulsive disorder (OCD),
* Somatoform disorder,
* Post-traumatic stress disorder (PTSD),
* Dissociative disorder

Exclusion Criteria:

* Pregnancy and lactation
* Hypersensitivity to ketamine
* Uncontrolled hypertension
* Other uncontrolled somatic diseases that may impact safety per the investigator's judgment
Nicotine's Effect on Cancer Stem Cell Markers in Human Umbilical Cord Tissue

The umbilical cord is generally an organ that clinicians and pathologists do not pay sufficient attention to. The absence of significant pathology in the umbilical cords, along with the lack of association between certain placental pathologies and perinatal mortality and morbidity, have led both clinicians and pathologists to inadequately evaluate the placenta and umbilical cord. In our study, İnvestigators aimed to perform immunohistochemical and biochemical analysis by comparing two groups, one consisting of women who smoked throughout their pregnancy and the other of those who never smoked, including different markers in accordance with the literature.

Method: The pregnant women included in the study were categorized according to their smoking status as follows:

Group I: Non-smokers (smoking -) Group II: Smokers (smoking +) during pre-pregnancy and throughout the pregnancy In this study, 40 pregnant women who smoked during their pregnancy (between 37 and 42 weeks of gestation) and 37 age- and parity-matched healthy non-smoking pregnant women with full-term births between 37 and 42 weeks of gestation were selected as the control group. Umbilical cord samples (2 ml of blood and a 5 cm tissue sample) were collected from both groups without delay and fixed in 10% formalin. The tissue samples were processed for histological analysis with routine hematoxylin and eosin (H\&E) staining following fixation in 10% formalin solution and routine paraffin embedding.

İnvestigators aimed to examine the presence of oncological factors such as CD44, CD34, CD90, and ALDH molecules in the umbilical cord tissue of smokers during pregnancy through immunohistochemistry, and to explore the biochemical relationship of these molecules with their counterparts, CD34, CD44, CD90, and ALDH, found in the umbilical cord blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnancy under 37 weeks
* Age range 18-50
* Being literate in Turkish
* Not having any additional disease
* Agreeing to participate in the study

Exclusion Criteria:

* High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
* Multiple pregnancy
* Pregnant women under the age of 18
* Smoking
* Medication use (excluding routinely used food supplements during pregnancy)
* Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
* Immunosuppressive use
* Presence of active or chronic infection
* Presence of active or chronic inflammatory disease
* Patients who gave birth at an external center or later chose to withdraw from the study
* Patients who did not have any exclusion criteria at the time of smokers or when blood was drawn for the control group, but who later developed any exclusion criteria.
* Premature birth of patients included in the control group
IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Large Lung Tumors

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with ablation therapy in treating patients with non-small cell lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave ablation kills tumor cells by heating them to several degrees above normal body temperature. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving ablation therapy together with stereotactic body radiation therapy may kill more tumor cells.

This is a dose-escalation study of stereotactic body radiation therapy.

Patients undergo stereotactic body radiation therapy once daily (QD) for a total of 5 fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1 week later.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Pathological (histologically or cytologically) diagnosis of non-small cell lung cancer (NSCLC); or if lung tumor is considered to be metastases (even from primary NSCLC), then clinical diagnosis is sufficient
* For NSCLC: Staging workup at initial diagnosis demonstrates T2-T4N0M0, or T2-T4,N1-3,M1; node-positive patients will be allowed on study only if they have M1 disease; clinical diagnosis of M1 disease is sufficient
* Patient is deemed (a) to be medically inoperable after evaluation by thoracic surgeon based on, but not limited to the following: baseline forced expiratory volume in one second (FEV1) \< 40% predicted, post-operative FEV1 \< 30% predicted, severely reduced diffusion capacity, baseline hypoxemia/hypercapnia, coronary artery disease, end-organ damage, or (b): patient has refused surgery after thoracic surgery consultation
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* NSCLC only: pleural effusion, if present, will undergo routine assessment for malignancy; inability to obtain fluid or non-diagnostic cytology will not preclude eligibility
* Negative serum or urine pregnancy test within 4 weeks prior to registration in women with childbearing potential
* Able to provide written, informed consent
* Minimum of 4 weeks from last dose of chemotherapy to start of treatment

Exclusion Criteria:

* For NSCLC only: prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 2 years, including previous history of lung cancer
* Prior radiation to the region of current cancer that would result in \> 50% overlap of the old treatment field on the new treatment area based on radiation oncologist evaluation
* International normalization ratio (INR) of \> 1.5
* Platelets of \< 50,000 /uL
* Inability to meet maximum point dose constraints
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants

The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol \[EE\] and norethindrone \[NET\]) in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
* Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m\^2), inclusive, at screening.
* Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.

Exclusion Criteria:

* Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
* History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
* Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.

Note: Other protocol-defined inclusion/exclusion criteria apply.
China Lymphoma Patient Registry Study

Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.

Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.

Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.

Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* The disease was diagnosed by Hodgkin's or non Hodgkin's lymphoma
* 18 years of age or older at diagnosis
* The diagnosis was confirmed within 6 months before admission
* Informed consent was obtained

Exclusion Criteria:

* There are no special exclusion criteria in this study
Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)

This project concerns a population at risk of sudden death by dissection of the thoracic aorta. Its interest is to make it possible to recognize the genes that protect or worsen the evolution of aneurysms, to better understand the mechanisms involved, to detect and treat aneurysms of the thoracic aorta, wich is a pathology that is completely silent clinically until life-threatening complications.

The variability in the severity of the disease within the same family is related to modifier genes.

The objective is to find the modifying factors that account for the variability in the severity of the progression of aneurysms of the thoracic aorta.

Thoracic aortic aneurysms are silent, asymptomatic, potentially fatal pathologies due to the risk of aortic dissection. More and more often they are found during imaging tests done for another reason. Some aneurysms have genetic origin (autosomal dominantly inherited) and are particularly interesting because they can be recognized early (due to possible family screening), which allows us to understand the natural history of this pathology. The discovery of genes whose mutations explain the occurrence of these family aneurysms (initiator gene) has also made it possible to improve family screening and to better understand the pathophysiology of these aneurysms: we now recognize 3 groups of genes involved (extracellular matrix, contractile proteins of smooth muscle cell, TGF-β pathway (Transforming Growth Factor) \[including mutations in TGF-β receptor 2 gene, TGFBR2\]).

The variability in the severity of signs and aortic involvement is particularly marked in patients with aortic aneurysms due to mutations in the TGFBR2 gene. Some patients with these mutations present aggressive aneurysms with early dissection. Other patients have isolated late-onset aneurysms, and others have no signs.

This variability generates problems for clinical practice to give appropriate genetic advice, but also to adapt imaging monitoring, therapy, or sports restriction.

The present protocol aims is to investigate the variability in the severity of the disease within a large family carrying a mutation in the TGFBR2 gene. The MFS1 family is a family in which the aortic pathology is due to a mutation in the TGFBR2 gene. All patients with this family carry the same TGFBR2 mutation, heterozygous.

Eligibility Criteria:
Inclusion Criteria:

Member of MSF1 family. The MFS1 family is a family in which the aortic pathology is due to a mutation in the TGFBR2 gene. All patients with this family carry the same TGFBR2 mutation (heterozygous)

Exclusion Criteria:

Refusal or linguistic or psychological inability to sign informed consent
Classification-Directed Treatment of Low Back Pain

The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.


Eligibility Criteria:
Inclusion Criteria:

* People who report a history of chronic LBP for a minimum of 12 months,currently are experiencing LBP symptoms but not in an acute recurrence,
* Between 18 and 60 years of age,
* Able to stand and walk without assistance,
* Able to understand and read English,
* Able to understand and sign a consent form

Exclusion Criteria:

* Any structural spinal deformity including scoliosis, kyphosis, or stenosis,
* A spinal fracture or dislocation,
* Osteoporosis,
* Ankylosing spondylitis,
* Rheumatoid arthritis,
* Disc herniation,
* Serious spinal complications such as tumor or infection,
* Previous spinal surgery,
* Frank neurological loss, i.e., weakness and sensory loss,
* Pain or paresthesia below the knee,
* Etiology of LBP other than the lumbar spine, e.g., hip joint,
* History of neurologic disease which required hospitalization,
* Active treatment for cancer,
* History of unresolved cancer,
* Pregnancy,
* Magnified symptom behavior,
* Worker's compensation or disability case,
* In litigation for the LBP problem,
* Referral from a specialized pain clinic source,
* Spondylolisthesis