cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241

The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects 30-65 years
* Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Previous history of frequent pre-syncope or syncope
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy

Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe lateral hip pain for greater than 3 months
* Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition
* Moderate to severe gluteus medius tendinosis with or without partial tear \<1 cm
* Normal neurologic exam except for hip abductor weakness on the affected side

Exclusion Criteria:

* Severe (Tonnis grade \>1) hip osteoarthritis with active synovitis or bone edema
* Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution
* No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI
* Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions
* Non-English speaking
Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness

Prolonged disorders of consciousness (pDoC) are pathologies in which there is a loss of consciousness for more than 28 days. The number of patients with pDoC is increasing as the level of critical care treatment and monitoring improves. However, clinical trials for patients with pDoC are limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use. In recent years, ketamine has been used with remarkable success in the treatment of neuropsychiatric disorders by inducing neuroplasticity, increasing neurophysiologic complexity, and expanding functional brain connectivity states. Considering increased brain plasticity as well as brain complexity, it may be beneficial for consciousness recovery. In this study, the investigators aimed to explore the effects of esketamine on brain networks and level of consciousness in patients with pDoC, and to discuss its possible use as a wakefulness-promoting treatment for patients with pDoC.


Eligibility Criteria:
Patients with prolonged disorders of consciousness:

Inclusion Criteria:

* Age 18 - 65 years old, native Chinese speaker, dextromanual;
* Chronic disorder of consciousness;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.

Exclusion Criteria:

* Continuous sedation was administered within 72 hours prior to the study;
* Open head injury, parenchymal resection and other damage of brain structural integrity;
* The intracranial compliance decreased due to hydrocephalus and swelling;
* Known hearing impairment;
* Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
* Known or suspected severe cardiac, pulmonary, hepatic, and renal dysfunction;
* History of drug allergy to esketamine;
* Associated with other mental or neurological diseases;
* Other reasons are not suitable to participate in this study.

Healthy brain volunteers:

Inclusion Criteria:

* Age 18 - 65 years old;
* Patients undergoing surgical treatment under elective general anaesthesia;
* American Society of Anesthesiologists (ASA) I-II;
* Native Chinese speaker;
* Dextromanual;
* Signed informed consent.

Exclusion Criteria:

* Previous history of craniocerebral disease, imaging suggests organic brain lesions;
* People with uncontrolled hypertension, hyperthyroidism, elevated intracranial pressure, epileptic seizures;
* History of drug allergy to esketamine;
* Hearing abnormality;
* History of drug and alcohol abuse;
* People with mental and behavioral disorders.
Smoking Cessation Program: A Quality Improvement Trial in a Resident-Based Outpatient Clinic

The researchers hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic.

We hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic. This will be an observational study in which differences in quality measures will be compared between baseline and re-measurement periods. Population target: 900 patients screened before and after the implementation of the QI intervention. Primary outcome: smoking status evaluation. Secondary Outcome: number of patients advised to quit, plan implementation for smoking cessation, smoking cessation program referrals, number of NRT and bupropion prescription.

Eligibility Criteria:
Inclusion Criteria:

* 21 years or older
* Seen at MMH family health center
* Current smoker
Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: a Prospective Observational Study

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Primary Objectives:

The objective of this study is to evaluate the protective benefit to performing LVB surgery at the time of ILND. In the secondary objective, we will compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

Eligibility Criteria:
Eligibility Criteria:

1. Patients greater than or equal to 18 years of age.
2. Patients willing to participate.
3. Patients able to complete informed consent.
4. Patients undergoing ILND.

Exclusion Criteria:

1. Patients taking anticoagulants within 7 days prior to surgery.
2. Patients that are known to be pregnant at the time of surgery.
3. Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
4. Patients with BMI greater than 50.0.
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer

This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.

This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab plus Pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks. The primary endpoints was pathological complete response.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 75 Years
* Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC 7.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Primary tumor must have positive estrogen receptor (ER) ≥10%
* Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification)
* Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan
* Normal organ and marrow function
* Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
* Baseline corrected QT interval (QTcF) \< 480 ms
* All patients must be female.

Exclusion Criteria:

* Inflammatory breast cancer
* Evidence of bilateral invasive breast cancer or metastatic disease
* Received any prior treatment for primary invasive breast cancer
* Pregnant or lactating women
* Abnormal baseline hematological values:
* Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio)
* Subjects with known infection with HIV, HBV, HCV
* Other investigational drugs while on study
* Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment

The objective of the study is to evaluate:

1. Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity.
2. Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.

Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.

Eligibility Criteria:
Inclusion Criteria:

One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)

Exclusion Criteria

1. simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)
2. Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
3. Combined with other eye diseases that affect vision prognosis.
4. History of other eye surgeries including cataract surgery.
5. Presence of systemic diseases that may affect postoperative observation and follow-up.
Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center

Exclusion Criteria:

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease
Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of "exposure" and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level \> 10 ppm). 72 patients in each group will be included in 2 majors sites.

The cognitive behavioural approach group : This group will receive an inclusion visit at first, then two "cigaret exposures cessions" during hospitalisation. Thereafter-one week after he's out- the patient will come for 5 follow up visits consisting in the specific technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six months, will tell us if the patient is an effective non smoker or not; We'll be also collecting psychological and medical informations (such as the treatment, IMC, cardiovascular check up and psychological tests). The control group : This group is managed as "usual" : the nurse gives very rapid recommendations to the patients concerning smoking cessation. Nicotinic substitutes are proposed to the patients but the patient must find them by itself.

Eligibility Criteria:
Inclusion Criteria:

* Patients are men and women of less than 70 years old
* Hospitalised for acute coronary syndrome in cardiology Intensive Care Unit
* Active smoking \>5 cigarettes/day
* Has given consent to participate in the study and haven't expressed its opposition the exploitation of data as part of the study

Exclusion Criteria:

* Presence of another dependence : alcohol abuse avowed or strongly suspected, addiction to drugs, high dose benzodiazepine dependence. clinical assessment
* Major psychiatric disorders or history. clinical assessment
* Treatment with lithium and neuroleptic. clinical assessment
* Patient whose cardiac problem could lead to hemodynamic instability during 48 h after admission.
* Patient scheduled for programmed hospitalisation within 6 months after release from hospital (\>3 days long, including coronary bypass)
* Patients presenting another severe pathology requiring 6 months specific treatments. clinical assessment
* Patient which cannot understand or read French
* Patient with possible side-effect to nicotine substitute
* Patient unaffiliated to any social security regime
Impact of Physical Exercise on Lymphedema Related to Breast Cancer: Assessment Using Thermography

Study Type: Clinical Trial

Primary Purpose: To determine whether physical exercise improves or prevents lymphedema in breast cancer patients.

Description of the Participant Population/Main Condition: The study is aimed at women who have been diagnosed with breast cancer and have experienced post-treatment lymphedema or are at risk of developing it. The target population includes adults aged 18 to 70 who have been diagnosed with this condition following their breast cancer treatment.

Main Research Questions:

Does physical exercise improve or prevent lymphedema in women with breast cancer? What are the effects of physical exercise on the reduction of arm volume affected by lymphedema? What are the effects of physical exercise on the reduction of perceived disability in the arm affected by lymphedema?

Hypothesis:

Physical exercise intervention significantly reduces lymphedema symptoms, such as arm volume. Physical exercise prevents the progression of lymphedema in women with breast cancer.

Comparison Group: Researchers will compare results between the experimental group (which will undergo physical exercise) and the control group (which will receive no intervention) to determine if physical exercise has a significant impact on the improvement or prevention of lymphedema.

Participant Tasks:

The experimental group will follow a supervised physical exercise program for a specific period. The control group will receive no intervention and will be monitored with standard follow-up care without exercise. Participants will be evaluated before and after the study period to measure the progression of lymphedema, including arm volume measurement and surface skin temperature using thermography.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old diagnosed with breast cancer.
* Residing in the province of León.
* Not currently undergoing any physical exercise intervention at the time of the study.
* Not participating in lifestyle modification programs at the time of the study.
* Not presenting any relative or absolute sequelae from chemotherapy treatment that would pose a relative or absolute contraindication to their participation in this intervention (e.g., cardiological sequelae).
* Having signed the informed consent to participate in the study.

Exclusion Criteria:

* Presenting physical and/or psychological limitations that would hinder understanding or the ability to carry out the established intervention program.
* Presenting an infection in the upper limbs or lymphangitis.
* Fluid accumulation in the breast area requiring drainage at the time of the intervention.
* Not having signed the informed consent to participate in the study
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:

  * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)
  * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
  * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
* Prior Systemic Therapy Criteria:

  * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
  * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
* Measurability of disease

  * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
  * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Participants with known loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
* Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
* Participants with history of increased risk of prolonged QT or significant arrythmia
* Significant cardiovascular disease
* Participants with active or recently treated (within 2 years) second primary malignancy and/or treated for an additional malignancy within 2 years prior to enrolment
* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention