cyrilzakka/clinical-trials huggingface dataset:
Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain

The purpose of this study is to know which combination of treatments are the most effective in patients with non-specific neck pain. Study design: This is a single-blind randomized controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a period of 4 weeks (8 sessions total; 2 per week).

Nonspecific chronic neck pain has a high prevalence and is very common in clinical practice.

Manual therapy (MT) studies of techniques like mobilization, manipulation, and therapeutic exercise, has been demonstrated effectiveness for the treatment of pain and disability in the neck. These investigations have thought of this treatments as individual interventions. Thus, multimodal ways of treatment to improve patients with nonspecific chronic neck pain are necessary.

The aim of this study is to evaluate the effectiveness of a multimodal treatment protocol compared to a unimodal treatment protocol in the medium-term, on patients with chronic non-specific neck pain.

Subjects are randomly allocated into three groups: MT group; MT+Educational therapy (ET) group; and MT+ET+Exercise group. Each subject receive a 4 weeks period treatment (8 sessions). Outcome measures include physical, somatosensory, and psychosocial characteristics; which are measure at 0, 4, 8, 16 weeks by a blinded assessor.

Eligibility Criteria:
Inclusion Criteria:

* The subjects for the study were selected if they fulfilled the following inclusion criteria: Aged between 18 to 60 years old, head and/or neck pain for at least 12 weeks and having the willing to undergo the treatment.

Exclusion Criteria:

* if they had appearance of "red flags", rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.
Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
* In British Columbia and Nova Scotia, subjects must be = 19 years.
A Study to Evaluate How a Drug That Alters Liver Enzymes (Rifampin) Affects the Metabolism of Enzalutamide in Men

This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in plasma.

The study consists of 2 randomized treatment arms. In both arms the subjects receive a single oral dose of enzalutamide.

In Arm 1 the subjects are admitted to the clinic on Day -1 where they remain until Day 3. Each subject receives a single oral dose of enzalutamide, administered under fasted conditions on Day 1. Ambulant visits take place from Day 4 to Day 50. Full PK profiles are obtained for enzalutamide, Major Inactive Carboxylic Acid Metabolite (M1) and Active Metabolite N-desmethyl Enzalutamide (M2) from Day 1 up to Day 50 after intake of enzalutamide.

In Arm 2 each subject receives a once-daily dose of rifampin on Days 1 to 21. On Day 8, a single oral dose of enzalutamide is administered under fasted conditions concomitantly with rifampin. Full PK profiles are obtained for enzalutamide, M1 and M2 from Day 8 up to Day 57 after intake of enzalutamide.

An End of Study Visit (ESV) takes place between 7 and 10 days after the last PK sample or early withdrawal.

Safety assessments are performed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a Body Mass Index (BMI) of at least 18.5 and no greater than 29.9 kg/m2 at screening.
* Subject must use a condom when having sex with a pregnant woman.
* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control.
* Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria:

* Subject has a confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
* Subject has a history of seizure or any condition that may predispose to seizure. Historically or currently on any convulsive medication or drugs that may lower the seizure threshold. History of any central nervous system (CNS) infections. Also history of transient ischemic attack or cerebrovascular accident with or without head trauma within 12 months of enrollment (Day -1 visit).
* Subject has any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX0902 in combination with adagrasib.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test:

  1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
  2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
* Unresectable or metastatic disease
* No available treatment with curative intent; standard treatment is not available or patient declines
* Presence of tumor lesions to be evaluated per RECIST 1.1:

  1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
  2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease
* Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Active brain metastases or carcinomatous meningitis
* Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only)
* History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
* Major surgery within 4 weeks of first dose of study treatment
* History of pneumonitis or interstitial lung disease
* Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors
* Cardiac abnormalities
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications
Epicardial Fat, Visceral Fat and Coronary Atherosclerosis

Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.

Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear. Aim: Evaluate the link between epicardial fat, visceral fat, liver fat accumulation and cardiovascular diseases and carotis atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to cardiac CT will be the source of recruitment.
* patients with excess of visceral fat,
* 30 patients with liver fat accumulation
* 30 sex-age-matched individual (controls) will be enrolled. All patients will undergo a complete family history, personal clinical history, physical examination and blood sampling for biochemical analysis.
* Informed consent will be obtained from each individual.

Exclusion Criteria:

* subjects with severe morbid obesity (body mass index \[BMI\] \> 40),
* recent history of acute illness,
* clinical history of ischemic heart disease and cerebrovascular disease,
* typical chest pain,
* previous coronary artery disease,
* conventional coronary angiography, percutaneous interventions, coronary by pass grafting, renal failure, cancer patients,
* subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others)
The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China.

The asthma control rate achieved by budesonide/formoterol in clinical practice in China.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of asthma at least 6 months;
2. Prescribed with budesonide/formoterol treatment at least 3 months before enrolled;
3. Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled.

Exclusion Criteria:

1. Participation in any clinical study within 3 months;
2. Have COPD history/suspicious COPD;
3. ≥ 10 pack years of smoking history
4. Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled
5. With asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral GCS medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled
Comparison of Aqueous Humor Adipokines in Glaucoma Patients and Healthy Controls

The purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (POAG) and healthy controls

1. Inclusion criteria: Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).

2. Exclusion criteria:

1. Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
2. Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
3. History of Ocular Trauma or Inflammation
4. Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
5. Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
6. Presence of any retinal or optic nerve disease other than glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).

Exclusion Criteria:

* Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
* Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
* History of Ocular Trauma or Inflammation
* Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
* Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
* Presence of any retinal or optic nerve disease other than glaucoma.
Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.

The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (\<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.

Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

Eligibility Criteria:
Inclusion Criteria:

* Be pregnant or in the first 1 month postpartum
* Be 18 years or older
* Have quit smoking cigarettes during or before this pregnancy
* Be willing to receive infant care and breastfeeding education
* Be able to read, listen, and talk in English

Exclusion Criteria:

* Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
* Current heavy drinking (more than 2 drinks a day)
* Current use of illicit substances
* Being strongly against breastfeeding
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis

Finding out how fast azelastine nasal spray works in subjects with hay fever.


Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
* Positive response to skin prick test to ragweed allergen at screening;
* Be willing to participate in the trial.

Exclusion Criteria:

* History of hypersensitivity to azelastine;
* Females who are pregnant or lactating;
* Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
* Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
* Known non-responsiveness to antihistamines;
* Alcoholism or drug abuse within 2 yrs. of screening;
* Current or regular use within 6 months of any type of tobacco product;
* Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
* History of a positive test to HIV, TB, hepatitis B or C.
Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

To evaluate the efficacy and safety of low-dose decitabine combined with tirelizumab in the treatment of patients with advanced esophageal squamous cell carcinoma who did not progress in first-line immunotherapy combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Subjects voluntarily participate and sign written informed consent; Age ≥18 years; Confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; At least one measurable lesion according to AJCC 8th staging and RECIST 1.1 solid tumor evaluation criteria.

Those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g., paclitaxel + cisplatin) in the first line, and the disease has not progressed;

Good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart disease, that is, the relevant indicators within 14 days before treatment meet the following requirements:

* ANC≥1.2×109/L and lymphocyte count ≥0.5×109/L without the support of granulocyte colony stimulating factor;
* Without blood transfusion, patients with platelet count ≥100×109/L and hemoglobin ≥90g/L can meet the criteria through blood transfusion;
* AST, ALT and ALP≤2.5× upper limit of normal (ULN), total bile red ≤1.5×ULN, except the following conditions: for known Gilbert patients: total bilirubin ≤3×ULN, creatinine ≤1.5×ULN, albumin ≥25g/L;
* For patients not receiving anticoagulant therapy: INR and aPTT≤1.5×ULN. estimated survival ≥3 months; Score of ECOG physical strength: 0\~1; The ability of patients to follow the study protocol according to the judgment of the investigator.

Exclusion Criteria:

Previous immunotherapy; no measurable lesions; There are small cell carcinoma, adenocarcinoma or mixed carcinoma components in the histology; Complete esophageal obstruction; Any NCI CTCAE≥ Grade 2 toxicity that has not recovered after previous chemotherapy; High risk of esophageal fistula was found through clinical evaluation or imaging examination, such as history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; had positive detection for EB virus (EBV) capsid antigen IgM during screening (PCR method); If a patient requires analgesic treatment, the treatment regimen used at the time of enrollment must be stable; The men who have HIV positive results at the time of screening; people who test positive for hepatitis C virus (HCV) during sieving; HBV positive screening, and cccDNA≥500 IU/mL; Any of the following diseases in the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident; Pregnant or lactating women or fertile but did not take contraceptive measures; suffer any other serious physical or mental problem of an acute or chronic nature; judging by the researchers, that doesn't fit to participate in the study.

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Survey to Identify Burdens and Unmet Needs of Patients With Epidermolysis Bullosa

This survey intends to collect information on key aspects of life with epidermolysis bullosa (EB), including diagnostic journey, treatment, management, daily living challenges, and overall psycho-social, socio-economic, academic and family impact.

Objectives:

* To understand the unmet needs for people living with EB in the US
* To assess the differences/similarities in the management/treatment of EB patients (including wound care, symptom management and other issues)
* To assess the EB patients' and caregivers' perceptions of current management/treatment
* To assess the challenges and the burden of daily living with EB
* To understand EB diagnostic journey (the time to diagnosis and by what type of healthcare provider)
* To identify professional disciplines involved in the diagnosis and management of EB
* To understand the psycho-social, socio-economic, academic, and family impact of EB

Epidermolysis bullosa (EB) is a rare, often severe genetic disorder characterized by mechanical fragility and blistering or erosion of the skin, mucosa, or epithelial lining of other organs, in response to little or no apparent trauma.

EB is chronic, potentially disfiguring, and in some cases fatal. Patients with EB have painful wounds and blisters that can lead to infection and scarring. There are many genetic and symptomatic variations of EB, but all forms share the common symptom of fragile skin that blisters and tears, sometimes from the slightest friction or trauma. There is currently no approved treatment for EB. Current standard of care consists of pain management and the bandaging and cleaning of open wounds to prevent infection.

While there are a number of publications/guidance/consensus statements related to the diagnosis and management of EB from the point of view of the health-care provider/disease expert, there is a need for more research to define the key aspects of life with EB (i.e. diagnostic journey, treatment, management, daily living challenges, and overall disease burden) from the perspective of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of EB including subtype
* Resident of the US
* Informed Consent
* Patient must be 18 years or older
* If the survey is done by a caregiver, they must be a parent or legal guardian and must be 18 years or older to answer on behalf of a patient under 18 years or on behalf of a patient 18 years or older who is unable to answer for themselves.
* Must participate in and complete a one hour telephone interview

Exclusion Criteria:

* Patient failing to meet the inclusion criteria above