cyrilzakka/clinical-trials huggingface dataset:
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)

The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are administered sarecycline (Seysara®) in real-world community practice settings in the United States (U.S). Investigator's Global Assessment (IGA) of AV and safety measures associated with use of sarecycline (Seysara®) will be assessed over the study observation period of 12 weeks. Clinicians will prescribe sarecycline (Seyara®) as per their own clinical judgment and standard practice.


Eligibility Criteria:
Inclusion Criteria:

Patient Inclusion Criteria:

* Male or female, aged 9 years and above
* Has facial non-nodular AV with IGA score of moderate or severe
* Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment

Caregiver Inclusion Criteria:

* Primary caregiver of the study-eligible patient
* Male or female, aged 18 years and above

Exclusion Criteria:

* Patients with any known resistance to other tetracyclines
* Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
* Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
* Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study

Other protocol defined Inclusion/Exclusion criteria may apply
Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial

Many patients with cervical disc disease have long-lasting and complex symptoms with chronic pain, low levels of physical and psychological function and sick-leave. Surgery on a few segmental levels might be expected to solve the disc-specific pain but not the non-specific neck pain and the patients'illness. As much as 2/3 of the patients have been reported to have remaining physical/ psychological disability long-term after surgery. A structured physiotherapy programme after surgery may improve patients'function and return to work. The main purpose of the study is to evaluate what a well structured rehabilitation program adds to the customary treatment after surgery for radiculopathy due to cervical disc disease in respect to function, disability, workability and cost effectiveness. The study is a prospective randomised controlled multi-centre study, with an independent and blinded investigator comparing two alternatives of rehabilitation. 200 patients in working age, with cervical disc disease with clinical findings and symptoms of cervical nerve root compression will be included after informed consent. After inclusion in the study patients will be randomised to one out of the two alternatives of physiotherapy, (A) customary treatment (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised and structured program of neck specific exercises combined with a behavioural approach plus customary treatment. Patients will be evaluated both clinically and with questionnaires before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main outcome variable are neck specific disability. Cost-effectiveness will be calculated. The inclusion will preliminary be closed 2012. The study could contribute to a better clinical decision making, a better health care which will reduce physical, mental and social costs for the patients, and improve the rates of patients returning to and staying at work.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included from four Neurosurgical clinics in the south of Sweden and the rehabilitation will be performed in primary care units in several counties.
* Patients in working age, with MRI-verified cervical disc disease with clinical findings and symptoms of cervical nerve root compression and who have had surgery with anterior decompression and fusion or posterior surgery (foraminotomy/ laminectomy) will be included after informed consent.

Exclusion Criteria:

* Patients with myelopathy or with a disease or trauma contraindicated to perform the treatment program or the measurements will be excluded and so also patients with lack of familiarity of the Swedish language or with known drug abuse.
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).


Eligibility Criteria:
Inclusion Criteria:

* The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (\>=) 80 percent (%) at baseline
* Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention
* A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* The study participant has a total score of JDA severity index for GPP \>=14 at baseline if participants have a diagnosis of GPP
* The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP
* The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* The study participant has a history of amyloidosis
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
* The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections
Comparison of Intubation Duration Between Rapid Sequence Intubation (RSI) Technique and Non-RSI Technique

The purpose of this study is to evaluate intubation duration between rapid sequence intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed by emergency medicine residents in Siriraj hospital.

A prospective cohort study was conducted in the non-traumatic emergency department (ED).

Eligibility Criteria:
Inclusion Criteria:

* patients required airway control by tracheal intubation

Exclusion Criteria:

* cardiac arrest
Proactive Outreach With FIT

The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Men and women aged 45-75
* Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites.
* Due or overdue for CRC screening.
* Medical visit of any type at clinic in past year.

Providers

* Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees)
* Provide care to CRC screen-eligible patients

Exclusion Criteria:

* Age younger than 45 years old or greater than 75 years old
* Up-to-date with colorectal cancer screening:
* History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy
* In hospice care
* Patients 66 years or older living long-term in an institution or with advanced illness
* No address or phone number on file

Providers

• No longer employed at an included clinic site
Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer

The primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.

This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week, 5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy, concomitant chemotherapy and radiation, and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction.

Eligibility Criteria:
Inclusion Criteria:

* Esophageal or gastroesophageal junction cancer that is locally advanced and surgically resectable (stage II or III disease).
* No prior therapy.
* Adequate organ function.

Exclusion Criteria:

* Evidence of metastasis (celiac axis lymph nodes are allowed).
* Cervical esophageal tumors.
* Peripheral or auditory neuropathy grade \>= 2.
Sinolpan® Pharmacy Non-interventional Study - Quality of Live

This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.

Within the scope of this non-interventional observational study, the quality of life of rhinosinusitis patients under self-medication with the 1,8 - cineole preparation Sinolpan® or Sinolpan® forte (Sinolpan® group) or with a nasally applied α-sympathomimetic (control group) is investigated during conditions of daily life. Patients who seek advice from a pharmacy regarding the treatment of their symptoms and who choose Sinolpan® (forte) or a nasal α-sympathomimetic can participate in this study and are asked to complete a questionnaire before and after the treatment. For organizational reasons, the recruitment of patients for the Sinolpan® group (planned number of patients: 500) or the control group (planned number of patients: 50) is conducted in different pharmacies.

The primary objective of this anonymous data collection is to assess the quality of life in patients with rhinosinusitis. The German version of the Rhinosinusitis Quality of Life questionnaire, which was only recently validated in a doctoral thesis, is used for this purpose. Additionally, for patients in the Sinolpan® group who also suffer from bronchitis, the bronchitis severity score is determined. In addition, data on side effects and tolerability of the treatment as well as on patients' satisfaction are collected.

Eligibility Criteria:
Inclusion Criteria:

* Suitable patients for the Sinolpan® group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and, where appropriate, their bronchitis and who choose the intake of Sinolpan® (forte) for therapy.
* Suitable patients for the control group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and who choose to apply nasal α-sympathomimetics for therapy.

Exclusion Criteria:

* According to the instructions for use
Short Term Dietary Serine Supplementation and Circulating Serine Levels

This study will test the effect of short-term, high-dose dietary serine supplementation on circulating levels of serine. Individuals with risk factors for type 2 diabetes will be recruited into the 2 week study. Effects of dietary serine supplementation on glycemic measures will also be explored.

This is a single-center, open-label, randomized, nutritional intervention study in adults. Subjects will have three visits to the Massachusetts General Hospital Clinical Research Center (CRC) during the 2 week study.

At the first study visit (Visit 1), the following will occur: informed consent; medical and nutritional history assessment; blood pressure, weight and height, fasting blood draw and blood work during a 2 hr oral glucose tolerance test; explanation and instructions for completion of a 4-day food log; randomized assignment to dose of dietary serine supplementation (6g, 12g, 24g, or 48g); provide 7 days of dietary serine supplements; take first dose of supplement with snack; schedule Visit 2 and Visit 3.

Between Visit 1 and Visit 2, participants will complete the Food Log and take the assigned dose of dietary serine supplementation 3 times daily.

Visit 2 will occur 7 days after Visit 1. Subjects will not take dietary serine supplementation prior to Visit 2 activities. At Visit 2, the following will occur: weight and blood pressure; fasting blood draw; administration of assigned dose of dietary serine supplementation with snack after blood work; review of the 4-day food log; provide 7 days of dietary serine supplements completion of anonymous survey to assess tolerability of supplement. Participants will continue to take the assigned dose of dietary serine supplementation 3 times daily between Visit 2 and Visit 3.

Visit 3 will occur 7 days after Visit 2. At Visit 3, the following will occur: weight and blood pressure; review of the 4-day food log; fasting blood draw and blood work during a 2 hr oral glucose tolerance test; completion of study survey to assess tolerability of the supplement.

Eligibility Criteria:
Inclusion Criteria:

* risk factors for type 2 diabetes

Exclusion Criteria:

* known type 2 diabetes
* women who are pregnant, nursing, or not using contraception or abstinence
* taking amino acid supplements during the study or at any time 1 month prior to enrollment in the study
* conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
* known active liver disease
* currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
* participation in any other interventional study during the study duration
* inability to adhere to study protocol.
HIV and Multi-Drug Resistant Tuberculosis: a Study on Clinical Outcomes

This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran. It will involve a detailed analysis of patient demographics, clinical characteristics, and treatment outcomes to enhance understanding of this co-infection. The findings may inform better treatment strategies and healthcare policies for managing these diseases in similar populations.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 years and older) diagnosed with both HIV and multi-drug-resistant tuberculosis (MDR-TB).
* Studies published in peer-reviewed journals.
* Studies that provide data on the co-occurrence of HIV and MDR-TB.
* Participants from diverse geographical regions to enhance generalizability.
* Studies with clear definitions of MDR-TB according to WHO guidelines.

Exclusion Criteria:

* Studies that focus solely on drug-susceptible tuberculosis without MDR-TB.
* Studies involving pediatric populations (under 18 years of age).
* Non-original research such as reviews, editorials, and commentaries.
* Studies lacking sufficient data on the co-occurrence of HIV and MDR-TB.
* Studies that do not adhere to ethical guidelines for human subjects or lack appropriate ethical approvals.
Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic.

Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.

Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology
* Estimated life expectancy over 3 months
* Performance status 0,1,2
* Signed informed consent
* Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine \< 2.5 mg/dL (221 mmol/L); serum AST or ALT \<5.0 x upper limit of normal (ULN); serum total bilirubin \<2.0 mg/dL (34 mmol/L)

Exclusion Criteria:

* History of chemotherapy or molecular targeted therapy
* Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy
* Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy
* Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* Pregnant or lactating
* Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
The Role of Hydrosalpinx in Recurrent Miscarriage

Miscarriage affects one in five pregnancies and little progress has been made in understanding and treating this distressing condition. C. trachomatis is the most common sexually transmitted infection in the UK. C. trachomatis infection can have serious health consequences, including fallopian tube damage. Untreated C. trachomatis infection and tubal damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm birth, low birth weight and stillbirth. A cohort study is needed to establish the prevalence of tubal disease in women with recurrent miscarriages. HyCoSy will be performed to identify tubal disease and establish the magnitude of the problem in the recurrent miscarriage population. The prognosis of tubal disease on miscarriage and other obstetric outcomes, and the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing miscarriage and adverse obstetric outcomes will also be studied.

Objectives

1. Establish the prevalence of hydrosalpinx in the recurrent miscarriage population.
2. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx.
3. Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
* Ability to give informed consent

Exclusion Criteria:

* Allergy to contrast media used for Hysterosalpingo-contrast-sonogram
* Allergy to sonographic gel used for ultrasound scanning
* Anatomical anomaly meaning transvaginal ultrasound scan not possible
* Stenosed/occluded cervix meaning contrast media unable to be introduced via cervix
* Inability to give informed consent
* Pregnant at the time of recruitment
* Declined recruitment
Evaluation of Quality of Care - Shared-Care Programme, HA

Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the shared-care (SC) programme to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the SC programme is achieved. Each SC participating clinic and private medical practitioner (PMP) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the programme will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records.

Main Outcome Measures: The primary outcomes are the proportion of participants who received the criterion process of care and achieved a HbA1c level \<7.5%.

Data Analysis: Descriptive statistics on proportions of clinics or subjects meeting the quality of care criteria will be calculated. The outcomes of SC patients will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between SC patients and control group will be compared by independent sample t-test or Chi-square test.

Hypothesis: The QOC of the SC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. The results of this study will provide empirical evidence on whether the HA's SC programme can achieve equivalent QOC as the usual HA care for diabetes mellitus (DM) patients. The information will be used to guide service planning and policy decision making.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC)for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level.

Exclusion Criteria:

* Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.