cyrilzakka/clinical-trials huggingface dataset:
A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old;
2. Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
3. Received previous biologic therapy with at least 4 months.

Exclusion Criteria:

1. Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
2. Previously treated with IBI112 or other IL-23 inhibitors;
3. Treated with two biologics for psoriasis within 4 months prior to screening;
4. Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
5. Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
6. Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
7. Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.
Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes

The main purpose of the study is to assess the feasibility and acceptability of a Culturally-Tailored Cognitive Behavior intervention (CT-CB) for African American patients with uncontrolled Type 2 diabetes. After the baseline visit subjects will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). The intervention duration is 12 weeks.

African Americans are approximately twice as likely to be diagnosed with diabetes and to experience gaps in diabetes care compared to Whites. Lower health literacy and socio-economic, language, and communication barriers are all associated with disparities in diabetes care. The role of Behavioral theory is foundational in understanding behavior change among patients in the self-management of diabetes. Further culturally tailoring increases acceptance and effectiveness of diabetes self-management.

The aim of this pilot study is to test the feasibility and acceptability of a culturally tailored, cognitive behavioral intervention (CT-CB) program using a group-based vs. a web-based format, and determine if it can improve diabetes self-management among African Americans compared with usual individual based care at the clinic. Forty-five African American patients with uncontrolled type 2 diabetes (HbA1C \> 8 %), aged \> 18 years, will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). After 12 weeks, patients will be followed for an additional three months to evaluate for diminution of treatment effects. Both the group -based and the web-based CBT intervention group will be followed for an additional three months to study for possible diminution of treatment effects over time.

Diabetic measures like Hemoglobin (HbA1C) at baseline vs. 3 months; the Patient Health Questionnaire to assess depressive symptoms; Diabetes Distress Scale, anxiety, self-efficacy, quality of life (SF-12), Diabetes Health Belief Scale, process measures such as Patient Activation Measure (PAM-13), medication adherence questionnaire, session-participation, glucose self-monitoring, diet and physical activity are measured at each visit pre and post intervention. Trained study staff will also conduct neuropsychological tests including language and memory tests, attention and executive function tests, clinical diagnosis, activities of daily living (ADL).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Fluency in English
* African American
* HbA1C\>8%

Exclusion Criteria:

* Subjects with no web access,
* Subjects using an insulin pump,
* Subjects that are pregnant
* Subjects that have active substance abuse including alcohol,
* Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
* Must be suitable for treatment with gemcitabine
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Serious heart conditions
A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency

The aim of this long-term observational study is the documentation of the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the investigators focus on the acquisition of data of the underlying diseases and the reduction of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this, exact assessment of medical tolerance and details of treatment requirements are further aims. Here the investigators take into account acute and chronic underlying medical conditions. Further health economic data are collected.

The observational study began on 01 November 2012 and is scheduled for a period of 10 years continued (until 01 November 2022). The duration of the observational study for each patient is not fixed corresponding to the character of a non-interventional study. According to the underlying disease, characterized either acute or chronic, there are 2 and 3 observations within the treatment period, respectively. Documentation comprises the course of the underlying diseases (by tracking of general and diseases-specific symptoms), drug compatibility (by ADR assessment), concomitant medication or other treatment, health economic data, details of treatment regimen and standard epidemiological data.

Eligibility Criteria:
Inclusion Criteria:

* patients with vitamin C deficiency
* patients \>= 12 years old

Exclusion Criteria:

* an oxalate urolithiasis,
* iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have received recently transfused packed red blood cells
* under 12 years of age or
* are pregnant or breastfeeding.
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation


Eligibility Criteria:
Inclusion Criteria::

* nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section
Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision

Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (volunteers) with age-related impaired twilight and night
* Age 50 to 70, men or women
* Written informed consent
* Full visual acuity (vision ≥ 0.7) according to DIN Standard condition
* Refraction ≤ +/-6.0 in the highest main step
* Age-related findings in the ophthalmologic examination (anterior chamber and eye ground)
* Normal intraocular pressure (10-20 mmHg)

Exclusion Criteria:

* Diabetes mellitus
* Epilepsy
* Abnormal visual acuity or eye ground (e.g. clouding of the lens)
* Age related vision problems
* Glaucoma and macular degeneration
* Disease of the retina
* Consumption of anthocyan preparations during the past six months
* Opthalmologic pathology: cataract, visus \< 0.7, retinal pathology, maculopathy, intraocular pressure (\> 21 mmHg), known acute or chronic eye disease, use of hard contact lenses, eye surgery performed within the last 12 months
* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus, anamnestic indications of diabetic microangiopathy or polyneuropathy, renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension \> 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino
* Any treatment that might interfere with the evaluation of the test drug, in particular drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis, ethambutol, chlorpromazine or phenothiazine derivatives such as thioridazine, periciazine, perphenazine)
* Known hypersensitivity to any of the ingredients of the study drug
* Drug and alcohol abuse
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Participation in another trial within the past 30 days
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center

The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.

This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

* undergoing outpatient ambulatory surgery
* recipient of general anesthesia
* pain score of 4 or greater in the PACU

Exclusion Criteria:

* non-english speaking patients
* cancer surgeries
* patients who have allergy or intolerance to the study drugs or derivatives
* patients on chronic opioids (defined as daily opioids for 3 months or longer)
Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.

The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.

Eligibility Criteria:
Inclusion criteria:

* Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization \[WHO\] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.
* Ann Arbor Stage III or IV disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Life expectancy \>3 months with no expected need of immediate intervention to treat life-threatening complications.
* Adequate organ function.
* Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.

Exclusion criteria:

* Histological Grade 3b or with \>50% diffuse architectural pattern.
* Circulating malignant cells \>25,000/mm\^3
* Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).
* Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.
* Radiotherapy within 2 months prior to Cycle 1 Day 1.
* Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.
* Concomitant disease that requires continuous therapy with prednisone at doses \>20 mg per day.
* Any medical contraindication for prednisolone as being dosed in the CVP regimen.
* Poorly controlled diabetes mellitus, as defined by institutional or local standards.
* Grade \>2 peripheral neuropathy.
* Has one of the following:

  1. is human immunodeficiency virus (HIV)-positive
  2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)
  3. has antibodies to Hepatitis C virus
* Has one or more of the following:

  1. Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.
  2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.
  3. History of a tuberculosis infection.
* Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.
* Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.
* Pregnant or breastfeeding.
Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates

The purpose of this study is to evaluate the feasibility of aspiration samples for mutational analysis in patients with a non-small cell lung cancer (NSCLC).

The investigators will compare results of mutational analysis from a core needle biopsy and fine needle aspiration.

Eligibility Criteria:
Inclusion Criteria:

* primary tumor or a metastatic lung lesion requested for mutational analysis

Exclusion Criteria:

* a) lesions located adjacent to the large central bronchi or vessels
* b) peribronchovascular lesions with prominent internal CT air-bronchograms, which were considered difficult to be avoided by needle pass
* c) lesions in patient with severe respiratory compromise
How Much Can the Thoracic and Lumbar Skin Slide?

The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups.

It is hypothesized that an explanation to late epidural failure could be related to excess back motion in individual subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Children age 0-17 and Adults 18 and older may participate
2. You agree to participate and sign the informed consent document

Exclusion Criteria:

1. Any type of back deformity
2. Tumor on back
3. Skin Disease on the back
4. Any condition that prevents skin measurements such as scleroderma
The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome

The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.

The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.

Specific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.

Specific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
* Have a smart phone in order to download apps on phone

Exclusion Criteria:

* Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)
* Have lactose intolerance
* Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.
* Are currently taking fibre or probiotic supplements
* Are taking any prescribed medication
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
* Are pregnant or breast feeding
* Currently have a diagnosed psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Have taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged ≥ 18 but ≤ 75 years
2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer
3. Treatment-naive patients with stage II-III
4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
5. Good level of organ function
6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits

Exclusion Criteria:

1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
2. Received any other anti-tumor therapy at the same time
3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
4. Stage IV breast cancer
5. Not confirmed by histopathology
6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
7. Participated in other drug clinical trials within 4 weeks before enrollment
8. Known allergic history of the drug components of this protocol
9. History of immunodeficiency
10. Clinically significant cardiovascular diseases
11. Known or suspected interstitial lung disease
12. Active hepatitis and liver cirrhosis
13. Known hereditary or acquired bleeding thrombotic tendency
14. History of neurological or psychiatric disorders
Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda

The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.

A single dose of 0.75mg/kg primaquine base is recommended by the WHO to block transmission of falciparum malaria from infected humans to mosquitoes by clearing gametocytes. However, the optimal dose for safety and efficacy has not been evaluated. Dose-finding data is important because primaquine has a dose-dependent risk of causing haemolysis (destruction of blood cells) in pre-disposed individuals, such as those with G6PD deficiency. G6PD deficiency is most prevalent in malaria-endemic areas. Therefore, it is essential that data on primaquine's safety is available in such areas.

The investigators hypothesise that lower doses of primaquine have a lower risk of adverse effects compared to the WHO-recommended dose, but retain the transmission-blocking efficacy.

The investigators propose to test this hypothesis in a four-arm clinical trial with a non-inferiority design to evaluate the efficacy and a superiority design to evaluate the safety of the WHO dose (0.75mg/kg) and lower doses of primaquine for clearance of P. falciparum gametocytes in children in Uganda. The study will include a pharmacokinetic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 1 year and \</= 10 years
* Weight over 10kg
* Fever \>38 degrees C (tympanic) or history of fever in the last 24 hours
* P. falciparum parasitaemia \<500 000/µl
* Normal G6PD enzyme function

Exclusion Criteria:

* Enrolled in another study
* Evidence of severe illness/ danger signs
* Known allergy to study medications
* Haemoglobin \< 8g/dL)
* Started menstruation
* Pregnancy or breastfeeding
* Primaquine taken within the last 4 weeks
* Blood transfusion within the last 90 days
* Non-falciparum malaria co-infection
Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery

This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.

PRIMARY OBJECTIVES:

I. To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.

SECONDARY OBJECTIVES:

I. To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.

OUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.

COHORT I: Participants receive standard post-operative care.

COHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.

After completion of study, participants are followed up for approximately 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be accrued using the following inclusion criteria:

  * Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer
  * Able to read and understand English
* Informal Caregivers will be accrued using the following inclusion criteria:

  * The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
  * Able to read and understand English
* All participants must have the ability to understand the willingness to provide informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study