cyrilzakka/clinical-trials huggingface dataset:
Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.

This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel syndrome predominant constipation. one-third of patients will receive Ficus carica, another one-third will receive Descurainia Sophia and remained patients only will follow their regular diet for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* patients with irritable bowel syndrome predominant constipation

Exclusion Criteria:

* Subjects with significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, hematologic disorders,
* structural abnormalities of the gastrointestinal tract or
* diseases ⁄conditions that affected bowel transition,
* surgery,
* any prokinetic or laxative drug used during the past month,
* any medication that may affect gastrointestinal motility,
* other therapeutic dietary advice for IBS,
* used Fig or Flixweed during the last month,
* diarrhea,
* pregnancy or
* breast-feeding
Weight-loss Treatment Program in Children and Adolescents

The study will evaluate the effect of an existing hospital-based obesity treatment in children and adolescents in relation to weight loss and motivation. This is to ensure that children who have developed obesity have the possibility to obtain a healthier lifestyle, including a healthier body weight during their school years. This study will test whether an obesity treatment program designed for school children can reduce the degree of overweight in children and adolescents with overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* 2-18 years old
* BMI SDS above the 90th percentile

Exclusion Criteria:

* Reached a BMI SDS below the 75th percentile
* Attained 19 years of age
Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics

The purpose of this study is to examine the content of the treatment being delivered for anxiety disorders for children and adolescents in the regular outpatient clinics in western Norway. The study will also collect data before and after treatment to evaluate the result of the treatment. Furthermore, as part of the study we aim to collect normative data on two questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere with daily functioning. We also aim to develop a quality indicator for anxiety treatment that can be used to monitor treatment in the regular outpatient service, based on the results of the current study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an anxiety disorder (including PTSD and OCD) based on the diagnostic interview ADIS (ADIS-C/P; Silverman \& Albano, 1996).
* The anxiety disorder is the patients primary diagnosis.
* Informed concent is given.

Exclusion Criteria:

* The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)
A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC

This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.


Eligibility Criteria:
Inclusion Criteria:

1. age≥18
2. Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
3. Voluntarily participate in this study and sign an informed consent form
4. The presence of evaluable size and number of pulmonary metastases on chest CT
5. There are indications for lung puncture biopsy
6. General physical condition (ECOG) 0-1
7. The laboratory test meets the following standards: white blood cell count\>3.5 × 109/L, absolute value of neutrophils\>1.8 × 109/L, platelet count ≥ 75 × 109/L, hemoglobin ≥ 100g/L; NR ≤ 1.5, and APTT ≤ 1.5 times the upper limit of normal value or partial prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; Total bilirubin ≤ 1.25 times the upper limit of normal value; ALT and AST\<5 times the upper limit of normal values; 24-hour creatinine clearance rate\>50mL/min or blood creatinine\<1.5 times the upper limit of normal value.

Exclusion Criteria:

1. Unable to tolerate or refuse further immunotherapy
2. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
Multi-center Application of Quantitative FIT Technology in Colorectal Cancer Screening

In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population

Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy people aged 30 years and planning to undergo colonoscopy;
2. No history of gastrointestinal tumor;
3. No ulcerative colitis or Crohn's disease;
4. No gastrointestinal hemorrhagic disease;
5. No history of gastrointestinal surgery, able to understand and willing to sign informed consent.

Exclusion Criteria:

1. Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
2. Patients with gastric and esophageal cancer and other malignant tumors;
3. Unable to cooperate after communication;
4. Subjects who have received radiotherapy and chemotherapy;
5. Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc
A Study of ERY974 in Patient With Advanced Solid Tumors

This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with Glypican 3 positive advanced solid tumor not amenable to standard therapy or for which standard therapy is not available or not indicated
* Measurable tumor
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Adequate bone marrow, liver, and renal function
* Adequate coagulation status

Exclusion Criteria:

* Patients with more than a single brain metastasis ( \>1 cm)
* Patients with acute or chronic infection
* Major surgery within 28 days
* Pregnant or lactating women
* Patients with interstitial pneumonitis
* Patients require regular ascites/pleural effusion drainage
Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

Eligibility Criteria:
Inclusion Criteria:

* Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

Exclusion Criteria:

* Previous participation
In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia

The standard treatment of chronic hepatitis C infection is pegylated interferon alpha combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, reducing the likelihood of sustained viral response. Recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. In this study, we will evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with hepatitis C eligible for treatment with pegylated interferon alpha containing regimes.

Exclusion Criteria:

* less than 18 years of age
A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)

This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.

The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.

Eligibility Criteria:
Inclusion Criteria:

Ocular

* Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist

Exclusion Criteria:

Concurrent Ocular Conditions

* Patients legally blind in one or both eyes
* History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction (any grading from trace and greater is excluded), including non-infectious uveitis or uveitis, or sterile inflammatory reaction after the past ITV injections with any agent
* Active disorder of ocular adnexa and skin in the study eye, including ocular surface infections
* History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after ITV injection or intraocular procedures
* Uncontrolled intraocular pressure greater than (\>) 25 millimeters of mercury (mmHg) in the study eye (uncontrolled means that it occurs even with intraocular pressure-lowering therapy)
* Use of therapies that are known to be toxic to any ocular tissues within the 6 months prior to enrollment

Prior Ocular Therapies

* Treatment with any ITV injection within the 27 days prior to Day 1
* Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the past 3 months

General

* Receipt of any systemic (non-ocular) investigational drug within 3 months prior to Day 1
* Current systemic coagulation or bleeding disorders and history of recurrent hemorrhages
* Intolerance or known reaction to prior biological therapies
* History of other diseases or physical or laboratory examination findings that per the retina specialist represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk.
* Uncontrolled hypertension (systolic \>160 mmHg and/or diastolic \>100 mmHg while sitting)
* Current systemic infectious disease or a therapy for active infectious disease
* Pregnant or lactating
Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug

Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598, therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach. This study will compare the time course of drug concentrations in the body, safety, and tolerability of CP-945,598 given with and without omeprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Body Mass Index (BMI) of 26.6 to 40.5 kg/m2.

Exclusion Criteria:

* Non-prescribed use of drugs or abuse of recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure measurements falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits; medically important health conditions; recent use of prescription or non-prescription medications.
Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer

Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;

Exclusion Criteria:

1. Her2-positive patients;
2. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
4. Previous or co-existing malignant neoplasms;
5. The presence of any active or known autoimmune disease;
6. People who have previously received an organ transplant;
7. Have clinical symptoms or diseases of the heart that are not well controlled;
8. Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;
The Effect of Soy Protein on Neuropathic Pain

Neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. Interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. Soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. Results from animal studies show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to determine the effects of soy protein supplementation on facial pain.

Neuropathic pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. To address this issue, we are implementing a unique methodology using a series of N-of-1 or single subject randomized, double blind, controlled studies. With this, we will explore the role of soy protein supplementation in neuropathic pain patients. Each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. This method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 18 years old
* Chronic neuropathic pain with tactile allodynia \> 6 months
* Suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary)
* Pain intensity score ≥ 5 on 11-point numerical rating scale (NRS) during 1-week screening period prior to randomization
* Stable medication use (if any) over 4 weeks before starting the trial. Current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial.
* Up to date mammogram and gynecological evaluations.

Exclusion Criteria:

* History of significant heart, gastro-intestinal, liver or kidney disease
* History of alcohol/narcotic abuse or current excessive alcohol consumption
* History or diagnosis of cancer
* History of breast tumors, predisposition to breast cancer or a family member with breast cancer
* History of hormonal or gynaecological disease
* Current use of hormonal replacement therapy (HRT), except thyroid HRT
* Pregnant or breastfeeding women
* Use of any anticoagulant or blood thinner except acetylsalicyclic acid
* Malabsorption of any kind
* Diagnosed lactase deficiency;
* Known allergy to any of the dietary products
* Known allergy to acetaminophen
* Daily consumption of soy protein in quantities exceeding 10 g/day
* Strict vegetarians (i.e. no animal derived dietary sources)
* Antibiotic use within the last 3 months
* Any previous psychiatric diagnosis before pain onset
* Body mass index \> 35
Hepatitis C Diagnosis to Treatment Management

The objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of hepatitis C treatment. A period of time without alerts will be compared to a period of time with alerts.

The hepatitis C virus (HCV) is one of the most common bloodborne pathogens in the United States. A large proportion of people with HCV infection progress to chronic HCV infection despite the availability of effective treatment; chronic infection can result in cirrhosis, end-stage liver disease, liver cancer, and liver-related death. HCV infection can be cured most of the time with treatment. The objective of this before and after study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of HCV treatment. A period of time without alerts will be compared to a period of time with alerts. Healthcare providers and clinic staff will not receive alerts during the before period of the study. Healthcare providers and clinic staff will receive alerts during the after period of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* In care at an AIDS Healthcare Foundation Healthcare Center
* Active, untreated HCV infection

Exclusion Criteria:

* \<18 years of age
* Patients with active HCV infection who have a current prescription for HCV treatment
Simplifying Treatment and Monitoring for HIV (STREAM HIV)

This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in improving ART adherence, maintaining durable VL suppression, and improving retention in care among HIV-positive individuals initiating first-line tenofovir disoproxil fumarate (TDF)-based ART in South Africa.

This study will be a two-arm, open-label, randomized controlled superiority trial at an HIV clinic in Durban. HIV-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line ART will be randomized to receive POC VL testing and POC TFV adherence testing, versus standard-of-care (SoC) viral load testing. The schedule for VL testing and management of VL test results will follow South African guidelines for HIV VL testing after ART initiation. 540 participants will be randomized (1:1) at ART initiation into the intervention arm (routine POC TFV adherence testing with POC VL monitoring) or the standard-of-care (SoC) arm (no objective TFV adherence testing and SoC VL monitoring).

Participants will be followed to compare concentrations between study arms at 24 weeks after ART initiation and a composite outcome of VL suppression and retention in care between the study arms at 72 weeks after ART initiation. The study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the POC assays. Micro-costing will be conducted to estimate intervention costs.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* ≥16 years old
* Initiating a TDF-based, first-line ART regimen
* Do not self-report being on an ART regimen in the prior month
* Willing/able to provide written informed consent

Exclusion Criteria:

* Does not plan to continue receiving HIV care at the CDC Clinic
* Per the decision or opinion of the PI (for example, a clinically significant acute or chronic medical condition or circumstances that would make the patient unsuitable for participation or jeopardize the safety or rights of the participant