cyrilzakka/clinical-trials huggingface dataset:
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.


Eligibility Criteria:
Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
* Infant's birth weight was \> 2490 g (\~5 lb 8 oz).
* Infant is between 0 and 8 days of age at enrollment.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
* Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics.
* Infant has received probiotics.
Risk and Aesthetic Assesment in Implant Patient

This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers.

: After completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. Patients are primarily divided into smokers and non-smokers. In all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old patients
* Patients who are systemically healthy and have a controlled medical condition
* Patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant

Exclusion Criteria:

* Patients with uncontrolled systemic diseases
* Those who have the habit of bruxism
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE Combined with Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.
2. Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
3. The tumor must be surgically resectable.
4. ECOG Performance Status 0-2.
5. Adequate liver function (Child-Pugh class A)
6. Life expectancy ≥ 3 months
7. Previous physical ablation is allowed.
8. Age 18 to 75 years
9. Able to sign and provide written informed consent.

Exclusion Criteria:

1. Patients previously took oral molecular targeted drug or received immunotherapy.
2. Patients with arteriovenous fistula.
3. Severe active infection \>grade 2 (except for Hepatitis B and C infection).
4. Concomitant malignant tumors in other organs.
5. Presence of severe cardiac, lung or kidney disease.
6. Pregnant or breast-feeding woman.
7. Patients with severe neuropathy and unable to report therapeutic effects.
8. Patients with severe atherosclerosis.
9. Patients with AIDS.
10. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
11. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
12. Currently enrolled or going to enroll in any other clinical trials.
13. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance, inability to follow up).
KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of KN046 combined with Ningatinib in subjects with advanced hepatocellular carcinoma.

The study consists of dose escalation and dose expansion, the mTPI-2 (Modified Toxicity Probability Interval) will be used for dose exploration. The preset dose of KN046 is 5 mg/kg Q3W and the preset dose of ningatinib is 10 mg (rapid titration), 20 mg QD, 30 mg QD, and 40 mg QD.Dose expansion will be divided into two cohorts, cohort 1 will enroll subjects who have not received system therapy and cohort 2 will enroll subjects who have previously received at least first-line system therapy.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
* Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
* ECOG performance status: 0-1；
* Child Pugh score≤7；
* Enough organ function；
* Has at least one measurable lesion based on RECIST 1.1；
* Life expectancy ≥3 months；
* Patients must be able to understand and willing to sign a written informed consent document；

Exclusion Criteria:

* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
* Past or present hepatic encephalopathy; or Budd-Chiari syndrome; or Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
* Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.); or have a history of ≥ grade 3 immune-related adverse reactions; or hyperprogressive after immunotherapy previously；
* Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
* Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
* Any previous or current active autoimmune disease or history of autoimmune disease;
* History of liver transplantation;
* History of interstitial lung disease or non-infectious pneumonia;
* History of allergic reactions to related drugs;
* LVEF\< 50% or LLN
* Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
* Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
* Untreated hepatitis infection: HBV DNA\>2000IU/ml or10000 copies/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive;
* Evidence of active pulmonary tuberculosis (TB);
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;
Yoga vs. Education for Restless Legs Syndrome: a Feasibility Study

The purpose of this study is to see whether adults with Restless Legs Syndrome (RLS) are willing to be in a 12-week study where they have a 50-50 chance of being placed in either a gentle yoga program or a film-based education program designed for people with RLS. If so, do they complete the program, and does their RLS, sleep, mood, or quality of life improve?


Eligibility Criteria:
Inclusion Criteria:

* ambulatory adults
* at least 21 years of age
* moderate-severe RLS, defined as:

  1. symptoms that meet all five of the International RLS Study Group essential diagnostic criteria for RLS (i.e., 1) an urge to move the legs, often associated with discomfort or disagreeable sensations in the legs, that 2) begins or worsen during periods of rest or inactivity; 3) is partially or totally relieved by movement; 4) is worse or only occurs in the evening or night; and 5) is not solely accounted for by another condition (e.g. leg cramps, positional discomfort, habitual foot tapping));
  2. RLS symptoms at least 1x/wk for the previous 3 months;
  3. a score of at least 2 points (moderate) IRLS question 6: "How severe was your RLS as a whole?"; and
  4. RLS diagnostic criteria applied as per training by the study physician, a sleep medicine expert; these criteria will help ensure exclusion of mimics (e.g. leg cramps, positional discomfort).
* willingness and ability to complete the 12-week yoga or educational film program and all study assessments;
* willingness to avoid use of any new drugs or treatments other than the assigned intervention.

Exclusion Criteria:

* practiced yoga within the past year;
* currently on dopaminergic agents (eg, ropinirole, pramipexole) or anti-psychotic medication;
* changed dosage if any other central nervous system agents (e.g., sedative hypnotics, gamma-aminobutyric acid (GABA) analogs, narcotic analgesics, antiadrenergic agents, or anticonvulsants) within the past 3 months;
* any orthopedic, neurologic or other condition that might prevent safe completion of a 12-week yoga program or confound assessments (e.g., neuropathy; Parkinson's disease; stroke; rheumatoid arthritis; renal failure; uncontrolled sleep apnea; recent (within the last 6 months) myocardial infarction; heart failure; cancer (other than non-melanoma skin cancer);
* pregnant or within 6 months post-partum).
Pre-operative Hypnosis to Prevent Side Effects After Surgery

The aim of the pilot study is to translate and feasibility test a brief hypnosis intervention in 8-10 patients that are about to undergo thoracic surgery and in 4-5 patients about to undergo breast cancer surgery.

The hypnosis intervention will be based on a protocol from Montgomery et al. They showed in a recent study that a brief 15-minute hypnosis intervention was effective in reducing a number of common side effects, including pain, fatigue and nausea. The scripted session includes a relaxation-based induction, suggestions for pleasant visual imagery, suggestions to experience relaxation and peace, and specific symptom-focused suggestions. The intervention will be professionally translated into Norwegian, and adapted and modified as necessary to the specific context of this study. The PI, who is a an experienced clinical psychologist, will hold the session in the pilot study. Patients will further be instructed to use hypnosis on their own following the intervention session.

The patients will further be invited to participate in semi-structured interviews upon completion of the intervention, either by phone or in person, to discuss their experiences with the intervention, and share any advice for modifications or changes to the interventions or procedures. Systematic text condensation will be applied in the analyses of the interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patients about to undergo either breast cancer surgery or thoracic surgery

Exclusion Criteria:

* Insufficient Norwegian speaking or writing skills to participate in the intervention
* cognitive and psychiatric impairment
* other serious malignancies
Nurse-assisted Intervention "eHealth@ Hospital -2-home"

A randomized controlled trial with non-communicable disease patients from two medical hospitals in Norway will be recruited prior to hospital discharge. The intervention group will participate in a 42-day nurse-assisted eHealth intervention "eHealth@ Hospital-2-Home". The intervention includes monitoring the patient's vital signs, self-reports of symptoms, health and well-being, communication between the patients and a Nurse Navigator in the hospital, and access to information about illness and health resources.

Heart failure (HF) and colon-rectal cancer (CRC) are two non-communicable diseases (NCDs) prone to a high rate of hospital admissions and re-admissions, and complex health care needs. For many patients with HF and CRC, self-management following hospitalization can be a challenge, and they may leave the hospital unprepared for self-managing their disease at home. The randomized controlled trial with NCD patients from two medical hospitals in Norway. Patients will be recruited before hospital discharge. The intervention group will participate in a 42-day nurse-assisted intervention ""eHealth@ Hospital-2-Home"". The intervention includes monitoring of patients' vital signs, self-reports of symptoms, health and well-being, communication between the patients and a Nurse Navigator in the hospital, and access to information about illness and health resources. The control group will receive care as usual. Data collection will take place before the intervention (baseline), at the end of the intervention (post-1), and 6 months after baseline (post-2). Data will be according to intention to treat principles. Qualitative data will be analyzed using thematic analysis.

Eligibility Criteria:
Inclusion Criteria:

* All participants: symptomatic HF or surgically treated for either colon or rectal cancer (Colon-Rectal Cancer Duke's class 1-3, curative), able to speak and write Norwegian

Exclusion Criteria:

* Heart failure population: patient is on a waiting list for a heart transplant, requires a Left Assist Ventricular Device (LVAD), and has a life expectancy \<6 months
* Colon-rectal cancer population: metastatic cancer, Surgical Complication Score \> 3, and acute medical crisis.
Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects attending emergency room due to potential HIV exposition of either sex:
* Aged 18 years or more.
* Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs.
* Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
* Individuals able to do follow up correctly.

Exclusion Criteria:

* Pregnant women or nursing mothers or women trying to conceive during the study period.
* Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens.
* Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
* Allergic reactions or intolerance to the compounds of the study treatment regiments
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.


Eligibility Criteria:
Inclusion Criteria (Proband)

* Male or female age ≥ 18 years
* Confirmed diagnosis of DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient
* Must have at least one living ≥ 18 years FDR
* Able to provide informed consent

Inclusion Criteria (FDR)

* Male or female age ≥ 18 years who are first-degree relatives of patients with DCM
* Proband has provided informed consent
* FDR able to provide informed consent
* Access to a smartphone or digital tablet with cellular data or Wi-Fi access

Exclusion Criteria (Proband)

* DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination
* Proband has previously informed FDR to undergo cardiac screening
* Ischemic cause of reduced LVEF

  * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease
  * history of acute coronary syndromes (STEMI, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or LAD or ≥75% stenosis of 2 major epicardial vessels on angiogram
* Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
* Congenital structural heart disease
* Severe and untreated or untreatable hypertension
* Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload
* Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug
* (CPC Participants only) Home address outside of traveling range

Exclusion Criteria (FDR)

* Previously informed about cardiac screening or has completed cardiac screening by TTE
* Previously diagnosed with reduced LVEF
* (CPC Participants only) Home address outside of traveling range
The Acute Coronary Syndrome Study

The investigators will make a prospective study in which they will look at the economics and security of the treatment of patients with acute coronary syndrome.

The investigators want to do a randomized trial. One group will be treated as they have been treated at Ullevål University Hospital (UUS) in recent years, and the other group will be returned to their refering hospital the same day. The objective of this study will be to provide increased knowledge about whether the rapid discharge from the intervention center is associated with differences in costs or security.

The topic of this study is whether patients with Acute coronary syndrome (ACS)may can be transferred to their refering hospital same day that they arrived intervention hospital.

This is to see if one can reduce the hospital stay and costs for the intervention center, and the total hospitalization time.

and this rapid transport not give more medical complications

Our 1 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day, will reduce the length of stay in intervention center without an increase for the stay at the refering hospital.

Our 2 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day as the treatment is performed, have no more complications than those who stay overnight in the intervention hospital.

Eligibility Criteria:
Inclusion Criteria:

* All patients with acute coronary syndrome who are referred from other hospitals

Exclusion Criteria:

* Patients younger than 18years.
* Known mental retardation, dementia or harmful use of alcohol or drugs.
* Allergy or intolerance to ASA and / or clopidogrel.
* Patients who have previously been involved in this study.
* Acute STEMI infarction for less than 72 hours ago.
Feasibility of Strategies to Increase SNAP Fruit and Vegetable Incentive Program Use for Families With Food Insecurity

The Veggie Vouchers pilot intervention aimed to increase awareness and utilization of an existing SNAP F\&V incentive program in South Carolina for families with food insecurity. Social determinants of health screenings were leveraged in a pediatric clinic to identify eligible families and provide information about this program. A free trial was then offered, with the long-term goal of increasing program use after the free trial ended. The primary aim was feasibility and acceptability of the Veggie Vouchers intervention among pediatricians and families.


Eligibility Criteria:
Caregiver Inclusion Criteria:

* 18 years of age or older
* Had a child 2-17 years of age
* Child lived in their home 50% of the time or more
* Child was a patient of the general pediatrics clinic enrolled in this study
* English-speaking
* Enrolled in SNAP
* Experiencing household food insecurity

Caregiver Exclusion Criteria:

* Had purchased fruits and vegetables within the past year at the community food site participating in this study
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma

The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.

* Patients will undergo surgery with pleurectomy/decortication which entails the removal of the inner and outer skin of the lung, including the pleura overlying the pericardium and diaphragm. Resection of the pericardium and diaphragm are occasionally necessary to debulk the tumor. This surgery is part of standard care for pleural mesothelioma.
* After surgery, a one hour lavage with heated cisplatin will be administered to the hemithorax (and abdominal regions if the diaphragm is no longer present). The lung itself is not removed, only the diseased portion of the lung and surrounding areas with tumor.
* Immediately following the one-hour lavage, a six hour infusion of sodium thiosulfate will begin to help reduce the side effects of the cisplatin.
* Patients will remain hospitalized until they have recovered from surgery (usually 7-14 days).
* Patients will return to the hospital three months after their surgery to have fluid drawn from their chest via an ultrasound guided thoracentesis. This is called a saline wash.
* Patients will be in the study actively for three months. This includes a 2-week and 4-week post-operative follow-up in which blood work is performed. As well as a 3-month follow-up for the saline wash. Long-term follow-up includes computed tomography of the chest and abdomen every 6 months to assess recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologic confirmation of malignant pleural mesothelioma
* Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion
* 18 years of age or older
* Malignancy is confined to the affected hemithorax.
* Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
* Evidence of adequate renal and hepatic function
* Karnofsky performance status of 70% or greater

Exclusion Criteria:

* Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively
* Distant metastases
* Non-malignant systemic disease
* Active concomitant malignancy
* Psychiatric or addictive disorders which would preclude obtaining informed consent
* Prior treatment within the last 2 months, other than surgical resection for their current malignancy
An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.


Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to a single TNF inhibitor
* Participants receiving rituximab therapy in accordance with the prescribing information
* Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
* Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

* Contra-indication to receive rituximab according to the local labelling
* Previous treatment with rituximab
* Treatment with any investigational drug within 30 days prior to enrolment