cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation


Eligibility Criteria:
Inclusion Criteria:

* Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
* Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
* Subject has measurable disease according to RECIST, v1.1

Exclusion Criteria:

Subject with unstable or progressive central nervous system (CNS) metastases.

* Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
* Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is \> 480 msec based on triplicate measurements of electrocardiogram (ECG).
* Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
* Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
* Subject is pregnant or lactating.
Liver, Pancreas and Thyroid Function in Burn Patients

The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid and the pancreas will be assessed via ultrasound (GE Medical Systems, Waukesha, USA) and standard blood parameters, respectively.

In this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively.

The patient will be enrolled during the first days on their admission to the intensive care burn unit, if they meet the inclusion criteria and no exclusion criteria are met. The first assessment of liver, pancreas and thyroid function will be performed within the first 48 hours of admission. The same measurements maybe be repeated approximately weekly until discharge, respectively. Furthermore at any follow-up visit up to 15 years post-burn if the patient consents to further participate in the study.

Eligibility Criteria:
Inclusion Criteria:

Patients with partial thickness burns. Only patients who sign an IRB-approved consent (≥18 years old) or assent and have their legal guardian consenting to their participation (6 months - 17 years old) will be included.

* Patient age \> 6 months
* Total body surface area (TBSA) burned ≥ 30 %
* Flame, electrical, scald or chemical injury, contact burn
* Toxic epidermal necrolysis (TENS)

Exclusion Criteria:

* Patient \< 6 months
* TBSA burned \< 30 %
MRI in Staging Ovarian Cancer Using MRI Contrast Agent

Can MRI be used to stage ovarian cancer?

Staging of ovarian cancer can best be performed with CT or MRI compared to ultrasound. Studies have shown an increase in pos. predictive value by adding contrast i.v. to the MR-examination protocol. We compare staging of ovarian cancer by 1.MRI without contrast (standard method) to 2.MRI with contrast agent i.v. (new method)in the same patient. Golden standard are findings at operation.

Eligibility Criteria:
Inclusion Criteria:

* suspicion of ovarian cancer

Exclusion Criteria:

* recurrence of disease
* contraindication to MRI, contrast agent
* inoperable patients for other reasons
Treatment for Migraine and Mood (Team-M)

The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.

This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This first phase is aimed at fidelity optimization of MBCT-T and MBCT-V in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).

Eligibility Criteria:
Inclusion Criteria:

* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent

Exclusion Criteria:

* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
* Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current meditation practice \>3x/week
Antibiotic Treatment to Patients With Low Back Pain

A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.

Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.

Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients

The patients will take the drug three times a day for 100 days.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* Previous lumbar herniated disc confirmed by MRI
* Time since lumbar disc herniation more than 6 months less than 2 years
* LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
* The present MRI shows Modic changes
* Positive Springing test (SPT) at the level of Modic changes

Exclusion Criteria:

* Allergy against antibiotics
* The Beck Depression Inventory \>7,
* Pregnancy
* Breast feeding
* All Kidney diseases
* Pending workers litigation or pension
* Danish as second language
* Fertile women who do not user safe anti conseption
* Reduced liver functions
* Reduced liver function due to previous treatment wiht amoxicillin/clavulanasid.
Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue

The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Study objective is to clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.

the study will be conducted on 16 extraction sockets in humans. Sockets will be randomly divided into two groups: Group I (test) will comprise 8 sockets sealed by PRF after immediate implant placement. Group II: (test) will comprise 8 sockets sealed by cyanoacrylate glue after immediate implant placement

Eligibility Criteria:
Inclusion Criteria:

* Any non-restorable hopeless tooth; a badly decayed tooth that cannot be restored, a Tooth with failed endodontic treatment, and tooth with longitudinal fracture.
* Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue graft
* A good standard of oral hygiene.
* No signs of active periodontal disease in the selected tooth.

Exclusion Criteria:

* The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
* The presence of Acute periapical infection.
* The presence of any local factor that may interfere with extraction as tooth ankyloses. (
* Subjects who had undergone therapeutical radiation. (38)
* Patients who had been subjected to or who were under bisphosphonate therapy
Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery

the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery


Eligibility Criteria:
Inclusion Criteria:1. All patients in the age of 18-60 year 2. ASA I-II 3. Undergoing elective nasal endoscopic surgery

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Exclusion Criteria:

1. Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
2. unsatisfactory preoperative peripheral arterial oxygen saturation.
3. Unsatisfactory preoperative hemoglobin level.
4. Neurological or psychiatric disease.
The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes

This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Diabetes Mellitus (DM) is a health problem that affects many lifelong systems and organs throughout the world, increases the risk of premature death, affects the individual, family, society and the world, has a serious spiritual and financial care burden, and has important and vital consequences.

Diabetes can cause damage to nerves as well as small and large vessels. Patients who have had DM for a long time will experience circulatory disorders in the upper and lower extremities.

Ankle-Brachial Index (ABI) is a non-invasive examination of blood vessels that functions to detect clinical signs and symptoms of ischemia, reduced peripheral perfusion that can lead to angiopathy and diabetic neuropathy.

Studies indicate that foot exercise and acupressure application can be used as an alternative intervention to increase the value of the ankle-brachial index in patients with type 2 diabetes.

When the literature was examined, no comprehensive study could be found comparing the effect of foot exercise and acupressure application on the Ankle Brachial Index in diabetic patients in our country. It is thought that acupressure application and ankle exercises will accelerate peripheral circulation and may be effective on the ankle brachial index.

This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with type 2 diabetes
* Be 18 years or older
* Ability to speak Turkish
* Ability to establish verbal communication
* Volunteering to participate in the research

Exclusion Criteria:

* Presence of any psychiatric disease diagnosed by a physician
* Presence of diabetic ulcers on both feet and legs
* Presence of any amputation in the foot or leg
* Having myalgia in the foot,
* Foot fracture
* Edema in the feet
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE, and a serum albumin level of 23-30g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary endpoint is the improvement of overt HE within 3-5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* A definite diagnosis of liver cirrhosis and overt HE
* A serum albumin level of 23-30g/L
* Age ≥18 years old
* Sign the informed consent

Exclusion Criteria:

* Contraindications to human albumin infusion
* A history of transjugular intrahepatic portosystemic shunt
* A diagnosis of acute liver failure
* Severe heart and/or lung diseases
* Psychiatric or nervous diseases
* Pregnant or lactating
Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster.

The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Exhibits at least 1 of the following risk factors for severe RSV disease:

  1. Age ≥ 60 years
  2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
  3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
  4. One or more of the following chronic lung diseases:

     * i) Bronchiectasis
     * ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
     * iii) Pulmonary hypertension
  5. Chronic cardiovascular disease exclusive of hypertension
* RSV infection confirmed ≤ 3 days before randomization
* New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization.
* RSV vaccine status:

  * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.

Key Exclusion Criteria:

* Currently requiring or expected to require hospitalization within 48 hours after randomization.
* Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
* Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
* Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
* Individuals with a history of cystic fibrosis.
* Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
* Pregnant at screening.
* Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
* Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

This research study is evaluating a new way to deliver oncology care for patients with cancer

Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. The study doctors want to know if daily electronic monitoring of the symptoms, such as pain, nausea, constipation, and diarrhea may improve care while participants are hospitalized.

The goal of this study is to evaluate a new way to deliver oncology care where patients' symptoms are systematically monitored during their hospital admission. The investigators are studying whether patients whose clinicians receive their patients' detailed symptom reports each day have improved symptom management compared to those whose clinicians do not receive their patients' detailed symptom reports each day.

The study will use questionnaires to measure the participant symptoms and involves participating in a study for as long as the participants are admitted to the hospital. The information the investigators collect will help them determine if electronic symptom monitoring improves the care of patients with cancer

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with advanced cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, oncology clinic notes, and/or trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
* Admitted to the oncology service at Massachusetts General Hospital
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Admitted electively
* Participated during a previous admission
Electroacupuncture for Diminished Ovarian Reserve

Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.


Eligibility Criteria:
Inclusion Criteria:

* Age younger than 40 yr
* 10IU/L ≤ FSH ≤ 40IU/L
* Volunteer to join the research and give the informed consent

Exclusion Criteria:

* A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation
* Reproductive system infection or tumor
* Autoimmune disease
* Amenorrhea due to reproduction abnormality or pregnancy
* Patients can not adhere to treatment due to personal situation
* Patients have taken immunosuppressive agents in past 6 months
* receive treatment for less than 1 week before withdrawal
An Early Enteral Nutrition Protocol in Shanghai

compare different enteral nutrition strategy in patients with mechanical ventilation

There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients
* Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
* Expecting MV more than 72 hours

Exclusion Criteria:

* Pregnancy
* ICU stay \< 72hr