cyrilzakka/clinical-trials huggingface dataset:
Review of the Pathological Results of Appendectomy Specimens

This is a retrospective review study to evaluate the histopathological findings post appendectomy

In this study, 940 cases will be reviewed. Patient demographics, accuracy of imaging modalities, and histopathological findings will be described.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent an appendectomy in king Abdulaziz university hospital in the period between 2010-2017

Exclusion Criteria:

* Any other patients will be excluded from the study
A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes

This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening
* Screening HbA1c 7.0-10.5%
* Male or female, age 18-75 years
* Screening BMI 24.5 - 40 kg/m2
* Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential

Exclusion Criteria:

* Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor \[DPP-4i\], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
* Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening
* Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
* Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
* Has active proliferative diabetic retinopathy or macular edema
* Has a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid cancer
* Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \<5 years prior to screening
* Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
* Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening
* Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening
A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma

The purpose of this study is to compare the relapse free survival and overall survival of Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit mutation. It is assumed that Gleevec may be more effective on relapse free survival as the adjuvant treatment compared with Interferon.

If mutation tests show that the patient is eligible and they choose to participate in the study, they will be randomized and receive imatinib/Interferon. Each imatinib pill will be 100mg and the participants will take 4 pills once daily (400mg).Participants randomized to the interferon arm will receive Interferon 1500wiu/m2 d1-5 for 4 weeks followed by 900wiu IH TIW for 11 months. The following study procedures will also be performed at routine intervals throughout the course of treatment including blood tests, medical history updates, physical exams and Chest/Abdomen/Pelvic CT examinations.Participants will be on this study for one year and then be followed up to relapse or distal metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Melanoma patients whose primary tumor and regional lymphonodes (if have)have been resected
* Histologically documented AJCC stage IIB to IIIC
* C-kit mutation documented from either primary or metastatic lymphnode site
* ECOG performance status 0 or 1
* Age 18 years or older
* Creatinine \< 1.5 x ULN
* ANC \> 1500 ul
* Platelets \> 100,000 ul
* Total bilirubin, AST, and ALT \< 2 x ULN
* Amylase and lipase \< 1.5 x ULN
* no prior chemotherapy or investigational drug

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Pregnant or nursing mothers
* Any other significant medical, surgical, or psychiatric condition that may interfere with compliance
* Patient is \< 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
* Concurrent treatment with Warfarin
* Prior treatment with c-kit inhibitor
* Patient with Grade III/IV cardiac problems as defined by NYHA criteria
* No H2 blockers or proton pump inhibitors
* Known chronic liver disease
* Known diagnosis of HIV infection
* Major surgery within 2 weeks prior to study entry
* Patient has received any other investigational agent within 28 days of first study drug dosing
* Chemotherapy within 4 weeks prior to study entry
OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer

The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.

Patients will be seen in the Ovarian Cancer Clinic. Patients that have or are suspected to have ovarian cancer, and are candidates for debulking surgery based on the clinician evaluation, may be considered candidates for this study. As over 90% of ovarian epithelial cancers express folate receptor, we would expect a high percentage of these patients scheduled for surgery, to have eligible cancer types for entry into the study. These patients will be prospectively consented to participate in this trial. There will be no randomization or control group and only patients previously scheduled to undergo surgery will be eligible to participate. We anticipate a 2-year period will be necessary to reach our accrual goal of up to 10 patients.

After obtaining informed consent, patients will receive a one-time dose of 0.025 mg/kg of OTL38, infused over approximately 60 minutes and completed at least 1 hour prior to intraoperative imaging. As a prophylactic measure, we recommend 25mg of IV Benadryl to the patient prior to the infusion of OTL38 to decrease the possibility of a hypersensitivity reaction.

The duration of surgical procedures to resect ovarian cancers varies substantially, anywhere from 3- 8 hours or more. During the phase 2 study, the median time spent imaging the patients with a single camera was 14 minutes. Utilizing two cameras to complete imaging would not overly increase the duration of time patients spend under anesthesia. However, there is a chance that being under anesthesia for the additional 25-35 minutes could put the patient at an increased risk of having of a common side effect associated with anesthesia. These common side effects include, but are not limited to: nausea and vomiting after surgery, sore throat and hoarseness, shivering/chills, confusion, and muscle aches

Eligibility Criteria:
Inclusion Criteria:

* Female patients \> 18 years of age
* Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
* Good operative candidate as determined by clinical presentation and laboratory assessments
* Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

* Pregnant women as determined by urinary or serum beta hCG.
* Patients with a history of allergy to any of the components of OTL38, including folic acid
* Known FR-negative ovarian cancer
* Patients with a known allergy to Benadryl
* Previous exposure to OTL38
* Vulnerable populations: the homeless, prisoners or not capable of participating in the consent process
Effectiveness of A Health Microinsurance Scheme for Private Primary Care in Malaysia

This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and effectiveness of a health microinsurance scheme in improving health equity and clinical outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post, quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and normal OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed households to access a defined benefit package at a selected PPC for treatment and follow-up.

This will be a quasi-experimental study designed to determine the effectiveness of a community health microinsurance scheme (HMI) in private primary care clinics in Malaysia via a pre-post study of an experimental and control clinic. A proposed HMI scheme, whose price and benefit package have been defined through the earlier Phases 1 and 2, will be accessible to subscribed households at the experimental clinic, while the control clinic has subscribed patients paying as per normal practise, which is by Out-Of-Pocket payment. The HMI scheme enabled subscribers to visit the selected clinic chosen for any form of primary care diagnosis, treatment and follow-up. Both the clinics are located in the Jalan Ipoh area, a suburb of Kuala Lumpur, and have common sociodemographic characteristics. A pre-intervention questionnaire will aim to capture health seeking behaviour, delay in seeking medical care, monthly health expenditure and improvements in clinical outcome (assessed by clinical test results). After six months, a post-intervention questionnaire is administered again to the respondents which then allows assessment of the outcome variables.

Eligibility Criteria:
Inclusion Criteria:

1. Households were located in the study area
2. Method of payment to clinic is by out-of-pocket
3. This is household's regular choice of primary care provider.
4. Patient has been seen in the clinic since at least the past two years i.e from before Jan 1, 2014

Exclusion Criteria:

1. Households had members who died in the year 2014.
2. Households had members who were away from this place of residence for work/transferred for more than 1 month in 2014.
3. Households had members who had regular follow-up in public facilities for chronic disease.
4. Households with members who have switched methods of payment in the last year- (e.g newly bought insurance or retired and lost health benefits so paying OOP)
5. Patients who refuse consent
The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment

Cervical spine disorders can cause neck pain with or without neurological dysfunction. The most common cause of acute and chronic neck pain is cervical degenerative changes. Surgical decision of cervical pathology is made by anamnesis, neurological examination and imaging methods. Airway management can be difficult for patients presenting for cervical spine surgery. In addition, these patients may have severe cervical spine instability or spinal cord level myelopathy and may develop serious neurological complications associated with the intubation technique. Videolaringoscopes, which have become widely used with the developing technology, provide a better view than direct laryngoscopy in terms of cervical immobilization during intubation. Therefore, videolaryngoscope is preferred for cervical pathologies. Nowadays, the use of videolaryngoscope is recommended in patients with airway difficulty. Neutral position is important for intubation of patients with cervical pathology and it is highly recommended in the literature to evaluate these patients as difficult airways. All cervical patients are intubated with videolaryngoscope in investigator's clinic. The aim of this study was to evaluate how long the duration of cervical pathology affects airway anatomy and how it affects airway management during anesthesia. On the other hand, airway-related measurements will be performed by MRI and ultrasonography (USG), which is routinely evaluated in the diagnosis process, and it will be aimed to evaluate these measurements in terms of their effects on intubation quality. At the end of the study, all evaluations were analyzed and it was aimed to compare the effects of other evaluated parameters (such as USG and MRI measurements) on intubation difficulty level, with cervical pathology duration being primary.


Eligibility Criteria:
Inclusion Criteria:

- Elective cervical surgery

Exclusion Criteria:

* Patients undergoing emergency surgery
* Cervical tumor patients
* Patients with cognitive dysfunction
* Patients with previous cervical surgery
* Pediatric patients
* Cervical trauma patients
* The presence of cervical spondylitis, spondylodiscitis
Exceptional Experiences (EE), Salience & Dopaminergic Neurotransmission

The dopamine hypothesis of schizophrenia implies that alterations in the dopamine system cause functional abnormalities in the brain that may converge to aberrant salience attribution and eventually lead to psychosis. Indeed, widespread brain disconnectivity across the psychotic spectrum has been revealed by resting-state functional magnetic resonance imaging (rs-fMRI). However, the dopaminergic involvement in intrinsic functional connectivity (iFC) and its putative relationship to the development of psychotic spectrum disorders remains partly unclear - in particular at the low-end of the psychosis continuum. Therefore, the investigators examined dopamine-induced changes in striatal iFC and their modulation by psychometrically assessed schizotypy. The randomized, double-blind placebo-controlled study design included 54 healthy, right-handed male participants. Each participant was assessed with the Schizotypal Personality Questionnaire (SPQ) and underwent 10 min of rs-fMRI scanning. Participants then received either a placebo or 200 mg of L-DOPA, a dopamine precursor. The investigators analyzed iFC of six striatal seeds that are known to evoke modulation of dopamine-related networks.

The investigators hypothesized that, within the L-DOPA treatment group, the striatal iFC would be disrupted due to increased availability of dopamine. The investigators further hypothesized that individuals with high schizotypal scores would show a disruption of striatal connectivity, as has been reported with schizophrenia. In addition, the investigators hypothesized that the L-DOPA-dependent change in striatal iFC would interact with the severity of positive symptoms, as has been found in previous studies in non-clinical psychosis. The investigators anticipated this symptom-dependent change, especially in the ventral striatal regions, because these are thought to modulate cortico-striatal loops associated with cognition and emotion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* Between 20 and 40 years of age,
* With exceptional experiences or skeptics,
* Caucasian origin,
* Normal visual and acoustic accuracy.

Exclusion Criteria:

* Persons with a personal or first-degree family history of neurological and psychiatric disease, including impaired cognitive abilities,
* Pregnant or breastfeeding women,
* Chronic or acute pain,
* Acute or chronic somatic disease,
* Women (i.e. only men included),
* Men over 40 years of age or below 20,
* left- or mixed-handedness,
* General MRI exclusion criteria,
* General Dopamine-Challenge exclusion criteria,
* Hormonal or herbal therapy,
* Smoker.
A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda \[capecitabine\] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>/=18 years of age
* metastatic colorectal cancer
* at least 1 measurable lesion according to RECIST v. 1.1
* patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
* disease progression \</= 8 weeks after last dose of Avastin
* ECOG \</=2
* No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin

Exclusion Criteria:

* disease progression \> 8 weeks after last Avastin administration
* clinically significant cardiovascular disease
* CNS disease except for treated brain metastasis
* history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
* major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients

we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.

This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization

Exclusion Criteria:

* Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.
Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery

Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)


Eligibility Criteria:
Inclusion Criteria

* Man or woman 18 years of age or older
* Scheduled for corneal transplant surgery
* Patients must be healthy enough to undergo surgery
* Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
* Women must be abstinent at the discretion of the investigator
* Women practicing an effective method of birth control
* Women agree before entry to continue to use the same method of contraception throughout the study
* Women of childbearing potential must have a negative urine pregnancy test at screening

Exclusion Criteria

* Presence of an active ocular infection or positive history of ocular herpetic infection
* History of severe dry eye syndrome
* Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
* Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
* Pregnant or breast feeding
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center as well as family members of the employees or the investigator
Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

On the basis of the current study, amlodipine seems to be a promising drug on improving uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and pregnancy outcome in patients with pco.

To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.

Eligibility Criteria:
Inclusion Criteria:

* Demographic features including females in age of ≥20 \& ≤35, and BMI of ≤39.
* Infertility secondary to polycystic ovary , The choice of polycystic ovary patients will be according to the Rotterdam consensus workshop (Rotterdam, 2004), and the diagnosis of polycystic ovary by ultrasonography will be made according to Adams et al. criteria which are the most often cited (Adams et al., 1985).The Rotterdam criteria as follows:

  * Oligo- or anovulation.
  * Clinical and/or biochemical signs of hyper androgynism
  * The presence of polycystic ovaries on ultrasound scan. Ultrasound findings of enlarged ovaries with multiple small cysts (10-12 or more of 2-9 mm in diameter) scattered around the periphery and highly echogenic stroma

Exclusion Criteria:

* Including other causes of infertility diagnosed during infertility work up.
* Patients refused to participate or to continue study.
* Also, hepatic, cardiac, and hypotensive patients will be excluded from the study.
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection

This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106 in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.


Eligibility Criteria:
Inclusion Criteria:

* Infection with hepatitis C genotype 1 or mixed hepatitis C genotype;
* Asymptomatic or nearly asymptomatic from hepatitis C;
* Previous therapy with interferon and ribavirin or peginterferon and ribavirin without an SVR or relapsed following an SVR;or Interferon naive subjects
* Chronically infected (at least 6 months since diagnosis) HCV-positive subjects;
* No evidence of bridging necrosis or cirrhosis;
* Liver biopsy within the last 2 years

Exclusion Criteria:

* Acute hepatitis C infection
* History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;