cyrilzakka/clinical-trials huggingface dataset:
Effect of MK0524A on Cholesterol Levels (0524A-048)

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female between 18 and 70 years of age
* Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria:

* Patient has a history of not being able to take niacin or niacin-containing products
* Patient consumes more than 2 alcoholic beverages per day
* Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
* Patient engages in vigorous exercise or an aggressive diet regimen
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)

This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
* At least Intermediate 1 risk MF according to the DIPSS.
* Prior treatment with ruxolitinib and/or fedratinib monotherapy
* Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF.
* Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
* Allogeneic stem cell transplant not planned.
* Platelet is greater than or equal to 50 × 109/L at screening.
* Ability to comprehend and willingness to sign a written ICF for the study.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
* Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
* For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
* Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
* Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
* Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
* Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
* ECOG performance status ≥ 3
* Life expectancy less than 24 weeks
* Not willing to receive RBC or platelet transfusions
* Participants with laboratory values at screening outside of protocol defined ranges
* Significant concurrent, uncontrolled medical condition
* Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor
* History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
* Evidence of HBV or HCV infection or risk of reactivation
* Known HIV infection.
Effect of HIIT VS Yoga on Level of Pain, Catastrophizing and QoL in Dysmenorrhea

This study is aimed at determining the effect of high intensity interval training VS yoga on pain, catastrophizing and quality of life among young females with dysmenorrhea.

Dysmenorrhea is defined as a pain experienced by females before or during menstruation and it is a common and important gynecological condition found in females of reproductive age that adversely affects their quality of life. The cause of PD is believed to be the excess release of prostaglandins during normal ovulation cycle.

The health care costs were altogether higher among females with dysmenorrhea compared with females who didn't experience the ill effects of this condition, and excess costs were essentially determined by outpatient care, so poses greater burden of disease than any other gynecological complaint. Females having more pain catastrophizing scores leads to increases chances of disability. Proper evidence behind HIIT training among females with primary dysmenorrhea is sparse and is based on different clinical experiences and a less number of studies with limited methodological design.

Eligibility Criteria:
Inclusion Criteria:

* Unmarried Females with age 18-25 years
* Normal Menstrual cycles 21-35 days
* Primary Dysmenorrhea diagnosis made on the WaLIDD score
* WaLIDD score of 1- 7 (Mild to moderate dysmenorrhea)

Exclusion Criteria:

* History of regular exercise (3 times weekly for 30-45 min)
* Motor Disabilities ( ALS, Multiple sclerosis, Muscular dystrophy )
* Autoimmune conditions (RA, Hashimotos Thyroiditis)
* Chronic illnesses that might contraindicate physical exercise (asthma, epilepsy, migraine, anemia, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension)
Appendicitis With Medical Treatment

prospective study to collect data of patients with appendicitis, not receiving operation

using ultrasound to follow up the resolution of acute appendicitis

Eligibility Criteria:
Inclusion Criteria:patients with appendicitis, not receiving operation -

Exclusion Criteria:nil

-
REmote Ischemic COnditioning in Septic Shock

Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalization in an intensive care unit for less than 24 hours
* Septic shock evolving for less than 12 hours defined as:
* Documented or suspected infection
* Norepinephrine administration to maintain a mean arterial pressure ≥ 65 mmHg after volemia correction
* Lactatemia \> 2 mmol/L at least once in the past 12 hours before inclusion
* Written informed consent signed by the patient or by a next of kin or oral consent given by the patient and as soon as permitted by the clinical state written informed consent signed by the patient.

Exclusion Criteria:

* Patient who has expressed the wish not to be resuscitated
* Contraindication of the use of brachial cuff on both arms
* Intercurrent pathology with an expected life expectancy of less than 24 hours
* Cardiac arrest
* Female patients currently pregnant or women of childbearing age who are not using contraception
* Previous inclusion in RECO-Sepsis study
* Previous inclusion in another clinical study
* Patients without health coverage
Afatinib Plus Nimotuzumb for NSCLC

To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of stage IIIB or IV NSCLC
* Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
* Disease progression on treatemtn with gefitinib or erlotinib within 30 days
* Biopsy on disease progression
* Age ≥20 years
* ECOG performance status of 0, 1, or 2
* Measurable disease by the criteria of RECIST 1.1
* Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 45 mL/min

Exclusion Criteria:

* Known interstitial lung disease
* Prior treatment with EGFR targeting antibodies or BIBW 2992
* Prior three or more lines of chemotherapy for advanced NSCLC
* Significant bowel disease impairing drug absorption
* Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
* Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.
Topical Ruxolitinib Evaluation in Chronic Hand Eczema

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting \> 3 months or ≥ 2 flares within the previous 12 months.
* Screening and baseline IGA-CHE 3 or 4.
* Baseline CHE-related Itch NRS ≥ 4.
* Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
* Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.

Exclusion Criteria:

* Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
* Any serious illness or medical, physical, or psychiatric condition(s).
* Laboratory values outside of the protocol-defined criteria.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Dome-type (Modified C-incision) Manual Morcellation During Laparoscopic Uterine Surgery

In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported. Therefore, we developed a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.

Background: In-bag manual morcellation is a safe alternative procedure after FDA's discouragement of electronic power morcellator. The traditional wedging (V-type incision) or semicircular coring (C-type incision or ExCITE) method are the most common morcellation techniques. For beginners, it is somehow not that easy to get familiar with these methods. No teaching or learning experiences were reported.

Objective: To describe using a dome-type (modified C-incision) technique to manually morcellate uteri leiomyoma or uterus at the time of laparoscopic surgery and report perioperative outcomes and the learning experiences of our residents for this technique from our two years of experience.

Study Design: Retrospective review of consecutive laparoscopic myomectomies or hysterectomies performed between May 2020 and September 2022 in which the specimen was manually morcellated using the dome-type technique by surgeon or trainees.

Eligibility Criteria:
Inclusion Criteria:

* Women at any age undergoing laparoscopic surgeries with dome-type morcellation

Exclusion Criteria:

* Women with extremely huge specimen (\>2000 gm)
A Study to Evaluate the Safety and Tolerability of ILB-202

This is a Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single Ascending Doses to Healthy Participants. Male or female subjects aged 18 to 50 years (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.

ILB-202 is an engineered exosome loaded with super-repressor IκBα. This is Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study.

Healthy volunteers, 18-55 years of age, selected from healthy participants fulfilling the inclusion/exclusion criteria.

18 subjects will participate in the study. Doses of investigational product (IP) will be administered intravenously on Day 1. During the Screening Period (within the 28 days) each subject will be assessed for eligibility. Each subject must sign and date an informed consent form (ICF) prior to undergoing any study-related procedures.

All dosed subject samples will be analyzed and their data will be included in the final study report.

Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and must be able to understand the full nature and purpose of the trial.
* Aged 18 to 55 years of age (inclusive).
* A body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 .
* Medically healthy male or female volunteers, without clinically significant abnormalities.
* Conventional 12-lead ECG recording in triplicate consistent with normal cardiac conduction and function.
* Must be of non-child-bearing potential, or must be on a suitable birth control method.

Exclusion Criteria:

* History or evidence of any clinically significant condition and/or other major disease or malignancy.
* History of drug allergies and drug or alcohol abuse .
* Clinically significant abnormalities in the physical examination, vital signs, ECG or clinical laboratory tests.
* Exposure to any prescription medications or, administered over the counter drugs, dietary supplements, or herbal remedies, within 14 days or 5 half-lives, prior to dosing.
* Received treatment with immune-suppressive or immune-modulative medication within 90 days prior to dosing.
* Exposure to biologics within 6 months prior to dosing.
* Participation in another clinical trial within 30 days (or 6 months for biologics) prior to dosing.
Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer

This study was a multicenter, retrospective cohort study. Although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. Anastomotic leakage (AL) complications directly impinge on postoperative quality of life and pose life-threatening risks if inadequately managed. Given AL's adverse prognostic implications and the financial strain on patients' families, identifying its risk factors aids in perioperative risk assessment, enabling timely clinical decisions on interventions to enhance prognosis and curtail adverse outcomes and economic investments.

Optimal cytoreduction, particularly in advanced cases, significantly extends 5-year survival compared to cases with residual disease exceeding 1 cm. Consequently, ultra-radical tumor cytoreduction procedures, commonly performed in advanced ovarian cancer, entail the excision of abdominopelvic tissues affected by the primary ovarian malignancy, including segments of the bowel, bladder, spleen, gallbladder, diaphragm, and other organs. Rectosigmoid resection (RSR) emerges as the predominant bowel resection, followed by colon and small bowel resections. Intestinal anastomosis post-RSR is indispensable for bowel reconstruction but bears a notable risk of postoperative anastomotic fistula (AL), a major complication. AL incidence rates fluctuate over time, reported between 8-14% in OC surgery patients undergoing RSR.

AL imposes considerable burdens, encompassing elevated hospital costs, prolonged stays, heightened rates of secondary admissions and surgeries, and mortality rates ranging from 3% to 21%. Furthermore, AL delays the commencement of adjuvant chemotherapy, detrimentally impacting overall survival and representing a significant consequence of colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with postoperative pathological diagnosis of primary ovarian, fallopian tube or peritoneal cancer
2. Patients undergoing tumour cytoreductive surgery combined with colorectal resection and stage I intestinal anastomosis
3. No history of other malignant tumours
4. Complete case data

Exclusion Criteria:

1. Previous combination of malignant tumours of other organs
2. Comorbidities with serious diseases related to other organs
3. Patients undergoing secondary tumour cytoreduction
Association Between Cancer Cells and Normal Versus (Vs.) Low Levels of Thyroid Hormones in the Serum

Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3, commonly over-expressed on many cancer cells. In the experimental settings, mimicking hypothyroidism in the cells is a difficult task. Currently, the use of charcoal stripped serum is used. Using this method, the serum is stripped not only from T3 and T4, as intended, but also from central and important cytokines and growth factor. This leads to a reduced rate of cancer cell proliferation and thus, does not reflect the natural environment in which cancer cells residue under hypothyroid conditions.

The investigators aim to characterize and establish the effects of serum from hypothyroid patients on the proliferation/viability of a variety of cancer cell models.


Eligibility Criteria:
Inclusion Criteria:

* Hypothyroid state

Exclusion Criteria:

* Non hypothyroid state
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.

People who suffer from migraines have many prescription medications to choose from, both to treat the migraine and to prevent it from starting. However, many patients have not had success in finding the drug that helps them best. Amitriptyline, an antidepressant, has been used successfully for many years to prevent migraine headaches. This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate, an anti-seizure drug, in preventing migraines. The safety of both drugs will also be assessed. The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines. During the first 4 weeks of the study, topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose, whichever is less. Treatment will continue at 100 mg per day for 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months
* no more than 15 headache days in the previous month before study start
* no heart rhythm problems or neurologic problems
* women must not be pregnant and must use birth control

Exclusion Criteria:

* Cannot have failed at least 2 previous trials of migraine prevention drugs
* cannot have failed a previous trial of topiramate or amitriptyline
* no cluster headaches
* no migraine with aura without headache
* no pain that is worse than the migraine pain
Resident Memory T Cells in Vitiligo

This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.

* Written informed consent obtained from every participant.
* Detailed history taking including onset, course, duration of the disease, aggravating factors and received medications
* VASI score assessed in every patient.
* Patients photographed, divided into two groups early \& late cases and 3 mm punch biopsies will be taken from perilesional and non lesional skin.
* Biopsies processed and stained for CD8 \& CD69 in cases of early group, \& late group and controls by immunofluorescence.

Eligibility Criteria:
Inclusion Criteria:

* - Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).
* Both genders.
* Early group: onset less than or equal 6 months.
* Late group: onset more than 6 months

Exclusion Criteria:

* Localized or Segmental Vitiligo.
* Age \< 14 years.
* Pregnant females
* Patient who received treatment of any type within the last 3 months for the late group.
* Patients with other skin diseases or immunosuppression
Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

OBJECTIVES:

I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.

II. Determine the toxicity of this drug in these patients.

PROTOCOL OUTLINE:

Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.

Patients are followed monthly for 6 months, and then every 3 months thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4 American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on SLEDAI

OR

Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy

--Patient Characteristics--

Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times normal

Renal: Creatinine no greater than 3.0 mg/dL

Cardiovascular: Ejection fraction at least 45%

Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other: Not preterminal or moribund; not pregnant or nursing; fertile patients must use effective contraception
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study

This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers.

Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Aged 18 years or older at the time of starting therapy with CDKi 4/6.
* Breast cancer diagnosis.
* At least one record of ribociclib or palbociclib donation during the identification period.
* Registration of the first supply of ribociclib or palbociclib between 1 March 2019 and 31 December 2019.

Exclusion Criteria:

* Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.