cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA

RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.

Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following inclusion criteria will be eligible to participate in the study:

1. Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;
2. Age \> 18 years old;
3. the extrapulmonary manifestations of RA were stable;
4. Patients with NSAIDs tolerance;
5. DAS28-ESR is highergreater than 2.6.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Patients with acute and chronic infection;
2. Platelet count \< 80\*10\^9/L, or white blood cell \< 3\*10\^9/L;
3. ALT or AST is 2 times higher than the upper limit of normal value;
4. Renal insufficiency: serum Cr ≥ 176 umol/L;
5. Pregnant or lactating women (breastfeeding);
6. Have a history of malignant tumor (the cure time is less than 5 years);
7. Patients with severe hypertension and cardiac insufficiency;
8. Other diseases or conditions in which immune suppressants cannot be used;
9. People who are allergic to TF.
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness

The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

Mass treatment with ivermectin (Mectizan, Merck \& Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.

Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth \[po; maximum 600 mg/day\]); B (azithromycin 12 mg/kg po \[maximum 500 mg/day\]); C (combination of rifampin 20 mg/kg po \[maximum 600 mg/day\] and azithromycin 12 mg/kg po \[maximum 500 mg/day\]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).

Nodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant/non lactating females \>5 years of age
* One onchocercal nodule in an anatomical position where it can be easily removed surgically

Exclusion Criteria:

* Pregnancy (based on urine pregnancy test)
* Breast-feeding
* Women taking oral contraceptives
* Allergy or other adverse reaction to either medication
* Use of other medications that might interact with rifampin
* Clinical evidence of liver disease (jaundice, swollen abdomen)
* Clinical evidence of chronic disease/alcoholism
SAPIEN 3 Ultra EU PMS

This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

This is a prospective, observational, single-arm, multicentre, post-market study.

Eligibility Criteria:
Inclusion Criteria:

1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
2. Less than 80 years of age at time of the procedure
3. Low surgical risk
4. Meets clinical and procedural requirements for early discharge
5. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent

Exclusion Criteria:

1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
2. Considered to be part of a vulnerable population
3. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
4. Cannot tolerate an anticoagulation/antiplatelet regimen
5. Active bacterial endocarditis
6. Participating in a drug or device study that has not reached its primary endpoint
Prevelance of Keratoconus

Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Patients who are at an advanced stage of ectasia are often led to corneal transplant or other treatments, which essentially aim at correcting the refractive error and not in treating the ectasia. The top of the protruding cone that corneal configuration may be close to the visual axis or below and nasal of that. The disease manifests during adolescence, followed by slow progressive course, although it is possible to stabilize anytime. In 85% of cases both eyes are affected, but the severity of the attack can present significant asymmetry.

Often in keratoconus a positive family history is present. Prevelance of keratoconus varies greatly worldwide.The reported prevalence of keratoconus varies widely depending upon the geographic location, diagnostic criteria used, and the cohort of patients selected. Environmental factors may contribute to the wide variation in prevalence.

the Middle East have higher prevalence than locations with cooler climates and less sunshine

Eligibility Criteria:
Inclusion Criteria:

1. persons attending refractive surgery centers in Asssiut.
2. patients found to have keratoconus are included , based on history , clinical examination and corneal topography

Exclusion criteria :

1. patients not attending those refractive surgery centers.
2. patients attending these centers but not diagnosed to be keratoconus .
3. Pregnancy or breastfeeding
Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers

To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males
* 18 - 45 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance and/or alcohol abuse within the past 3 years
* Use of tobacco-containing or nicotine-contining products within 6 months
* Use of any prescription of over-the-counter (OTC) medication within 14 days
Correlation Between H.Pylori Colonization and Gastritis

To study the prevelance rate of H.pylori colonization in patients with gastritis.

To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori colonization and endoscopic finding with clinical manifestation.

Helicobacter pylori is a gram negative microaerophilic spiral bacterium that is usually found in the stomach and thereby cause infection , which is associated with varying degrees of damage of superficial and glandular epithelium.

Chronic gastritis is a histological entity that is defined by an inflammatory infiltrate of lymphoblasma cells, cocsometimes polynuclear neutrophils and by progressive glandular atrophy of the gastric mucosa,and probably the main cause of chronic inflammation in the gastric mucosa which is usually caused by H.pylori infection.

In addition to chronic gastritis almost all benign gastroduodenal diseases including peptic ulcer , mucosa associated lymphoid tissue lymphoma and malignant gastroduodenal adenocarcinoma occurs due to previous H.pylori infection that is usually started with gastric precancerous lesion, gastric atrophy , gastric intestinal metaplasia , dysplasia and then turned to gastric carcinoma.

So the evaluation of H.pylori infection status yo non-infection, past infection, current infection by endoscopy has therefore become increasingly important.

The Sydney grading system is one of the most important recognised tools yo charactize histological lesions of chronic gastritis.

The system categorise gastritis according to intensity of mononuclear inflammatory cellular infiltrate , polymorph activity , atrophy , intestinal metaplasia and H.pylori density into mild , moderate and severe categories, but up till now there is non-standard histology reporting formats are still widely used for gastritis and even specialists are often frustrated by the histological definition that make it difficult to identify candidates for clinico-endoscopic surveillance.

Therefore the eradication of this bacterium aimed to interrupt the carcinogenesis process and prevent recurrence of gastritis and peptic ulcer disease.

However despite of the significant researches conducted on H.pylori colonization in gastric mucosa and its association with endoscopic finding and severity of clinical manifestations, and its impact on the Egyptian population is still a topic of debate.

Currently, there is no study has definitively determined this relationship in the Egyptian population despite the high prevalence rate of H.pylori infection

Eligibility Criteria:
Inclusion Criteria:

- All patients with gastritis above 18 years old with chronic H.pylori infection documented by histological examination included in the study.

Exclusion Criteria:

All patients mentioned above who have previous gastrointestinal surgery and patients below 18y .
Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study

This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.

This study's objectives include: 1) develop a better understanding of the composition and structures of breast milk over the early stages of lactation with specific emphasis on the glycans and lipids; 2) how glycan diversity relates to maternal and infant gut microbiota with an emphasis on bifidobacteria species; 3)how milk composition and structure relate to maternal health and diet.

These samples will be analyzed using comprehensive gas and liquid chromatographic methods, nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS); and next generation sequencing, terminal restriction fragment length polymorphism and quantitative polymerase chain reaction.

There are several cohorts to the main study.

Gestational Diabetes Mellitus Cohort. The aim of this study is to investigate the differences between milk composition, infant and maternal gut microbiota from women with and without gestational diabetes mellitus or type 2 diabetes vs. controls.

Fresh Milk Study. The aim of this study is to elucidate the relationship between the expression of glycan metabolizing genes of mammary epithelial cells and levels of milk glycans.

RNA Study. The aim of this study is to compare the RNA of milk fat globule membrane crescents in human milk against epithelial expression profiles in non-human primate milk.

Skin Study. The aim of this study is to provide skin samples from healthy term infants to act as the control group for a different study with preterm infants.

Breast Milk, Gut Microbiome, and Immunity (BMMI) Project. The aim of this study is to provide healthy control samples for the BMMI project. The BMMI project is a multi-investigative project designed to elucidate how maternal nutrient status, and milk composition and structure influence infant gut microbiome from participants in developing countries.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years and older who plan to breastfeed for at least 6 months
* Women who are in good health
* Women with or without diagnosis of gestational diabetes mellitus, or type 2 diabetes mellitus or impaired glucose tolerance

Exclusion Criteria:

* Women who do not plan to breastfeed for at least 6 months
* Women who give birth to pre-term infants
* Women who smoke, either currently or 1 year before becoming pregnant
* Women who have chronic medical conditions or communicable diseases
* Women who take metabolic altering drugs such as corticosteroids or thyroid medication
Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy adults
* Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
* Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria:

* Known CAD, DM, uncontrolled HTN
* Pregnancy or unable to complaint with the birth control method required
Prospective Evaluation of Etravirine for HIV-infected Patients in Need of Lipid-lowering Drugs

Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL) cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in HIV-infected individuals, and has been associated with HIV infection itself and antiretroviral therapy (ART). These abnormalities are well-established markers of cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk of CVD associated with ART exposure over and above that conveyed by traditional cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual clinical strategy remains to add a statin treatment.

Recent studies suggested ART switch can represent an interesting alternative to statins to reduce lipid plasma levels.

The purpose of this study is to evaluate the frequency with which the replacement of LPV/r (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate the necessity to administer statins.

A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.

At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined. Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will be measured at baseline, at drug switch and at the end of the study

Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for study drug will be done at week-4 and week-12, Returned study medication will be counted and the amount notified on the Case Report Form (CRF).


Eligibility Criteria:
Inclusion Criteria:

* On statin treatment for at least 3 months (fluvastatin, simvastatin, pravastatin, rosuvastatin, or atorvastatin) for primary prevention of cardiovascular disease
* HIV Ribonucleic Acid (RNA) below 50 copies/mL, minimum duration 3 months
* On a stable (\> 3 months) ARV treatment including at least one of the following drugs: LPV/r, ATZ/r, DRV/r, or EFV
* No previous virological escape or virological escape documented with a genotype at the time of failure only showing a K103M mutation.

Exclusion Criteria:

* Probability of cardiovascular complications of \> 20% according to the Swiss GSLA ("Groupe de travail Lipide et Athérosclérose"/Swiss Atherosclerosis Association) guidelines
* Previous cardiovascular disease (including stroke)
* Known diabetes
* Known intolerance of ETR
* Presence of a documented drug mutation (excluding the K103M)
* Regimen including non-boosted ATZ
* Known hyperlipidemia before ARV initiation
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with haemophilia A or B with inhibitors
* Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed activated recombinant human factor VII
* Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities
* Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn)

Exclusion Criteria:

* Known hypersensitivity to the active substance or the excipients in the formulation of activated recombinant human factor VII, or to mouse, hamster or bovine protein
Quantra QPlus Sample Type Comparison

This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
* Subject is ≥18 years
* Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.

Exclusion Criteria:

* Subject is younger than 18 years
* Subject is pregnant
* Subject is incarcerated at the time of the study
* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
* Subject, or subject's legally aurthorized representative is able to provide written informed consent
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of endometrioid endometrial carcinoma.
* Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent.
* Participant has received at least 1 but not more than 3 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination.
* PI3K/AKT/mTOR pathway gene alteration identified.
* At least 1 measurable target lesion according to RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods..

Exclusion Criteria:

* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study
* Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
* Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
* Clinically significant hemoptysis or tumor bleeding.
* Significant cardiovascular impairment.
* Active, uncontrolled (requiring systemic antimicrobial therapy) infection.
* Concurrent participation in another therapeutic clinical trial.
* Prior radiation therapy within 21 days prior to start of study treatment.
* Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.
* Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH.
* Prolongation of QTc interval to \>480 ms.
* HbA1c ≥ 8.0%, fasting serum glucose \> 160 mg/dL, fasting triglycerides \> 300 mg/dL or receiving treatment with insulin.
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Low rectal cancer below 5 cm from the anal verge
* Fit for laparoscopic total mesorectal excsion
* T2, T3 rectal cancer
* No distant metstasis

Exclusion Criteria:

* T1, AND T4
* Distant metastasis
* Tumor infiltrating the dentate line
* unwilling to participate