cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

Study with completed results acquired from Horizon in 2024

Eligibility Criteria:
Inclusion Criteria:

* Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
* Did not use a NSAID within the 30 days prior to study entry

Exclusion Criteria:

* History of erosive esophagitis
* History of any of the following serious gastrointestinal complications:

  * perforation of ulcers,
  * gastric outlet obstruction due to ulcers,
  * gastrointestinal bleeding.
* Active cardiac, renal, and/or hepatic disease
* Current Helicobacter pylori (H. pylori) infection
* Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
* Uncontrolled diabetes
* Uncontrolled hypertension
* Positive pregnancy test at screening
* Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* Currently participating, or participation within 30 days prior to study entry, in an investigational drug study

Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.

Eligibility Criteria:
Inclusion Criteria:

* a. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, world health organization \[WHO\] II or III).

  b. Original clinical staged as II-IVa (according to the 8 th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-65 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

  i. With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine\< 1.5×ULN.

  j. The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.

  k. Patients must be informed of the investigational nature of this study and give written informed consent.

  l. Patients receive induction chemotherapy plus concurrent chemoradiotherpy or concurrent chemoradiotherapy, or radiotherapy alone.

Exclusion Criteria:

* Age \<18 or \>65years. c. With clinical stage of I or IVb (according to the 8 th AJCC edition). d. Patients with tumor recurrence or distant metastasis. e. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

  f. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

  g. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

  h. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

  i. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and mental disturbance.
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer

To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented NSCLC
* Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
* Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
* Only one prior anti-tumor treatment regimen in the curative setting
* Progressive disease following the previous anti-tumor treatment regimen
* Measurable disease by RECIST criteria
* Brain metastasis must be stable and well-controlled
* ECOG performance score 0-2
* All anti-tumor therapy discontinued at least 3 weeks prior to study entry
* All adverse events from prior treatment are resolved or stable
* Adequate hematologic, renal, and hepatic function
* Females must not be pregnant
* Willing to take adequate measures to prevent pregnancy
* Life expectancy of at least 3 months
* Able to complete the Quality of Life questionnaire
* Voluntarily signed informed consent

Exclusion Criteria:

* Greater than Grade 1 neurological findings
* Allergy to sulfa medications
* Previous treatment with ABT-751 or pemetrexed
* Receipt of more than one investigational agent for NSCLC
* Significant weight loss (\>10%) within 6 weeks of study entry
* Glucose-6-phosphate dehydrogenase deficiency or porphyria
* Significant systemic disease that would adversely affect participation
* Class 3-4 New York Heart Association classification status
* Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity in the study eye between 20/40 and 20/320.
* Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV.
* Any subretinal hemorrhage must comprise no more than 50% of total lesion size.

General Criteria:

* Patients of either gender, aged greater than 50 years.
* Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
* Written informed consent.

Exclusion Criteria:

* Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
* Patients who are eligible for PDT with Visudyne
* Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B.

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18-75 years;
* KPS≥70;
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
* Patients must have at least one tumor lesion that can be accurately measured;
* The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm.
* Diagnosed as unresectable with consensus by the panel of liver surgery experts;
* Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
* No past history of TACE, TAI, chemotherapy or molecule-targeted treatment;
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL;(b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits;(h) Absolute neutrophil count (ANC) \>1,500/mm3;
* Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
* Poor compliance that can not comply with the course of treatment and follow up.
Prevalence of Obesity Hypoventilation Syndrome

Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.

No additional description

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ans more
* BMI over 30 kg/M2
* Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
* Addressed to a clinical labs for a blood check-up whatever the prescription

Exclusion Criteria:

* No social security
* Non cooperative patient, as judged by the investigator
Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia

Cryptorchidism is the most common genitourinary anomaly in male children. Its incidence can reach 3% in full term neonates, rising to 30% in premature boys . The treatment of the crypt orchid testicle is justified by the increased risk of infertility and malignancy, as well as an associated inguinal hernia and the risk of trauma to the ectopic testicle against the pubis. Furthermore, the psychological stigma of a missing testis for the patient, as well as the parents' anxiety is also factors that justify this type of treatment .

About 20% of crypt orchid testicles are non palpable. The treatment of non-descended testicles is mandatory due to the increased risk of infertility, present in up to 40% of the patients, as compared to 6% of control groups, including malignancy, which reaches 20 times that of normal adults .

The treatment of the crypt orchid testis before 2 years of age is recommended, treatment is necessary not only for the risk of malignancy, but also for the satisfaction and improvement in the quality of the patient's life and parents´ concern for their children's health.

In relation to diagnosis, despite a sensitivity of 70-90% in the diagnosis of inguinal testes, ultrasonography is not useful in intra-abdominal cases . Although presenting a better quality, both computed tomography and nuclear magnetic resonance lack sufficient sensitivity and specificity to be considered as gold standard diagnostic tools . More recently, the magnetic angioresonance was introduced with sensibility of 96% and specificity of 100%, but it is still a new method, with high costs, also requiring general anesthesia in children .

In relation to the treatment, the use of gonadotrophin for un descended testes presents a success rate of definitive descent to the scrotum of 21 to 56%, with better results in bilateral cases . Surgical treatment via an inguinal incision is the main treatment option for palpable testicles, but can also be employed for the evaluation and treatment of non-palpable testis. In this situation, however, surgical exploration can often require large incisions and extensive dissections, especially in bilateral cases. This can be avoided using laparoscopic evaluation, with a sensitivity and specificity reaching more than 90%

Eligibility Criteria:
* INCLUSION CRITERIA

  1. Age above six months
  2. SEX must be male
  3. Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis
* EXCLUSION CRITERIA

  1. Age less than 3 months
  2. Patients with palpable undescended testis
  3. Any associated major congenital anomalies like cardiac anomalies
Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.

Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.

Eligibility Criteria:
Inclusion Criteria:

1. 35-80 years old
2. Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard)
3. Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA
4. Agree to participate in the clinical trial and sign the informed consent

Exclusion Criteria:

1. Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%)
2. Left ventricular ejection fraction \< 50% or heart failure
3. Other types of dementia have been diagnosed
4. Severe depression, mental illness, epilepsy
5. Not cooperating with cognitive task evaluation
BEST vCLI Registry

For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.

The study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.

Population: Patients over age 18 presenting with critical limb ischemia After initial enrollment at 40 study sites throughout the US. participants will complete follow-up 6 months and 12 months via call center telephone calls.

The study plan calls for enrollment of approximately 1,200 participants throughout the US that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.Additionally, the BEST-CLI trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of Quality of Life using validated instruments: EQ-5D, VASQOL, SF-12.and bill review to determine economic impact of disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* age 18 years or older
* Infrainguinal peripheral artery disease (occlusive disease of the arteries below the inguinal ligament)
* Critical limb ischemia, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6
* Documented consideration for enrollment in the BEST-CLI Trial with documented failure to meet inclusion / exclusion criteria. Phase ll After BEST CLI official enrollment ends, this inclusion criteria will be removed.
* Willingness to comply with vCLI protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion Criteria:

* Presence of a popliteal aneurysm (\> 2 cm) in the index limb
* Life expectancy of less than 2 years due to reasons other than peripheral artery disease
* Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
* Current chemotherapy or radiation therapy
* Pregnancy or lactation
* Administration of an investigational drug for peripheral artery disease within 30 days of randomization
* Participation in a clinical trial (except observational studies) within the previous 30 days
* Prior enrollment or randomization into the BEST-CLI trial
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).


Eligibility Criteria:
Inclusion Criteria:

- Male or female at least 18 years of age.

Exclusion Criteria:

* Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
* Female who is pregnant, breast feeding, or intends to conceive a child during the study.
* Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
Association Between Handgrip Strength and Small Airway Disease in Patients with Stable Chronic Obstructive Pulmonary Disease

The goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Is handgrip strength correlated with small airway disease in COPD patients? Participants will perform handgrip strength test and impulse oscillometry (IOS).

This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and impulse oscillometry will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Small airway disease will be assessed using IOS.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients aged 40 years or older
* Confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC \<0.7)
* Smoking history 10 pack-years or more

Exclusion Criteria:

* COPD exacerbation within 3 months
* Inability to perform handgrip strength test or impulse oscillometry