cyrilzakka/clinical-trials huggingface dataset:
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.

The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility Criteria:
Main inclusion criteria:

* In general good health other than gastroesophageal reflux disease (GERD)
* History of GERD-related symptoms for at least 6 months prior to inclusion into the study
* Endoscopically confirmed gastroesophageal reflux disease

Main exclusion criteria:

* Acute peptic ulcer and/or ulcer complications
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day
* Intake of Proton Pump Inhibitors and Histamine 2-receptor antagonists within the previous 14 days
* Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents
* Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception
PSG Versus Oxim-capnography to Setup Home NIV

The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.

The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

Eligibility Criteria:
Inclusion Criteria:

* COPD (as defined by GOLD criteria\[4\])
* OSA (ODI \> 7.5 events/hr, AHI \> 5events/hr)
* PaCO2 \> 6 kPa
* BMI \> 30 kg/m2

Exclusion Criteria:

* Decompensated respiratory failure (pH \< 7.35)
* Inability to tolerate NIV (\< 4 hours usage at in hospital titration)
* Contraindication to NIV
* Pregnancy
* Aged \<18
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
* Age from 18 to 70 years old
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* ECOG 0-1
* Expected life time longer than 12 weeks
* Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion Criteria:

* Patients have not used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception
Trial With Metformin in Women With Polycystic Ovary Syndrome

The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.

Eligible women who gave written informed consent were assigned to 6 months of treatment with either 850 mg of metformin or placebo twice daily, followed by a wash-out period of 3 months before cross-over to the alternate treatment for another 6 months. Randomization defining treatment sequence was done at inclusion by random number tables. The appearance of the tablets was identical, and patients and investigators were blinded to treatment allocation. The randomization code was stored in a closed envelope until all participants had finished the treatment. Participants were seen by one of the investigators before inclusion and every second month during treatment periods, always in the morning after an overnight fast of at least 8 h. They were weighed wearing light clothing. Waist circumference was measured at the umbilical level and hip circumference at the trochanter region. Systolic and diastolic blood pressure was measured with a semiautomatic blood pressure monitor and a blood sample was drawn for immediate analysis without respect to bleeding periods. All participants registered their bleeding periods in a calendar during both study periods and the 3 months wash-out period. Calculation of sample size was based on the assumption that at least 50% of the women would experience at least 30% more menstrual periods on metformin than on placebo. Based on a power of 90 (b = 0.10) to detect a significant difference \[two-sided P-value of 0.05\], the minimum sampling size was calculated to 44 subjects.

We also assumed a 10% drop-out rate, and thus aimed at including 50 women. As drop-out rate quickly rose higher than expected, we decided to include 60 women. In the intention-to-treat analysis, the values of each participant after 6 months of metformin or placebo were compared with the baseline values. Linear regression analysis with the changes in testosterone and homeostasis model assessment (HOMA) index as dependent variables was performed to examine potential relations between the changes. The per protocol analysis included data from participants completing both study periods, i.e. the difference between the values of each participant after placebo and metformin, respectively, was calculated, and a significance test performed on the differences.

Eligibility Criteria:
Inclusion Criteria:

* testosterone value above the upper normal limit and
* oligo- or amenorrhea,

Exclusion Criteria:

* periclimacteric gonadotrophin values,
* hyperprolactinaemia,
* diabetes mellitus,
* impaired thyroid,
* renal or hepatic function,
* hormonal treatment,
* pregnancy,
* lactation or a wish for fertility treatment.
A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.

A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.

This study is designed to assess the mass balance of \[14C\]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.

Eligibility Criteria:
Inclusion Criteria

* Subject must be \>/= 18 years of age.
* Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
* Eastern cooperative Oncology Group (ECOG) Performance Score of 0 to 2.
* Subject must have adequate bone marrow, renal and hepatic function.
* Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \</= 1.5.
* Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent.

Exclusion Criteria

* Subject has received previous administration of a radiolabeled research substance within 12 months prior to Study Day 1 or exposure to significant radiation (e.g., barium meal, etc.) within the past 3 months or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
* Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
* Subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g., rifampin) of cytochrome P450 3A (CYP3A) within 1 month prior to Study Day 1.
* Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy.
* Subject has undergone major surgery within 21 days of Study Day 1.
* The subject has brain or meningeal metastases.
* The subject has non-small cell lung cancer (NSCLC) with a predominant squamous cell histology.
* Subject is receiving therapeutic anticoagulation therapy.
* Subject has a history of/or currently exhibits clinically significant events of bleeding (e.g., hemoptysis).
* Subject has proteinuria Common Terminology Criteria (CTC) Grade \> 2 at baseline.
* Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
* Subject has a history of myocardial infarction within 6 months.
* Subject has known autoimmune disease with renal involvement.
* Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV).
* Clinically significant uncontrolled conditions/medical symptoms.
* Subject has a documented left ventricular (LV) ejection fraction \< 50%.
* Subject has previously received linifanib.
Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms

Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in management of symptomatic hemorrhoids in a double blind randomized placebo-control trial

Purpose of study: evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy for the management of hemorrhoids study design:Double blind randomized placebo-control trial, uni-central Study population: Participants having symptomatic hemorrhoids attending Shiraz University of Medical Sciences clinics Inclusion criteria: Patients with symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination Exclusion criteria: Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer Sample size: 75 patients (tree groups) Interventions: Topical Allium ampeloprasum cream/ placebo cream/anti-hemorrhoid cream Time period: 3 week Outcome measures: pain,itching, bleeding, defecate discomfort, total improvement, constipation

Eligibility Criteria:
Inclusion Criteria

* Participants having symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination
* Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period:

Exclusion Criteria:

* Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
* Participants having hypersensitive predisposition or hypersensitive to Allium ampeloprasum or history of skin hypersensivity
* Female participants under pregnancy or during breastfeeding period
* Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or neurologic disorders or ascitis g- history of steroid or anticoagulant drug consumption
Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness

The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.

In a single blind randomized parallel group design, we will evaluate the whether a single dose of GLYX-13 vs. placebo increases cognitive performance on tasks of learning, declarative memory, and working memory, and associated task-related increases in blood oxygen level-dependent (BOLD) activation in hippocampus and dorsolateral prefrontal cortex, respectively. Positive findings will provide biomarker evidence for GLYX-13 effects on neural systems underlying these cognitive processes.

Eligibility Criteria:
Inclusion Criteria:

For all Individuals

* Male and female subjects
* Ages 18 - 40 years
* General intellectual abilities falling broadly within the average range (estimated intelligence quotient (IQ) between 80 - 119)
* Sufficient ability to understand study requirements and provide written informed consent

For Patients

-Diagnosis of Schizophrenia or Schizoaffective Disorder

Exclusion Criteria:

For all individuals:

* History of neurologic disorder or systemic medical condition that may interfere with central nervous system function
* History of seizures
* History of heard injury with loss of consciousness or concussion
* Positive screen for drugs of abuse: cocaine, marijuana, phencyclidine, ketamine, opioid, or other agent that is being abused in the opinion of the investigator
* Females who are currently pregnant or plan to become pregnant during the study period
* History of allergy, sensitivity, or intolerance to N-methyl-D-Aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
* History of any ferromagnetic object in the body
* Presence of any medical device or implant for which MRI is contraindicated including cardiac pacemaker, aneurysm clip, cochlear implant, copper intrauterine device (IUD), neurostimulator, or any other device deemed unsafe
* Bullet or shrapnel in body
* Metallic braces or permanent retainer
* Significant claustrophobia

For Healthy Individuals

* Personal history of any Axis I disorder according to the Structured Clinical Interview for the DSM-5 (SCID-5) criteria
* History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
* History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder)

For Patients

* Treatment with Clozaril
* Change in medication within 1 month
* Hospitalization within 1 month
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

To determine if the addition of Astym treatment to traditional therapy produces a more positive outcome then traditional therapy alone for the treatment of de Quervain's tenosynvitis. Two groups will be examined with one group receiving traditional therapy and the other group receiving traditional therapy in addition to Astym treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

i. Positive Finkelstein's test: The client will report pain over the first compartment of the extensor retinaculum when the thumb is tucked in the hand and deviated ulnarly.

ii. Persistent symptoms for \>3 wks which have not resolved after an additional 3 weeks of splinting

iii. A diagnosis by a physician of "de Quervain's", "fist compartment tenosynovitis", or "radial styloid tenosynovitis"

iv. Patients must agree and comply to a predetermined splinting regimen

Exclusion Criteria:

i. History of cortical steroid injection to affected wrist and/or thumb

ii. History of previous wrist trauma to affected limb

iii. Comorbidity such as carpal tunnel syndrome (CTS), radial tunnel syndrome, osteoarthritis, rheumatoid arthritis, auto-immune disease or inflammatory conditions, lateral epicondylitis or tendinopathies

iv. Clotting deficits

v. Positive Cozen's sign which would indicate intersection syndrome

vi. Post-partum mothers \<6 months and pregnant women
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures

Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.

The study objective, demonstrate superiority of the Aspero Ancora-SB balloon overtube compared to the Olympus ST-SB1 Balloon Overtube, is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers. Investigators propose to recruit patients scheduled for enteroscopy and use capsule endoscopy to identify patients with lesions in the middle third of the small bowel. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent;
2. Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
3. ≥ 18 years of age to ≤ 90 years of age;
4. Video capsule endoscopy identified lesions in the middle third of the small bowel;
5. Willing and able to comply with all study procedures and follow-up.

Exclusion Criteria:

1. History of gastric bypass or related procedures;
2. History of foregut and/or midgut surgery;
3. Pathology identified by video capsule is in the proximal 1/3 of the bowel;
4. Pathology identified by video capsule is in the distal 1/3 of the bowel;
5. Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
6. Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
7. Inability to tolerate the investigator's method of sedation that is the standard of care;
8. Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
9. Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
10. Pregnancy;
11. Life expectancy \< six (6) months.
Cold Water Immersion Stirring in Hyperthermic Individuals

The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.


Eligibility Criteria:
Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy
* Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* History of any contraindications on the CoreTemp contraindications and warnings document
* Current tobacco use or regular use within the last 2 years
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* History of exertional heat stroke
* Currently pregnant or breastfeeding
* Inability to follow the rules of the protocols or understand the consent form
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (\>=2 episodes per night)

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)

The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.


Eligibility Criteria:
Inclusion Criteria:

* has type 2 diabetes
* treated with oral agents in monotherapy or combined therapy ± basal insulin
* previously educated to self-monitoring blood glucose (SMBG) use

Exclusion Criteria:

* has type 2 diabetes non-pharmacologically treated
* has type 2 diabetes treated with multiple daily injections of insulin
* is unable to use the telemedicine system
* pregnancy
* has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months
* has any disease or condition, including alcohol or drugs abuse, that may interfere with study completion