cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Alliance and Treatment Outcome

This study aims to inform scientific understanding of the impact of the therapeutic alliance and the transition from inpatient to outpatient care.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to in-patient treatment in the private psychiatric clinic Hohenegg (PKH) from November 2021 onwards

Exclusion Criteria:

* Due to the naturalistic approach of the study, there will be no selection or exclusion made
Cerebrovascular Reactivity in American Football Players

Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment CVR in patients with a history rmTBI.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-65 years
2. Former National Football League (NFL) players or former varsity college football players
3. Ability to undergo MRI scanning
4. Ability to read, write, and speak English
5. Stable doses of concomitant medications for last 2 weeks prior to enrollment
6. Diagnosis of post-concussive syndrome according to Diagnostic and Statistical Manual 5 (DSM-5) criteria

Exclusion Criteria:

1. Contraindication to sildenafil
2. Past medical history or evidence of penetrating brain injury
3. Daily therapy with a PDE5 inhibitor within the past 2 months, or taken as needed within past 4 weeks
4. History or evidence of pre-existing disabling neurological or psychiatric disorder not related to previous head injuries
5. History of melanoma
6. History of diagnosed obstructive/ restrictive pulmonary disease 7 .) Contraindication to MRI
Dual Frequency Stimulation in Parkinson's Disease

Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 18 years and older
* Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
* Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
* Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN

Exclusion Criteria:

* Individuals unable to provide consent and/or lack capacity to consent
* Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
* Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
* Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
* Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
* Non-English speaking individuals. Cognitive tasks will only be conducted in English.
Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN

To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2009 and March 31st, 2009.
* For PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.

Exclusion Criteria:

* According to the study design there will not be any exclusion criteria in order to provide a high external validity and to obtain the most accurate real daily practice information.
Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment.

PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

OBJECTIVES:

* Evaluate the ability of the microculture kinetic (MiCK) assay to predict the outcome of patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma treated with first-line chemotherapy.
* Evaluate the ability of the MiCK assay to guide chemotherapy in a third-line, refractory treatment setting (exclusive of anti-vascular endothelial growth factor) in these patients.

OUTLINE: Patients are stratified according to prior chemotherapy (no \[stratum I\] vs yes \[stratum II\]).

Tumor tissue and/or effusion specimens are collected at baseline. Specimens are examined by the microculture kinetic (MiCK) assay and immunocytochemical or flow cytometry assay.

MiCK assay results do not influence treatment for stratum I patients. Stratum II patients may receive treatment based on MiCK assay results for tumor sensitivity to specific chemotherapy drugs.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed adenocarcinoma of 1 of the following types:

  * Ovarian
  * Primary peritoneal
  * Fallopian tube
* Must meet 1 of the following criteria:

  * De novo malignancy with no prior chemotherapy
  * Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols
* Tumor must be accessible for biopsy or drainage of effusions
* Chemotherapy is considered a treatment option
* No symptomatic or uncontrolled parenchymal brain metastases
* No meningeal metastasis

PATIENT CHARACTERISTICS:

* Not pregnant
* Negative pregnancy test
* Fertile patients must agree to use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen \& are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

This is interventional study and single arm study. N/A

Eligibility Criteria:
Inclusion Criteria:

* Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
* ER positive.
* The patient must be postmenopausal woman.
* The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).

Exclusion Criteria:

* Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.
* Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).
Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

The goal of this observational study is to compare laboratory and ultrasound findings between letrozole-resistant and letrozole-sensitive PCOS patients in Egypt. The study will include women aged 18-40 years diagnosed with PCOS based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time.

The main questions it aims to answer are:

What are the baseline laboratory and ultrasound differences between letrozole-resistant and letrozole-sensitive PCOS patients? What factors can predict letrozole resistance in PCOS patients? Researchers will compare letrozole-resistant and letrozole-sensitive PCOS patients to determine whether specific laboratory markers and ultrasound findings can predict resistance to letrozole.

Participants will:

Undergo baseline clinical, laboratory, and ultrasound assessments before starting letrozole treatment.

Receive letrozole treatment with dose escalation up to 7.5 mg/day over a maximum of three cycles if ovulation is not achieved.

Be monitored through serial transvaginal ultrasounds to assess follicular development.

Have ovulation confirmed via mid-luteal serum progesterone levels. The study aims to improve the understanding of predictors of letrozole resistance to guide personalized ovulation induction strategies in PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-40 years.
* Diagnosis of PCOS based on Rotterdam criteria.
* No prior ovulation induction with letrozole.
* Willing to follow the treatment protocol and attend follow-up visits

Exclusion Criteria:

* Infertility due to other causes such as tubal obstruction or male factor infertility.
* Previous ovarian surgery or use of medications that could influence ovulation.
* Comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.
A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes

The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-70 age years, both inclusive;
2. BMI is 20.0 to 40.0 kg/m2, both inclusive;
3. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
4. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
5. At screening:

1) Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose \[MTD, ≥1000 mg\]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.

Exclusion Criteria:

1. Use of systemic glucocorticoids within 3 months prior to the screening;
2. Use of weight loss drugs within 3 months prior to the screening.
3. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);
4. Laboratory findings at the screening visit:

   * Amylase and/or lipase \>3 x upper limit of normal (ULN);
   * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 x ULN;
   * Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin;
   * Urinary albumin creatinine ratio (UACR) ≥300 mg/g;
   * Total bilirubin \>2.0 x ULN;
   * Calcitonin ≥50 ng/L;
5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
6. Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;
7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
8. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
9. History of pancreatitis (acute or chronic);
10. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology

The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.

Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.

Eligibility Criteria:
Inclusion Criteria:

* Suboptimal iron stores (Serum ferritin \< 40 µg/L)
* BMI in range 18.5 - 24.9 kg/m2
* Willing to consumed meals containing iron supplement
* Willing to discontinue blood donation two weeks prior and during the study
* Willing to discontinue vitamin and mineral supplement use during the study
* Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days)
* Willing to attend 8 lab visits during the study

Exclusion Criteria:

* Pregnant
* Lactating
* Smoker
* Anemic (hemoglobin \< 120 g/L)
* Has gastrointestinal disease/condition that can affect absorption
* Vegetarian
* Allergic to corn, wheat, soybean nor fungal supplements
Clopidogrel Prevention of Early Arteriovenous (AV) Fistula Thrombosis

The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)


Eligibility Criteria:
Fistula Study Protocol

Inclusion Criteria:

* Age 18-21 depending on state regulations
* Life expectancy of at least six months
* Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
* Planned creation of native upper extremity AV fistula
* The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months.
* The patient is expected to stay at a participating dialysis facility for at least 6 months.
* The patient's physician(s) will allow the patient to participate.
* Ability to give informed consent.

Exclusion Criteria:

* Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study.
* The presence of ongoing bleeding.
* The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
* Recent bleeding episode requiring transfusion within 12 weeks of entry.
* The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
* A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or nonsteroidal anti-inflammatory drugs during the six week study drug administration period. Use of heparin during dialysis is allowed.
* Required use of oral or intravenous glucocorticoids at a dose greater than the equivalent of prednisone 15 mg per day during the six week study drug administration period.
* Current unstable angina.
* Required use of clopidogrel.
* Known hypersensitivity to clopidogrel.
* Medical considerations making anti-platelet therapy dangerous.
* Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.
* Baseline platelet count less than 75,000/mm3.
* Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices.
* Current problem with substance abuse.
* Concurrent participation in another medical intervention trial.
* Anticipated non-compliance with medical care based on physician judgment.
* Patient refusal.
Efficacy Study of Nicorandil on Neointima

The investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.

In the era of bare metal stent (BMS), the restenosis rate was about 25%. The introduction of drug-eluting stent (DES) reduces restenosis rate to 4%-10%. Neointimal hyperplasia and restenosis remain to be problems after DES implantation. Besides, DES causes an increase in uncovered struts, late stent thrombosis, neoatherosclerosis, and heterogeneous neointima. Diabetes mellitus (DM) results in increased risk for atherosclerosis, in-stent restenosis, neoatherosclerosis and late-stent thrombosis. Nicorandil, a hybrid of adenosine triphosphate-sensitive potassium (K-ATP) channel opener and nitrates, has been shown to reduce target vessel revascularization after stent implantation, target lesion revascularization after rotational atherectomy, and restenosis in patients undergoing percutaneous coronary intervention (PCI). Intracoronary optical coherence tomography(OCT) has emerged as a high-resolution imaging method for analysis of neointima that grows over the stent. We aim to examine the effect of nicorandil on the neointima after coronary DES implantation in patients with unstable angina and DM.

Eligibility Criteria:
Inclusion Criteria:

* unstable angina with diabetes mellitus and is not given glibenclamide
* have clinical indication of percutaneous coronary intervention
* de novo severe stenosis in a native coronary artery
* lesion suitable for stent and optical coherence tomography examination
* reference vessel size between 2.5 and 4.0mm
* drug-eluting stent implantation only

Exclusion Criteria:

* acute myocardial infarction within 2 weeks before percutaneous coronary intervention
* contraindications to treatment with nicorandil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
* bypass restenosis
* PCI history
* hypotension
* intolerance of platelet inhibitors and statins
* impaired liver function
* renal insufficiency requiring hemodialysis
* pregnancy
* connective tissue disease
* life expectancy ≤ 12 months
* left main coronary artery disease
* bypass graft lesion and lesions unsuitable for OCT
* unwillingness or inability to provide informed consent
Preoperative Carbohydrate Loading in Bariatric Surgery

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance


Eligibility Criteria:
Inclusion Criteria:

* Obtaining written and informed patient consent.
* No medical contraindications to perform a bariatric operation
* No contraindications for the use of a rich carbohydrate drink

Exclusion Criteria:

* No consent to participate in the study
* Age under 18 years
* The intolerance of the carbohydrate drink used in the test
* The contraindications to perform bioimpedance measurements of body composition
A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males\>50 kg (110 lbs). For females, total body weight \>45 kg (99 lbs).
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

* Evidence of any clinically significant illness, medical condition, or disease.
* Evidence or history of any clinically significant infections within the past 3 months.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.