cyrilzakka/clinical-trials huggingface dataset:
GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject ≥18 years of age on the day of signing the ICF.
* A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation.
* Stable intake of physician prescribed Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior to the first study drug administration, and planned continuation of Orkambi for the duration of the study.
* FEV1 ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
* Sweat chloride concentration ≥60 mmol/L at screening.

Exclusion Criteria:

* History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to any component of the study drug.
* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration.
* History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices, etc.).
* Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or gammaglutamyl transferase (GGT) ≥3 x the upper limit of normal (ULN), and/or total bilirubin ≥1.5 x the ULN at screening.
neuroQWERTY: a Transparent Patient-centered Outcome Method to Quantify Parkinsonian Motor Signs for Drug Trials

The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. The investigators seek to develop an objective assessment of motor deficits by monitoring the participants natural interactions with a keyboard (on a computer or smart device). This approach provides a window to how the brain behaves during typical daily use of these devices, i.e. writing a report, sending an email or any other task performed on a digital device and thus has the potential to be used easily and regularly. (Importantly, the data gathered are non-sensitive and based only on timing information).

PD participants will be recruited during outpatient visits to PD clinics throughout the Madrid metropolitan region. General entry criteria will be those patients who are scheduled to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact on participants' standard clinical management other than by asking the participants to type for 15 minutes at each of the clinic visits, and installing the investigators proprietary software on their home computer. This software will collect keystroke data alone. (None of the actual information about what is being typed will be collected.) The keystroke data collected will be analyzed and compared with standard clinical metrics of therapeutic response, as well as the in-clinic typing data.


Eligibility Criteria:
Inclusion Criteria:

1. Participants between 18 years and 70 years (older subjects will be deemed eligible on an individual basis after review by the study team).
2. Parkinson's disease (PD) diagnosis according to the United Kingdom Brain Bank Criteria.
3. PD patients without cognitive or psychiatric disturbances, as measured by the baseline assessment.
4. Prescription of symptomatic therapy with L-Dopa or dopamine agonists based on functional impairment attributed to PD. This will be based on the participant's physician criteria based on:

   * Involvement of the dominant hand and/or upper limbs.
   * Employed patients which the disease impairs their ability to work.
5. Daily computer use \> 30 minutes

Exclusion Criteria:

1. Mild cognitive impairment or dementia.
2. Psychiatric symptoms
3. Expected or current use of sedative medication (benzodiazepines, opiates, antihistaminergic drugs).
4. Neuroleptic use.
5. History of parkinsonism for the controls.
6. Severe osteo-articular problems with upper limb functional limitation (amputations, severe osteo-arthritis).
7. Alcohol risk use (\>40 gr/day or 4 standard drinks for male / \>24gr/day or 2 standard drinks for female).
8. Narcolepsy or other sleep disorder producing hypersomnia (obstructive apnea, acute confusional states).
9. Any other life- threatening condition (advanced cancer, severe hepatic or renal insufficiencies.
Use of Care Services by Patients With Borderline Personality Disorder

Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability and impulsivity. Several North American prospective studies support the high level of mental health care utilization in this population. There is little data in other systems of health organization, such as France. Furthermore, little is known on the variables associated with the mental health service utilization among BPD patients.

The main objective was to compare the utilization of mental health care among BPD patients, to the general population and patients with another personality disorder (PD) and to describe the demographic and clinical factors associated with the group of patients who use the most health care.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated with the health insurance
* Inpatient Psychiatry

Exclusion Criteria:

* Patient in forced hospitalization
* chronic psychotic disorder, mania or hypomania state, known mental retardation.
* Patient does not speak or read French
Glucagon Resistance in Patients With NAFLD

The investigators propose that the sensitivity to glucagon in hepatic lipid metabolism is impaired in subjects with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH). Moreover, they propose a dys-coordinated, reduced glucagon sensitivity in hepatic lipid metabolism and endogen glucose production in patients with NAFLD and NASH compared with healthy subjects and patients with simple steatosis. This reduced sensitivity may be the basis of a more severe dyslipidemia and the production of increased concentrations of toxic lipid intermediates in plasma and muscle tissue. The study will include healthy subjects with obesity and subjects with simple steatosis and NASH, tested at basal glucagonemia and moderate hyperglucagonemia to mimic insulin resistant levels during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers in combination with indirect calorimetry as well as skeletal and adipose tissue biopsies will be employed to assess free fatty acid and VLDL-triglyceride kinetics (turnover, and oxidation) and hepatic fatty acid-esterification.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 28 kg/m2
* steatosis FF% \> 5,6% on MR spectroscopy for NAFLD and NASH groups

Exclusion Criteria:

* active smoking
* pregnancy
* comorbidity other than hypertension and hyperlipidemia
* participation in other radioactive isotope studies within the past 3-5 months (depending on radiation dose)
* blood donation (within 3 months)
Electroacupoint for Diminutive Milk Production

The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women.

Postnatal scanty milk secretion is a common complaint. Some physical and medicinal therapies have been proposed to enhance milk production. These therapies must be both successful and safe for both the mother and the child. In many cases, milk supply can be increased by frequent, regular milk removal, Medication to increase milk supply (galactogogues) such as domperidone.

Domperidone has been linked to maternal adverse effects in galactogogue trials and cases reported to the Food and Drug Administration include dry mouth, headache, dizziness, nausea, abdominal cramping, diarrhea, palpitations malaise, and shortness of breath. Some of these were more frequent with dosages greater than with 30 mg daily. Drug withdrawal symptoms consisting of insomnia, anxiety, and tachycardia were reported in a woman taking 80 mg of domperidone daily for 8 months as a galactogogue who abruptly tapered the dose over 3 days.

Eligibility Criteria:
Inclusion Criteria:

* They were complaining of insufficiency of lactation within the first month after cesarean section.
* They are using mixed feeding; both breast and bottle feeding, between three and six bottles per day.
* Their age ranged from 25-30 years old.
* Their body mass index didn't exceeded 30 kg/m2.

Exclusion Criteria:

* Postpartum haemorrhage.
* Cardiorespiratory disease.
* Diabetes mellitus.
* Breast cancer.
* Previous surgeries in the chest, breast, or the surrounding area.
* Anemia.
* Any causes that hindered their normal breastfeeding (retraced, cracked, inflamed, or inverted nipples).
* Receiving contraceptive pills.
* Having infants with conditions that may affect the lactation process such as congenital abnormalities of the mouth (tongue tie, cleft palate).
* Congenital heart disease.
Dry Needling for Spasticity in Stroke

Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.


Eligibility Criteria:
Inclusion Criteria:

* first-ever unilateral stroke;
* hemiplegia resulting from stroke;
* age between 40 and 65 years old;
* presence of hypertonicity in the upper extremity;
* restricted range of motion of the shoulder

Exclusion Criteria:

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
* previous treatment with BTX-A in the 6 months prior the study;
* severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;
* fear to needles;
* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor

The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.

Two regiment are used: N.B. The two regiments will be reported separately

1. Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
2. FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.

Eligibility Criteria:
Inclusion Criteria:

* liver metastasis
* solid tumor

Exclusion Criteria:

* poor performance
Observer Reactivity During Gait Measurements in a Clinical Setting

Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. Although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that are performed as part of clinical care. Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes and most studies examined the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking, and observed walking combined with awareness of measurement, in a within-subjects repeated measures design.

Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration in behaviour as a consequence of observation or awareness of measurement. It is believed that this could influence research outcomes in prospective experimental and observational studies. However, as described in a recent systematic review, the extend of the effect on research outcomes is still debated. The available studies on observer reactivity with various populations and tasks generate contradicting findings and conclusions. Especially within the health sciences, more research is necessary as observer reactivity may confound study results in the direction of better health outcomes.

Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes. For example, some studies showed a higher walking velocity and better gait symmetry under observation, while others showed an opposite effect. This may be caused by the variation in diagnosis group between the studies or small sample sizes. Because of these mixed results and the low number of studies available on this topic, there is yet no consensus on a generalizable effect of observation during gait measurements. Furthermore, most studies examine the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals.

For clinical decision making, it is essential to investigate whether gait measurements are representative for the actual gait pattern of the patient. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking by a researcher, and observed walking combined with awareness of measurement by sensors.

Eligibility Criteria:
Inclusion Criteria:

* Subacute or chronic stroke (\>3 months ago)

Exclusion Criteria:

* Not able to walk 50 meters without resting.
* Not able to understand instructions given by the researcher.
Ergonomics in Robotic Surgery

This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.


Eligibility Criteria:
Inclusion Criteria:

* Fellowship trained, specialty board certified gynecologic surgeon.
* Robot used for hysterectomy until completion of vaginal cuff closure.

Exclusion Criteria:

- Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).
Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

The main objective of this study is to assess the safety of administering intravenous (IV) pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with hematologic malignancies and stem cell transplant recipients. There will also be an assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic therapy.

This study is a prospective, single arm study to assess safety of IV pentamidine for PJP prophylaxis. Patient satisfaction associated with IV pentamidine will also be assessed using a survey adapted from the validated Treatment Satisfaction Questionnaire for Medication (version 1.4).

Adult patients with a hematologic malignancy or who are receiving or have received a stem-cell transplant at the University of Illinois Hospitals and Clinics who have an indication for PJP prophylaxis therapy. They will receive intravenous pentamidine during their planned admissions for chemotherapy when they have an indication for and/or are due to receive pentamidine prophylaxis. These patients are outlined below in the inclusion criteria. Patients may or may not have received aerosolized or IV pentamidine prior to inclusion in the study.

Eligible patients will receive IV pentamidine during hospital admissions. Patients will be routinely monitored by nursing staff during and after the infusion. Nursing staff will monitor the systolic and diastolic blood pressure at baseline and one hour post infusion. Patients will also be monitored for nausea/vomiting. Patients who receive IV pentamidine will have anti-emetics available on call to use in the event that they become nauseous. Data will be collected on the type, grade, and incidence of adverse effects by research personnel.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Hematologic malignancy diagnosis or stem-cell transplant recipient
* Eligible for PJP prophylaxis therapy at time of enrollment as per institutional guidelines in compliance with NCCN guidelines. These patients include:
* Acute myeloid leukemia patients receiving induction and consolidation (first line and relapsed/refractory)
* Acute lymphoid leukemia patients receiving HyperCVAD/R (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, rituximab)
* Lymphoma patients receiving ICE (ifosfamide, carboplatin, etoposide), DA-R-EPOCH (dose-adjusted rituximab, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin), and other inpatient lymphoma regimens
* Patients receiving other inpatient chemotherapy regimens that are given on a monthly basis
* Patients who have received an allogeneic stem cell transplant
* Have given informed consent
* May have previously received inhaled or IV pentamidine

Exclusion Criteria:

* Pregnancy
* Prisoners
* Patients with a documented allergy or hypersensitivity to pentamidine.
Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients

In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion Criteria:

* The patient will not participate
* The patient participates in other randomised stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578
Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

This is multicentric, spontaneous, observational, retrospective and prospective study.

In the retrospective part of the study, Tissue Microarrays (TMA) will be prepared from surgical samples of breast tissue from a series of patients with TNBC type breast cancer.

In the prospective part of the study will be evaluated the expression of some selenoproteins by ELISA in plasma samples obtained from up to 100 healthy subjects and about 300 (\~100 per year) patients with basally metastatic TNBC breast cancer (150) and metastatic (150) before any treatment.

Eligibility Criteria:
Inclusion Criteria:

* TNBC breast cancer patients, before any drug treatment
* healthy women aged 25-60

Exclusion Criteria:

* donors suffering from diabetes, hypertension, active infectious states, HIV infection, Hepatitis B or C, chronic inflammatory diseases, current or previous neoplasms, heart disease or drug treatment.
Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Eligibility Criteria:
Inclusion Criteria:

- spine surgery ASAI,II

Exclusion Criteria:

* revision surgery hypotension bradycardia
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
* age 18 years or above

Exclusion Criteria:

* Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
* Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
* Other contraindications against immunoadsorption or plasma exchange
Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

1) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.

Exclusion Criteria:

1) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.