cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.

The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.

The purpose of this study is to provide continued treatment with macitentan to subjects with PAH or CTEPH who participated in "parent studies" and to continue to accrue long-term safety data. The design of this study is widely used in clinical programs to give participants in a clinical study access to an effective study treatment beyond completion of the parent study. This is considered the best option to collect long-term safety and tolerability information of macitentan 10 mg and survival status of participants with PAH and CTEPH. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH and CTEPH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231, NCT02382016, NCT02060721) and may be completed before the participants have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in countries where no access to commercial macitentan is expected in the near future.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent to take part in the study before any study mandated procedure.
2. Participants from one of the parent studies and: a) the sponsor has decided to terminate the parent study in that country and b) the participant has completed the end of treatment (EOT) Visit of the parent study
3. Women of childbearing potential are able to take part in the study if the following applies: a) Urine pregnancy test is negative at Enrollment; b) Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation; and c) Agreement to adhere to the planned contraception scheme from Enrollment up to at least 30 days after study treatment discontinuation

Exclusion Criteria:

1. Hemoglobin less than 80 gram per liter (g/L)
2. Serum Aspartate aminotransferase (AST) and/or alanine aminotransferases (ALT) more than three times the upper limit of normal range
3. Known and documented history of severe hepatic impairment that is Child-Pugh Class C.
4. Pregnant, planning to become pregnant, or breastfeeding
5. Known hypersensitivity to macitentan, its excipients, or drugs of the same class
6. Planned or current treatment with another investigational treatment up to 3 months prior to Enrollment
7. Any known factor or disease that may interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease
8. Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)

The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.

Rationale: Patients with COPD are often chaacterized by disturbed metabolic health affecting physical and cognitive function, which is reflected in altered body composition. current studies in healthy subjects suggest that resveratrol improves metabolic health by enhancing muscle mitochondrial function and adipose tissue morphology.

Study design: Proof-of-concept randomized placebo-controlled double blinded clinical trial of 4 weeks.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects may be confronted with certain inconveniences and risks. Subjects will be asked to wear an accelerometer two times for one week. During the entire study period subjects will visit the MUMC+ 2 times for various non-invasive measurements (questionnaires, anthropometry, and physical function test) as well as some minor invasive procedures (venous blood sampling and muscle and fat biopsies) which can cause a local haematoma afterwards. However, the patients will be informed about their metabolic and cardiovascular health, which we expect to be positively affected by the intervention. In addition, all patients will receive a lifestyle advice tailored to their health status.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* Current or ex-smoker
* Age \>18 years

Exclusion Criteria:

* COPD patients planned for pulmonary rehabilitation or who recently participated in a rehabilitation program in the previous 6 months
* Investigator's uncertainty about willingness or ability of the patient to comply with the protocol requirements
* Participation in any other study involving investigational exercise training, nutritional or pharmacological intervention
* Oral glucocorticoid use
* Recent exacerbation (\<4 weeks) that required oral steroids and/or hospital admission
* Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life and are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation;
* Diabetes mellitus (all types), active cardiovascular disease or a cardiovascular event (such as myocardial infarction, cerebrovascular haemorrhage/infarction) in the previous 6 months, recent major surgery, thyroid dysfunction, hepatic or renal disorders, current malignancy (except for dermal malignancies) or central or obstructive sleep apnea;
* Current alcohol consumption \> 20 grams alcohol/day;
* Intake of resveratrol containing dietary supplements.
Biomarkers and Unstable Carotid Plaque

This prospective study investigated associations between circulating miRNAs and symptomatic and asymptomatic ICAS, carotid plaque morphology and future cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Presence of significant internal carotid artery stenosis referred to carotid artery endarterectomy.
* Age\>18 years

Exclusion Criteria:

* Presence of significant internal carotid artery stenosis referred to carotid artery stenting
The Effects of Oral Dipyridamole Treatment on the Innate Immune Response During Human Endotoxemia

During sepsis and septic shock the immune response can be overwhelming leading to excessive tissue damage, organ failure and death. Ideally, the inflammatory response is modulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant immune response. In the last few years adenosine is proposed to have a central role in the modulation of inflammation. In unfavorable conditions such as hypoxia, ischemia or inflammation adenosine is quickly up-regulated; with concentrations up to tenfold in septic patients. Many animal studies have shown that adenosine is able to attenuate the inflammatory response and decrease mortality rates. Therefore, pharmacological elevation of the adenosine concentration is an potential target to attenuate inflammation and limit organ injury. Dipyridamole, an adenosine re-uptake inhibitor is able to increase the adenosine concentration and limit ischemia-reperfusion injury. In order to study the effects of dipyridamole on the inflammatory response we aim to use the so called human endotoxemia model. This model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 35 years
* Male
* Healthy

Exclusion Criteria:

* Use of any medication.
* History of allergic reaction to dipyridamole
* Bleeding disorder.
* Smoking.
* Previous spontaneous vagal collapse.
* History, signs or symptoms of cardiovascular disease.
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90).
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50).
* Renal impairment (defined as plasma creatinin \>120 μmol/l).
* Liver enzyme abnormalities or positive hepatitis serology.
* Positive HIV serology or any other obvious disease associated with immune deficiency.
* Febrile illness in the week before the LPS challenge.
* Participation in another drug trial or donation of blood 3 months prior to the planned LPS challenge.
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress.

Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3- and 6- months post-implant.

Eligibility Criteria:
Inclusion Criteria:

* Age of 21 and older
* Uncontrolled cancer-associated pain (pain score of \>5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening
* Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function
* Life expectancy of \> 3 months

Exclusion Criteria:

* Active infections
* Controlled pain without adverse side effects that are limiting day to day function
* Mechanical barriers
* Obstruction of Cerebrospinal Fluid (CSF)
Optimal Duration of Stretching of the Hamstring Muscle Group

OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.

DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures were assessed immediately after the treatment session and 24 hours after the treatment session.

A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection.

Inclusion Criteria Subjects who demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects will also be screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position Exclusion Criteria Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study

Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine.

Exclusion Criteria:

* Using of medical aids.
* suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
* had undergone recent surgery (within the past 12 months).
* Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease

In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.


Eligibility Criteria:
Inclusion Criteria:

* children aged 4 to 18 years with active Crohn's disease
* Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40

Exclusion Criteria:

* Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Meet American College of Rheumatology (ACR) criteria for RA
* Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints
* ACR functional class I-III

Exclusion Criteria

* At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
* Significant concurrent medical diseases
* Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration
Treatment of Disseminated High Grade Lymphoma

Interest of the use of pegylated liposomal doxorubicin (caélyx)

R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Eligibility Criteria:
Inclusion Criteria:

* high grade lymphoma
* disseminated
* \> 60 years old and \< 75
* informed consent signed
* cardiac state compatible with antracyclin
* ECOG \</= 2

Exclusion Criteria:

* patients \> 75 years old
* Cardiac insufficiency
Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)

the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint

After being informed about the study and potential risks, all patients are giving written informed consent. Occlusal splints for the upper and lower jaws are made for each of the patients. An assessment is made of the relative values and distribution of chewing forces in two cases:

1. "maxillary occlusal splint - lower dentition";
2. "mandibular occlusal splint - upper dentition". The obtained values are used in the final elemental analysis of the stress-strain state and the degree of displacement of the dentition in both indicated cases.

Eligibility Criteria:
Inclusion Criteria:

* continuous dentition
* diagnosis (by ICD\*-10): K03.0 Excessive attrition of teeth
* diagnosis (by ICD-10): K07.6 Temporomandibular joint disorders
* complaints of nocturnal bruxism
* complaints of discomfort in the area of the chewing muscles
* no history of orthopedic and / or orthodontic treatment
* absence of concomitant general somatic pathologies in the stage of decompensation
* no history of psychogenic and psychosomatic disorders
* no history of cancer \*ICD - Classification of Diseases

Exclusion Criteria:

* refusal of the patient during the clinical trial from further treatment
Study of Teriparatide in Stress Fracture Healing

Investigation into the use of teriparatide in the treatment of stress fractures.

Primary outcome is healing on MRI, secondary outcomes are pain, time spent in rehabilitation and future stress fractures. This study will help the investigators understand how to treat stress fractures in the future.

Teriparatide is a drug that is designed to have a similar effect on the body as parathyroid hormone. Parathyroid hormone is made naturally in the body and is released in response to low calcium levels. It helps to maintain bone health and repair bone damage. Parathyroid hormone and medicines like teriparatide can strengthen bones and are often given to people with osteoporosis (a condition that weakens bones, making them more likely to break) to reduce the risk of fractures. Recent studies have also shown benefits in people with stress fracture injuries, a form of bone damage sometimes caused by repetitive exercise. The investigators want to know if teriparatide is also beneficial to healthy, younger people who have a stress fracture injury.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form;
2. Participant must be aged 18 - 40 years inclusive;
3. Participant must have a lower limb stress fracture, either unilateral or bilateral, as confirmed via MRI scan;
4. Undergoing phase 1 or 2 training within an Army training establishment;
5. Blood Tests within reference range. Minor abnormalities will be assessed by the PI. Patients will still be entered if these are felt to be of no clinical importance.
6. Participants able to adhere to the visit schedule and protocol requirements.

Exclusion Criteria:

1. Hypersensitivity to the active Parathyroid Hormone substance or any of the excipients listed in the SmPC.
2. Pre-existing hypercalcaemia.
3. Patients with skeletal malignancies or bone metastases.
4. Any contraindications that would prevent the participant from undergoing an MRI scan.
5. Concurrent therapy that, in the investigators opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
6. Pregnancy, suspected pregnancy or breastfeeding. Female participants must have a negative serum pregnancy test at screening and be willing and able to use a "highly effective" method of contraception, as per the Clinical Trial Facilitation Group (CTFG) guidance.
7. Severe renal impairment. Participants with moderate renal impairment will be treated with caution at the Principal Investigator's discretion and in accordance with the SmPC.
8. Metabolic bone diseases including hyperparathyroidism and Paget's disease of the bone.
9. Unexplained elevations of alkaline phosphatase.
10. Prior external beam or implant radiation therapy to the skeleton.
11. Patients participating in a concurrent drug trial.
12. Presentation with open epiphyses during the diagnostic MRI scan.
13. Participants with depression, as identified by completion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline.
Insomnia and Drug Relapse Risk

The purposes of this study are:

1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.

Eligibility Criteria:
Inclusion Criteria:

* Recent methadone maintenance enrollment
* Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
* No medical contraindications to trazodone

Exclusion Criteria:

* Methadone maintenance enrollment not recent
* No sleep complaints as measured by the PSQI
* Medical contraindications to trazodone