cyrilzakka/clinical-trials huggingface dataset:
Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients

Migraine is a very common disorder, and many migraine patients have symptoms from their neck and muscles. 50% of migraine patients have a sensation of stiff neck in relation to migraine attacks. Furthermore it is well established, that migraine patients have tender muscles during migraine attack, which can be measured with pressure pain threshold.

In this study the investigators aim to establish the variation in ultrasound elastography and pressure pain threshold in migraine patients over time. And establish the significance of headache, migraine and prodromes on these measurements.

The study includes daily measurements of muscle hardness and muscle tenderness. The patients are asked to fulfill a headache diary and a short questionnaire asking about current headache, physical activity, stress and current infectious diseases. Sleep and physical activity is also measured objectively using a fitbit Charge2. Furthermore the patients are asked about symptoms which often are associated with migraine (prodromes).

Eligibility Criteria:
Inclusion Criteria:

* Migraine Patient fulfilling international classification of headache disorders (ICHD 3) criteria

Exclusion Criteria:

* regular medication use other than medication for migraine or headache
* Other Pain disorders
* Musculoskeletal disorders affecting neck or upper body
Clinical Follow-up of Pregnant Subjects Undergoing NIPT

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.

Eligibility Criteria:
Inclusion Criteria:

* Subject was pregnant and received NIPT from Sequenom/Integrated Genetics
* Subject was 18 years of age or older at the time of NIPT
* Pregnancy outcome is available

Exclusion Criteria:

* None
A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study

This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.

This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis. The tropomyosin receptor kinase (Trk) receptor family comprises 3 transmembrane proteins referred to as Trk A, B and C (TrkA, TrkB and TrkC) receptors that are encoded by the NTRK1, NTRK2 and NTRK3 genes, respectively. These receptor tyrosine kinases are expressed in human neuronal tissue and play an essential role in the physiology of development and function of the nervous system through activation by neurotrophins. Gene fusions involving NTRK genes lead to transcription of chimeric Trk proteins with constitutively activated or overexpressed kinase function conferring oncogenic potential. These genetic abnormalities have recently emerged as targets for cancer therapy, because novel compounds have been developed that are selective inhibitors of the constitutively active rearranged proteins. Developments in this field are being aided by next generation sequencing methods as tools for unbiased gene fusions discovery. However, the incidence of NTRK aberrations in solid tumors is unknown as well as the natural history of NTRK-rearranged tumors This study will provide better knowledge of NTRK gene fusion incidence to allow recommendations for pathological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 1 month.
* Subject has/had a histologically or cytologically confirmed diagnosis of solid tumor including but not exclusively: soft tissue sarcoma, BRAF wild type melanoma, KRAS wild-type colorectal cancer, central nervous system, EGFR-wild type non-small cell lung cancer.
* Subject has locally advanced/unresectable or metastatic disease.
* Subject has received at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic disease for which there is available outcome information in terms of PFS, or the latter can be estimated based on the subject's records.
* Subject has tumor material available for immunoscreening (IHC for NTRK gene fusions).
* Written and voluntary informed consent understood, signed and dated, or a waiver of consent is granted according to French régulations.

Exclusion Criteria:

• Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.
Identifying Methylation Biomarkers for Monitoring Bladder Tumors

To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer.

Exclusion Criteria:

* Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.
Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix

This study aims to provide a comprehensive report on clinicopathologic features, immunohistochemical/biomarker testing and molecular profile of cervical clear cell carcinoma. This study may help researchers learn more about the molecular profile of cervical clear cell carcinoma.

PRIMARY OBJECTIVE:

I. To perform a retrospective clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix at M D Anderson Cancer Center (MDACC) and to delineate the immunohistochemical and molecular profile of these cases.

OUTLINE:

Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with clear cell carcinoma of the cervix at MDACC
Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease patients may be provided using a new computerized system over standard network - called Collaborative Imaging - with similar patient experience compared to a conventional clinic visit.

Significant advances in gastroenterology have led the field to grow into a number of advanced subspecialties: inflammatory bowel disease (IBD), motility, therapeutic endoscopy, and transplant hepatology. Telemedicine, the application of information technology in support of health care delivery from a distance, has been employed with good success in various chronic conditions with excellent patient satisfaction.

Primary Aim: Our primary study endpoint was measuring patient clinical experience between two groups: A telemedicine remote clinic visit and a standard "in-house" visit.

Secondary Aim: To compare standard clinic metrics including clinic wait time, patient throughput, and appointment time between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years old) outpatient IBD patients in the Veterans Affairs medical system

Exclusion Criteria:

* VA patients without IBD
* Hospitalized IBD patients
Diagnostic Value of Exome/ Genome Sequencing, Conventional Methods in Rare Diseases and Familial Tumor Syndromes

For the retrospective data analysis, patients with genetic diseases of any age and, if available, other family members, for whom genetic analyzes were carried out between 10/2016 and 12/2020, should be included. This equates to approximately 13,000 records, minus combined analyzes in the same patient, an estimated 12,000 individuals.

The methodological developments of the last few years allow the broad use of next-generation-sequencing (NGS) -based methods in the routine molecular genetic diagnosis of genetic diseases.The aim of the retrospective data analysis is to create a solid data basis for further discussion regarding the development and mapping of diagnostic algorithms and subsequent supply routes. For the genome data, this evaluation is to be expanded to include the evaluation of the Polygenic risk scores (PRSs) in the sense of an additional finding.

Eligibility Criteria:
Inclusion Criteria:

* Patient with genetic disease or
* Family members
* Genetic analysis between 10/2016 and 12/2020 at the Institute for Medical Genetics and Applied Genomics at the University Hospital Tübingen

Exclusion Criteria:

- None
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns

Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.


Eligibility Criteria:
Inclusion Criteria:

* Childbirth between 34 and 35 GA
* Breast-feeding
* Caucasian
* Affiliation to social security
* Obtained consent from mother, and parents for the child
* Mother with balanced diet
* No allergy to eggs
* Single pregnancy

Exclusion Criteria:

* Allergy to egg
* Unbalanced diet
* Diabetes
* Known digestive disease
* Counter-indication with breast-feeding
* Cigarettes (more than 5 per day)
* Alcoholism (daily consumption of alcohol)
* Multiple pregnancy
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

* Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.
Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB

Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).

ESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for PCNL under general anesthesia
* ASA status I-II

Exclusion Criteria:

1. Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
2. Patient who has difficulty understanding the study protocol or patient refusal.
3. Chronic respiratory disease patients.
4. Diabetic patients.
5. Body mass index (BMI) \> 30 Kg/m2
6. Routine corticosteroids, pain medication, or anticonvulsant.
7. Psychiatric diseases.
Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

* To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
* To assess the effect of xaliproden on the rate of at least partial recovery of grade \> 2 PSN at 6 months
* To assess the effects of xaliproden on the time to complete recovery from PSN
* To evaluate the safety profile of xaliproden


Eligibility Criteria:
Inclusion Criteria:

* Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
* Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
* Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d) neutrophils ≥1.5x10\^9/L ; (e) platelets ≥50x10\^9/L; (f) Serum D-dimer within normal limits

Exclusion Criteria:

* Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
* Receiving any further anti-cancer treatment
* History of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
* Unstable cardiac disease
* History of significant neurological or psychiatric disorders including dementia or seizures,
* Active uncontrolled infection
* Active disseminated intravascular coagulation
* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
* Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed
* Concurrent treatment with any other experimental drugs
* Pregnant or breast-feeding women;
* Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function

Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.

L-Citrulline is a non-protein amino acid and an efficient precursor of L-arginine, the substrate for endothelial nitric oxide synthesis. Glutathione is a tripeptide with antioxidant effects. Postmenopausal women will ingest 6g/d of L-Citrulline or 2g of L-Citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular function testing prior to and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year).
2. Between the ages of 50-79 years.
3. Body mass index of 18.5 - 34.9 kg/m2.
4. Brachial systolic blood pressure \< 150 mmHg, and diastolic blood pressure \< 90 mmHg.
5. Sedentary (defined as \< 120 min/week of exercise).
6. Be willing and able to comfortably abstain from any of food supplements for the period of time beginning 1 month prior to the study to the time of the termination of the study.
7. Not participating as a subject in another study for at least 2 months prior to the study and for the duration of this study.

Exclusion Criteria:

1. Current or prior use of tobacco products, e-cigarettes or other inhaled substance.
2. Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, but not limited to those.)
3. Taking hormone replacement therapy during the 3 months before the study.
4. More than a moderate intake of alcohol (\>7 drink per week).
5. Cardiovascular diseases, diabetes and other metabolic or chronic diseases.
6. Musculoskeletal disorders that will prevent exercise performance.
7. Currently taking more than one vasoactive drug for blood pressure control.

   * Subject having no more than one drug for prevention, which does not affect variables, may be included, but will be diagnosed as not having a disease.
Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test \[BCTT\]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40
* Received a concussion at work and are engaged with the workers compensation program
* Within 3 weeks of concussive injury

Exclusion Criteria:

* 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
* Moderate or severe TBI
* Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \> 24 hours
* Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
* History of more than 3 diagnosed concussions
* Active substance abuse/dependence
* Report of injury mechanism occurring due to physical assault
* Unwillingness to perform intervention
* Limited English proficiency.
Identification and Treatment of the Liability to Develop Schizophrenia

This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.


Eligibility Criteria:
Inclusion Criteria:

* Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
* Desire to participate in a medication trial.
* Is able to provide informed consent.
* Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
* Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
* Scoring at least one standard deviation below normal in a second cognitive domain.

Exclusion Criteria:

* IQ less than 80.
* Formal education less than 10 years.
* History of psychotic disorders.
* History of treatment with an antipsychotic medication.
* A substance abuse diagnosis within 6 months of diagnosis.
* A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits).
* A history of neurologic disease or damage.
* A medical condition with significant cognitive sequelae.
* A history of electroconvulsive treatment.
Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Episode of symptomatic acute pulmonary embolism objectively proven

Exclusion Criteria:

* Below 18 years of age
* Patient chronically receiving therapeutic anticoagulation
* Pulmonary embolism complicating a current hospitalisation for another medical reason
* Asymptomatic pulmonary embolism