cyrilzakka/clinical-trials huggingface dataset:
PACAP27 Headache Properties in Migraine Without Aura Patients

Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.


Eligibility Criteria:
Inclusion Criteria:

* Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.

  * Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

* Tension Type headache for more than 5 days the month on average in the last year.

  * All other primary headaches .
  * Headache later than 48 hours before trial start.
  * Daily intake of any medicine other than oral contraception.
  * Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
  * Pregnant or breastfeeding women.
  * Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
  * Migraine within 5 days before the trial date.
  * Ancestral information or clinical signs of (on the day of inclusion):
* Hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg)
* Hypotension (systolic blood pressure \<90 mm Hg and / or diastolic blood pressure \<50 mmHg)

  * Cardiovascular disease of all kinds, including cerebrovascular disease.
  * Anamnestic or clinical signs of mental illness or abuse.
  * Patients with glaucoma or prostatic hyperplasia
  * Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled for cardiac catheterization procedure.
* Be at least 18 years of age.
* Be medically stable.
* If a female of child-bearing potential, must have a negative pregnancy test.
* Be conscious and able to comply with study procedures.
* Have signed Informed Consent to participate in the study.

Exclusion Criteria:

* Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome
* Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary
* Females who are pregnant or nursing.
* Patients not scheduled for cardiac catheterization procedure.
* Patients who have received an investigational drug in the 30 days before, or will receive one within 72 h after, study drug administration.
* Patients currently on chemotherapy or with other primary cancers requiring treatment.
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable.
* Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalised urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID).
* Patients with congenital heart defects.
* Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
* Patients with respiratory distress syndrome or a contraindication to pharmacological vasodilator stress agents.
* Patients with thrombosis within the hepatic, portal, or mesenteric veins.
Amlodipine Diabetic Hypertension Efficacy Response Trial

To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of \<130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.


Eligibility Criteria:
Inclusion Criteria:

* Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges).

Exclusion Criteria:

* A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.
Efficiency Of High Power Laser Versus Pulsed Electromagnetic Therapy On Hemiplegic Shoulder Pain

This study will be conducted to determine the effectiveness of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain

One common problem that often manifests two weeks to two months following a stroke is shoulder pain. It adversely impacts patients' quality of life and hinders their ability to regain motor and sensory function. Psychological alterations and sleep problems, such as depression, anxiety, hypervigilance, fear avoidance, pain catastrophizing, trouble falling asleep, and early awakening, can also occure.

The majority of HSP develop in the first 2 weeks up to 6 months and about 65% of those will continue to experience the problem several months after that .

The actual cause of HSP is uncertain and frequently complex. So far, numerous pathogenic processes have been found that are likely to be associated to HSP: Joint subluxation, adhesive capsulitis, complex regional pain syndrome, rotator cuff injury, spasticity, and other conditions .

In the last few decades, an enormous number of treatment options have been developed due to the multiple etiology of HSP, But there is still a great deal of uncertainty regarding their efficacy because several etiologies probably lead to the same problem .

High power laser therapy is one suggested therapeutic option for shoulder pain HPLT has long been used to treat conditions that low power laser therapy (LPLT) cannot, such as increased microcirculation, accelerated tissue regeneration, decreased swelling, inflammation, and pain, because of its photomechanical, thermal, electrical and bio stimulating effects on deep tissues. Benefits of HPLT over LPLT include higher power, deeper tissue penetration, shorter emission durations, and longer rest intervals that avoid heat buildup.

It is hypothesized that compared to single-wavelength low-level laser therapy (LLLT), Multiwave Locked System (MLS) allows for better penetration and therapeutic efficacy .

Magnetic field therapy enhances local cellular activity, organizes collagen fibers, enhances oxygen use in tissues, and speeds up circulation by enhancing blood vessel vasodilation without raising local temperatures but There is insufficient evidence supporting its efficacy and superiority to physical therapy agents .

To our knowledge this is the first study to determine the efficiency of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

1. HSP patients aged 40-65 years.
2. unilateral hemiplegia for the first time.
3. duration of stroke of more than 6 months.
4. Visual Analogue Scale (VAS) of more than 4.
5. patients with 1-3 degrees of spasticity according to Modified Ashworth Scale (MAS).

Exclusion Criteria:

1. Patients with a history of inflammation-related rheumatic disease
2. cervical radiculopathy
3. cardiovascular disease or cardiac pacemakers
4. uncontrolled siezures or sever arrthymia
5. shoulder operations, or shoulder injection during the previous three months were excluded.
Bladder EpiCheck European Haematuria Study

The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.

Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 45 years or older
2. Participants who are willing and able to provide written informed consent and adhere to study procedures
3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
5. Participants who are able to produce at least 10 ml of voided urine

Exclusion Criteria:

1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract
2. Participants who had prior cystoscopy for haematuria within the past 2 years
3. Participants previously enrolled in this study
4. Participants treated for prostate cancer within the last 12 months
5. Participants treated for kidney cancer within the last 12 months
6. Participants with untreated urinary tract infection
7. Participants with symptomatic urinary tract stones (e.g. flank pain)
8. Participants on dialysis for end stage renal failure
9. Participants with a long term urinary catheter
10. Pregnancy (self-reported)
11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
* Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin
* Patients must satisfy 1 of the following criteria for prior therapy:

  * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor or tamoxifen
  * Progressed during treatment or within 2 months after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer, or prior endocrine therapy for advanced/metastatic breast cancer
  * Received ≤ 2 chemotherapy regimens (Part 1) or ≤ 1 chemotherapy regimen (Part 2) for advanced/metastatic disease
* For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
* For Part 2, measurable disease as defined by RECIST, Version 1.1
* ECOG performance status 0 to 1
* Adequate organ function

Exclusion Criteria:

* For Part 1, prior treatment with fulvestrant
* For Part 2, prior treatment with any CDK inhibitor or fulvestrant
* Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Chemotherapy within 21 days of first G1T38 dose
* Investigational drug within 28 days of first G1T38 dose
* Concurrent radiotherapy, radiotherapy within 14 days of first G1T38 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
* Prior hematopoietic stem cell or bone marrow transplantation
Growth Hormone (GH) in Congenital Adrenal Hyperplasia

Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoids. The treatment consists in supplementing children using hydrocortisone. Despite care for these children has improve substantially across decades, short adult height still remains an important consequence of the disease. About 20 % of patients have an AH below 2 standard deviations compared to their expected height.

In the OPALE model study, the investigators have collected data from a cohort of 496 French patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, they have built a model which allows to predict their AH using data available at 8 years of age. This model has shown that the currently used formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children with CAH.

In this project, the investigators plan to use the prediction model to compare the AH in patients who have received GH treatment to their predicted AH using the model.

The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this has not been shown on the actual AH.

This study will allow to reinforce the investigators' hypothesis.


Eligibility Criteria:
Inclusion Criteria:

Patients with CAH, born between 1970 and 1998, having received GH treatment for a minimal one year duration.

Exclusion Criteria:

* Patients with chronic any growth altering disease, Turner syndrome or other genetic anomaly; 8-year wrist Xray and adult height should be available to allow the use of the OPALE model prediction.
Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study

The ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. After birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. The persistent presence of ductus arteriosus leads to significant pressure changes in the systemic and pulmonary circulation, which have adverse effects on extremely/very premature infants. Therefore, persistent patent ductus arteriosus (PDA) is a systemic disease.

hemodynamic significant PDA(hsPDA) is a risk factor for intraventricular hemorrhage(IVH), bronchopulmonary dysplasia(BPD), necrotizing enterocolitis(NEC). A meta-analysis from Cochrane shows that compared to conservative treatment, drug therapy for PDA within 3 and 7 days after birth does not promote PDA closure and reduce the incidence of BPD. Therefore, there is currently a tendency not to provide medication intervention. Although ductus arteriosus quickly closes itself after birth in normal term infants, however, the dynamic changes detail of ductus arteriosus in preterm infants are unknown.

Eligibility Criteria:
Inclusion Criteria:

* less than 32 weeks' gestational age
* admission with 1 hours after birth

Exclusion Criteria:

* congenital abnormalities
* parents' refusal
Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study

Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the investigators will be doing a 3-year follow-up study on the swimmers studied previously.

Even though studies suggest that elite sport can cause AHR and airway inflammation, more studies are needed to elucidate how and when AHR and airway inflammation develop; and there is a lack of follow-up studies. The present study will give us a chance to do a follow-up study to register changes in AHR and airway inflammation in athletes without any significant airway changes at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-19 years
* Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
* Informed consent

Exclusion Criteria:

* Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)
Chrysalis Day Program Body Mass Index Study

This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)

As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients.

At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician.

When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values.

The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .

Eligibility Criteria:
Inclusion Criteria:

* clients of the Chrysalis Program

Exclusion Criteria:

* clients of the Chrysalis Program who do not consent to the study
Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years

Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2 requiring intravenous general anaesthetic

Exclusion Criteria:

-
Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm

This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

Open surgery of abdominal aortic aneurysms (AAA) is the reference treatment in a large number of cases. This is a heavy procedure performed in patients around 70 years of age.

In post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients.

The goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living.

The pre-habilitation protocol includes 3 parts :

1. Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism
2. Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently
3. Cardio-respiratory endurance.

For the experimental group:

Initial visit with adaptive rehabilitation physician, 6-8 weeks prior to surgery:

* Clinical examination with Wood classification - limits and restrictions.
* Assessment of environmental resources
* Definition pre-habilitation protocol and post-operative rehabilitation pathway
* application of the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician.

For the control group:

Support without pre-approval with application of other common practices of the service.

Follow up of both groups:

Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).

Mail-out of World Health Organisation Disability Assessment Schedule (WHODAS) 2.0, Euro Qol (EQ)-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Supra renal/Juxta-renal/Sub renal) treated with conventional surgery.
* Surgical indication of aneurysm by size (50-55mm)

Exclusion Criteria:

- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.
Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery
* RV/LV diameter ratio ≥ 1.0 assessed by CTPA
* Serum troponin levels above upper limit of normal as per hospital policy
* ≥ 18 years of age
* At least one of the following:

  1. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
  2. Systolic blood pressure ≤ 110mmHg for at least 15 minutes
  3. Respiratory rate \> 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while breathing room air
  4. Known history of heart failure
* Willing and able to provide written informed consent prior to receiving study specific procedures.

Exclusion Criteria:

* A contraindication to therapeutic anticoagulation
* Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer)
* Known serious, uncontrolled sensitivity to radiographic agents
* Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale \>12
* Indication for ECMO
* Pregnant or breastfeeding
* Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
* Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.
* History of congenital or acquired bleeding disorder predisposing to hemorrhagic state
* Platelet count \< 100,000/μL
* Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention)
* A known clot in transit
* IVC filter
* A do not resuscitate limitation at inclusion in the study
* Deprived of liberty or under court protection