cyrilzakka/clinical-trials huggingface dataset:
Sleep and Cerebral Responses to High Altitude

Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on one hand and cerebral perturbations on teh other hand may be key mechanisms. The investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days in order to better describe sleep and cerebral responses. The investigators hypothesized that sleep and cerebral disturbances play a critical role for the developement of acute mountain sickness and for exercise performance limitation during acute high-altitude exposure.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 yrs old
* Male

Exclusion Criteria:

* Respiratory, cardiac, metabolic or neuromuscular diseases
* History of severe acute mountain sickness
Dry Needling and Electromyographic Changes in Neck Pain

There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can affect motor control behaviour, it is possible that management of these trigger points with dry needling could be effective for improving muscle activity during low-load activities, such as the cranio-cervical flexion test. Therefore, the aim of this study will be to investigate the effects on electromyographical activity, pressure pain thresholds and cervical range of motion after the application of dry needling over active TrPs in the upper trapezius muscle in patients with mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.

Exclusion Criteria:

* whiplash injury;
* previous cervical or thoracic surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone physical therapy in the previous 6 months;
* less than 18 or greater than 55 years of age
* fear to needles
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria:

* Subjects for whom ERCP procedures are contraindicated
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
* Age less than 18 year
* Emergency surgery
* Previous pancreatic surgery
Is Augmentation of PORH by Rosuvastatin Adenosine-receptor Mediated?

Rationale:

Statins form a class of drugs that is widely prescribed for hypercholesterolaemia, specifically to reduce the risk on atherosclerosis by lowering LDL-cholesterol. Next to the effect for which the drug was originally developed, it became obvious that statins have several other beneficial effects. Such pleiotropic effects include the activation of ecto-5'-nucleotidase which can increase endogenous adenosine production (by dephosphorylation adenosine monophosphate into adenosine) and subsequently cause vasodilation. A recent study of Meijer et al (not yet published) showed that rosuvastatin significantly augments vasodilation after a brief period of ischemia (post occlusive reactive hyperaemia). However, it is not yet verified whether this increase in post occlusive reactive hyperaemia is truly caused by a rise of extracellular adenosine and subsequent adenosine receptor stimulation. In this study, the mechanism by which rosuvastatin augments post occlusive reactive hyperaemia will be investigated by blocking adenosine receptors with caffeine, a competitive A1 and A2 adenosine receptor antagonist. Caffeine is a substance that can be safely used in normal concentrations to block the adenosine receptor.

Hypothesis:

The augmenting effect of rosuvastatin on PORH is caused by an increase of extracellular adenosine formation and this effect can be diminished by blocking the adenosine receptor using caffeine.

Objective:

To study the influence of caffeine on post occlusive reactive hyperaemia before and after 7 days treatment with rosuvastatin.

Study design:

Open label cross-over design Study population: Healthy volunteers, 18-50 years of age

Intervention:

Eight volunteers will receive a 7 day treatment with rosuvastatin 20 mg daily before and after rosuvastatin treatment caffeine will be administrated intra-arterially.

Main study parameters/endpoints:

Forearm blood flow (FBF) will be measured as an indicator for post occlusive reactive hyperaemia (PORH).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Written informed consent

Exclusion Criteria:

* History of any cardiovascular disease
* Hypertension (in supine position: systole \>140 mmHg, diastole \>90 mmHg)
* Diabetes Mellitus (fasting glucose \>7.0 mmol/L or random glucose \>11.0 mmol/L)
* Hyperlipidemia (fasting total cholesterol \>5.5 mmol/L or random cholesterol \>6.5 mmol/L)
* Alanine amino transferase \>90 U/L
* Creatin kinase \>440 U/L
* Raised rhabdomyolysis risk (GFR \<80 ml/min and/or overt clinical signs of hypothyroidism and/or myopathy in family history
* Alcohol abuse
* Concommitant chronic use of medication
* Participation to any drug-investigation during the previous 60 days as checked with VIP check
Virtual Reality Training in Occupational Rehabilitation

Work-related attention bias modification training and virtual reality training in occupational rehabilitation is a multisite pilot study.

The quantitative aim of this pilot study is to compared virtual reality (VR) training and attention bias modication (ABM) training to investigate whether the different training forms result in different results measured with work-related outcomes and cognitive outcomes. The qualitative aim of this pilot study is to investigate the patients' experiences with the usage of VR.

Three rehabilitation insitutions will be recruiting patients participating in occupational rehabilitation, and the study will compare the outcomes of work-related interventions with and without the addition of ABM or VR training.

The study seeks to determine if these interventions can improve work ability, reduce symptoms of depression and anxiety, and change attentional bias from negative to positive stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 67 years
* Must be on sick leave, work assessment allowance or on disability pension
* Receiving work-related rehabilitation or treatment at clinics with either an International Classification of Primary Care, Second edition (ICPC-2) within the musculoskeletal (L), psychiatric (P) or unspecific disorders (A) categories or International Classification Disorders-10 diagnosis within the mental and behavioral disorders (F), Diseases of the musculoskeletal system and connective tissue (M) or other diagnoses.

Exclusion Criteria:

* Applying for a full disability pension;
* Unable to complete the measures and receive instructions in Norwegian.
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.

This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients with solid cancer
* Patients with implantable catheter
* Patients receiving parenteral nutrition
* Patient affiliated to a social security scheme or beneficiary of such a regime

Exclusion Criteria:

* Patients refusing to participate in the protocol
* Patients already receiving preventive lock of IRCIC
* Known citrate or (cyclo) allergy -taurolidine
* Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.
* Participation in another protocol for the prevention of infections associated with central venous catheters
* Patients who did not sign the consent
* Patient with a status of socio-legal protection
Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age more than 18 years old.
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin \>10 g/dl
4. Missed abortion

Exclusion Criteria:

1. Mullerian Uterine anomalies as septate, bicornuate uterus.
2. Fibroid uterus.
3. Coagulopathy.
4. Medical disorder that contraindicate induction of abortion.
5. Allergy to misoprostol or letrozole.

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Motivational, Movement and Self-Management Training for Adolescents in Pain

With this randomized controlled trial, we have three aims. First of all, to investigate underlying mechanisms that might contribute to the success of a physical activity focused self-management program in paediatric chronic pain.

Second of all, to determine the minimum intervention needed for improving physical activity amongst adolescents who live with chronic pain. For this we are comparing an in-person and a video-based motivational interviewing training combined with self-management techniques.

Third of all, to investigate the mediating effect of autonomy in adolescents with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Age between 12-18 years
* Experiencing pain at least 3 months
* Good reading, writing and listening skills in Hungarian language
* Self-sufficient
* Access to internet and phone
* No active cancer.

Exclusion Criteria:

* Age is not between 12-18 years
* Experiencing pain less then 3 months
* Not able to read, write and listen in Hungarian
* Not self-sufficient
* No access to internet and phone
* Active cancer.
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.


Eligibility Criteria:
Inclusion criteria:

1. Surgical procedure: Two-stage, three-stage or transhiatal esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects
2. Disease-free at least one year post-resection

Exclusion criteria:

1. Pregnancy, breastfeeding
2. Significant and persistent chemoradiotherapy and/or surgical complication
3. Other previous upper gastrointestinal surgery
4. Unwell or unable to eat
5. Other disease or medications which may affect satiety gut hormone responses
6. Active and significant psychiatric illness including substance misuse
7. Cognitive or communication issues or any factors affecting capacity to consent to participation
8. History of significant food allergy, certain dietary restrictions
9. Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
10. Requiring adjuvant chemotherapy
11. Contraindication to octreotide administration
12. History of eating disorder
Urinary Incontinence and Practice of Physical Exercises

Introduction: Urinary incontinence is often seen as a problem that affects multipara and old-aged women, however, there is evidence that during high impact physical activity, mainly, or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is common, even among young women, physically active, and without known risk factors.

Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women who regularly practice physical activities.

Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old) who exercise regularly. They were divided into 3 groups according to the regular practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were questioned about the perception of leakage of urine during the practice of exercises. The established exclusion criterion included: surgeries of urinary tract, urinary infections, gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form of physical activity.

The assessment was carried out in academies of the city of Franca. All participants were questioned about the perception of loss of urine during the practice of exercises.

Eligibility Criteria:
Inclusion Criteria:

* practice of exercises

Exclusion Criteria:

* surgeries of urinary tract
* urinary infections
* gestations
* child-birth
* advanced aged
* obesity
* sedentary and practice of only one form of physical activity
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients

Exclusion Criteria:

* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)

This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects,
* 40 to 80 years of age,
* with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC \< 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
* Subjects who demonstrate a plethysmographic functional residual capacity \>120% predicted normal

Exclusion Criteria:

* No COPD exacerbations within 6 weeks prior to dosing,
* no concomitant lung disease such as asthma,
* no requirement for long term oxygen treatment or history of lung reduction surgery.
* No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
* Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease

Other protocol-defined inclusion/exclusion criteria may apply
Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).


Eligibility Criteria:
Inclusion Criteria:

* First Delivery
* Vaginal Delivery
* Birthweight \> 3000
* Singleton pregnancy

Exclusion Criteria:

* Anal sphincter disruption before birth
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)

This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP compared to a historical control group.

Asfotase Alfa was formerly referred to as ENB-0040

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Efficacy analyses were prospectively defined in the protocol with a comparison to historical controls. The historical control group came from patients whose characteristics matched as closely as possible the entry criteria for the trial. The control group included all patients who had x-rays within the age range defined by the inclusion criteria of this study (5 to 12 years of age, inclusive, with open growth plates).

The pre-specified plan for analysis was to combine the two asfotase alfa treated groups (asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week) and compare them to historical controls.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent from parent or legal guardian prior to participation
2. Patients \> 5 and \< 12 years of age with open growth plates at time of enrollment
3. Tanner stage of 2 or less indicating pre-pubescence
4. Documented history of HPP, as evidenced by:

   * Presence of HPP-related rickets on skeletal radiographs of the wrist and knee
   * Serum alkaline phosphatase (ALP) below age-adjusted normal range
   * Plasma PLP at least twice the upper limit of normal
5. 25(OH) vitamin D level \> 20 ng/mL
6. Ability of patient and parent/guardian to comply with study requirements

Exclusion Criteria:

1. Serum calcium or phosphorus below age-adjusted normal range
2. History of sensitivity to any study drug constituent
3. Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities
4. Treatment with an investigational drug within 1 month before start of study drug
5. Current enrollment in any other study involving an investigational new drug, device, or treatment for HPP (e.g., bone marrow transplantation)
6. Current evidence of a treatable form of rickets
7. Prior treatment with bisphosphonates
8. Bone fracture or orthopedic surgery within the past 12 months that, in the opinion of the Investigator would interfere with the ability of study patient to comply with study protocol
9. Major congenital abnormality other than those associated with HPP
Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle

About 10-15% of all couples attempting to conceive will not become pregnant within one year. Among those, the majority will have ovulatory dysfunction, mild male infertility or unexplained infertility. The traditional first line therapy for those couples is ovulation induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects of this agent will, some patients will have a thin endometrium as measured by sonography at the time of ovulation. This phenomenon may be associated with a lower chance to conceive. Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown to be equally effective to clomiphene in ovulation induction. Preliminary observations showed that tamoxifen does not cause a negative effect on the endometrium as compared with clomiphene, and may increase the chance to conceive in those patients who have a thin endometrium under clomiphene.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary infertility due to:
* Ovulatory dysfunction
* Mild male infertility
* Unexplained infertility
* Endometrium \< 6 mm at time of hCG during previous treatment with clomiphene citrate
* Age 18-35

Exclusion Criteria:

* Serious adverse effects under clomiphene citrate or known sensitivity to either tamoxifen or clomiphene citrate