cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

The purpose of this study is 1) to determine what physiologic factors (extracellular fluid overload or vasoconstriction) contribute more to increased blood pressure levels between dialysis treatments in hemodialysis patients whose blood pressure increases and decreases during hemodialysis and 2) to determine whether carvedilol provides better control of blood pressure between dialysis treatments than prazosin in patients whose blood pressure increases during dialysis.


Eligibility Criteria:
Inclusion Criteria (for Aims 1 and 2):

* age more than 18 years
* Hypertension defined as systolic blood pressure more than 140 mmHg before dialysis or more than 130 mmHg after dialysis
* For case subjects with intradialytic hypertension: systolic blood pressure increase more than 10 mmHg from pre to post dialysis in at least 4 out of 6 screening treatments
* For control subjects: systolic blood pressure decrease more than 10 mmHg from pre to post dialysis in at least 4 out of 6 screening treatments

Inclusion criteria for Aim 3 includes the case subjects described above.

Exclusion Criteria:

For Aims 1 and 2:

* Hemodialysis vintage less than 1 month
* Amputated arm or leg
* Presence of cardiac defibrillator or pacemaker
* Presence of large metal prosthesis
* Failure to achieve dry weight

For Case subjects participating in Aim 3:

* Patients with a specific indication for beta blocker therapy including systolic heart failure, history of myocardial infarction, history of tachyarrhythmia or angina being managed with beta blocker therapy.
* Patients with contraindications to beta blockade including bradycardia (heart rate less than 60 beats per minute) while not on a pulse lowering drug, severe reactive airway disease, prior intolerance to beta blocker therapy
* Prior intolerance to alpha blocker therapy
Early Detection and Characterization of Primary Ciliary Dyskinesia

Primary Ciliary Dyskinesia (PCD) is a severe genetic disorder caused by various mutations in genes affecting ciliary motility. Various new and complementary diagnostic techniques, including measurements of nasal nitric oxide (NO), Video Microscopy (VM), Immunoflourescence (IF) and genetic analysis have recently been recognized as simpler and more accurate modalities for the diagnosis and characterization of patients with PCD compared to electron microscopy. While considered a rare disease worldwide, PCD is more prevalent among highly consanguineous populations, such as those found in Israel. We hypothesize that using modern state of the art and novel test modalities on a national scale in Israel will improve diagnosis, improve phenotypic-genotypic correlations and create a national registry for PCD.

Primary Ciliary Dyskinesia (PCD) is a severe genetic disorder caused by various mutations in genes affecting ciliary motility. While diagnosis of PCD in Israel is currently based for the most part on electron microscopy (EM) detection of ciliary ultrastructural defects, this technique may be unsatisfactory and does not overcome the inherent heterogeneity. Thus, late and under-diagnosis and suboptimal characterization of patients is common. Various newer and complementary diagnostic techniques, including measurements of nasal nitric oxide (NO), Video Microscopy (VM), Immunoflourescence (IF) and genetic analysis have recently been recognized as simpler and more accurate modalities for the diagnosis and characterization of patients with PCD. While considered a rare disease worldwide, PCD is more prevalent among highly consanguineous populations, such as those found in Israel. Given the rarity of cases particularly familial ones, the most useful implementation of new diagnostic techniques requires multicenter collaboration.

We hypothesize that using modern state of the art and novel test modalities on a national scale in Israel will improve diagnosis, improve phenotypic-genotypic correlations and create a national registry for PCD.

We propose to perform such a multicenter study whose aims are:

* To characterize the complex phenotype and genotype of PCD in Israel, using state-of-the-art and novel diagnostic techniques.
* To create a national registry of patients and families with PCD in Israel
* To develop robust national standards of diagnosis and evaluation, which will lead to better and earlier diagnosis, treatment and counseling.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PCD diagnosis
* Subjects with suspected diagnosis of PCD

Exclusion Criteria:

* Subjects Uncooperative with study procedures
Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia

This is a study of only patients with idiopathic hypersomnia. It is a rare and still poorly understood pathology. In clinical practice, we have found that the treatment and care offered were not always effective. The idea of this study to improve knowledge of this pathology by studying the demographic characteristics of patients and other co-morbidities, in particular psychiatric patients, to see if we can identify common factor to our patients and useful in their medical care. The main objective of this research is to allow a quantitative study of the demographic and psychiatric characteristics of patients with idiopathic hypersomnia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with a diagnosis of idiopathic hypersomnia according to the ICSD 3 criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today.

Exclusion Criteria:

* minors persons and under legal protection persons.
Chlorhexidine Vaginal and Infant Wash in Pakistan

Infection is a major health problem during birth in Pakistan. This study will look at the possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.

Sepsis in mother and infant is a major cause of perinatal morbidity and mortality in low-resource settings. Several studies have investigated the likelihood that an anti-bacterial agent, chlorhexidine, administered during labor and delivery to mother and infant could reduce the risk of infection and of subsequent maternal and infant morbidity and mortality. In this trial, chlorhexidine wash and placebo will be randomly administered to women in labor and newborn infants in a public hospital in Karachi, Pakistan.

Delivery attendants will administer 0.6% chlorhexidine solution every four hours until delivery (4 washes maximum) and one neonatal wash with the same solution. The control group will receive 200 ml of sterile physiologic saline solution. A total of 5000 women will be randomized in the hospital study, 2500 control and 2500 intervention. All women and infants will be evaluated 24 hours post delivery and at a 7-day follow-up. Women who delivered at home will also receive a 28 days post-partum assessment. Women will be carefully monitored for side effects to the dosage. In addition a community-based feasibility trial of 200 patients (100 CHX, 100 control) will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Gravidas with living fetus delivering at home in the care of identified study birth attendant (community) or admitted to the identified hospital (Civil Hospital Karachi) for delivery

Exclusion Criteria:

* Contraindications to cervical exam (e.g., placenta previa)
* Active genital herpes or vulvovaginal ulceration
* Known or suspected allergy to chlorhexidine
* Fetus with face presentation
* Fetal death
* Unwilling/unable to give informed consent
* Less than 16 years of age
Cardiovascular Safety After Continuous Ketamine Infusion

Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain

Severe acute pain and opioid tolerance is an important symptom in patients after surgery.

Ketamine in analgesic infusion has been described to decrease acute pain, in patients with opioid tolerance. Ketamine use has been associated with side effects, which are doses dependant. Those side effects are mainly cardiovascular: Hypertension, tachycardia, and neuropsychiatric: delirium, hallucinations,nightmares that potentially compromise recovery of patients.

Objective:

To determine retrospectively in data bases the frequency of tachycardia, hypertension, delirium, hallucinations and nightmares, in adult patients that received ketamine infusions before and after administration of this drug in the first 48 hours to treat acute and postoperative pain

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Acute and Postoperative pain
* Ketamine infusion at 0.15 mg/kg/h or below

Exclusion Criteria:

* Cognitive disfunction psychiatric illness
* Acute cardiovascular disease
* Anemia with Hb less than 7 g/dl
* Decompensated hyperthyroidism
* Low cardiac output
* Incomplete medical history
Coaching Intervention for Caregivers of Persons With Stroke

Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.

Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, "Health Coaching-in-Context" and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Survivor criteria: First-time stroke, discharged from hospital within the past 30 days.
* Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer.
* Both: 18 to 80 years of age, understand and speak English

Exclusion Criteria:

* Children
* 81 years of age or older
* Unable to understand and speak English
* Does not provide consent
* Caregiver does not pass cognition screen
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors

To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.

The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. The study will be divided into two groups:

Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Control Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be of either gender, aged between 18 and 65 years;
2. Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
3. Must have undergone standard chemotherapy and require en bloc resection;
4. Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.

Exclusion Criteria:

1. Severe dysfunction of the heart, liver, kidney, lung, or brain.
2. Pregnant women or women who are breastfeeding.
3. History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.
4. History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.
5. Participation in any other clinical study currently or within 3 months prior to the screening visit.
6. Patients have any other conditions that the researcher deems unsuitable for the study. Age is between 18 to 75 years old.
Comparison of Pericapsular Nerve Group Block With Suprainguinal Fascia Compartment Block in Hip Fractures

Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery will also be evaluated.

The study was conducted as a retrospective cohort feasibility design within a tertiary hospital. Patient records and electronic data systems were used to gather the required data for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

* Previous operation on the same hip
* Hepatic or renal insufficiency
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \>40
* ASA IV
The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.

The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of 9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.

patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above 200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the capsules is about 1:1.


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* Fibrate treatment (for at least 6 weeks)
* HDL-Cholesterol lower than 40mg/dl.
* Triglyceride over 150mg/dl.

Exclusion Criteria:

* High CPK.
* Elevated liver functions.
* Active CHD.
* Smokers.
* Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.
Evaluation of Oncoxin-Viusid® in Cervical Cancer and Endometrial Adenocarcinoma.

The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with histological diagnosis of cervical cancer and endometrial adenocarcinoma. This is a phase II, prospective, randomized and double blind clinical trial, which will include 66 patients assigned to 2 treatment arms: 33 patients will receive conventional treatment, plus a placebo of the nutritional supplement and another 33 patients will receive along with the conventional treatment the Oncoxin-Viusid nutritional supplement produced by the Catalysis Laboratories of Spain. Patients will receive oral treatment throughout the onco-specific treatment and up to 3 weeks after completion.

Patients will be evaluated clinically and hematological at the beginning of the treatment, before each cycle of treatment with QTP / RTP, at month, two and three months after the end of the treatment with follow-up every three months for 1 year. The self-perceived quality of life related to health will be assessed by means of the EORTC questionnaires (QLQ-C30 and the specific questionnaire QLQ-CX24) at the beginning and a year after completing the treatment. The toxicity to the research product will be described according to Common Criteria of Terminology for the Report of Adverse Events (CTCAE version 4) and the tolerance to onco-specific treatment. It is expected that with the joint administration of the research product, the patients will have a better tolerance to the treatment of QTP / RTP with a decrease of the interruptions by toxicity in 25% and will preserve a better quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmation of cervical cancer and adenocarcinoma of the endometrium that are treated with chemotherapy and ionizing radiation.
* Patient with age equal to or greater than 18 years and up to 80 years.
* Patients who do not present decompensated concurrent diseases at the time of diagnosis that prevent or contraindicate the application of treatment with chemo-radiotherapy.
* Informed consent to participate in the investigation.
* Patients with an ECOG \<or equal to 3.

Exclusion Criteria:

* Patients with a history of renal failure that contraindicates the administration of cisplatin.
* Concomitant diseases unbalanced at the time of diagnosis or during the application of treatment.
* Patients with an ECOG\> 3.
* Pregnant or lactating women.
* Patients who are receiving another research product.
* Patients who do not show consent to participate in the study.
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).

Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of frozen shoulder of at least one month duration

Exclusion Criteria:

* shoulder arthritis
* rotator cuff tears
* any chronic, serious, uncontrolled medical condition
* inability to conform to study visits (20-30 per year)
Motivation and Executive Control in Schizophrenia

In order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. This control is required in unusual situation. Appropriate actions are selected and coordinated according to context and aim.

Several studies try to draw a model of executive function. Recently, Koechlin has suggested a three levelled organisation to explain how the prefrontal cortex controls actions.

Contextual control is useful to answer appropriately with the immediate context. Episodic control allows selecting the action according to specific information given before. Sensorial control is the automatic response when a stimulus is presented.

Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal cortex. Chambon and al (2008) have identified a dysfunction of contextual control in schizophrenia.

As the prefrontal cortex is involved in motivational process, it seems interesting to study potential links between executive function and motivation. A study from Kouneiher shows contextual and episodic activation of motivation in healthy population.

Investigators aim to study the way motivational process are recruited in schizophrenia.

behavioral protocol. Letters (vowel and consonant; upper- or lower- case) are presented in several colours into successive blocks. Each block included a series of eight letters. Each colour required a specific task given by a fixed rule (contextual control) but for some colour, the rule changes sometimes (episodic control). Participants are informed that payoffs vary according to their own performance. A frame indicates essay with bonus reward. Moreover a dashed frame indicates a low-bonus reward and a solid frame means a high-bonus reward. Thus different blocks are designed: low-incentive block and high incentive block.

This reward increased from standard to bonus motivation in high-incentive block (contextual motivation) and from low to high according to the type of blocks (episodic motivation) Reaction time may be higher in bonus reward Patients with schizophrenia are not sensitive to contextual motivation, and therefore patients should behave differently than control in contextual motivation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old
* schizophrenia
* french native speaker

Exclusion Criteria:

* Neurological disease
* Motor or visual deficit
* Somatic treatment with neurological impact
* Drug abuse
Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation

The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.

Primary objective:

• Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient.

Secondary objectives:

* Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation.
* Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation.
* Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®).
* Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
* Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment

Exclusion Criteria:

* Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months
* Left atrial diameter \> 50mm or ejection fraction \< 35%
* Instable coronary artery disease or clinically relevant cardiac valve insufficiency
* Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance
* Concomitant disease with expected lifespan \< 2 years
* Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (\< 24 hours) before catheter ablation.