cyrilzakka/clinical-trials huggingface dataset:
Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).

The purpose of this study is to investigate the effect of moderate altitude (\>1000 m.a.s.l.) on sleep examinations (polysomnography).

Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 600 m.a.s.l.) as well as for 2 consecutive nights at the participants home elevations (CH; \>1000 m.a.s.l.). Between the measurements at those two different altitudes there will be a two-week washout period at \>1000 m.a.s.l.. The sequence of altitude exposure will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no current medical condition or intake of regular medication, except negligible medical issues or accidents not interfering with the current health status or physical performance.)
* Living above 1000 m.a.s.l. since at least 1 year
* No overnight stay at altitudes \<1000 m.a.s.l. in the previous 4 weeks
* 18-70 years old
* Body mass index 18,5-30 kg/m2
* informed consent

Exclusion Criteria:

* Active diseases or health related conditions that require treatment (sleep disorders (mainly sleep apnea), chronic rhinitis, cardiovascular and lung diseases)
* Use of drugs that affect the respiratory center drive (sedatives, sleep inducing drugs, opioids), stimulants or illegal drugs
* Regular consumption of recreational drugs (alcohol and nicotine included)
Study on Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus

The study intends to establish a closed-loop management from prenatal to postnatal through prospective cohort, and comprehensively utilize ultrasound and MRI technology to establish a prenatal diagnosis and evaluation system for congenital talipes equinovarus. On the basis of existing genetic testing, further use of whole-exome sequencing and other genomic methods to explore possible pathogenic genes and loci, and clarify the pathogenic mechanism of congenital talipes equinovarus. Therefore, congenital talipes equinovarus can improve its diagnosis and treatment capacity, reduce the disability rate related to congenital talipes equinovarus, and prevent it well.


Eligibility Criteria:
Inclusion Criteria:

1）Single pregnant women 2) "congenital talipes equinovarus" suggested by ultrasound

Exclusion Criteria:

Twin or multiple pregnancies
Obstetric Anaesthesia And Analgesia Month Attributes - International

A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic.

A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Women in labor undergoing anesthesia care

Exclusion Criteria:

* not meeting inclusion criteria
Health Education for Preventing Falls in Older Adults Living in the Community

This clinical trial aims to evaluate the effectiveness of three health education intervention modules in preventing falls among older adults living in the community. The study is designed as a factorial randomized controlled trial, assessing the impact of three health education intervention modules: Fall prevention knowledge education，Exercise education, and Home hazard reduction education. Each module will have a 'yes' and 'no' version, resulting in eight experimental conditions.

The primary questions it seeks to address are: (1) What is the main effect of different health education intervention modules on preventing falls in older adults living in the community? (2)What is the interactive effect of different health education intervention modules on preventing falls in older adults living in the community?

The trial will be conducted in twenty four sub-district in Baiyun District, Guangzhou City. An estimated 37 participants will be recruited from each of the 24 sub-districts, with the sub-districts being randomly assigned to one of the eight experimental groups by a statistician independent of the research team using computer-generated random numbers.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 inclusive
* Live in the community
* Expected to live in their current place of residence for the next 12 months
* can walk 50 metres without the assistance of an assistive device

Exclusion Criteria:

* Exclusion of subjects with acute illness or acute stages of chronic disease
Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic

During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.

During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.

We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.

Eligibility Criteria:
Inclusion Criteria:

age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009

-

Exclusion Criteria:

any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion
Clinical Study of Endocardial Myocardial Biopsy

In this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. If necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the Second Affiliated Hospital of Zhejiang University School of Medicine;
* Patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause;
* Have the ability to understand the test, can cooperate with investigators.

Exclusion Criteria:

* Unable to understand or unwilling to fill in informed consent forms or follow visitors.
Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection

Linear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar. Despite high demand for the early intervention to prevent and treat surgical scars, there is yet no universal consensus on satisfactory treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in medicine for more than 30 years. It induces chemodenervation through acting on the presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation of striated muscle for about 6 months after injection. The aim of this randomized controlled trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in the early postoperative of median sternotomy for the purpose of preventing excess scar formation.

The goal of this study is to conduct a randomized controlled trial about using Botulinum toxin type A ( BTA) to prevent hypertrophic scar in median sternotomy wound. The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline. The patient and the surgeon will be blinded to the treatment arm. The primary end point was the evaluation of upper and lower half scar using the Vancouver Scar Scale (VSS). At 6 months follow-up, two blinded dermatologists examined the patients and took photographs of the scar in the outpatient clinic of XiJing Hospital. Scars were assessed using the VSS and assigned the mean score of the two observers. At 6-month follow-up, ultrasonography to measure the scar width will be performed. At the same time, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar(1= very satisfied, 2= satisfied,3= slightly satisfied, 4= unsatisfied ).Paired t-test was used to compare the VSS scores, scar width and the overall satisfaction between the BTA-treated group and normal saline group.

Eligibility Criteria:
Inclusion Criteria:

* Patients included are older than 18 years with a median sternotomy less than 14 days.
* Patients are willing and able to participate in the study as an outpatient, making several visits to the study center during the treatment and follow-up periods.
* Patients can comply with all study requirements including concomitant medication and other treatment restrictions.
* Patients have good wound healing condition, without infection sign.

Exclusion Criteria:

* The exclusion criteria applied is current pregnancy or breast feeding, allergy to botulinum toxin type A, previous injection of botulinum toxin within 6 months prior to enrollment, Myasthenia gravis or other neuromuscular disorder,and refusal to participate in this trial.
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

This study is a phase Ib/II study of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). This study include Phase Ib and Phase II study. The phase Ib study is designed to evaluate the safety and tolerability of MAX-40279-01 in combination with Azacitidine (AZA) in patients with Relapsed or Refractory AML. The phase II study is designed to preliminarily assess the efficacy and safety of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. A diagnosis of AML according to the World Health Organization (WHO) 2016 criteria with relapsed or refractory disease and have exhausted, or are ineligible for therapeutic options, or int-risk or high-risk or very high-risk MDS according to revised International Prognostic Scoring System (IPSS-R);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Expected survival \>3 months.
5. No radiotherapy, surgery or hormonal therapy for any kind of within 2 weeks prior to participating in this study. Patients must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs (including hypomethylating agents in MDS patients), radiotherapy or other anti-cancer modalities (i.e., returned to baseline status as noted before most recent treatment) for any tumors. Patients with persisting, stable chronic toxicities from such prior treatment ≤Grade 1 are eligible, but must be documented as such.
6. Signed informed consent form.

Exclusion Criteria:

1. Acute promyelocytic leukemia according to World Health Organization 2016 criteria
2. Known central nervous system involvement
3. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
4. Known allergies, hypersensitivity, or intolerance to Max-40279-01 or AZA or the excipients of these treatments
5. Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry
Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed colorectal cancer
* KRAS wild type metastatic colorectal cancer
* Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
* Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
* Must have at least one measurable lesion
* Must be 18 years of age or older
* ECOG performance status 0-1
* Life expectancy must be greater than 12 weeks
* For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion

Exclusion Criteria:

* Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
* Metastasis to the CNS
* Prior treatment with any Hsp90 inhibitor compounds
* Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:

  * Radiotherapy, conventional chemotherapy: within 2 weeks
  * Palliative radiotherapy: within 2 weeks
  * Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
  * Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
* Treatment of therapeutic doses of coumadin-type anticoagulants. \[Maximum daily dose of 2mg, for line patency permitted\]
* Known sensitivity to cetuximab
* Unresolved ≥ grade 1 diarrhea
* Malignant ascites that require invasive treatment
* Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
* Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
* Impaired cardiac function
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

The investigators earlier clinical study in 754 young Finnish men demonstrated a significant negative association of serum 25-OHD concentration with acute respiratory tract infections. The present study aimed to determine whether vitamin D supplementation may decrease the incidence of acute respiratory tract infections.

Subjects comprised 164 male conscripts at a military base in Finland. Half of the participants were randomly allocated to receive 400 IU vitamin D daily and half received placebo from October through March. Serum vitamin D and plasma parathyroid hormone concentrations were determined. Subjects were followed for 6 months and the primary outcome was the number of days absent from duty due to ARTI.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Use vitamin D
Effect of Early Education on the Observance of CPAP Treatment

Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (\> 5 h/night).

Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).

Eligibility Criteria:
Inclusion Criteria:

* Patients affiliated or entitled to a French medical insurance
* Patients of both gender, aged from 18 to 80 years
* Patients with AHI \> 30/hour or between 15 \& 30/h with Sleep Fragmentation Index (SFI) of more than 10/h
* Signature of consent

Exclusion Criteria:

* Known diseases which contraindicated used of CPAP treatment
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Is a healty male between 20 and 55 years old
* Has BMI result between 19 and 26 kg/m2 at screening
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Agrees to use an adequate means of contraception during clinical trials

Exclusion Criteria:

* Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
* Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
* Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history
MAC-cbt Group Therapy for Adults With ADHD

The study is developed to validate a new short psychotherapeutic group treatment for adults with ADHD diagnosis. The participants will be treated in a monocentric, parallel group randomized superiority study - one group with the new treatment and one group with well established relaxing treatment.

Background: Attention deficit hyperactivity disorder (AD(H)D) symptoms are often assumed to decease in adolescence, however in up to 60% of children, AD(H)D persists into adulthood. Currently, pharmacological therapy is the number-one choice AD(H)D treatment. Despite its evidenced effects of pharmacological interventions there are side effects, contraindications and non-responders, which send some patients disliking the use of medication and asking for alternative treatments. In previous studies mindfulness-based interventions already have shown similar effects in neural regions as pharmacological treatment and positive changes in AD(H)D symptoms, quality of life, awareness and concentration. The following study wants to improve mindfulness-based treatment approaches in AD(H)D with a new therapy concept.

Methods: Mindfulness, acceptance, commitment and cognitive behavioral group therapy (MAC-CBT) combines 3rd wave therapies with focus on mindfulness meditation, acceptance of unchangeability, commitment to new goals with elements of cognitive behavioral therapy. The design of this study is a single-center, parallel-group, randomized superiority trial. The aim is to compare MAC-CBT group with progressive muscle relaxation training (PMR by Jacobson). Both groups will be held over a period of eight weeks. Participants will be assessed two times before treatment to determine natural course of adult AD(H)D and two times after treatment to evaluate short and long term effects. A questionnaire battery and neuropsychological tests are to be used to obtain results regarding a possible change in the symptoms and attention, including selective attention.

Discussion: This trial will offer new knowledge about the effects of third wave therapies on AD(H)D. Furthermore, the following study is one of few studies that will compare AD(H)D treatment to relaxation training instead of comparison to waiting list. The aim of the following study is to verify previous outcomes of mindfulness-based treatments on AD(H)D and to evaluate superiority of mindfulness towards relaxation programs.

Eligibility Criteria:
Inclusion Criteria:

* adult ADHD
* written informed consent
* stable medication for at least two weeks
* sufficient knowledge of the German language

Exclusion Criteria:

* personality disorder
* schizophrenia / psychotic disorders
* bipolar disorder
* acute suicidality
* disease of the central nervous system
* no other psychotherapeutic treatment at the time of the study
* pregnancy
* IQ below 70 Points
Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period.

In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature.

On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.

Eligibility Criteria:
Inclusion:

School-aged 6-12 years old. Children who require PIVC.

Exclusion:

1. Chronic diseases,
2. Physical impairment,
3. Disability contributes to difficult communication,
4. Children of unsatisfied parents,
5. Children with neurodevelopment delays,
6. Cognitive impairment, hearing impairment, or visual impairment,
7. Taking an analgesic within 6 hours, or those with a syncope history.