cyrilzakka/clinical-trials huggingface dataset:
Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants

This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.

Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.

After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.

Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 37 weeks.
* Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
* On less than 35% oxygen.

Exclusion Criteria:

* Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
* Phrenic nerve injury and/or diaphragm paralysis
* Congenital/acquired neurological deficit and/or seizures
* Hemodynamic instability
* Congenital heart disease (including symptomatic patent ductus arteriosus)
* Undergoing treatment for sepsis or pneumonia.
* Use of muscle relaxants, narcotic analgesics, or gastric motility agents.
* Congenital anomalies of respiratory tract.
* Infants requiring more than 35% oxygen.
* Infants with facial anomalies.
* Infants with pneumothorax and/or pneumomediatinum.
* Infants in the immediate postoperative period.
* Infants with significant gastric residues and vomiting.
Cryoplasty CLIMB-registry

In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the "Instructions For Use" of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only data are collected that have been made available conform the Standard the Standards of Care for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.

Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.
Pain Elimination and Anxiety Control Through Experiential Virtual Reality

The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\[s\] it aims to answer \[is/are\]:

* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?

If there is a comparison group: Researchers will compare active group to passive group and standard of care.

Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents 8-21 years old undergoing IV placement .

  * Ability to understand study procedures and to comply with them for the entire length of the study.
  * Participants and caregiver speaking English or Spanish.

Exclusion Criteria:

* Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).

  * Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).
  * Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).
  * Critically ill Participants (ESI 1).
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section

Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing cesarean delivery

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy
* Concurrent bowel surgery
* Previous bowel surgery
* Concurrent bowel obstruction
* History of inflammatory bowel diseases
* Previous abdominal/pelvic radiation
* Postoperative placement of endotracheal tube/nasogastric tube
* Postoperative admission to intensive care unit
Lactose Intolerance at IBS

This cross-sectional study aims to determine the prevalence of lactose intolerance among patients with chronic diarrhea, assess its correlation with age and gender, and evaluate common symptoms in affected patients. The study will collect demographic data, conduct lactose intolerance testing via PCR, and use a symptom questionnaire.

The study is designed as a cross-sectional analysis conducted at a single healthcare center. Its primary objectives are:

To determine the point prevalence of lactose intolerance in patients suffering from chronic diarrhea (lasting more than four weeks).

To explore potential correlations between lactose intolerance and demographic factors such as age and gender.

To identify the most common symptoms associated with lactose intolerance in this patient population.

Methodology:

Data Collection: Demographic information (age, sex, medical history, and diarrhea duration) will be gathered.

Lactose Intolerance Testing: Polymerase Chain Reaction (PCR) will be employed to diagnose lactose intolerance.

Symptom Questionnaire: A standardized questionnaire will be administered to document symptoms like abdominal pain, bloating, flatulence, diarrhea, and nausea.

Eligibility Criteria:
Inclusion Criteria:

* All Patients with IBS diarrhea dominant type meet Rome criteria attending at Al-Rajhy University Hospital during 6 months (from march to September). A patient must have recurrent abdominal pain (at least 1 day per week in the last 3 months) associated with at least two of the following:

  1. Related to defecation (pain improves or worsens with bowel movements).
  2. Change in stool frequency (diarrhea or constipation).
  3. Change in stool form (appearance) (loose, watery, hard, or lumpy).
* Patients aged \>18 years.
* Both males and females

Exclusion Criteria:

* -patient aged\<18 years old.
* Patients with chronic diarrhea don't meet Rome criteria
* patients with malignancies
Effects of Nonlinear Signal Processing Algorithms on Speech Perception

The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.

In this study, we are interested in how nonlinear algorithms influence speech perception.

Nonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms:

* The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs)
* The type of background noise (20 people talking or 2 people talking)
* Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly)

To address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception.

Our study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Native speaker of English
* Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.

Exclusion Criteria:

* Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
* Subjects who younger than 18 or older than 65.
* Subjects who are not native speakers of English.
* Subjects with thresholds more than 70 dB HL at 2000 Hz and below
Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.

PRIMARY OBJECTIVE:

I.To longitudinally assess cardiac injury (serum biomarkers, and grade \>=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-NSCLC patients receiving chemoradiation.

OUTLINE:

Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.

After completion of study treatment, patients are followed up annually for up to 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
2. The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
3. \>/= 18 years of age
4. KPS \>/= 70
5. Willing and able to sign informed consents
6. Willing to perform 6minute walking test
7. Willing to preform required cardiac biomarker test for primary end point assessment.

Exclusion criteria:

1. Unable or unwilling to give written informed consent
2. Previous history of RT to the thorax overlapping with the current treatment field.
3. Pregnant or breast-feeding
4. Renal failure necessitating dialysis
5. Unwilling to perform protocol tests
6. Contraindication for any protocol tests
Endodontic Treatment Using CTZ Paste in Primary Teeth

The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* children aged from 3 to 6 years and 11 months;
* children present at least one upper or lower molar or primary upper incisor with untreated carious lesion with pulp envelopment;
* children assent to participate in the study through collaborative behavior;
* children's parents/guardians consent to their participation by signing the Informed Consent Form (ICF).

Exclusion Criteria:

* tooth with carious lesion involving three or more dental surfaces, making the restoration extremely difficult or impossible;
* tooth with internal or external resorption in more than 1/3 of the root length;
* tooth whose crypt of the successor permanent is affected;
* tooth which have less than 2/3 of the root;
* patients who present health problems with oral impairment.
PREventing CHemotherapy Induced Neuropathy (PreChIN)

The project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical activity will be studied. The study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.

Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable methods for the prevention or the treatment of CIPN. On the basis of the dose-related pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would aim to reduce the development of CIPN. This project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.

Eligibility Criteria:
The inclusion criterion for the healthy subjects

* Age 21-80 years
* Signed informed consent from patient
* No history of neuropathy
* ECOG 0
* No history of hospitalization in the past 6 months

The inclusion criteria for the cancer patients undergoing taxane-based chemotherapy

* Age 21- 80 years.
* Signed informed consent from patient or legal representative.
* Scheduled to receive taxane-based chemotherapy

The exclusion criteria for both healthy subjects and cancer patients

* Open skin wound or ulcers of the limbs
* A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (Not applicable for healthy subjects)
* History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients

The purpose of this study is to determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study participants will then be randomized into one of four groups; either they will receive 2 drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA) or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face mask for 15 minutes. Linalool makes up \~30% of Lavandula Angustifolia oil and is believed to be its most active anti-anxiety component. Before and after treatment, anxiety level will be measured using the Spielberger State-Trait Anxiety Inventory.


Eligibility Criteria:
Inclusion Criteria:

* Women, older than 18, American Society of Anesthesiologists (ASA) classification I-III, undergoing elective breast surgery on Tisch 10th floor Day Surgery. Cancer patients are included.

Exclusion Criteria:

* History of asthma, bronchitis, COPD, contact dermatitis to cosmetic fragrances, positive patch test, pregnancy, and significant laboratory abnormalities.
Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System

The primary objective of this study was to compare the adhesive quality of the current Mylan estradiol placebo transdermal system, with that of an alternate second generation Mylan estradiol placebo transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 40-66 years.
2. Sex: Females only.
3. Weight: At least 52 kg (115 lbs) and within 20% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
4. All subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ECG) performed within 14 days of the initial patch application.

Exclusion Criteria:

1. Institutionalized subjects will not be used.
2. Any prior history of skin diseases (eczema, psoriasis, atopic dermatitis).
3. Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.
4. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
   2. Abnormal and clinically relevant ECG tracing.
5. Subjects who have received an investigational drug within 30 days prior to the initial patch application and/or participated in any transdermal system test for irritation or sensitization within the last 4 weeks.
6. Allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).
Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.

Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic chondral lesions of the knee

Exclusion Criteria:

* Inflammatory arthritis
* Septic arthritis
* Total meniscectomy
* Previous microfracture at chondral lesions
* Paget
* Ochronosis
* Acromegalia
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

Patients wiith selected malignant or non-malignant conditions meeting eligibility criteria will be enrolled on this study. Patients will receive one of either full intensity, reduced intensity, or reduced toxicity conditioning appropriate based on disease, disease status, organ function and performance status and will undergo α/β T-cell and CD 19+ B cell depleted alloSCT.

Patients will be following for engraftment, chimerism, immune reconstitution, GVHD and QOL.

Eligibility Criteria:
Inclusion Criteria:

1. ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (\<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (\<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;
2. AML: History of AML induction/reinduction Failure (\<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(\<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML
3. High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission

5. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function

Exclusion Criteria:

1. Females who are pregnant or breast-feeding are not eligible.
2. Patients with documented uncontrolled infection at the time of study entry are not eligible.
3. Karnofsky/Lansky (age appropriate) Performance Score \<60
4. Demonstrated lack of compliance with medical care
5. Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.
6. Patients with active \<Grade 2 GVHD.