cyrilzakka/clinical-trials huggingface dataset:
The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process.

Breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. The handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting.

The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.

Research Hypotheses Ho: Respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.

H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.

In the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients.

The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Least 18-years-old,
* Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
* not have any communicative problems,
* not have Coronavirus disease (COVID-19) disease or respiratory disease,
* Hb value of 10 and above and
* knowing how to read, write, and speak Turkish

Exclusion Criteria:

* have respiratory disease and Coronavirus disease (COVID-19),
* having any communication and psychiatric problem,
* not knowing how to read, write, and speak Turkish,
* not wanting to participate in the study and have anemia.
The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer

The present study evaluates the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer. A single-blinded prospective, randomized controlled trial will be used.

To conduct a study to evaluate the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer using a single-blinded prospective, randomized controlled trial.

The aims are to test:

1. To evaluate the impact of yoga therapy on scarring contractures and range of motion in shoulder joints among women recovering from surgical treatment of breast cancer.
2. To evaluate the impact of yoga therapy on health-related quality of life and symptom distress.

Primary Hypotheses

1. Intervention and control groups mean scores on measures of shoulder movement range will show no differences at baseline or significant changes at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
2. Mean scores of quality of life and symptom distress between intervention and control groups at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention will show no differences relative to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese-speaking Chinese patients
* were newly diagnosed with breast cancer
* had completed breast cancer surgery plus chemotherapy
* were able to give consent

Exclusion Criteria:

* Patients who have residual breast tumors or loco-regional metastasis after treatment
* who were practicing yoga since the diagnosis of breast cancer
* or are otherwise physically unable to yoga
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Eligibility Criteria:
Inclusion Criteria:

age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \>10 and ≤40, and SES-CD of \>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy

Exclusion Criteria:

patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
Daytime Profile of Salivary Progesterone

The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* One or two good quality embryos for transfer on day 5.
* BMI \>18,5 \<30 kg/m²

Exclusion Criteria:

* No good quality embryos for transfer
* Uterine abnormalities
* One ovary
* Oocyte donation
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. As the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
* On treatment with erythropoietin stimulating agent
* With written informed consent

Exclusion Criteria:

* On treatment with epoetin beta pegol as ESA
* On supplementation with native vitamin D
* Hypercalcemia (\>=10.5 mg/dL of corrected serum calcium)
* On treatment with intravenous iron agents
* Judged as ineligible to the randomized study by the investigators
Coronary Artery Disease Mortality in Turkiye

This study aims to analyze the geographical variations and identify key environmental and behavioral predictors of coronary artery disease (CAD) mortality in Turkiye.

A 10-year longitudinal province-level data was used to identify change trajectories of CAD mortality. . Environmental determinants (such as air quality and climatic conditions) and behavioral factors of alcohol consumption and smoking were examined for their association with CAD mortality change trajectories using Ordinal Logistic Regression models.

Eligibility Criteria:
Inclusion Criteria:

* All citizens in a given province

Exclusion Criteria:

* None
Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Retin A or Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
14. The subject has an allergy to lidocaine and epinephrine.
Analysis of Human Tear Proteins in Children

The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film, and any unique aspects of tears in children. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.


Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age
* A parent or legal guardian provide written informed consent to participate
* Able to cooperate with tear sample collection, or a previously planned sedation for other medical purposes

Exclusion Criteria:

* Age greater than or equal to 18 years
* Patients' parents or legal guardians who refuse to sign study consent
Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

Eligibility Criteria:
Inclusion Criteria:

* Female 50-74 years or male 60-74 years
* Dorsally displaced intraarticular distal radius fracture
* Dorsal angulation \>20 degrees measured from the plane perpendicular to the radius axis
* Low energy trauma
* Injury \<72 hours when diagnosed
* Patient independent of help for ADL

Exclusion Criteria:

* Earlier dysfunction in any wrist
* Other major injuries
* Rheumatoid arthritis or other systemic joint disease
* Dementia or severe psychiatric disease
* Severe medical condition making general anesthesia a major risk
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects

This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.

This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained
* Age ≥ 18.0 years and ≤ 55.0 years, male or female
* BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
* No clinically significant findings in medical examination

Exclusion Criteria:

* Known hypersensitivity or allergy to lactose
* Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
* HbA1c \> 5.7 % at Screening
* Subject with a history of severe visual diseases; or visual changes
* Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in Patients With Symptoms and Signs in Favor of PTE

In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and signs in favor of Pulmonary Thromboemboli (PTE).


Eligibility Criteria:
Inclusion Criteria:

* Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital.

Exclusion Criteria:

* previous history of Allergy to IV contrast
* Serum creatinin more than 1.8
* patients that will not agree to participate in the study.
* pregnancy
* Body weight more than 120 kg
Efficacy of Adding Interleukin-2 to an Optimized Antiretroviral Regimen in HIV Patients in Therapeutic Failure (ANRS123)

Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients with a CD4 cell count over 200/mm3, but its activity in patients with treatment failure and low CD4 cell counts is unknown. This study will test the efficacy and safety of IL-2 with an optimized antiretroviral regimen in patients with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml.

IL-2 is produced naturally in the body and helps CD4 cells multiply. In earlier studies in HIV-infection, most of the patients with a controlled viral load and a high level of CD4 count (over 200/mm3) who received IL-2, experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone.

The efficacy of IL-2 when the viral load is high and the CD4 cell count is low is not known. The purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without IL-2.The choice of the antiretroviral regimen will be made from a genotype resistance test.

Ninety eight HIV-1-infected patients experiencing advanced treatment failure with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml, will be randomly assigned to one of two treatment groups: with or without IL-2.

The group with IL-2 will receive a dose of 4.5 million International units by subcutaneous injection twice a day for 5 days (up to a total of 8 cycles, ending at Week 42), the first two cycles 4 weeks apart, the following cycles 6 weeks apart.

Evaluation will be done at week 52 and further at W76. The primary endpoint is the proportion of patients reaching an absolute CD4 count over 200/mm3 at Week 52. Secondary endpoints include the proportion of patients increasing their CD4 count over 50/mm3 between Week 00 and Week 24,and between Week 00 and Week 52, the occurrence of HIV-related events, drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with proven HIV-1-infection
* Prior or current exposition to at least 1 molecule from each of the 3 antiretroviral classes (NRTI, NNRTI and PI)
* In a situation of therapeutic failure on an ongoing regimen

Exclusion Criteria:

* Patients included in the Macrolin® expanded French access program
Ridge Preservation Comparing a Flap Versus Flapless Technique

To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Eligibility Criteria:
Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
2. Study subjects at least 18 years old
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

Exclusion Criteria:

1. Patients with debilitating systemic disease, or a disease affects the periodontium
2. Have an allergy to any material or medication used in the study
3. Require prophylactic antibiotics
4. Previous head and neck radiation therapy
5. Chemotherapy in the previous 12 months
6. Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
7. Smoked more than one pack of cigarettes per day
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL wearer
* Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
* Has less than 0.75D spectacle cylinder in each eye
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule (at least 40 hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of - 1.00 to -9.00D
* Has a spectacle cylinder greater than -0.50D of cylinder in either eye
* Has best corrected spectacle distance vision worse then 20/25 in either eye
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is presbyopic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine

For each arm:

The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design.

Phase II total of 52 patients (26 per arm) will be treated at established phase I dose.

Enrollment to be simultaneous to each arm.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of refractory/relapsed AML or high-risk MDS

   * Arm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapies
   * Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
2. FLT3 mutation positive (ITD, TKD or other)
3. ECOG PS 0-2
4. Adequate liver and renal function
5. Negative pregnancy test
6. Extramedullary leukemia allowed except CNS disease

Exclusion Criteria:

* Arm 1 and 2 Exclusion:

  1. \<5% blasts in marrow or blood at time of screening
  2. Active HIV, hepatitis B or C
  3. CNS leukemia
  4. Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
  5. Patient with AML-M3 (APL)
  6. Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation

The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.

This study will evaluate the potential therapeutic benefit of VentaProst in treating patients with COVID-19 at risk for respiratory and/ or cardiac/circulatory failure. This is a double-blind, placebo controlled study of VentaProst in 10 confirmed COVID-19 patients compared to 10- COVID-19 placebo patients to assess the efficacy and safety of VentaProst given over 10 days at varying doses.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 positive by RT-PCR test
* Patients who require invasive mechanical ventilation.
* Consent or professional consent obtained

Exclusion Criteria:

* Patients on ECMO support.
* Patients receiving another inhalation research medication or inhaled nitric oxide.
* Not expected to survive for 48 hours.
* Allergy to Epoprostenol and its diluent