cyrilzakka/clinical-trials huggingface dataset:
Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy

This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20)

This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20).

The investigators included male or female, between 18 and 60 years old, American Society of Anesthesiologists score 1, 2 patients in this study. The investigator excluded patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation from this study. In postoperatively, control group will take 4lt/min oxygen with Plasti-med oxygen therapy mask for 6 hours, IS group will carry out Plasti-med TRIFLO 5 min per hour for 6 hours, CPAP group will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. Lung functions and arterial blood gas analysis will be recorded preoperative baseline, postoperative 1st, 6th and 24th hours.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score 1, 2 patients

Exclusion Criteria:

* Patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation
Developing and Evaluating the Yorkshire Dialysis Decision Aid

The purpose of this research is to develop a patient decision aid in paper and web formats to help patients with chronic kidney disease make informed dialysis treatment decisions.

This research will develop and evaluate a paper and web resource known as a decision-aid to help patients make informed decisions about dialysis treatment. The Yorkshire Dialysis Decision Aid (YoDDA) will help patients' with chronic kidney disease make informed decisions between haemodialysis and peritoneal dialysis choices by a) re-writing dialysis information in a more meaningful way for patients, b) restructuring information to make this difficult decision more manageable, and c) using prompts to help patients imagine the choices' consequences. The research will assess the acceptability of a patient decision aid in paper and web versions to patients and their carers, and its impact on patients choices about dialysis.

The programme of research included:

A survey using qualitative methods of patients with chronic kidney disease and professionals providing predialysis services to develop the Yorkshire Dialysis Decision Aid content, and integration within usual predialysis care practices.

A before-and-after study was carried out to evaluate the acceptability of the YoDDA-booklet to patients with sustained deterioration of kidney function making dialysis decision across the Yorkshire and Humber region, UK.

An experimental study was carried out on-line to evaluate the acceptability of three versions of YoDDA-web (YoDDA; YoDDA+values tasks; YoDDA_patient videos) to people, or carers of people, with kidney disease. The study was advertised with flyers within UK renal units and notices on the National Kidney Federation's website and members' magazine.

Eligibility Criteria:
Inclusion Criteria: Adult patients with chronic kidney disease and carers of people with chronic kidney diseae who are making decisions about dialysis treatments.

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Exclusion Criteria: Those not literate in English

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The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women

Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.

Inofolic Plus® contains several nutritional elements including myo-inositol, melatonin, and folic acid. Myo-inositol was found to be helpful in improving egg quality and/or quantity in women with an ovarian abnormality called polycystic ovarian syndrome as well as in women without the disorder undergoing assisted reproduction.

Myo-inositol and folic acid are compounds that belong to the family of B-vitamins. Inositol is normally found in several types of foods. Folic acid has been found to significantly decrease the incidence of certain types of birth defects in women taking sufficient amounts prior to and during pregnancy. Preliminary studies using myo-inositol and folic acid demonstrated improvement in egg quality in-vitro and in-vivo as well as multiple metabolic parameters in women with irregular menstrual cycles and certain types of hormone imbalances.

Melatonin is a potent antioxidant. Folic acid is not classified as an antioxidant but has been reported to have antioxidant-like activity. Antioxidants have been given to infertile men for years to improve egg parameters. Most recently, studies have documented the efficacy of antioxidant treatment on human egg parameters and fertilization rates, especially in the setting of in-vitro fertilization (IVF). Inofolic Plus® contains melatonin and folic acid. Dr. Roseff hypothesizes that Inofolic Plus® may be effective in correcting abnormal egg parameters in women. A woman may have abnormal eggs from being exposed to environmental and workplace toxins that generate oxygen free radicals in her body (known as reactive oxygen species, or ROS). These ROS circulate through the blood stream and can enter the ovaries where eggs are stored. Eggs may be sensitive to ROS, and damage from the ROS may result in poor egg quality or quantity or both. The combination of nutrients and antioxidants in Inofolic Plus® may help to correct these abnormalities. Melatonin is a natural hormone normally found in the brain. This hormone helps regulate sleep/wake cycles. Melatonin levels increase during the evening and remain high during the night. This elevated level of melatonin is thought to induce drowsiness. It is because of this effect that we recommend taking Inofolic Plus® in the late evening near bedtime.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 - 42 years of age
* Diagnosed with "Diminished Ovarian Reserve" (DOR)

Exclusion Criteria:

* Ongoing history of illicit drug or tobacco use
* Ovarian surgery within 90 days of signing the consent form
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

The purpose of this study is to identify and confirm new blood and tissue markers for prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has been shown to increase the risk of tumor spread and enhance tumor resistance to the standard treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently identified several proteins or markers in the blood and in tumors (including osteopontin, lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.

The endpoints of the study are

1. To validate the prognostic significance of OPN in H\&N and lung cancer patients and to monitor its level during active therapy and follow up for cancer surveillance.
2. To identify a gene and protein signature for hypoxia in H\&N and lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the head and neck sites or non-small cell lung cancer, or relatives of patients with histologically confirmed squamous cell carcinoma of the head and neck.
* Able to sign a Stanford IRB approved consent form

Exclusion criteria:

* Refuse or unable to sign an IRB approved consent form.
* Refuse to be contacted in the future for follow up.
Therapeutic Hypothermia After the Return of Spontaneous Circulation

The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.

Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6

The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.

This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.

Eligibility Criteria:
Inclusion Criteria:

* All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH

Exclusion Criteria:

* Less than 18
* Cardiac arrest due to trauma or hemorrhage
* Pregnant women
* patients whom are already hypothermic
* transported to a hospital that can not maintain hypothermia for 24 hours
Antioxidant Effect of Aged Garlic Extract

This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.


Eligibility Criteria:
Inclusion Criteria:

* Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)

Exclusion Criteria:

* Under medication for chronic disease
* Garlic allergy
* Engaging in vigorous exercise
* Taking drugs or functional food that may possess antioxidant property
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
Bone Health and Vitamin D Status

This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.

To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.

Eligibility Criteria:
Inclusion Criteria:

* HIV uninfected:

  * HIV negative confirmed by HIV testing
  * Age 30 years and older
  * Thai nationality
  * Signed informed consent form for the study
* HIV-infected, HAART naïve:

  * Recorded HIV infection
  * Age 30 years and older
  * Thai nationality
  * Signed informed consent form for the study
* HIV-infected, HAART group:

  * Recorded HIV infection
  * Age 30 years and older
  * Thai nationality
  * HAART naïve at baseline, planned to start HAART within 90 days. Past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of HIV ≥ 3 months prior to screening will be allowed
  * Signed informed consent form for the study

Exclusion Criteria:

* HIV uninfected

  * Currently pregnant or lactating
  * Recent hospitalization
  * Use of anticonvulsants, steroids or vitamin D supplements
* HIV-infected, HAART naïve

  * CD4 \< 350
  * Currently pregnant/lactating
  * Recent hospitalization
  * Signs of wasting
  * Use of anticonvulsants, steroids or vitamin D supplements
* HIV-infected, HAART group:

  * Prior antiretroviral therapy use
  * Currently pregnant/lactating
  * Recent hospitalization
  * Signs of wasting
  * Active opportunistic infection
  * Use of anticonvulsants, steroids or vitamin D supplements
Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations

Acamprosate for alcohol use disorder may benefit liver transplant (LT) recipients with alcohol-associated liver disease (ALD), yet data on feasibility and safety in LT recipients are lacking. This was a single-center unblinded randomized controlled trial of adults (≥18 years) with LT for ALD enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three time daily) or standard of care (SOC) for 14 weeks. The primary outcome was safety \[prevalence of adverse events (AE)\]. Secondary outcomes included feasibility (weekly survey response rate \>60%), adherence (self reported acamprosate use\>60%), and efficacy (reduction in Penn Alcohol Craving Scale \[PACS\]) and relapse). Relapse was defined as blood phosphatidylethanol≥20ng/mL or reported alcohol use. All analyses were done in the intention to treat (ITT) population and per-protocol population (PPP) (excluding withdrawals/acamprosate non-adherent).

Acamprosate for alcohol use disorder may benefit liver transplant (LT) recipients with alcohol-associated liver disease (ALD), yet data on feasibility and safety in LT recipients are lacking.

This was a single-center unblinded randomized controlled trial of adults (≥18 years) with LT for ALD enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three time daily) or standard of care (SOC) for 14 weeks. The primary outcome was safety \[prevalence of adverse events (AE)\]. Secondary outcomes included feasibility (weekly survey response rate \>60%), adherence (self reported acamprosate use\>60%), and efficacy (reduction in Penn Alcohol Craving Scale \[PACS\]) and relapse). Relapse was defined as blood phosphatidylethanol≥20ng/mL or reported alcohol use. All analyses were done in the intention to treat (ITT) population and per-protocol population (PPP) (excluding withdrawals/acamprosate non-adherent).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* must have received a transplant for liver disease secondary to alcohol-associated hepatitis or alcohol-associated cirrhosis
* greater than 24 hours of abstinence.

Exclusion Criteria:

* patients with hypersensitivity to acamprosate calcium or any of its components
* severe renal impairment (creatinine clearance ≤30 mL/min)
* substance dependence other than THC, alcohol, or nicotine
* need for inpatient detoxification or inpatient treatment of alcohol use
* participation in a clinical trial within the past 60 days
* women of childbearing potential without a medically acceptable form of contraception
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy

The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Response assessment of complete response (CR), partial response (PR), or long-term stable disease (SD) for \>6 months with a cancer immunotherapy treatment for metastatic cancer or hematologic malignancies either through a marketed CPI or through participation in a Roche/Genentech CPI clinical trial.
* Availability of tissue sample.

Exclusion Criteria:

* Pregnant, lactating, or intending to become pregnant during the study.
* Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.
Acute and Chronic Responses to Blood Pressure After Exercise

The study will evaluate the variability of blood pressure in postmenopausal and hypertensive women after only one session and after training of ten weeks of combined physical exercises (aerobic and resisted).

Before starting the training program, all the volunteers will sign the Free and Informed Consent Form (TCLE) and must present a medical certificate releasing the participation. In addition, the volunteers will respond to an anamnesis questionnaire and will undergo an anthropometric evaluation before the experimental sessions. The physical exercise program will be held three times a week for 10 weeks, containing aerobic exercise (exercise treadmill) and resistance exercises (bodybuilding). Initially, a familiarization of the ergometers used will be performed, followed by a session to evaluate the intensity of resistance exercise through a maximal repetition test (1RM), and a session to evaluate aerobic fitness through an incremental treadmill test.

Before starting the training, volunteers will perform a single exercise session, following the same exercise protocol. All the volunteers will be submitted to the evaluation of the blood pressure during 24 hours through the measurement of ambulatory blood pressure (ABPM) in three moments:

* PR: pre-training rest - the volunteers will arrive at the laboratory, will be in rest for 15 minutes and after that they will place the ABPM, without having done any exercise.
* PE: post exercise - upon arriving at the laboratory, the volunteers will be submitted to a single combined exercise session, will have a maximum interval of 20 minutes for the bath and will place the MAP device.
* CR: rest after chronic training - after the end of the 10 weeks of training, the volunteers will be submitted to ABPM, again at rest, with a maximum interval of 72 hours, between the end of the training and the placement of the device.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 50 and 70 years;
* Be in the postmenopausal phase;
* Be able to practice physical exercise on treadmill and resistance exercises (bodybuilding).
* Present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension
* Make use of anti-hypertensive medication, except beta-blockers
* Participants should be evaluated with a cardiologist beforehand and present a certificate attesting that they are able to perform physical activities.
* Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises.

Exclusion Criteria:

* Make use of beta-blockers
* Present history of stroke or acute myocardial infarction;
* Smoking;
* Present diagnosis of Diabetes Mellitus.
* Present renal pathologies
* Use hormone replacement therapies
Proof-of-Concept Study of ACT001 in Adult Patients With Recurrent Glioblastoma Harbouring STAT3-High Signature

This trial will study the effectiveness of ACT001 in adult patients whose Glioblastoma have recurred with a STAT3-high signature after standard-of-care treatment with at least radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of GBM according to 2021 WHO classification
* Availability of tumor tissue representative of GBM from definitive surgery or biopsy and tested to harbour STAT3-High Signature
* Previous treatment with at least radiation therapy
* Documented recurrence of malignant glioma by diagnostic biopsy, resection or MRI performed within 21 days of study enrolment per RANO criteria.

There is no limit on number of previous recurrences or lines of treatment

* At least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) n new enhancement on MRI outside of the radiation treatment field
* An interval of at least 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of STAT3 inhibitor
* Age 21 years or older on the day of signing informed consent
* Karnofsky performance status (KPS) of 70 or higher
* Patient has adequate bone marrow, renal, and hepatic function ≤ 21 days prior to study enrolment (Step 2) as follows:

  * Absolute neutrophil count (ANC) ≥1,500/mm3
  * Platelets ≥ 100,000/mm3
  * Hemoglobin (Hgb) ≥ 9.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dL is acceptable.)
  * Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault formula
  * Hepatic function: Total bilirubin, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) ≤ 1.5 times upper limit of normal (ULN). Patients with Gilbert's syndrome documented in medical history may be enrolled if bilirubin is \< 3 times ULN.

Exclusion Criteria:

* Presence of extracranial metastatic or leptomeningeal disease
* Previous or current treatment with a JAK or STAT3 inhibitor
* Previous or current treatment with bevacizumab/VEGF inhibitor
* Patient is a lactating or pregnant female.
* Symptomatic intra-tumoural haemorrhage
* Severe, active co-morbidity, defined as follows:

  * Patients with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness.
  * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the Investigator may put the patient at high risk of toxicity
  * Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
Postoperative Pain and Recovery Time After Pulpotomy

The aim of this retrospective study was to compare immediate postoperative pain scores and the need for rescue analgesia in children who underwent pulpotomies and general restorative treatment and those who underwent general restorative treatment only, all under general anaesthesia.

Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation under general anaesthesia were enrolled in the study and reviewed. The experimental group included patients who were treated with at least one pulpotomy, and the control group was treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate self-reported pain and the need for rescue analgesia. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and Pearson's correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent full mouth dental rehabilitation under GA because of their lack of chairside cooperation
* Patients with at least 1 pulpotomy were included in the experimental group (n=45), and patients treated with dental fillings only were included in the control group (n=45); a total of 90 patients were eligible for the study.

Exclusion Criteria:

* Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.