cyrilzakka/clinical-trials huggingface dataset:
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
* ECOG PS 0-2
* At least one measurable or evaluable lesion in the first-line chemotherapy
* The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
* The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
* Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN)

Exclusion Criteria:

* Received 2 or more regimens for palliative chemotherapy
* Pregnant or lactating women
* Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
* Clinically significant active bleeding, OB 2+ or higher
* Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions
Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE

Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns.

Aim: To explore the safety and efficacy of intrasaccular neck occlusion devices in patients with acute subarachnoid hemorrhage caused by a ruptured saccular aneurysm by a one arm prospective registry.

Study outcome: The primary outcomes is the rate of complete occlusion (Raymond-Roy I) and rebleeding at one year follow-up. The primary safety outcome is rate of rebleeding during the admission.


Eligibility Criteria:
Inclusion Criteria:

* Acute subarachnoid hemorrhage due to an intracranial ruptured aneurysm. Diagnosis must be done with acute CT or MRI.
* Intracranial saccular aneurysm with neck diameter 2-11mm and neck-dome height ≥2 mm.
* Clinical severity measured by World Federation Neurological Surgeons scale score ≤ III.
* Age ≥18 years.
* Previous modified Rankin scale ≤2.
* Informed consent obtained from the patient or acceptable patient surrogate.

Exclusion Criteria:

* Hemodynamically unstable patients with requirement of advanced vital support.
* Patients with limited life expectancy (\<6 months) due to terminal disease.
* Previous antiplatelet or anticoagulation treatment.
* Participation in any other clinical trial with a drug or device which could influence the outcome.
* Patients with neurological or psychiatric disease that could undermine future evaluations.
* Lack of availability for 12 months tracing.
Effects of Intraoperative GDFT on the Postoperative Brain Edema

Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative brain image indicating high-grade glioma (HGG), verified by postoperative histology of the World Health Organization (WHO) as grade III or IV tumors.
2. Age 18-65 years, and American Society of Anaesthesiologists (ASA) physical status I to III.
3. Signed informed consent.

Exclusion Criteria:

1. Renal insufficiency or the creatinine clearance is \< 30 mL/kg.
2. Heart disease, New York Heart Association Functional Classification (NYHA) class II or higher heart failure, or if their cardiac ejection fraction is \< 20%.
3. Chronic obstructive pulmonary disease.
4. Extensive peripheral arterial occlusive disease.
5. Coagulopathy.
6. Surgery in the prone position.
7. Recurrent carcinoma or tumor in the brain ventricular.
8. Body Mass Index \<18.5 kg·m-2 or \>30.0 kg·m-2.
9. Awake craniotomy.
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL on the intestinal flora of male and female healthy volunteers after multiple administrations over 7 days. An assessment of the effect on intestinal flora is an important aspect to understand for the safe clinical use of the investigational products and is expected by regulatory agencies.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Healthy male and female volunteers aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venepuncture.

   Females: Female healthy volunteers are authorised to participate in this study if both of the following criteria are met:
   1. A negative serum pregnancy test BOTH at screening AND at admission to the study centre.
   2. Agrees not to attempt pregnancy while receiving investigational product and for a period of 7 days after last investigational product administration, and agrees to the use of acceptable methods of contraception (according to instructions) prior to, during, and for 7 days after the last investigational product administration.
3. Have a body mass index (BMI) between 19 and 30 kg/m2.

Exclusion Criteria:

1. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
2. Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, coagulation, or urinalysis results, as judged by the investigator.
3. Pregnant or breastfeeding female healthy volunteers.
4. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study.
5. Known history of Clostridium difficile infection in last 3 months.
Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain

Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of allergy to cow's milk protein (CMPA): either confirmed through a placebo-controlled food challenge (DBPCFC) or highly suspected based on specific suggestive symptoms;
2. Patients under the age of 1 year at the time of cow's milk protein allergy diagnosis.
3. Patients taken Damira 2000 for at least 4 months at the time of data extraction.
4. Patients with information available on child growth (weight and height) and the following anthropometric indices at diagnosis and for at least 2 follow-up visits after first hospital visit/4 months\*: Z-scores for weight-for-age (WAZ), height-for-age (HAZ), weight-for-height (WHZ) and body mass index (BMI)-for-age (BAZ).

Exclusion Criteria:

1. Patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period.
2. Premature children with a low birth-weight (\<2.5 kg).
3. Patients diagnosed with a metabolic condition that impacts development and growth.
4. Patients diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the investigator could potentially interfere with the aim of the study.
Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* CD4 cell count below 300/mm3
* Plasma HIV RNA over 30,000 copies/ml
* Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
* Written informed consent

Exclusion Criteria:

* Biological abnormalities
* Pregnancy
* Alcool abuse
* History of pancreatitis, hepatic failure
* Acute HIV related infection
* Chemotherapy
Effects of Aerobic Exercise and Core Muscle Strengthening on Pain, Menstrual Pattern and QOL in Endometriosis

Endometriosis is a complex and debilitating gynecological condition affecting millions of women worldwide. It is characterized by the abnormal growth of endometrial-like tissue outside the uterus, leading to chronic pelvic pain, dysmenorrhea, dyspareunia, and reduced quality of life. While pharmacological interventions are commonly prescribed to manage symptoms, their efficacy may be limited, and they often come with adverse effects. Therefore, exploring non-pharmacological approaches, such as exercise, is crucial in improving the management of endometriosis-related symptoms. Aerobic exercise has gained attention as a potential therapeutic intervention for endometriosis due to its positive effects on pain modulation, hormonal regulation, and overall well-being.

This randomized controlled trial (RCT) will be conducted at Jinnah Hospital in Lahore, Pakistan, to investigate the effects of aerobic exercise with and without core muscle strengthening on pain, menstrual pattern, and quality of life in women diagnosed with endometriosis. The study will employ a convenient randomization sampling technique, aiming to recruit approximately 30 participants who meet the inclusion criteria. Eligible participants will be reproductive-age women experiencing endometriosis-related pain, with regular menstrual cycles or irregularities associated with endometriosis. They should be medically stable, cleared for physical activity, and willing to participate in an exercise intervention program. Exclusion criteria include pregnancy, severe endometriosis-related complications, significant comorbidities, recent surgery, ongoing hormonal treatments targeting endometriosis, inability to participate in exercise programs, and severe mental health conditions. By investigating these interventions, the study seeks to improve symptom management, menstrual regularity, and overall quality of life for women with endometriosis while considering safety and feasibility within the study setting.

Keywords: Endometriosis, Menstrual pattern, Aerobic Exercise, Core Muscle Strengthening, Quality of Life

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with endometriosis.(16)
* Age range (e.g., 18-49 years)
* Regular menstrual cycles or menstrual irregularities associated with endometriosis.
* Medically stable and cleared for participation in physical activity.
* No contraindications for aerobic exercise or core muscle strengthening

Exclusion Criteria:

* Pregnant individuals or those actively trying to conceive.
* Recent endometriosis-related surgeries/procedures
* Use of hormonal therapies/medications targeting endometriosis
* Severe endometriosis complications requiring immediate medical intervention
* Inability to engage in aerobic exercise.
* Significant cardiovascular/respiratory conditions
* Concurrent participation in another exercise/rehabilitation program
Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

Colonoscopy patients will be fitted with a virtual reality head-mounted display, and virtual experiences will be initiated prior to colonoscope insertion. Colonoscopy will be initiated without standard sedatives and narcotics. The colonoscopy will proceed with the subject using virtual reality distraction instead of pharmacological sedation for as long as s/he would like. Standard sedatives and narcotics will be administered upon participant request at any time during the procedure. Questionnaires will be administered to the subject and the endoscopist after each procedure to assess the acceptability of use of virtual reality in the colonoscopy setting.

This study aims to assess whether virtual reality is an acceptable alternative to pharmacological sedation during colonoscopy. Past research has shown that in order to fully experience pain, one must pay attention to it. Virtual reality has been shown to help mitigate pain by providing distraction from the painful stimulus.

In this study, participants undergo screening or surveillance colonoscopy under virtual reality distraction.

Individuals who are scheduled for a routine screening or surveillance colonoscopy and have had at least one prior colonoscopy under conscious sedation are eligible to participate. Those who give written, informed consent are fitted with and oriented to a virtual reality head-mounted display. The subject is then prepped for the colonoscopy by a registered nurse per institution protocol. This includes placement of an intravenous line.

Written consent is obtained for colonoscopy with medication by the performing endoscopist. The patient is again fitted with the virtual reality head-mounted display and virtual experiences are initiated. The endoscopist performs the colonoscopy with the subject using virtual reality distraction instead of pharmacological sedation for as long as the subject likes. Standard sedatives and narcotics will be administered by a registered nurse upon participant request at any time during the procedure.

Following the procedure, participants and endoscopists complete a questionnaire about their subjective experience with virtual reality during colonoscopy. The research coordinator fills out a case report form for each subject with information about the procedure including length, colonoscopy findings, and complications as noted by the endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older)
* Scheduled for screening or surveillance colonoscopy
* Has undergone at least 1 prior colonoscopy under conscious sedation

Exclusion Criteria:

* Children (\<18 years)
* Scheduled to undergo colonoscopy under general anesthesia
* Scheduled to undergo colonoscopy with no sedation
* First-time colonoscopy patients
* Scheduled for colonoscopy to assess symptoms or pre-existing disease
Correlation Between Eye Rubbing and Keratoconus Severity in a Treatment-naive Keratoconic Population

determination if, within a keratoconic population, strong eye rubbing was correlated with visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry, keratometry, and tomography classification determinating keratoconus stage.

A retrospective study was performed between november 2014 and october 2015 in the Metz Hospital Center. Were included 33 patients presenting with treatment-naive keratoconus. Patients responded to a questionnaire that assessed eye rubbing habits, family history of keratoconus, history of atopy. 2 groups were separated: group 1 constituted by 15 eyes with no eye rubbing, and group 2 constituted by 18 eyes with moderate or severe eye rubbing. The following informations were collected: best visual corrected acuity (BCVA), spherical equivalent value (SEV), corneal opacities or Vogt striae. For each eye were performed an anterior segment OCT (AS-OCT) to determine the OCT stage for keratoconus (Fourrier domain OCT classification, 2013), and a Scheimpflug camera imaging to determine the maximal keratometry (Kmax) and the minimal corneal thickness (MCT).

Eligibility Criteria:
Inclusion Criteria:

* patients presenting with treatment-naive keratoconus.

Exclusion Criteria:

-
A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2) resistance exercise, or 3) usual care. Baseline measurements will be done on all study subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA) for bone mineral density and lean body mass measurements, blood will be taken to measure serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels. Fitness will also be evaluated using a graded exercise test. Questionnaires on health and personal history will also be completed. Men randomized to the aerobic exercise treatment arm will participate in a walking program three times a week for eight weeks. The participants will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men randomized to the resistance training treatment arm will participate in an eight-week program of eight strength training exercises three times per week. Men in the usual care arm will receive written materials from the American Cancer Society about coping with cancer, which includes information about participation in physical activity. At the end of the eight week intervention participants in all three study arms will complete the same questionnaires and measurements they completed at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Men with metastatic prostate cancer receiving ADT and men who have failed primary therapy and are receiving ADT.
* Men from the radiology practice who are receiving ADT as neoadjuvant therapy to primary radiotherapy (enrolled only following completion of primary radiotherapy).

Exclusion Criteria:

* Men with the following counter-indications to exercise:

  * Lower limb, bone, muscle, or joint pathology of a severity which limits their ability to be physically active.
  * A history of significant cardiac disease using criteria established by the American College of Sports Medicine ( Criteria: pain, discomfort in the chest, neck, jaw, arms, or other areas that may be due to ischemia; shortness of breath at rest or with mild exertion; ankle edema; palpitations or tachycardia; known heart murmur; unusual fatigue or shortness of breath with usual activities' syncope)
  * Other medical contraindications which would compromise participation in a lifestyle physical activity program.
  * Those who are currently physically active
The Effect of 6 Week Hamstring Exercise Programs on Hamstring Muscle Function Performance in Female Athletes

This study aims to compare the effect of two hamstring strengthening programs on hamstring muscle strength in female university athletes. 60 participants will be recruited for this study. They will be randomly assigned to one of two 6-week hamstring strengthening programs, namely the single leg bridge exercise and the Nordic hamstring exercise protocol, and one control group. Eccentric and isometric hamstring strength, gluteal strength and will sprint speed will be measured before and after the intervention.

Participants will be recruited from the local university sports clubs. Club chairpersons will be asked to send an email to club players. Players interested in participating in the study will be asked to attend a meeting where the study will be explained to them. Those who were interested will then be assessed for inclusion and exclusion criteria.

Group allocation:

A four block randomization method will be used to allocate participants to the Nordic hamstring exercise protocol or the single leg bridge protocol.

Interventions:

The Nordic hamstring exercise program or the single leg bridge program.

Testing procedure:

The eccentric strength of the participants' hamstrings and hip extensors will be recorded before and after the exercise intervention.

30 metre sprint performance will be recorded before and after the intervention. A 10 point visual analogue scale will be used to record the level of muscle soreness experienced after each training session.

Eligibility Criteria:
Inclusion Criteria:

* female
* university athlete competing in team sports at least three times per week
* free from hamstring injury in previous 6 months

Exclusion Criteria:

* history of a hip or knee injury in the 3 months prior to the study
* a history of anterior cruciate ligament rupture
* a history of involvement in a hamstring strengthening, injury prevention programme in the 3 months prior to the study
The Method to Reduce Displacement of Double-lumen Tube

The purpose of this study is to devise the method to reduce displacement of a left-sided double-lumen tube during patient positioning.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* intraluminal lesion of left bronchus
* very distorted anatomy of tracheobronchial tree