cyrilzakka/clinical-trials huggingface dataset:
Tendency to Suicide as a Sequel of Computer Vision Syndrome

CVS-F4 questionnaire will be used as an instrument to survey prevalence of tendency to suicide among medical students in the Egyptian Universities and analyse associated risk factors and any correlated determents

CVS-F4 (30 questions) will be an online survey via the SurveyMonkey Company. We will collect the responses and analyze the results. Informed consent will be obtained from the participants as an item within the survey itself that he/she agrees to use his/her data in this research work. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. CVS-F4 questionnaire will be used as an instrument to survey prevalence of tendency to suicide among medical students in the Egyptian Universities and analyse associated risk factors and any correlated determents Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* university students
* university staff members

Exclusion Criteria:

* hysteria
* ocular surgery
* amblyopia
* anisometropia
* strabismus
* systemic disease
PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.


Eligibility Criteria:
Inclusion Criteria:

Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor

Exclusion Criteria:

1. Age \< 18 years old and \> 90 years old;
2. Pregnancy;
3. EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
4. Severe intracranial hypertension;
5. Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
6. Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves)
7. End status of disease;
8. Patients or their families refused to participate in the study
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age. 12-80
* Documented physician-diagnosed asthma for at least 12 months
* Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
* Morning pre-BD FEV1 \<80% predicted normal (\<90% for subjects 12-17 yrs)
* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
* Documented history of at least 2 asthma exacerbation events within 12 months.
* ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

* Pulmonary disease other than asthma.
* History of cancer.
* History of a clinically significant infection.
* Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
* History of chronic alcohol or drug abuse within 12 months.
* Hepatitis B, C or HIV.
* Pregnant or breastfeeding.
* History of anaphylaxis following any biologic therapy.
* Subject randomized in the current study or previous tezepelumab studies.
Athlete Whey Protein Sensitivity: Prevalence and Performance

The objective of this study is to identify the prevalence of whey protein sensitivity in UIW athletes and to assess the effectiveness of 4-weeks of whey versus plant-based protein supplementation on athletic performance and recovery, specifically in those with whey sensitivity.

Dependent t-tests and repeated measures analysis of variance (ANOVA) will offer comparative analyses between whey and plant protein conditions in subjects with and without whey sensitivity. Symptom questionnaires, perceived performance questionnaires, wearable fitness tracking data, and strength test results will be compared across all four conditions (baseline, washout, whey supplementation, and plant supplementation).

Related variables will be analyzed using GLM univariate, multivariate, and repeated measures. The overall multivariate Wilks' Lambda and Greenhouse-Geisser univariate p-levels will be reported. Differences among groups will be determined using Tukey's least significant differences (LSD) post hoc analyses.

Eligibility Criteria:
Inclusion Criteria:

* NCAA Division I collegiate athletes at the University of the Incarnate Word
* Must complete a medical history form
* Must be cleared by sports medicine staff for intercollegiate athletic participation

Exclusion Criteria:

* Individuals with a diagnosed food allergy, lactose intolerance, or inflammatory bowel disease (such as Chron's, Ulcerative Colitis, or Celiac Sprue)
Addition of Naltrexone to Methadone Taper

There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.

Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.

Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.

Eligibility Criteria:
Inclusion Criteria:

* Current DSM-IV diagnosis of opiate dependence
* Reads and understands English

Exclusion Criteria:

* Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
* Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
* Mental retardation or other disorder that might limit ability to give informed consent
* Pregnant
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children with Generalized Myasthenia Gravis

The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the trial only if all of the following criteria apply:

1. The participant completed ARGX-113-2006 or ARGX-113-2207, defined as:

   1. The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial.
   2. The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period (IP) visits within the ARGX-113-2006 trial's timeframe.
2. Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures.
3. Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children.

   1. Contraceptive requirements for male participants are presented in Section 10.4.2.2.
   2. Female adolescents of childbearing potential (FAOCBP) must have a negative urine pregnancy test at trial entry (TP1V1 or IP0V1)

Exclusion Criteria:

Participants are excluded from the trial if any of the following criteria apply:

1. Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study.
2. Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment.
3. A known hypersensitivity reaction to efgartigimod or any of its excipients.
4. Any of the following medical conditions:

   1. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigator's opinion.
   2. Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of generalized myasthenia gravis (gMG) or put the participant at undue risk
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.

The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy, ≥ 18yrs old
* GA 18w0d to 26w0d inclusive @ time of enrollment
* Documentation of complete placenta previa (≥ 10mm over internal os)
* Agrees to participate in trial and signs/date an informed consent form.

Exclusion Criteria:

* Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
* Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
* Known uterine anomaly at time of enrollment
* History of two or more prior cesarean deliveries
* Suspected placenta accrete, increta or percreta on US at enrollment
* Cervical cerclage present at time of enrollment
Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim.

This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.

This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.

The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years;
2. Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
3. ECOG performance status ≤ 1;
4. ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
5. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
6. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.

Exclusion Criteria:

1. Lymphoma central involvement;
2. Recipients of hematopoietic stem cell transplantation or organ transplantation;
3. Currently conducting clinical trials of other drugs;
4. There is an uncontrollable infection with body temperature ≥38℃;
5. liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of \>; if they were caused by liver metastasis, the upper limit of the normal value of \> was 5 times;Renal function test: serum creatinine (Cr. \>2 times the upper limit of normal value
6. Patients with serious chronic diseases of heart, kidney, liver and other important organs;
7. Patients with severe uncontrolled diabetes;
8. Pregnant or lactating female patients.
Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia

This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Stroke is a disease characterized by neurological symptoms and signs lasting more than 24 hours, which can lead to death after the interruption of brain blood flow or due to focal brain damage. Post-stroke disability affects the patient's quality of life, makes the patient dependent on the caregiver, creates a caregiver burden, and brings socioeconomic and social consequences. Different hemispheres of the brain undertake different tasks. Different clinical conditions may occur in stroke patients with right or left hemiplegia following cerebrovascular infarction. This may affect the care burden of caregivers and the severity of depression. It was thought that knowing the care burden of patients with right and left hemiplegia would positively contribute to the quality of care given to patients.This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia patients between the ages of 18 and 75 were included.
* Caregivers over 18 years of age
* At least 3 months must have passed since the patient was diagnosed.
* Caregivers of patients should be their first and second degree relatives.
* Caregivers must be competent to understand what they read and complete the questionnaires.
* Caregivers must have been caring for their patients for at least 3 months.

Exclusion Criteria:

* Patients and caregivers with a history of psychiatric illness
Comparing IM vs. Vaginal Progesterone for Pre-term Birth

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
* Gestational age between 16 weeks 0 days and 20 weeks 6 days.
* Signed consent to participate in the trial

Exclusion Criteria:

* Multiple Gestation
* Prior elective fetal reduction or planned termination
* Known spontaneous reduction to singleton
* Major fetal anomaly or known fetal chromosomal abnormalities
* Progesteone used this pregnancy
Balance Disorders Related to Pregnancy

Primary aim of this study is to evaluate postural equilibrium and risk of falls during pregnancy by comparing static postural stability between pregnant and non-pregnant control women. Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability. The investigators also determine level of vitamin D in the blood.

Several hormonal, anatomical and physiological changes occur in the female body during pregnancy. These changes caused by pregnancy include significant weight gain, increased ligamentous laxity and spinal lordosis, decreased neuromuscular control and abdominal muscle strength, altered biomechanics and an anterior shift in the location of the centre of mass. These alteration of pregnant woman body can lead to balance problems.

Falls during pregnancy are very common. Pregnant women especially in advanced stage of pregnancy are at higher risk of falling compared to non-pregnant women. Falls during pregnancy may cause maternal injuries such as bone fractures, joint sprains, muscle strains, head injury, rupture of internal organs, abruptio placentae, rupture of the uterus and membranes and occasionally maternal death or intrauterine fetal demise. Pregnant women are hospitalized due to a fall 2,3 times more than non-pregnant reproductive-aged women.

There is few evidence in a literature about postural stability but not about risk factors, that caused stability disorders. By determination of risk factors, the investigators can reduce number of falls in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* The investigators involve every pregnant woman in 36.-38. week of pregnancy that attending an outpatient clinic at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic.

Exclusion Criteria:

* Unwilling to participate
* Minors (under 18 years old)
* Musculoskeletal and neurological abnormalities
* Unfamiliar with slovak language
* Multiple pregnancy
Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.

* Patients will be admitted to hospital and receive a one hour infusion of taxotere. Approximately 2 hours after taxotere is finished they will receive cisplatin, 5-fluorouracil, and leucovorin continuously over a 4 day period.
* Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's ANC level is greater than 10,000.
* Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days).
* During each cycle patients will have blood tests performed weekly and may be asked to return to the Head and Neck Clinic for examination around the middle of each cycle.
* At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. However, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed.
* During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy.
* Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of squamous cell carcinoma of head and neck.
* All patients with previously untreated Stage III or IV.
* Measurable disease
* Complete recovery from previous diagnostic or therapeutic procedures.
* Life expectancy greater than 3 months
* Creatinine less than or equal to 1.5
* SGOT less than 1.5 x ULN
* Alkaline phosphatase less than 2.5 x ULN
* WBC greater than or equal to 4,000/mm
* Platelet count greater than to equal to 100,000/mm
* Hemoglobin greater than or equal to 10gm/dl
* Patients of childbearing age must use effective contraception methods.

Exclusion Criteria:

* Patients with previous head and neck cancer except those treated with surgery only.
* Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Peripheral neuropathy exceeding grade 1.
* Cardiovascular or pulmonary disease
* Pregnant or breastfeeding women