cyrilzakka/clinical-trials huggingface dataset:
Fetal and Maternal Head Circumference During Pregnancy in Israeli Population

In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Valid first trimester sonogram

Exclusion Criteria:

* Women under 18 years of age
* Women over 40 years of age
* Multi fetal pregnancy
* No accurate dating of pregnancy age
* Participant non compliance or cannot complete contact details
* Technical difficulty measuring fetal or maternal skull
* Abnormal fetal or maternal skull
* Familial hereditary disease, mental retardation
* Chronic maternal illness
* Maternal on chronic medication
* Abnormal screening test during current pregnancy
* Abnormal sugar metabolism or Hypertension during current pregnancy
Modelling Interface Pressure Applied by Superimposed Compression Bandages

The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.

The measurement of the patients' legs shapes will be performed thanks to an optical scanner. The patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs.

Pressure measurements, applied by the different bandages, will be taken at the height of measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs.

2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann \& Rauscher)) and their different combinations will be applied on the patient's legs.

The order of bandage application for each patient is randomized, but is the same for both legs. The order of the leg (right or left) on which the bandages are applied is randomized.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 80 years old
* at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage)
* Hospitalized in the Service of Physical Medicine and Rehabilitation, in Saint-Etienne, France
* BMI between 20 and 35
* Able to stand for at least 10 minutes in a standing frame
* Signed informed consent to take part in the study
* Covered by a health insurance system
* Not taking part in another study which interfere with the results of the present study

Exclusion Criteria:

* Compression bandages contraindications
* Allergy to one of the different bandages components
* History of deep or superficial vein thrombosis
* Venous or arterial ulcer
* Cutaneous wound on the lower leg
* Cognitive, behavior or physical disorder preventing the communication and the active participation to a rehabilitation program, or a clinical study
* Patient under any legal protection (except curatorship)
* Not covered by a health insurance system
Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training.

Design/Methods

One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:

1. Early postoperative rehabilitation initiated as early as two weeks after surgery
2. Postoperative rehabilitation initiated 14 weeks after surgery Intervention The intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling.

The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct measurement) Secondary endpoints include: Six minutes walk distance (6MWD), One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival.

Results The results of PROLUCA will identify the optimal timing of postoperative rehabilitation in NSCLC patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.


Eligibility Criteria:
Inclusion Criteria:

* All subjects are assigned for curative lung cancer surgery at Department of Cardiothoracic Surgery RT at Copenhagen University Hospital (Rigshospitalet)
* Performance status 0-2 (WHO)
* Living in the City of Copenhagen or surrounding Municipalities
* Ability to read and understand Danish
* Approval by primary surgeon

Exclusion Criteria:

* Presence of metastatic disease or surgical inoperability. Diagnosis of Lung Cancer not verified by histological diagnosis.
* Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome
* Contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients
Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants

The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new fluid and electrolyte problems that have not been encountered previously,in particular electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium value \>150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration of intravenous fluids(IV)that contain sodium. The current treatment modality for hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease elevated electrolytes, there would be less need for large volumes of IVF that contribute to the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular hemorrhage(IVH)and patent ductus arteriosus(PDA).

The purpose of this proposed study is to determine whether enteral sterile water feedings is effective in decreasing the incidence, duration and severity of hypernatremia in ELBW infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants less than or equal to 1,100 grams birth weight
* Less than or equal to 28 weeks gestational age

Exclusion Criteria:

* \* Congenital heart disease, other than a PDA

  * Major congenital anomalies
  * A surgical condition (gastroschisis,omphalocele)
  * Renal disease
  * Hypotension treated with pressor support
  * Reverse end diastolic flow on Doppler study prior to delivery
  * Emergency medication received in the delivery room,except fluid boluses
  * Apgar scores recorded at 10 minutes of life \< or up to 5 and/or pH less than 7.0 on the first blood gas upon admission to the NICU
Planned Semi-Elective Lung Tx Study

In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.


Eligibility Criteria:
Recipient inclusion criteria

* Primary lung transplantation
* Informed consent provided
* 18-80 years old

Recipient exclusion criteria

* Re-transplantation
* Multi-organ transplantation
* \>80 years old

Donor inclusion criteria

* Age ≤70 years old
* Donor lungs are suitable to go straight to lung transplantation

Donor exclusion criteria

* Age \>70 years old
* Concerns with organ preservation technique
* Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)

The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight and sleep.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Must be enrolled in a Residential Drug Treatment Program at a collaborating drug treatment center
* Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) and self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
* Must be approved to exercise in the study by the drug treatment center Medical Director, physician or other relevant clinical staff or primary care physician (PCP)

Exclusion Criteria:

* Any substantive contraindications to exercise
Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

This protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study. Conservative therapy will be not protocolized.

Patients with non-metastatic retinoblastoma undergoing enucleation will be staged using the American Joint Committee on Cancer (AJCC), version 8, Tumor, Node, Metastasis (TNM)- H system and the International Retinoblastoma Staging System (IRSS). IRSS stage I patients recognized as higher risk will be assigned for adjuvant therapy. Those with standard risk will not receive adjuvant therapy after enucleation. Higher risk patients are defined as those with pathological retrolaminar optic nerve invasion and-or any degree of scleral invasion (pT3b, pT3c, pT3d). Based on the results of the GALOP I protocol, they will receive a reduced dose adjuvant chemotherapy regimen with 3 cycles of alternating cyclophosphamide, vincristine and idarubicin alternating with another 3 cycles of carboplatin and etoposide. Six doses of intrathecal topotecan will be given. Patients presenting with severe buphthalmia (cT3c-cT3e) will receive neo-adjuvant therapy with the same intensive regimen but including a higher dose of carboplatin as per GALOP I protocol plus intrathecal topotecan and secondary enucleation followed by adjuvant chemotherapy for a total of 8 cycles. Stage II patients (pT4) will receive the same adjuvant regimen plus orbital radiotherapy (45 cGy).

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of retinoblastoma confirmed at participating institutions
* Ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy.
* No prior therapy for retinoblastoma
* Lansky Performance Scale greater or equal to 50
* Normal organ function in those patients assigned for chemotherapy
* Signed informed consent

Exclusion Criteria:

* Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency

The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts:

Part 1: single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

- Healthy subjects study

1. Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent);
2. 18.5kg/m2 ≤BMI\<30 kg/m2, and the weight of men should be ≥ 50kg, and that of women should be ≥ 45kg.

Study on subjects with renal insufficiency

1. Age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent), both men and women can;
2. 18.5kg/m2≤BMI\<30 kg/m2；
3. The estimated glomerular filtration rate of subjects with chronic renal insufficiency conforms to 15 ≤ EGFR \< 30 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme).

Exclusion Criteria:

- Healthy subjects study

1. The researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance;
2. The estimated glomerular filtration rate conforms to EGFR \< 90 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme);
3. According to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.

Study on subjects with renal insufficiency

1. Those who received renal replacement therapy within 12 weeks before screening; Or the two tests in the screening period indicate that the renal function is unstable (the results in the screening period meet the diagnostic criteria of 2012 KDIGO acute renal injury, or the changes that do not meet the above criteria but are judged to be clinically significant by the researcher. If there are reasonable reasons, the third test is allowed, and the interval between two consecutive tests should be more than 3 days but not more than 7 days);
2. According to the judgment of the researcher, the subject has any of the following: in the state of progression or prognosis of disease (including primary renal disease, complications and other complications); The treatment plan needs to be adjusted at any time; Any physical or mental disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.
Sexual Functions and Marital Adjustment for Spouses in Menopause

Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Materials and Methods: The sample of the study consisted of a total of 254 people, 127 of whom were postmenopausal women and their spouses. The data were collected with The Descriptive Information Form (DIF), The Female Sexual Function Scale (FSFS) and the Arizona Sexual Experiences Scale (ASES), The Marital Adjustment Scale (MAS). T test was used for two-group comparison of parametric data, Mann Whitney U test was used for two-group comparison of non-parametric data, and Kruskal Wallis Test was used for non-parametric data comparison of more than two groups. In addition, the relationship between the mean scores of FSFS, ASES and MAS was evaluated with Spearman's rho Correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* The sample of the study consisted of women aged between 45-65,
* who were aged between 45-65,
* had at least 1 year of menopause,
* had no communication barriers,
* volunteered to participate in the research, -lived in the same house with their spouses, -
* had sexual activity in the last four weeks,
* selected using the simple random sampling method.

Exclusion Criteria:

* have diabetes,
* have hypertension,
* have depression
Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with pancreatic cancer.

PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with pancreatic cancer.

OBJECTIVES:

* To test the effects of an advanced practice nurse (APN) standardized nursing-intervention protocol (SNIP) model vs usual care on overall quality of life (QOL) and psychological distress from initial treatment to 6 months post diagnosis for patients with pancreatic cancer.
* To compare symptom control in these patients.
* To compare geriatric assessment outcomes in these patients.
* To test the effects of the SNIP intervention as compared to the usual care group on resource use by these patients.
* To test the effects of SNIP on patients' and clinicians' satisfaction with care.
* To describe the effects of SNIP on patients' management of transitions from one phase of chronic illness to another.
* To identify subgroups of these patients who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
* To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of pancreatic cancer patients.

OUTLINE: Patients are sequentially enrolled to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 during months 25-54.

* Group 1 (usual care): Patient questionnaires are administered at baseline and at 3 and 6 months. The clinicians' satisfaction with care is also evaluated.
* Group 2 (advanced practice nurse \[APN\] intervention): Patients are accrued by an APN. Patients meet with the APN periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. Questionnaires are administered at baseline and at 3 and 6 months.

In both groups, questionnaires include the FACT-Hep, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, Comprehensive Geriatric Assessment, and Patient Satisfaction with Intervention. Clinicians also complete questionnaires. Patients' medical charts are also reviewed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pancreatic cancer (all stages)

PATIENT CHARACTERISTICS:

* Admitted to City of Hope National Medical Center

  * Resides within a 30-mile radius of the medical center
* No prior cancer

PRIOR CONCURRENT THERAPY:

* No prior therapy
Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab

Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.

There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction patients between 3 and 12 hours after symptoms onset

Exclusion Criteria:

* Hemodynamic instability
* TIMI flow 2 or 3
* Life expectance less than 6 months
* Contraindication to AAS, clopidogrel or abciximab
* Severe tortuosity of occluded vessel
Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair

This study will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.

Endovascular aneurysm repair of abdominal aorta activates a significant inflammation reaction and has an impact on coagulation. Platelet activation seems to have a major role in this prothrombotic and hypercoagulable state. In complex thoraco-abdominal aortic aneurysm repair the implants are more complexed and the duration of operation longer. The main hypothesis is that all the above have a greater impact on platelet activation and coagulation alterations.

The aim of this study is the evaluation of the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.

Exclusion Criteria:

* Refuse to participate
* Prior surgery within 3 months
* ASA PS \> 3
* Known medical history of thrombophilia or functional platelet dysfunction