cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥18 and ≤ 80 years
2. Karnofsky Performance Score (KPS) ≥ 60%
3. Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
4. Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
5. Patient's written IC obtained at least 24h prior to surgery
6. For women with childbearing potential: adequate contraception
7. Patients must have adequate organ functions

   Bone marrow function:
   * Platelets ≥ 75.000/μL
   * WBC ≥ 3.000/μL
   * Hemoglobin ≥ 10.0 g/dL

   Liver Function:
   * ASAT and ALAT ≤ 3.0 times ULN
   * ALP ≤ 2.5 times ULN
   * Total Serum Bilirubin \< 1.5 times ULN

   Renal Function:
   * Serum Creatinine ≤ 1.5 times ULN

   Inclusion Criteria Related to Surgery:
8. IORT must be technically feasible
9. Histology supports diagnosis of GBM

Exclusion Criteria

1. Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
2. Previous cranial radiation therapy
3. Cytostatic therapy / chemotherapy for cancer within the past 5 years
4. History of cancers or other comorbidities that limit life expectancy to less than five years
5. Previous therapy with anti-angiogenic substances (such as bevacizumab)
6. Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
7. Participation in other clinical trials testing cancer-derived investigational agents/procedures.
8. Pregnant or breast feeding patients
9. Fertile patients refusing to use safe contraceptive methods during the study

   Exclusion Criteria Related to Surgery:
10. Active egress of fluids from a ventricular defect
11. In-field risk organs and/or IORT dose \>8 Gy to any risk organ
Oxytocin Effectiveness in First Trimester Dilatation and Curettage

The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use.

Study Design

This study is a prospective randomized placebo-controlled double-blind trial. Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.

Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.

The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy, coded with serial numbers, and randomized using computerized software. Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding.

A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.

Inclusion Criteria:

All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.

Patients aged 18 years and older who are capable to provide informed consent.

Exclusion criteria

* individual intolerance to oxytocin
* mullerian anomalies
* Fibroid uterus
* thrombophilia or coagulation disorders
* cardiovascular disease

Primary outcome

Perioperative Blood Loss Assessment:

We will assess perioperative blood loss by:

* Measuring the content collected in the vacuum apparatus after the procedure.
* Recording hemoglobin and hematocrit levels prior to the procedure.
* Measuring hemoglobin and hematocrit levels immediately after the procedure.
* Monitoring hemoglobin and hematocrit levels two weeks post-procedure.

Secondary outcomes

-perioperative complications according to the Dindo-Clavien scale

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.

Patients aged 18 years and older who are capable to provide informed consent.

Exclusion Criteria:

* individual intolerance to oxytocin
* mullerian anomalies
* Fibroid uterus
* thrombophilia or coagulation disorders
* cardiovascular disease
Impact of Different Shoe Heel Heights on Spinal Configuration

90 healthy female subjects with regular menstrual cycle ,their ages ranged from 19-25 years,their BMI ranged from 18-25 will be participated in this study.

Formetric Raster Stereography will be used to assess spinal configuration while each participant wear shoes of different heel heights 2.5 cm (low),4.5 cm (moderate) and 7 cm (height) during early follicular and mid luteal phases of menstrual cycle.

* this study will be conducted on healthy females to investigate effect of different heel heights footwear on spine posture and pelvic position by using formetric 4 D analysis system which is a light-optical scanning method based on Video-Raster-Stereography (VRS). Accordingly, the system consists of a light projector which projects a line grid on the back of the patient which is recorded by an imaging unit. A computer software analyzes the line curvature that generates from it. the formetric provides comprehensive information about the whole body statics and posture in only one measuring process, e.g. spine curvature (lateral and frontal), vertebral rotation, and pelvic position.
* There is generally no need for reflecting markers, because the anatomical fixed points Vertebra prominens (VP), Sacrum Point (SP), Dimple Left (DL) Dimple Right (DR) as well as the spinal center line and spinal rotation are automatically detected by the system. That allows a very time-saving and reliable examination procedure.
* shoe characteristics: standard shoes will be used and designed to fit females in sizes ranging from 37-41 and different heel heights (2.5 cm low, 4,5 cm moderate and 7 cm high).
* Descriptive statistics including mean and standard deviation will be applied for dependent variables and participant demographics. repeated measures analysis of variance will be implemented to detect the difference in dependent measures among three heel condition.

Eligibility Criteria:
Inclusion Criteria:

* Their ages ranged from 19-25.
* Their BMI ranged from 18-25
* They wear high heeled shoes occasionally for less than 10 H/week or not at all
* they are able to wear high heel without pain.

Exclusion Criteria:

* any female with spinal deviation,previous spinal surgeries,leg length discrepancy or foot deformities
* Joint stiffness, ankle sprain
* any case with orthopedic or neurological problems
* Females with irregular menstrual cycle
The ACES Study for Aseptic Pleural Effusion

The study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. Baseline assessment will include a history and physical, chest imaging and quality of life questionnaires.

After ACES implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea.

Pleural Dynamics is the first company to provide a fully implantable automatic effusion shunt that is powered by normal breathing and is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters."

The current standard of care, pleurodesis, is often painful, requires an extended hospital stay, and is often unsuccessful requiring additional procedures to manage the effusion1. While an alternate approach-indwelling pleural catheters-exists, it requires that the patient have a portion of the catheter to be external to the chest and requires frequent drainage into proprietary external canisters to relieve symptoms. Pleural Dynamics' patented ACES™ System addresses these shortcomings with its' one-piece, fully implanted system that can be placed during a short hospital stay. This technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief.

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

Exclusion Criteria:

1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP

The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender, aged 50 to 90 years;
* Assured follow-up examinations;
* Healthy eyes besides clinically significant bilateral age-related cataract.
* Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
* Calculated IOL power within the available dioptre range;
* Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Per operative inclusion criteria:

* IOL implanted in the capsular bag;
* The 2 IOL models (CT LUCIA 611P and CT ASPHINA 409MP) have been implanted in the 2 eyes of one patient;
* No intraoperative complications; no damaged capsular bag, no intraocular haemorrhage; no can opener rhexis.

Exclusion Criteria:

* Allergy to heparin
* Monophthalmic patient
* Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye;
* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
* Floppy iris syndrome;
* Diabetic retinopathy;
* Traumatic cataract;
* Aniridia;
* Microphthalmus;
* Amblyopia;
* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders);
* Patient expected to require retinal laser treatment before the end of the last follow-up;
* Previous intraocular and corneal surgery;
* Expected postop. astigmatism greater than 1 D;
* Any type of corneal disorder;
* Dementia;
* Pseudoexfoliation syndrome (PEX);
* Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
* Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient.
* Pregnancy and/or lactation
Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).


Eligibility Criteria:
Inclusion Criteria:

1. Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
2. Adult aged 18 or over, at the time of inclusion
3. Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation\> 94% in room air, and having a respiratory rate below 24 incursions per minute.
4. Patients with comorbidities only, due to the increased risk of developing SARS

Exclusion Criteria:

1. Patients with chronic use of drugs known to prolong QTc interval.
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy

One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions.


Eligibility Criteria:
Inclusion Criteria:

* previous head and neck radiotherapy for oncological treatment

Exclusion Criteria:

* complete edentulism
* pregnancy or breastfeeding
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.


Eligibility Criteria:
Inclusion Criteria:

* Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
* Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
* Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

Exclusion Criteria:

* Predominant stress or insensate incontinence
* History of neurogenic bladder
* Two urinary tract infections in the last six months
* Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
* Donated \>500mL blood in the 30 days prior to the screening visit
Telephone Interview Study for Men and Women With Osteoarthritis

The telephone interviews will be conducted to gather information on goal setting and goal attainment from men and women with osteoarthritis.

Interview data used to develop a new self-administered questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 80 years of age
* Have moderate to severe pain
* Diagnosed with osteoarthritis of the hip and/or knee at least 6 months ago
* Currently receiving treatment for osteoarthritis
* Able to speak and read English
* US resident
* Willing to share your thoughts and experiences in a 45-minute telephone interview

Exclusion Criteria:
Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)

This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose of 1000 mg once daily; Proliverenol at a dose of 1000 mg twice daily; and Placebo two caplets daily for a 12-week course of therapy.

Proliverenol is a bioactive fraction derived from the dried fruit of Phaleria macrocarpa (Scheff.) Boerl (Thymelaeaceae). Proliverenol possesses a hepatoprotective activity via anti-inflammation, DNA repairing, and the antiapoptosis properties.

There will be 4 groups of treatment; each group will consist of 20 subjects with the treatment regimens for 12 weeks:

Treatment I : 1 caplet of Proliverenol 500 mg twice daily Treatment II : 2 caplets of Proliverenol 500 mg once daily Treatment III : 2 caplets of Proliverenol 500 mg twice daily Treatment IV : 2 caplets of Placebo daily

Study subjects will be asked to come to the clinic every 4-week interval throughout the study period.

Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 12-week course of therapy. Throughout the 12-week therapy, subjects should record the product consumption and adverse event occurred during the study in the provided Patient's Diary.

The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Male or female subjects with age of 18 years or older at screening.
3. Diagnosed as NAFLD with liver ultrasonography (USG). Patients with bright liver appearance based on USG, will be followed by CAP examination. Steatosis is defined if CAP \>263 dB/m
4. Presence of hepatic impairment, defined as any of serum ALT level \> ULN
5. Able to take oral medication.

Exclusion Criteria:

1. Suspected positive COVID-19 based on clinical symptoms or SARS-COV-2 antigen test
2. Pregnancy and lactation period.
3. Suspected alcoholic liver disease
4. History of or presence of autoimmune liver diseases
5. Presence of Bilirubin level \> 2x ULN
6. Uncontrolled Diabetes Mellitus with HbA1c ≥ 9.0%
7. History or presence of significant/advanced CV, metabolic, acute or chronic infectious diseases, including viral hepatitis (B and C), or malignancy.
8. Suspected cirrhosis as supported by biochemical profile (PLT count, albumin)
9. Presence of severe renal dysfunction
10. Current or regular use of drug-induced hepatotoxicity, such as: such as non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, anti-epileptic drugs (e.g. carbamazepines, phenytoin, barbiturates), or anti-tuberculous drugs other than the investigational product
11. Current or regular use of herbal medicines with hepato-protective properties
12. Known or suspected hypersensitivity to the trial product or related products
Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

This prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (ICIs) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. This study aimed to assess the use, effectiveness, and safety of ICIs for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of ICIs for the treatment of cancer patients in the real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years.
* Pathologically confirmed diagnosis of a solid tumor cancer.
* Patients receiving treatment with immune checkpoint inhibitors.
* Ability to understand and willingness to provide the informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Patients with hematological malignancies or solid benign tumors.
* Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction

This is a crossover phase 4 study to evaluate the impact of blood flow restriction on immunometabolism and gene expression in immune cells in individuals undergoing rehabilitation from anterior cruciate ligament reconstruction.

This is a single-blind crossover phase 4 study in which participants will be randomized as to the order in which each of two sessions are completed. Although all analyses will be performed by a blinded investigator and participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed, participants will likely know which of the two interventions is being performed on which study day.

The AirBands will be placed at each of the two training sessions and inflated while an ultrasound probe is placed over the femoral artery. The cuff will be inflated until the artery reaches 60% occlusion. The force will be applied using a wireless Bluetooth signal; participants will not be asked to adjust the device. Participants will be observed by a certified Personal Therapist throughout the training session in order to determine compliance and ensure safety as is standard protocol for a physical therapy session.

The study team hypothesizes that the BFR will:

* Promote an anabolic immunometabolic signature, reflected in the composition of serum amino acid concentrations and anabolic hormone content
* Enhance anaerobic glycolysis in leukocytes (which has been associated with increased activation in other settings (Marelli-Berg and Jangani, 2018; Pearce and Pearce, 2013))
* Increase leukocyte glucose and pyruvate concentrations, which corresponds to acute energy provision to promote repair

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for two study visits at least 1 week apart
3. All genders, between 18 and 60 years of age
4. In good general health without any underlying medical conditions or prior injury that would place the subject at risk of further injury/illness by participating in the study

Exclusion Criteria:

1. Serious medical conditions including cardiovascular, metabolic (diabetes), rheumatologic, pulmonary, or musculoskeletal.
2. Multiple ligament ruptures or trauma
3. Rheumatoid arthritis or other significant comorbidities
4. Lower extremity vascular pathology, including history of deep vein thrombosis
5. Those with a history of sickle cell trait or disease
6. Use of anticoagulant medications
7. Pregnancy
8. Treatment with another investigational drug or other intervention within one month of Study Day 1
9. Current smoker or tobacco use within 3 months of Study Day 1
10. Febrile illness within 2 weeks of Study Day 1