cyrilzakka/clinical-trials huggingface dataset:
Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment

The purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. It may also set base for a larger randomized trial.

30 patients with intermediate / extensive low risk (all core biopsies involvements \> 50%) prostate cancer (not necessitating to treat the nodal regions) will be included in this study. Patient stage T1 - T2, Gleason score ≤ 7, prostate-specific antigen (PSA) ≤ 20 will be considered.

Fiducial gold markers will be introduced in the prostate 1-week before the CT planning. 36 gray (Gy) in 12 fractions using intensity-modulated radiation therapy (IMRT) will be administered to the prostate (margins of 0,5cm) +/- first centimeter of the seminal vesicles.

Brachytherapy boost (15 Gy x 1) dosimetric parameters should respect our current standard (Prostate V100 \> 90% and V150 ≤ 40%, V200 ≤ 15%, Urethra V125 ≤ 1 cc, Rectum V75 ≤ 1cc, Bladder V75 ≤ 1cc). Short course (4 months) hormonal therapy (Degarelix) will be administered to the patient based upon recommended litterature11, 12.

Genitourinary (GU), GI and Sexual toxicity will be self reported. QOL questionnaires will be given to the patients to be answered. Results will be monitored and compared to our currently used standard fractionation regiment.

Follow-up will be scheduled 6 weeks after the implant and every 4 months for the first year, every 6 months for the second year 2 to 5, and on a yearly basis after 5 years. PSA \& testosterone tests will be done every 3 months for the first 3 years, every 6 months on years 4 and 5, and yearly thereafter.

Eligibility Criteria:
Inclusion Criteria:

* 30 patients
* intermediate / extensive low risk (all core biopsies involvements \> 50%)
* prostate cancer (not necessitating to treat the nodal regions)
* Patient stage T1 - T2,
* Gleason score ≤ 7,
* PSA ≤ 20 will be considered

Exclusion Criteria:

* patient unfit for biopsy or brachytherapy
* high or low risk prostate cancer
Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)

This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function

In order to assess the mid term effects of beta-glucans on lipid profile, glycemia and intestinal function, moderately hypercholesterolemic subjects will be involved in a cross-over study and supplemented for 8 weeks with 3 g/day of beta-glucans or placebo. The two intervention periods will be spaced by a 4 week washout period

Eligibility Criteria:
Inclusion Criteria:

* Total cholesterol between 200 and 240 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
* Triglycerides lower than 200 mg/dL
* Cardiovascular risk at 10 years lower than 10%
* Informed consent

Exclusion Criteria:

* Secondary prevention for cardiovascular diseases
* TG \> 400 mg/dL, HDL-C \< 35 mg/dL
* BMI higher than 30
* Assumption of lipid lowering drug or supplement with fibre or probiotics during the last 2 months
* Alcohol abuse
* Food allergy
* Alterations in thyroid, liver, or kidney functions, muscle diseases
* Diabetes, irritable bowel syndrome or chronic disturbed gut function
Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19

Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is \<10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition


Eligibility Criteria:
Inclusion Criteria:

* •Age: more than 20 years.

  * Gender: both males and females will be included.
  * Mechanically Ventilated patients.
  * COVID 19 confirmed diagnosis

Exclusion Criteria:

* •Immunocompromised patients.

  * Oxygen saturation more than 95% without ventilation.
  * Malignancy.
  * Patients refuse to be enrolled in the study.
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Body mass index ≥ 27 kg/m\^2.
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
* Diagnosis of T2DM.

Exclusion Criteria:

* Type 1 diabetes mellitus.
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
* Obesity induced by other endocrinologic disorders.
* Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
* History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
* History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
* Lifetime history of suicide attempt.
Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. To this end, 60 participants will be randomized into three groups: therapeutic exercise group + photobiomodulation (n = 20), and therapeutic exercise group. There will be 8 treatment sessions and participants will be evaluated before, after the 8 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* With chronic neck pain (for more than 90 days)
* Identified according to the following criteria: NDI score ≥ 5
* Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement

Exclusion Criteria:

* Individuals who had a history of cervical trauma; head, face, or cervical surgery
* Degenerative diseases of the spine
* Pain radiating to the upper limbs
* Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
* Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
* medical diagnosis of fibromyalgia.
An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Have received at least one course of standard systemic chemotherapy or radiation therapy
* Are ineligible for chemotherapy or radiotherapy
* Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H\&NC
* Are, in the investigators opinion, not medically suitable for chemotherapy.

Exclusion Criteria:

* Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
* Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
* Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
* Incomplete healing from prior oncologic or other major surgery
Metabolomic Effects of Probiotics Administration

Background: The establishment of the beneficial interactions between the host and its microbiota is essential for the development and correct functioning of the organism, since microflora alterations can lead to many chronic degenerative diseases. In this context, probiotics are used to improve balanced microbial communities and therefore exert substantial health-promoting effects to the host.

Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut microflora modulation through probiotic treatment, on human urine and serum metabolic profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.

Design: In a first phase twenty-two healthy subjects are enrolled in the study and administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum and Bifidobacterium longum at two different concentration. During the course of the study all the probiotic types were administered both singularly and in combination. From each subject urine and serum samples are collected before and during the supplementation and are analysed by nuclear magnetic resonance spectroscopy and statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

- healthy subjects

Exclusion Criteria:

* previous surgery on the intestinal tract;
* a probiotic / prebiotic and antibiotic treatments within 3 and 1 months, respectively, before the beginning of the study;
* subjects have changed drastically their diet or lifestyle during the study.
Symptom Management After Breast Cancer Surgery

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.


Eligibility Criteria:
Inclusion Criteria:

* Adult women \>18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery
* Has a healed incision(s)
* Has no recurrent disease in the painful area
* Is able to read, write and understand English

Exclusion Criteria:

* Presence of another type of pain that is more severe than the neuropathic pain
* Use of an opioid analgesic of greater than 60 mg codeine/day
* Is actively trying to become pregnant
* Has a medical contraindication to the use of lidocaine
* Has an allergy to lidocaine
* Is taking a coanalgesic for neuropathic pain.
Viagra in the Treatment of Primary Dysmenorrhea

The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.

It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of \>35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.

Exclusion Criteria:

* Secondary dysmenorrhea
* Any current medication
* Serious medical condition
Guideline Directed Medical Therapy in Patients with Heart Failure

The TEAM-MGH study will formerly evaluate impact of the GDMT Clinic versus matched usual care patients on the proportion of GDMT administration over a 12 week period in approximately 300 total patients with HF across the spectrum of LVEF (with a minimum of 150 with HFrEF). The study will also assess impact of the GDMT Clinic on health status, functional capacity, biomarker profiles, cardiac remodeling and cardiovascular events.

The lack of adherence to Goal-Directed Medical Therapy (GDMT) is a major problem in modern HF care. Despite advances in therapies for those with HF along with well-articulated goals for achieving guideline-directed medical therapy (GDMT) for affected individuals, the treatment of persons with HF lags behind current recommended guideline approaches, with 30% of ambulatory patients with HFrEF not being prescribed angiotensin receptor/neprilysin inhibitors (ARNI), angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), or evidence based beta blockers (eBBB) and the majority not receiving target doses of these medications despite lack of medical contraindications. The reasons for gaps in care include hesitancy to change medical programs in ostensibly stable patients, concerns about risk of drug intolerances, worries about drug costs, as well as uncertainty about benefits. Additionally, complexity of medical therapy, rapid evolution in the currently recommended therapeutic options, and challenges in care coordination also result in missed treatment opportunities. Given that most individuals with HF are cared for by specialists other than those trained in advanced HF therapies, this intersection of increasing complexity of care results in substantial gaps in care. The proposed research is to study impact of the GDMT clinic for patients across the spectrum of HF.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HF, including new onset disease
* Established cardiovascular follow up at MGH
* Receiving sub-optimal medical care defined as \<50% target doses of GDMT agents
* Age ≥18 years
* For HFpEF:

  * Presence of structural heart disease (LAVi \>34 mL/Kg2, E/e' \>14, or LVH)
  * Recent HF hospitalization or historical NT-proBNP \>300 pg/mL

Exclusion Criteria:

* Planned referral to the Advanced HF program
* Decompensated HF
* End-stage kidney disease

  * eGFR \<15 mL/min/1.73m2 or on renal replacement therapy
* Untreated severe valvular heart disease
* Advanced HF

  * Inotropic support
  * Transplant or MCS planned
  * Enrolled in hospice or palliative care
* Life expectancy \<12 months due to non-CV disease
* Pericardial constriction
* Hypertrophic cardiomyopathy
* Unwillingness or inability to take GDMT
* Pregnancy or breast feeding
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.

Genetic testing of tissue samples before and after the maintenance therapy were also used to further explore the pattern of gene mutations and the subgroups who may benefit.

Eligibility Criteria:
Inclusion Criteria:

1. Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.
2. The patient had at least one measurable lesion according to the RECIST V1.1 criteria.
3. The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.
4. ECOG score 0\~1,age 18\~75 years old
5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
6. CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
7. Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#

Exclusion Criteria:

1. Had used bevacizumab within 6 months of enrollment
2. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.
3. The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.
4. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
5. Activity or uncontrol severe infection
Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy

Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome measure. This would result in less narcotic analgesia usage, and shorter hospital stays as secondary outcome measures.

Objectives:

This study will attempt to assess the impact of cryotherapy on post-surgical inflammation and narcotic use. End-points for the study will be patient use of narcotics and pain level, regularly measured by nursing staff.

Patient Selection:

This study will accept all consecutive consenting patients who visit the Grady Hospital and Emory University urology clinics who require abdominal surgery.The study will require 55 patients, based on prior power calculations.

Registration/Randomization:

Because this study will enroll all consenting patients, no registration is required. Patients will be enrolled by their urologist during a standard visit. With consent, the urologist will direct the patient to the researcher. Patients will be randomized to either cryotherapy or no adjunctive therapy following abdominal surgery.

Therapy:

Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for 24 hours following surgery.After 24 hours, patients had the option of using ice packs for as long as they wished.

Patient Assessment:

Patients will be assessed by the nursing staff as they would otherwise be assessed postsurgically.

Data Collection:

During recovery time in the hospital, nurses will monitor both groups of patients as they do all patients. As with all patients, nurses will ask about pain levels and check the amount of narcotics you require for pain control. This study will not require any additional effort on patients' part. Once they are discharged, patient participation in the study will be complete.

Eligibility Criteria:
Inclusion Criteria:

* Any open transperitoneal abdominal surgery with a midline incision

Exclusion Criteria:

* Additional surgeries required