cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer

The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.


Eligibility Criteria:
Inclusion Criteria:

* stage IB2-IVA , histological proven cervical carcinoma
* no previous diagnosis of carcinoma
* no prior history of chemotherapy or radiotherapy
* ECOG less than or equal to 2
* Above 21 years old
* medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy
* Hemoglobin \>10g/dL
* Adequate hematological, renal and hepatic function according to all of the following laboratory values:

  * Absolute neutrophil count ≥ 1.5 ×109/l
  * Platelets ≥ 100 ×109/l
  * Serum creatinine ≤ 1.5 times upper limit of laboratory normal
  * Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
  * ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal
  * Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal

Exclusion Criteria:

* Age below 21
* Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
* Psychological, familial, sociological, or geographical condition that would preclude study participation
* Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
* Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
* Life expectancy \< 6 months
* Patients with insulin dependent diabetes
* Prior tumor-directed surgery
* Previous systemic chemotherapy or pelvic radiation therapy
* As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception
The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.

To evaluate the impact of a supervised exercise program (SEP) on self-efficacy,quality of life status and cardiovascular fitness among people with HIV in a 24 week randomised controlled trial.We hypothesised that a combined aerobic and resisted exercise (intervention) would improve these parameters compared to an individual walking program with monthly group forum (control).

With combination antiretroviral therapy, HIV has become a chronic, manageable medical condition. Medication adherence is now a critical determinant of patient outcomes. Quality of life (QOL) rather than just survival has also become an important consideration in HIV management strategies. The role of non-pharmacological interventions such as exercise to enhance self efficacy (which correlates with adherence) and QOL among people with HIV requires formal investigation.

We evaluated the impact of a supervised exercise program (SEP) on self-efficacy among people with HIV in a 24 week, randomised controlled trial of participation in a SEP with combined aerobic and resisted exercise (intervention) versus an individual walking program with monthly group forum (control). QOL and cardiovascular fitness were also evaluated as secondary endpoints. Twenty subjects were enrolled in each arm, and assessments were performed at baseline, 2 month and 6 months, including a Generic Self Efficacy Scale, 1 minute heart rate response post 3 minute step test, and a validated HIV-specific QOL survey.

Self efficacy and cardiovascular fitness improved in the intervention but not the control subjects over the study period (p\<0.0001 for both). QOL also improved (8 out of 10 dimensions) in the intervention group but not in controls (0 out of 10 dimensions).

These data support the use of SEP as an important therapeutic intervention for people with HIV, with significant benefits to self efficacy, cardiovascular fitness and QOL over six months. Importantly, these benefits were not achieved through unsupervised exercise over the same period.

Eligibility Criteria:
Inclusion Criteria:

HIV, aged at least 18 years

Exclusion Criteria:

* any contraindications to exercise testing and training , severe cognitive impairment
* inability to follow instructions,
* regular exercise ( participating in 2 or more structured exercise sessions weekly for more than or equal to 6 months prior to enrolment).
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)

Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).

Detailed Description:

The trial is a non-inferiority trial; patients, depending on intra-operative or post-operative sentinel lymph node assessment, are randomly assigned to one of the two intervention groups:

group 1: removal of I-II level of axillary lymph nodes (standard treatment). Removal of at least 10 lymph nodes is recommended.

group 2: no axillary lymph nodes dissection (experimental treatment). Patients for whom sentinel lymph node cannot be found, will undergo complete dissection of the axillary cavity as required by international guidelines.

After surgery, according to their bio-pathological profile and to the international guidelines criteria, patients will be able to receive:

* no further treatment
* complementary radiotherapy
* adjuvant medical therapy (chemo and / or hormone therapy).

Patients will be checked for at least 5 years in the following ways:

* six-monthly clinical examination for the first 5 years and yearly thereafter
* mammography + annual breast ultrasound
* annual axillary ultrasound in cases not subjected to dissection.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 ≤75 years old
* Breast cancer with infiltrating histology
* Tumor size ≤50 mm (T1 - T2)
* Clinically and ultrasound node-negative (cN0) breast cancer
* No distant metastases (M0)
* No neoadjuvant therapy
* Negative history of previous infiltrating neoplasm
* Maximum number of metastatic sentinel lymph nodes: 2
* Lymph node macro-metastases \> 2mm

Exclusion Criteria:

* Pregnancy or breastfeeding in progress
* Inflammatory breast cancer
* Breast cancer in situ
* Synchronous contralateral breast cancer
* Co-morbidities such as to preclude the possible use of adjuvant therapy
* Conditions that make it impossible to carry out a regular follow-up
* Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca)
* Breast cancer with non-infiltrating or inflammatory histotype
* Tumor size\> 50 mm
* No sentinel lymph nodes identified
* No positive sentinel lymph nodes (pN0)
* Positive sentinel lymph node number \> 2
* Lymph node micro-metastases \<= 2
Effectiveness of the NephroCheck™ After TAVI

Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI) early enough to prevent an organic dysfunction triggering, consequently, cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly. These markers, sonographic and biologic, have both the advantage to be non-invasive and easy to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI after a TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing TAVI.

Therefore, the aim of this prospective observational study will be first to determine the effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure. The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an earlier stage than the traditional method an AKI.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo a TAVI

Exclusion Criteria:

* Chronic dialysis patients with anuria
NAVASET: Nava Level Titration Using Comfort Scales

Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.

Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.

We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Hospitalized in intensive care unit for an acute respiratory failure
* Intubated or tracheotomized and mechanically ventilated
* RASS score: 0;-2
* Weaning period

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent
* Contraindication of nasogastric catheter insertion
the Degree of Forward Head Posture and Hamstring Muscles Tightness

is the degree of forward head posture correlated with the degree of hamstring muscles tightness

I will measure the degree of forward head posture by photogrammetry method and classify the degree according to its severity measuring the hamstring muscles tightness and classify it too according to its severity and calf muscle tightness lumber flexibility and correlate the to the degree of forward the forward head posture and the degree

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants 18-30 of age
2. Craniovertebral angle \< 490
3. With or without neck pain

   * subjects with mechanical neck pain (in individual with chronic non-specific neck pain)
   * Subjects are not engaged in any sports or athletic routine Neck disability index \>5 points

Exclusion Criteria:

.Prevalence of serious pathology (rheumatoid arthritis, ankylosing spondylitis, malignancy, infection, inflammatory disorders).

Vascular syndrome such as vertebrobasilar insufficiency Cervical spine history of trauma, fracture, congenital anomalies, or surgical intervention .

Progressive neurological deficits .

.History of lumbar and cervical herniated intervertebral disc with spinal stenosis History of neurological (Guillain-Barre, peripheral neuritis) or orthopedic disorders (osteoporosis, osteoarthritis) Moderate or severe scoliosis History of lower extremity fracture and surgery with malunion Leg length discrepancy BMI \<18 or BMI \>29.9
"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"

Drainage manoeuvres described in different Manual Lymphatic Drainage methods, suggest modificactions in vital signs, by changes at nervous system, that would involve modifications to heart rate, breathing rate, blood pressure, cardiac vascular level (arteries and lymphatics). In addition this hypothetical relaxing effect could be beneficial for other types of pathologies associated with the presence of stress, cardiac problems, respiratory pathology, muscle tension, muscle trigger points, etc. With this study investigators compare different manoeuvres in the neck area to observe the results in the participants regarding the basal state.

Differentes drainage manoeuvres suggest changes at nervous system (sympathetic and parasympathetic nervous system) and other vital constants

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent

Exclusion Criteria:

* systemic diseases, trauma history, neurological diseases, subjects with chronic pain, cardiovascular history of importance, depression, individuals who know the technique of MLD or that are under any medical treatment.
A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis

The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.

Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.

A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments

Eligibility Criteria:
Main Criteria for Inclusion:

* Men or women ≥18 years of age at the time of screening.
* Subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation.
* Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI 10, affected BSA \>10%, and DLQI \>10.
* Subject has no known history of active tuberculosis.
* Subject has a negative test for tuberculosis taken at screening (negative Quantiferon test).
* Subject and/or subject's designee is/are capable of administering subcutaneous injections.

Main Criteria for Exclusion:

* Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
* Previous or current PUVA (psoralens and ultraviolet A) therapy.
* Washouts and non-permitted drugs:

  1. Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or
  2. Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)
  3. Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer
  4. Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.
* Subjects with any of the following laboratory abnormalities at screening:

  1. Leukocyte cell count below 3×10\^9/L or lymphocyte count below 0.7×10\^9/L
  2. Aspartate aminotransferase (AST) or alanine transferase (ALT) \> 2× ULN (upper level of normal limit)
  3. Absolute neutrophil count \< 2×10\^9/L
  4. Serum creatinine \> ULN.
* History of depressive disorder within the last 2 years including current antidepressive treatment.
* Subjects with a history of suicidal behaviour (suicide attempt).
* Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.
* A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.
Soy Fiber Improves Weight Loss and Lipid Profile

The aim of this study is to examine the effects of soy fiber on body weight, body composition and blood lipids in overweight and obese participants.

Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d). Information on body weight, body mass index, waist/hip circumference, blood pressure as well as measures of lipoprotein, glucose concentrations, and HbA1c was obtained at baseline, 8 and 12 wk after intervention. Body composition was also assessed at baseline and wk 12, respectively.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 23-35 kg/m2

Exclusion Criteria:

* Subjects taking any drugs, botanicals or nutraceutical known to influence body weight or blood pressure
* significant history of eating disorders
* strenuous exercise to lose weight
* lipid-lowering medication
* use of steroids and other agents that may influence lipid metabolism
* hyperlipidemia
* hyperglycemia
* diabetes mellitus
* cardiovascular disease
* major systemic diseases
* gastrointestinal problems
* liver and renal failure
Pain After Laparoscopic Hysterectomy

The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.

The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.

This study is double blind randomized controlled study.

inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition

exclusion criteria: maling cases and conversion to laparotomy

after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .

Eligibility Criteria:
Inclusion Criteria:

* all of cases that had laparoscopic hysterectomy for bening conditions

Exclusion Criteria:

* maling cases
* conversion to laparotomy
Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Helicobacter pylori colonizes approximately to 50% of the world-wide population.

There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.

The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.

The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 - 65 years
* Infection with H. pylori defined as ∆ \> 20 ppm in the UBT test
* Non-ulcer dyspepsia
* No earlier eradication therapy for H. pylori infection
* Written informed consent
* Stated availability throughout the entire study period
* Mental ability to understand and willingness to fulfil all the details of the protocol

Exclusion Criteria:

* Duodenal or gastric ulcer
* MALT lymphoma
* Penicillin allergy
* Gastric resection (at any time)
* First level relatives of gastric cancer patients
* Absence of GI symptoms
* Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
* Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
* Pregnancy
* Participation in other clinical trials
A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer

The purpose of this study is to find out if it is practical to provide the program contained within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform that re-configures according to the specific needs of patients through physician prescriptions.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lung cancer

  * Patients with suspected primary lung cancer per recent chest CT scan (with or without contrast) may be enrolled in the trial. These patients may be randomized and begin study intervention without a biopsy. If a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. The patient will continue to receive full access to the AmDTx app for 2-years.
  * Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice \[intervention group\] 14 days preoperatively)
* Age ≥18 years of age at time of signing informed consent
* Access to a smartphone/tablet with data connection
* Willing to give time for mindfulness practice (Patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of a minimum of 6 weeks to do the mindfulness meditations and practices)
* Willing to be randomized to mindfulness MBCR or CI group and complete all assessments
* High distress level (Distress Thermometer score ≥4 at initial visit)
* Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent
* Able to read, speak, and understand English

Exclusion Criteria:

* Currently engaging in app-based mindfulness or meditation for one or more times per week
* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility before consent
* Individuals with impaired decision-making capacity
* Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation)
* Patients undergoing active treatment of other non-lung cancers
* Patients with recurrent lung cancer
Treatment Effect According to Timing of Administration of DWP14012 40 mg

The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease