cyrilzakka/clinical-trials huggingface dataset:
Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study

This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study

The purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral syndrome : a - quasi experimental study

Pain , gait parameters, ROM and dynamic knee valgus angle of young adults (age : 18-35 years ) will be determined using:

1. Numeric pain rating scale
2. Goniometer
3. 30 meter walk test
4. dynamic knee valgus angle via kinovea software Data will be before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Females
* Having pain from at least 2 months
* Pain score greater than 3 on NPRS
* Retro patellar pain in at least two of the following activities:

  1. Ascending, descending stairs
  2. Hooping / jumping
  3. Prolonged sitting with flexed knees
  4. Kneeling and squatting
* Pain on palpation of medial or lateral patellar facet.
* Pain on palpation on anterior portion of medial or lateral femoral condyles.

Exclusion Criteria:

* Diagnosed with Chondromalacia patellae
* Instability of tibiofemoral joint
* Subluxation of patellofemoral joint
* Patellar instability
* Previous surgery of lower limb
* Negative findings on examination of knee ligaments, menisci and bursa.
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Migraine headache (International Classification of Headache Disorders 3B criteria)

Exclusion Criteria:

* Brain imaging ordered
* Fever
* Objective neurological findings
* Pregnancy/ breast feeding
* Allergy/ contraindication to investigational medication
* History of addiction to opioids, use of methadone, any use of opioids previous 30 days
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old. Other age restrictions may apply as per local regulations.
* Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772_A775dup / A775_G776insYVMA, L755S, G778_P780dup / P780_Y781insGSP, T862A, and V842I locally determined by NGS or a validated nucleic acid-based methodology (eg, qPCR, digital PCR) on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
* Prior HER2 targeted therapy is permitted.
* All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
* LVEF ≥50%
* ECOG 0-1
* All patients have measurable target disease assessed by the Investigator based on RECIST v1.1

Exclusion Criteria:

* HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
* HER2 mutant NSCLC.
* Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke.
* History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
* Corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG.
* Lung-specific intercurrent clinically significant severe illnesses.
* History of active primary immunodeficiency, known HIV, active HBV or HCV infection
* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
* Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
* Has spinal cord compression or clinically active central nervous system metastases.
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

* compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
* evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* operable primary invasive breast cancer;
* completed definitive loco-regional surgery;
* primary tumor centrally confirmed as triple negative.

Exclusion Criteria:

* locally advanced breast cancers;
* previous breast cancer history;
* clinically significant cardiovascular disease.
Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain. It is not yet know whether combination chemotherapy followed by surgery alone is more effective than combination chemotherapy followed by surgery and radiation therapy in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by surgery to see how well it works compared to combination chemotherapy followed by surgery and radiation therapy in treating young patients with stage II or stage III neuroblastoma.

OBJECTIVES:

* Compare the local control and event-free and overall survival of young patients with stage IIB and III neuroblastoma treated with neoadjuvant combination chemotherapy followed by surgery with vs without radiotherapy.
* Determine the toxic effects of these regimen in these patients.

OUTLINE: This is a multicenter, randomized study.

* Induction combination chemotherapy: Patients receive vincristine IV and cyclophosphamide IV on day 1. Patients also receive cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 2 during courses 1, 3, and 5 and carboplatin IV over 1 hour and etoposide IV over 4 hours on day 1 during courses 2 and 4. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery unless complete resection was done during initial staging and complete response was maintained.
* Surgery: Patients undergo biopsy or surgical resection of the tumor 2-3 weeks after completion of induction combination chemotherapy.
* Post-surgical treatment: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive two additional courses of combination chemotherapy comprising vincristine, cisplatin, etoposide, and cyclophosphamide in course 6 and vincristine, carboplatin, etoposide, and cyclophosphamide in course 7.
  * Arm II: Patients undergo radiotherapy 2-4 weeks after surgery. Beginning 3 weeks after completion of radiotherapy, patients receive chemotherapy as in arm I After completion of study treatment, patients are evaluated periodically.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IIB or III neuroblastoma

  * No n-myc amplification

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
The United States Healthy Living Study

The purpose of this study is to pilot test the efficacy of a patient-centered, tailored message intervention delivered via virtual human technology for increasing colorectal cancer (CRC) screening within guidelines. Although participation is not limited to these groups, the study team is particularly interested in the feasibility of the intervention for reaching racial/ethnic minority and rural patients.

The primary goal of the study is to reduce colorectal cancer (CRC) morbidity and mortality by increasing CRC screening rates among the at-risk patient community and to reduce racial and geographic (rural vs. urban) disparities in CRC screening and mortality rates. To accomplish this long-term goal, this study aims to develop and test precision messaging tailored to target audiences through development and evaluation of culturally sensitive, interactive messages about CRC screening delivered using VHT. The study will investigate whether interactive, tailored messages contribute to an overall enhancement of knowledge of CRC and screening options by eliciting positive attitudes and behaviors toward FIT screening.

To date, there is no other study that has looked to partner specific message strategies and colorectal cancer screening with an emphasis on racial concordance and modality. As such, the researchers hope to shed new light on how, as health communicators, to more successfully engage target audiences to change attitudes and/or behaviors towards getting screened for colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* reside within the United States but outside of Florida
* speak English
* are of either black or white racial background.
* are out-of-guidelines for colorectal cancer screening (\>10 years for colonoscopy, \>3 years for Cologuard, \> 1 year for fecal immunochemical test)

Exclusion Criteria:

* does not meet the above criteria
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day Care Center.

The sample of the study will be patients who will have Autologous Fat Transfer for Breast Reconstruction.

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile anesthetics (desflurane-remifentanil).

Specifically, the TIVA group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. Patients with cardiac and respiratory problems will be included in the DES group.

The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age), Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and perioperative pain levels will be assessed with CPOT scale (values 0-8).

Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b. How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS questions will also be given preoperatively and postoperatively to the ward. The sedation levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The level of patient's awareness will be assessed by GCS Scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)).

The presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. Finally, post-operative stress will be examined with stress biomarkers, salivary ACTH hormone and salivary cortisol hormone.

Eligibility Criteria:
Inclusion criteria:

TIVA group

* patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III
* age \>50 years
* high risk of nausea / vomiting
* high risk of postoperative delirium
* suspicion of malignant hyperthermia.

Volatile anesthesia

* patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III
* 20-70 years
* Patients with cardiac problems
* Patients with respiratory problems

Exclusion Criteria

•In both groups, the exclusion criteria are the opposite of the inclusion criteria
Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.

Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.

This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Birth weight greater than or equal to 1000 grams.
2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
3. Candidate for non-invasive respiratory support as a result of:

   1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
   2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

Exclusion Criteria:

1. Birth weight less than 1000 grams.
2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
3. Active air leak syndrome.
4. Subjects will not be eligible if they are not considered viable.
5. Infants with abnormalities of the upper and lower airways
6. Infants with significant abdominal or respiratory malformations .
Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®

The aim of the study is to evaluate in primiparous patients the benefit of supplementation with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture. The patient is followed from the delivery to 6 to 8 weeks after.

For this study, 60 patients are going to be included. There will be 2 groups : a supplemented one (proteochoc®) and a non supplemented one (control). The patients of these two groups will have the same follow-up At the time of inclusion, an inclusion card is completed describing the patient's socio-demographic characteristics, major medical, surgical and obstetric history. After an uncomplicated delivery, women stay in maternity for a maximum of 3 days. In accordance with standard medical practice, women will be seen daily from D0 to D + 3 by the nursing staff. The investigating physician and his team will complete the follow-up sheets in the aftermath (day1), day3 and 6-8 weeks after the usual visits.

The data collected are information on medication treatments, prescribed care, assessment of the patient's overall condition and recovery, and monitoring of perineal lesions and complications if applicable.

In the same time (day1, day3, day6, day14 and 6-8 weeks after, the patient will also complete a patient follow-up sheet to collect her impressions.

The data collected are the medications taken, the care taken, the general pain felt, the perineal pain felt if applicable, and the fatigue felt.

Eligibility Criteria:
Inclusion Criteria:

* Female aged over 18
* First pregnancy
* Having given birth, at a term greater than or equal to 37 SA, by low route, of a single child born alive and not hospitalized in the aftermath of immediate layers
* For whom the investigator has freely decided to propose a complementation by Protéochoc® on the day of delivery and its sequences of layers
* Having freely decided to buy Protéochoc® and follow the advice of consumption proposed by its gynecologist-obstetrician
* Having agreed to sign a consent to participate in the investigation after receiving informed information from the investigator

Exclusion Criteria:

* Serious pathology running
* Suffering before the pregnancy of any of the following conditions:
* Chronic pelvic pain syndrome
* Ilio-inguinal, ilio-hypogastric and genito-femoral pudendal neuralgia
* Pains with osteo-ligamentary component: the syndrome of the dorsolumbar hinge and the coccygodynia
* Myofacial Syndrome
* Pain of muscular origin: the syndrome of the pyriform muscle, syndrome of the obturator muscle
* Pains of venous origin: pelvic varices
* Allergy to any of the components of Proteochoc®
* Patient refusing to participate or unable to participate in the survey due to major language problems or major neuropsychiatric disorders
The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus

The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.

There will be a parallel-group randomized controlled trial study and consists of two groups.

Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application.

The aim of this study is to evaluate the effect of 4-7-8 breathing exercise technique on tinnitus handicap, psychological factors and sleep quality. It is also aimed to compare the results of the experimental group and those who received only 1 hour of informative session on tinnitus (Control group).

The study will employ a parallel-group randomized controlled trial design. Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks.

Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory,and perceived stress scale will be applied to all patients before and after the application.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years with subjective idiopathic tinnitus complaints for at least six months
* Must be able to speak and read Turkish
* Must be able to answer the questionnaire questions and perform the 4-7-8 breathing exercises regularly

Exclusion Criteria:

* Any neuro-otologic, psychiatric, neurologic, or cognitive problems, objective tinnitus, chronic medication use, asthma diagnosis or respiratory distress
* Receivement of any tinnitus treatment or tinnitus informative session actively
Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF.

The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US).

This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines.

Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control.

The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective DP via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor
* ASA score \< 4
* Ability of the subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Pancreas thickness \>17mm measured at the intraoperative ultrasound at the pancreatic transection level
* Metastatic disease
* Kidney or adrenal gland resection
* Arterial resection (celiac axis, superior mesenteric artery, hepatic artery)
* Intestinal resections and anastomoses or stoma
* Acute necrotizing and chronic pancreatitis
* Immune suppressed patients
* Pregnant women
* Patients with contraindications for distal pancreatectomy
* Impaired mental state or language problems