cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection

This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 18-40.
* The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
* The subjects have no family planning within 3 months and could select contraceptive method
* The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
* Echocardiography showed left ventricular ejection fraction (LVEF) \> 50% ,which two weeks before administration of experimental drug.

Exclusion Criteria:

* The subjects with a history of malignant tumor.
* The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
* The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
* The subjects who had undergone surgery within 2 months prior to signing the informed consent.
* Anti-drug antibody (ADA) detection positive.
* Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.
Adjuvant Growth Therapy in in Vitro Fertilization

In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.

The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.

This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35 to 42
* Primary or secondary infertility)

  * No previous treatment IVF cycle using the same proposed protocol
* Negative pregnancy test at randomization (urine or blood)

Exclusion Criteria:

* Contraindication to Saizen®
* Simultaneous participation in another clinical trial
* follicle stimulating hormone \> 12 IU/L and/or anti-mullerian hormone \< 0.5 pg/ml
* Body mass index ≥ 35 kg/m2
* Known risk of gestational diabetes
* Administration of any investigational medication three months prior to study enrolment
* Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
* Not able to communicate in French or English
Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics

The psychotherapies to be assessed in the present study, delivered on-line, are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT). Objectives: 1) to assess the efficacy of TBCT compared to MBHP and PPT in reducing the symptoms of PTSD during the COVID-19 pandemic.

Background: Research has suggested the use of different forms of psychotherapy to decrease drop-out rates in the post-traumatic stress disorder (PTSD) treatment. The psychotherapies to be assessed in the present study are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP) and Positive psychotherapy (PPT). Objectives: Our objectives are: 1) to assess the efficacy of TBCT compared to MBHP and PPT to reduce the symptoms of PTSD in the context of the COVID-19 pandemic, all delivered online; 2) to compare the efficacy of these psychotherapies in reducing symptoms of anxiety and depression, and in improving well-being; 3) to describe how patients and professionals perceive teletherapy. Methods: This is a three-arm, randomized, multicenter, single-blind, clinical trial. An estimated sample of 135 patients will receive either TBCT, MBHP or PPT, individual, weekly visits, totaling thirteen sessions. The primary outcome measure will be the CAPS-5, and the secondary outcome measures will be the Hospital Anxiety and Depression Scale (HADS), the Negative Core Beliefs Inventory (NCBI), and the Trauma-Related Guilt Inventory (TRGI). Other measures are the WHO-5 Well-being Index (WHO-5), and the California Psychotherapy Alliance Scale (CALPAS-P). Also, questions about patients perception of teletherapy will be asked. Expected results: PTSD symptoms are expected to be reduced after TBCT, MBHP and PPT. The null hypothesis is that no statistical difference is expected to be found among the three psychotherapies, as opposed to the alternative hypothesis that TBCT and MBHP are superior to PPT.

Eligibility Criteria:
Inclusion criteria:

* both sexes;
* aged 18 to 60 years;
* scoring 45 or more on the PCL-5
* PTSD developed (or aggravated by) as a result of direct or indirect exposure to COVID-19 \[e.g., health professionals, people who tested positive for Covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves\];
* Participants should be able to read, write and follow instructions, and have access to the a stable internet connexion.

Exclusion Criteria:

* severe suicide risk (plans, attitudes or suicide attemps for the last 12 months);
* self-mutilation behavior (for the last 12 months);
* already in psychotherapy;
* psychotic symptoms;
* current substance abuse or addiction (last 12 months).
Bioavailability of Apixaban Crushed Tablet

The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.
* Women of childbearing potential allowed. Must be following highly effective methods of contraception

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of significant head injury within the last 2 years, including individuals with base of skull fractures
* Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study
* Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug
* History of Gilbert's Syndrome
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
* Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration
* Any laboratory test results outside of the range of normal, confirmed by repeat results of:

  * Platelet count \<150,000 cells/µL
  * Activated partial thromboplastin time \>upper limit of normal (ULN)
  * International normalized ratio \>ULN
  * Alanine aminotransferase \>ULN
  * Aspartate aminotransferase \>ULN
  * Total bilirubin \>ULN
  * Serum creatinine ≥1.5 mg/dL
  * Hemoglobin \<lower limit of normal (LLN)
  * Hematocrit \<LLN
Enteral Nutrition and Abdominal Massage

This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes.

Introduction: Many multiple and challenging problems are encountered in patients followed in intensive care. The most important of these symptoms is nutritional problems. One of the most commonly used methods in the treatment of nutritional problems is enteral nutrition. In addition to its beneficial results, gastrointestinal problems such as abdominal distension, constipation, diarrhea, nausea and vomiting may be encountered in enteral fed individuals in intensive care units. Although different methods are used in the management of complications that may develop in enterally fed patients, abdominal massage, which is one of the non-invasive nursing practices, has been shown to reduce feeding intolerance and balance blood glucose levels.

Purpose: This study will be conducted to determine the effect of abominal massage applied to intensive care patients who are continuously fed enterally and have diabetes, on feeding intolerance and blood sugar levels.

Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 64 patients hospitalized in the intensive care units of a state hospital in Merzifon and who meet the inclusion criteria. Research data will be collected using the clinical status information form, patient parameters monitoring form, and Bristol stool scale. Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. For the control group, routine treatment and care practices in the hospital will continue without any additional intervention for these 5 days, and the same data will be evaluated at the same time.

Conclusion: It is thought that abdominal massage applied to intensive care patients with diabetes who are continuously fed enterally will reduce feeding intolerance and affect blood sugar levels.

Eligibility Criteria:
Inclusion Criteria:

The age of 18 years and over

Diagnosed with diabetes mellitus

Having just started continuous enteral feeding via nasogastric tube

Glasgow coma scale \>3

Patients who do not have a wound in the abdominal area

Patients without current diarrhea, constipation, vomiting, abdominal distension

Patients who gave their consent to participate in the research

Exclusion Criteria:

Patients who had started enteral feeding before starting the study

Patients who received radiotherapy to the abdominal area

Abdominal surgery within the last three months

Patients with ileus

Patients using medications that affect gastrointestinal motility
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
3. No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \[TKI\] such as alectinib is not allowed in any setting)
4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
5. Pretreatment tumor tissue (archived or a fresh biopsy)
6. Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

Exclusion Criteria:

1. Patient's cancer has a known oncogenic driver alteration other than ALK.
2. Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
4. Major surgery within 4 weeks prior to randomization
5. Uncontrolled clinically relevant infection requiring systemic therapy
6. Known active tuberculosis, or active Hepatitis B or C
7. QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 msec on repeated assessments
8. Clinically significant cardiovascular disease
9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
10. Active malignancy requiring therapy within 2 years prior to randomization
Subjects Through the Application of the Mindera Kit Part 2

A 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.


Eligibility Criteria:
Inclusion Criteria

1. Subject must have the ability to understand and sign written informed consent.
2. Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening.
3. Subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter.
4. Subjects must be treated with anti-TNF-α (or biosimilar) therapy once enrolled in the study.A two-week period is required to washout of the previous biologic when switching therapies.

Exclusion Criteria

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
2. Subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout.
3. Subjects currently treated with Hydroxychloroquine (Plaquenil), unless otherwise approved by Sponsor
The Effect of Exergame Games on Geriatric Individuals With Kinesiophobia

The study included 15 geriatric individuals over the age of 65 staying in Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Nursing Home. Participants in the study were rehabilitated by playing exergame games with Xbox 360 KinectTM for 30 minutes once a week for 8 weeks. Before starting the application, the participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, Nintendo Wii balance platform and basic balance game for balance measurement, geriatric depression scale-short form for depression, cognitive functions, and mini-mental state test for the lower extremities. functional strength and risk of falling. The shuttle test was applied 5 times. These tests will be repeated at the end of 8 sessions and before and after values were measured. As a result of the analysis, the effects of Xbox 360 KinectTM games on kinesiophobia, balance, lower extremity muscle strength, depression, and cognitive functions in geriatric individuals with kinesiophobia were investigated.

15 geriatric individuals over 65 years old living in Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Care Center were included in the study. The ethics committee of Istanbul Gedik University Ethics Committee, dated 17/01/2023 and numbered E-56365223-050.01.04-2023.137548.27-433, was accepted. A consent form was signed by geriatric individuals who met the conditions of this study. Participants participating in the study played 30 minutes of exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance measurement, geriatric depression scale-short form for depression, mini-mental state test for cognitive functions, and lower extremity functional strength and risk of falling 5 times. lift test was applied. These tests were repeated at the end of 8 sessions and before and after values were measured.

Eligibility Criteria:
Inclusion Criteria:

* Getting 38 or higher on the Tampa Kinesiophobia Scale
* Getting a Mini Mental State Test Score of 20 and above
* Being physically competent to apply the scales to be used
* Being 65 years or older
* Volunteering to work

Exclusion Criteria:

* Having a mental and psychiatric problem diagnosed by a physician
* Having a serious neurological and orthopedic problem diagnosed by a physician
* Having serious hearing and vision problems
* Having uncontrolled diabetes and hypertension
* Using a walking device other than a cane (crutches, walkers, etc.)
* Drug use that increases the risk of falling (to be determined by the information obtained from nurses and physiotherapists working in nursing homes)
Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.

It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult.

Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.

The sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation.

In the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-II
2. Age 3 to 7 years
3. Children undergoing adenotonsillectomy.

Exclusion Criteria:

1. Parents' refusal.
2. Children with behavioral changes
3. Children with physical developmental delay
4. Children on treatment with sedative or anticonvulsant.
The Impact of FIFA 11+ on Isokinetic Muscle Strength and Balance

FIFA 11+ program; It consists of simple, easily remembered, and time-consuming, sport-specific exercises underlying fair play. Although the FIFA 11+ program is a well-established warm-up protocol for injury prevention among football players, the performance improvement aspect of the program is not often discussed in the literature. The study's objective is to investigate the efficacy of the FIFA 11+ program on sports performance parameters such as dynamic balance, isokinetic muscle strength performance in adolescent amateur male football players.

This study was planned in a randomized controlled experimental type. The footballers of a team from an amateur league will be included in the research. All participants will be tested at baseline and 9 weeks after baseline. The participants will be submitted to the following testing procedures: dynamic balance (Star Excursion Balance Test), muscle strength assessment (Isokinetic assessment). After the baseline measurements will be completed, the control group members will be advised to continue their regular warm-up program. This program consists of jogging and stretching exercises. The experimental group will complete the FIFA 11+ training, which consisted of six different types of running exercises; six exercises with three levels of increasing difficulty to improve the participants' strength, agility, core stability, eccentric control, etc.; and advanced running exercises, such as running across the pitch, bounding, planting, cutting. The FIFA 11+ will be applied to the experimental group 3 times a week for 9 weeks. The control group's warm-up duration will be matched to the experimental group's duration (20-25 min). This routine workout will perform 3 times a week for 9 weeks. At the end of 9 weeks, the evaluations will be repeated (Star Excursion Balance Test, Isokinetic assessment).

Eligibility Criteria:
Inclusion Criteria:

* ) To accept being a case study member
* ) Being in the 15-18 age range
* ) To be a soccer player in amateur league clubs with experience for at least one year
* ) Having no systemic diseases
* ) Having the necessary mental and physical activity level to be able to take and complete the tests

Exclusion Criteria:

* ) Refusing to be a member of a case study
* ) Having visual impairment and perceptual disorder at a severe level
* ) Having pain that prevents testing
* ) Having diseases with neurological dysfunction
* ) Footballers who stop playing active football during the study period and disrupt the training program by not participating in 3 exercises in a row
* ) Having an injury in the research process
* ) Having an injury in the last six months before the research
Relationships Between Physical Activity and Inhibitory Control Among College Students

The primary aim of this study is to explore the impact of a 20-minute aerobic exercise on inhibitory control, microvascular diameters, and brain function. The main questions it aims to answer are:

1. Is there a correlation among the level of physical activity, performance in inhibitory control, and the diameter of retinal microvasculature, and do retinal microcirculation parameters mediate this relationship?
2. Does short-term aerobic exercise (moderate and high intensity) improve inhibitory control and physiological markers, such as retinal diameter and frontal brain activation, compared to a sedentary control group?


Eligibility Criteria:
Inclusion Criteria:

* right-handed (how was handedness assessed; i.e., "What hand do you write with?") with normal or corrected-to-normal vision and normal color vision

Exclusion Criteria:

* reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.
MR Guided tDCS in Alzheimer's Disease

The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.

The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's Disease, mild and moderate stage

Exclusion Criteria:

* Other neurological diseases or injuries
* Stroke
* Cancer
* Psychiatric disorders (moderate/ severe depression, psychosis)