cyrilzakka/clinical-trials huggingface dataset:
The Effect of IVF Counseling on Psychosocial Well-Being

In this study, İt was aimed to determination of the effect of counseling given in accordance with the Roy Adaptation Model in women in the in vitro fertilization (IVF) process on emotional capacity and well-being.

The study will be conducted in the Infertility clinic of a medical school hospital. The study included women receiving IVF treatment. In the pre-initial evaluation, "Introductory Information Form, Screening on distress in fertility treatment (SCREENIVF), Infertility Stress, Life Quality Scale for Persons with Fertility Problems(FertiQol), Subjective Units of Distress Scale-SUD application is planned. A "Consultancy Program" will be applied to the experimental group in the form of two modules in addition to drug applications, egg pick up and embryo transfer before, during and after clinical routine health care. The first module of the counseling program is the definition of infertility, the treatment process, its effects on the life process and coping methods. The second module includes the application of breath awareness and Emotional Freedom Technique (EFT) within the scope of coping methods with infertility stress. Emotional Freedom Technique-EFT is an energy psychotherapy based on the principle that each limiting thought, disturbing emotion and memory of an individual disrupts the energy flow in the body and creates congestion. This technique, the stimulation on the meridian system by focusing on the thought, disturbing emotion or memory that prevents the individual (often by touching) regulates the energy flow and provides the individual to relax. With breath awareness, beneficial results can be obtained, such as physical, sensory and mental control, life-facilitating techniques, individual and social awareness, re-existence and raising the level of consciousness. Within the scope of the counseling program, a total of seven follow-ups will be made, five-to-one, via two phone calls. On the day of follicle development (2nd Follow-up), Egg Pick up Procedure (4th Follow-up) and Embryo transfer (5th Follow-up), the patient will be given breathing exercises and EFT and Subjective Units of Distress Scale will be scored. The control group will continue clinical routine health care and will be followed up on the first day of IVF treatment (1st follow-up) and on the seventh day of embryo transfer (2nd follow-up). For ethical reasons, a consultancy program will be applied to the control group after the second follow-up. Data collection tools will be applied again to both groups in the final evaluation.

Eligibility Criteria:
Inclusion Criteria:

* IVF treatmant
* Women
* Women aged18-40 years
* Sign the informed consent form

Exclusion Criteria:

* Having a psychiatric diagnosis /
* Having a situation that prevents communication (language, etc.)
Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.

OBJECTIVES:

Primary

* Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.
* Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.

Secondary

* Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1, etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence of disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed small cell lung cancer

  * Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)
* Measurable disease
* Concurrent CNS metastases allowed provided patient remains asymptomatic

  * Radiotherapy or surgery for uncontrolled symptoms allowed before study entry

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion allowed)

Hepatic

* ALT ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN

Renal

* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Concurrent corticosteroids for brain metastases allowed

Radiotherapy

* See Disease Characteristics
* Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.

A previous study has indicated that silkworms (Bombyx mori L.) pupae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 12 weeks of intervention. Fifty four adults were administered either 2,400 mg of silkworms (Bombyx mori L.) pupae extracts or a placebo each day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer
* Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2

Exclusion Criteria:

* Vegetarian
* History of any central bone fracture within 1 year
* History of cancer or serious cerebro-cardiovascular diseases within 6 months
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* History of medication for psychiatric diseases such as severe affective disorder, schizophrenia, and substance use.
* Alcohol abuser
* Allergic reaction to constituent foods
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or planning to become pregnant during the clinical trial
* Those who have participated in other drug clinical trials within the last 3months
Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial

Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.

In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.

The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.


Eligibility Criteria:
Inclusion Criteria:

* Aged above 40
* Self-reported knee-related walking disability
* In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit.
* A body mass index (BMI) of ≤35 kg/m2
* Speaks, reads and writes Danish language

Exclusion Criteria:

* Usage of Rosehip nutritional supplements within the last 3 months
* History of symptoms of autoimmune disorders.
* Planned surgical procedure during the duration of the study
* History, diagnosis, or signs and symptoms of clinically significant neurological disease
* Alcohol or drug abuse within the last 5 years
* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
* Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
* Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.
Impact of Iron Injection on Blood Donation

This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field

This study aim to investigate the impact of an iron injection on the proteins involved in iron metabolism during blood donation and to compare the blood and urinary matrix. A messenger RNA profiling will be performed as well. The goal is to investigate the impact of iron injection on the markers of blood donation detection in the anti-doping field.

The study will take place over a period of 8 weeks.

Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.

The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.

On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).

Eligibility Criteria:
Inclusion Criteria:

* Male between 20 and 35 yo
* BMI between 18 and 30
* Ferritin \< 50ug/l
* Transferrin saturation \< 20 if ferritin between 20 and 50ug/l

Exclusion Criteria:

* high level athlete
* blood donation within 6 months before the study
* liver disorder
Tropism and Pathogenesis of Influenza Virus and Coronavirus in Human Brain Explant Culture

Background:

Influenza and coronavirus have been repeatedly causing pandemic recently. Like the Influenza A/H7N9 virus has caused five epidemics in China since its first detection in East China in 2013. In 2017, the previously low pathogenic avian influenza (LPAI) H7N9 virus underwent mutation in its haemagglutinin to give to a highly pathogenic avian influenza (HPAI) virus causing 32 human cases and potentially poses a threat to animal and human health. More recently, the SARS-CoV-2 pandemic has been heavily affecting the world. Therefore an effective risk assessment platform is urgently required for better pandemic preparation.

Hypothesis:

The tissue tropism and pathogenesis of a newly emerged infectious viruses, like the highlypathogenic influenza, like H7N9 and coronavirus, like SARS-CoV-2 would be different from that of their low pathogenic subtype and it would infect and replicate the human respiratory system more efficiently.

Because of its resistance to oseltamivir for influenza and no effective antiviral for coronavirus, investigators therefore propose to set up an novel and effective risk assessment platform for emerging infectious viruses.

Experimental Design:

The tissue tropism and viral replication kinetics of a HPAI and LP influenza and coronavirus will be determined in ex vivo cultures of human brain and compared with their LP subtype. The replication competence and innate immune responses of influenza and coronavirus will be studied and compared with other LP virus in in vitro cultures of human brain cells and human microvascular endothelial cells (HMVEC) both isolated from human brain tissues.

Expected outcomes:

HPAI influenza and coronavirus particularly SARS-CoV-2 will infect and replicate the human brain tissues and cells more efficiently than their LP subtype. Besides, HPAI influenza and SARS-CoV-2 will induce dysregulated host innate immune response than the LP subtype.

In this study, 80 subjects who will undergoing elective or emergency craniotomies for intrinsic brain lesions at Prince of Wales Hospital, will be recruited.

This is a prospective and qualitative study. There is no randomization in the study procedure nor therapeutic invention for study subjects. No investigational product is involved.

Brain tissues that are normal discarded during the operation from patients who undergo elective or emergency craniotomies for intrinsic brain lesions will be collected for this study.

A consent for operation and agreement to use of removed tissue for scientific research will be obtained prior to the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age: \> 1 year old and \< 70 years old
2. Undergo elective or emergency craniotomies for intrinsic brain lesions

Exclusion Criteria:

a. Samples containing infected material
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears

There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery.

According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.

Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.

Various techniques have been developed to prevent the development of perineal tears. As reported in the literature, active protection of the perineum during the second stage of labor can reduce the rate of tears. These include massage of the perineum, hands-on technique, use of gel, and warm compresses.

According to a Cochrane review that examined the use of warm compresses published in 2017, there is no difference in terms of the rate of events of an intact perineum, perineal trauma that requires suturing, but in a subanalysis it showed that there is a decrease in the rate of advanced tears, involving the anal sphincter and the rectal mucosa (grade three and four).

According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.

Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Singleton pregnancy
* Vertex presentation

Exclusion Criteria:

* Women with a history of third degree perineal tear in the past
* Intrauterine fetal death
* Crohn disease with perineal involvement
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

* Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
* Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\> 35
* Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
* Subject is pregnant or lactating
Treatment of Schizophrenia Through Internet-Based Psychoeducation

The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease.

This study will provide a comprehensive psychoeducational program which includes education, social support, information, coping strategies, and guidance from mental health, social services, and medical professionals. This study will work to reduce relapse, facilitate patient rehabilitation, decrease family distress, and improve family well being.

Patients and their families participate in an in-person Psychoeducational Survival Skills Workshop that is designed to provide patients and their families with basic information about schizophrenia and its treatment. After the workshop, participants are provided with 6 Web-based modules that are designed to increase mental health and schizophrenia knowledge. Patient relapse, family distress, family knowledge of schizophrenia, and data on user's acceptance and utilization are measured to determine the intervention's effectiveness.

Eligibility Criteria:
Inclusion Criteria

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* At least 4 hours/week in-person contact with a family member
* Primary caregiver with a telephone
* Patient and primary caregiver speak and read English

Exclusion Criteria:

* Enrolled in another clinical trial
* Evidence of organic brain syndrome
* Current alcohol or substance abuse that could explain the presenting index psychotic episode
* DSM-IV diagnosis of psychoactive substance dependency
Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.

The purpose of this investigation is to evaluate the effectiveness of a multicomponent structured physical exercise program for adults aged 65 years or more, classified as pre-frail and with chronic pain to improve the Perceived Health Related Quality of Life, compared with usual care.

Design: Randomized controlled, pragmatic clinical trial with two groups and 3 months follow-up.

Unit of randomization: Patient. Unit of analysis: Patient. Setting: A Primary Health Care Center in the Spanish Autonomous Community of Madrid.

Population: Pre-frail patients aged 65 years or more with chronic pain. Intervention: Multicomponent structured physical exercise program. Control group: Usual care. Variables: Perceived Health Related Quality of Life (EuroQol 5D-5L), Pain Intensity (Visual Analogue Scale), Frailty (SHARE-Frailty Index), Physical Performance (Short Physical Performance Battery, SPPB), Depression (Yesavage).

Analysis: Mean change differences after 3 months in EQ5D dimensions between groups with CI 95%. Mean differences or proportion differences will be calculated according to variable characteristics between groups with appropriate statistical test.

Eligibility Criteria:
Inclusion Criteria:

* Clinical record of Chronic Pain by International Classification of Primary Care (ICPC) Code A01.
* Being classified as pre-frail by SHARE-FI questionnaire.
* Informed consent

Exclusion Criteria:

* Housebound patients
* Institutionalized patients
* Not living in the area of the investigation
* Dependence for bADL
* Not being fluent in Spanish
* Severe mental illness or cognitive disorder