cyrilzakka/clinical-trials huggingface dataset:
Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.

This study consists of phase Ia and Ib portions for patients with solid tumors.

Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of Mogamulizumab.

Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more efficient dose.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.
2. Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.
4. Patients should be 20 years or older at the time of informed consent.
5. No serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : \>=1,500/mm3 2) Hemoglobin : \>=8.0g/dL 3) Platelet count : \>=75,000/mm3 4) Serum total bilirubin : \<=2.0 x ULN 5) AST and ALT : \<=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease\<=5.0 x ULN) 6) Serum creatinine : \<=1.5 mg/dL 7) SpO2 : \>=93 % 8) ECG : No abnormal findings. 9) EF : \>=50 %
6. Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
7. Given written informed consent.
8. Patients who can be hospitalized from the day of first administration to the next day.
9. Patients who have target lesions measurable by RECIST ver.1.1.
10. Life expectancy \>= 3 months.

Exclusion Criteria:

1. Patients with HIV antibody positive.
2. Patients with HCV antibody positive.
3. Patients with autoimmune disease.
4. Patients with HBs antigen or HBV-DNA positive.
5. History of serious anaphylaxis induced by antibody preparation.
6. Patients with double cancer.
7. Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.
8. Pregnant or breast-feeding females and females who have a possibility of pregnancy.
9. Patients with active infection.
10. Patients with psychosis or dementia.
11. Patients who need continuous systemic administration of adrenocorticosteroid.
12. Patients who have received hematopoietic stem cell transplantation.
13. Patients who have presence or suspicion of CNS involvement.
14. Patients who are administered the other investigational product within 4 weeks of the entry.
15. Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.
16. Any other inadequacy for this study.
Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

Several and complex mechanisms are involved in the regulation of appetite and food intake in humans. By means of rapid hypnosis techniques, it is possible to induce some individuals to hallucinate a meal.

The same meal (breakfast) is administered as i) a real meal and ii) is evoked as a hallucination under hypnosis in healthy postmenopausal women. The aim of this pilot randomized-controlled cross-over trial is to assess appetite sensation and the blood levels of the appetite-related hormones in the participants.

The regulation of appetite is crucial to control food intake and consequently body weight. Hypnosis has been successfully used to modulate gastrointestinal functions, by imagining eating food.

In the present pilot trial, the investigators search to investigate the effects a hallucinatory meal by hypnosis on subjective appetite and appetite hormone blood levels. Hence, two different breakfast meals are randomly administered to eight healthy postmenopausal women, in a crossover design, consisting of i) a hallucinatory breakfast meal (HB) and ii) a real breakfast meal (RB). On each test day, participants undergo baseline measurements, including appetite sensation and blood sample, then the test meal is hallucinated or served. Subjective appetite is assessed each 30 minutes for 4 hours and half, while blood samples are taken at 20', 60', 90' and 180 minutes. At the end of each session, participants are instructed to fill in a food record for the following 3-days.

Eligibility Criteria:
Inclusion Criteria:

* female gender,
* ability to develop a visual hallucination during hypnosis,
* body mass index (BMI) range 20-27 kg/m2,
* menopausal status

Exclusion Criteria:

* smoking,
* breakfast skipping,
* current intake of any supplements,
* current use of any drug,
* presence of any pathological conditions, including mental and eating disorders,
* any alimentary restrictions or specific diets,
* allergies or food intolerances or dislikes of the offered breakfast-meal,
* being a shift or night workers,
* unable to give a written informed consent
Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.

This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。

This study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years old; 2. A preliminary diagnosis of pulmonary结节 or lung tumor by chest CT; 3. Planning to undergo thoracoscopic lung resection surgery; 4. Voluntary participation of patients.

Exclusion Criteria:

1. Patients with severe condition who cannot tolerate pre-rehabilitation training; 2. Patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. Patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.
SCS Research Study

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. 22 years of age or older
2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures, including diary completion, and visits
6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

1. Implanted with neurostimulation system for an off-label indication
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
4. Has untreated major psychiatric comorbidity
5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software

The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.

Object: The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.

Method: The BWLP program utilized Webex video conferencing software to deliver a 12-week, interactive, small group, weekly weight loss intervention. Participants were randomized to a standard BWLP or a standard behavioral weight loss program augmented with self-compassion skills training (BWLP+SC).

Eligibility Criteria:
Inclusion Criteria:

* 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups

Exclusion Criteria:

-
The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.

\* The 3 assessments are

1. passive upright tilt table testing,
2. quantitative sudomotor axon reflex testing (QSART)and
3. punch biopsy.

The comparison of results will be from two subject groups:

* Group A, the migraine suffering patient with or without aura
* Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65
* male or female
* migraine diagnosis
* may or may not have orthostatic intolerance
* able to demonstrate study understanding and complete informed consent process

Exclusion Criteria:

* subjects who do not meet inclusion criteria
* subjects unable to complete informed consent process
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing.

Participants will be asked to do

* A gynecological examination at one month after birth and 9-12 months after birth.
* Have a picture taken of the healing process
* Answer a questionnaire at one month, three months, and 9-12 months after birth

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence.

The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management.

All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.

Eligibility Criteria:
Inclusion Criteria:

* Women with a vaginal delivery who have had a primary repair of a second-degree perineal tear or episiotomy
* At least 18 years old
* Able to understand, read and speak Danish or English
* Able to give informed consent

Exclusion Criteria:

* None, first, third- and fourth-degree tear
* Cesarean Section
Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

* Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in sputum pellets.
* Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™
* Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert MTB/RIF tests

Eligibility Criteria:
Inclusion Criteria:

* • Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB);

  * Age 18 years or above;
  * Willingness to have a study follow-up visit, if necessary, approximately two months after enrollment
  * Willingness to provide 3 sputum specimens at enrollment
  * Provision of informed consent.

Exclusion Criteria:

* • Receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment (defined as combination anti-TB therapy intended to treat active TB) within 60 days prior to completion of sputum collection;

  * Inability to provide informed consent (e.g. mentally impaired)
  * Enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a second and third sputum sample of ≥ 1ml each will be classified as early exclusions.
ValidationTurkishVersionQualityofRecovery-15

The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.

The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean.

Eligibility Criteria:
Inclusion Criteria:

* being over age of 18 and had a planned elective major gastrointestinal surgery

Exclusion Criteria:

* under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery
Validity and Reliability of The Turkish Version of Breathlessness Beliefs Questionnaire

In our study, we aimed to evaluate the validity and reliability of the Turkish version of the Breathlessness Beliefs Questionnaire-BBQ in our study.

Pulmonary diseases are a common cause of mortality and morbidity throughout the world. In pulmonary diseases such as asthma and COPD, the main symptom is dyspnea and it causes activity limitation. Dyspnea is defined as the difficulty that a person experiences during breathing. As a result of painful situations or injuries, avoidance of physical activity or movement due to the fear of repetition of the problem are defined as kinesophobia. Pulmonary patients are compensated by reducing the rate of activity, while avoiding dyspnea.This reduces the severity of the symptom that precedes the symptom that may occur. As a result, dyspnea causes kinesyphobia. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, quality of life is reduced. The Breathlessness Beliefs Questionnaire (BBQ) was developed based on the Tampa Kinesiophobia Scale to assess dyspnea and dyspnoea-related kinesophobia and anxiety in respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC\<%70
* To be able to read and understand Turkish

Exclusion Criteria:

* Having undergone a COPD exacerbation in the last 6 weeks
* Having comorbidities affecting ambulance
* Having cognitive disorders
SEP and the Impact of Portion Size on Daily Energy Intake

Reducing food portion size is a potential strategy to reduce energy intake. There is some evidence to suggest that individuals with lower socioeconomic position (SEP) intend to eat more from larger portions, suggesting that the effect of portion size on food intake might vary by SEP. However, no study has tested this by measuring actual food intake. This study examines whether reductions to the portion size of components of a main meal will reduce daily energy intake, and whether and how socioeconomic position (higher vs lower) moderates the portion size effect.

In a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main meal components at lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). All other foods offered are identical. Food intake from the portion-manipulated lunch and dinner, as well as all other meal components (breakfast, dessert, seconds, snacks) will be measured, and any additional food consumed by the participant will be measured using self-report, giving total daily energy intake (kcal).

See attached protocol document.

Eligibility Criteria:
Inclusion Criteria:

* Female
* UK (United Kingdom) residents, aged 18 or over
* Fluent in English
* willing to consume the test foods
* Self report liking of test foods
* BMI between 22.5 - 32.5kg2

Exclusion Criteria:

* taking medication which affects appetite
* currently pregnant
* history of eating disorders
* currently on a diet to lose weight
* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* participated in 2018 Mood Study
* currently participating in another study where meals are provided
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

1. reduce fasting glucose levels
2. reduce androgen hormone levels
3. improve sex steroid binding, and
4. improve lipids (fatty substances in the blood)

Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.

Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Eligibility Criteria:
Inclusion Criteria:

* Menstrual irregularity defined as cycle length \> 45 days
* Overweight as BMI \> 25
* Clinical evidence of hirsuitism or acne
* Testosterone \> 50ng/dL

Exclusion Criteria:

* History of diabetes mellitus
* History of Cushing's disease
* History of hyperprolactinemia
* Untreated hypo or hyperthyroidism
* History of adrenal hyperplasia
* Significant renal impairment
* Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
* Exercise \> 10 hours per week
Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures

Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate visualization of the mucosal surface. In fact, no laxative has all the characteristics of an ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose has a significant improvement in the quality of bowel preparation compared with PEG alone. The present study aim to assess the efficacy of lactulose with or without PEG in bowel preparation to improve mucosal visualization, reduced volume of fluid consumed, and preparation intolerance.

This study will conduct in 5 clinical central. 1000 participants who were scheduled for colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were patients with uncontrolled acute or recurrent chronic intestinal infections, with active gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with severity coronary heart disease or heart failure or renal failure and liver failure or severe electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to colonoscopy examination. Central stratification and block randomization is achieved via a computer-generated random-sequence table by using R software. The participants will be assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose combined with 2L PEG. The following parameters were then obtained: time of the first defecation, defecation frequency, the overall drink liquid volume, the taste of the preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and adverse reaction.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were scheduled for colonoscopy age between 18 and 80 years

Exclusion Criteria:

* uncontrolled acute or recurrent chronic intestinal infections
* active gastrointestinal bleeding, gastrointestinal stricture, intestinal obstruction
* severe electrolyte metabolism disorder, severe coronary heart disease, heart failure, renal failure or liver failure
* pregnant, lactating, have metal diseases or refuse to colonoscopy examination