cyrilzakka/clinical-trials huggingface dataset:
Perioperative Rehabilitation in Operation for Lung Cancer

Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.

Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.

Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.

What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.

1. Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.

What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).

Will all participants receive the same treatment?

By draw it is decided which of the 4 groups the participants will attend to in the study:

* Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
* Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
* Group 3: Rehabilitation initiated as early as two weeks after surgery
* Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Performance status 0-2 (WHO)
* Living in the City of Copenhagen or surrounding Municipalities
* Ability to read and understand Danish
* Approval by primary surgeon

Exclusion Criteria:

* Presence of metastatic disease or surgical inoperability
* Diagnosis of Lung Cancer not verified by histological diagnosis
* Cardiac disease
A Quit Smoking Study Using Smartphones

The objective of this research is to determine whether smartphone games show promise for helping smokers increase their chances of quitting. The central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.


Eligibility Criteria:
Inclusion Criteria:

* being age 18 or older;
* being able to read and write English;
* being willing and able to learn how to use a smartphone if they have not used one before;
* smoking 10 or more cigarettes per day for the past 6 months;
* having an expired carbon monoxide rating of 6 ppm or greater;
* not having been diagnosed with or treated for schizophrenia, psychosis or bipolar disorder in the past 10 years;
* being willing to make a quit attempt in 2 weeks;
* agreeing to attend clinic visits, receive coaching calls, and complete brief smartphone assessments;
* planning to remain in the area for at least the next 2 months;
* using the following alternative tobacco products (a pipe, full sized cigars, snuff or chew) no more than two times a week over the past month;
* being willing to stop using electronic cigarettes (e-cigarettes) for the 6 weeks they are in the study;
* not currently taking bupropion, Wellbutrin, or Zyban;
* if currently using nicotine replacement therapy or Varenicline, agreeing to use only study medication for the duration of the study;
* being willing and able to use the nicotine patch;
* never having had a serious skin reaction or other allergic reaction to the nicotine patch;
* not pregnant, trying to conceive, or nursing;
* if a woman of childbearing potential, agreeing to use or having their partner use an acceptable method of birth control during a 2 month period (1 month of nicotine patch and 1 month after). (Acceptable methods of birth control include: abstinence, condoms, diaphragm, birth control pills or injectable contraceptive \[e.g., Depo-Provera\], an intrauterine device, hysterectomy, tubal ligation, sterilization, vasectomy, or being more than 2 years post-menopausal.)
* Participants need to report playing video games for no more than 60 minutes a day.
* Although participants can play console games, they need to be willing to not play any mobile games for 6 weeks during the study if they are asked to do so.
* Participants need to report being willing to stay in the study even if they are not at first successful in quitting smoking.
* They need to report that they have a way to get to the clinic.

Exclusion Criteria:

* They will be excluded if in the last 4 weeks they have been hospitalized for any of the following: a stroke, heart attack, congestive heart failure, or an abnormal electrocardiogram.
A Study of LY3361237 in Participants With Psoriasis

The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic plaque psoriasis for at least 6 months
* Be willing and able to undergo skin biopsies
* Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
* Female participants must agree to use birth control during the study

Exclusion Criteria:

* Have had certain types of infection within the last six months
* Have a clinically significant active infection, or recent acute active infection within the last 30 days
* Have other serious or unstable illnesses
* Have a history of organ or bone marrow transplant
* Have received any live vaccine within the last 4 weeks prior to screening
* Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
* Have received topical psoriasis treatment within 14 days prior to study day 1
* Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1
Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery

This study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

Forty children aged from 1-15 years undergoing correction for different congenital heart procedures with cardiopulmonary bypass \[CPB\] were included in this study. Simultaneous samples were taken from the central venous line, pulmonary artery, and from venous side of the heart lung machine. Samples were taken after 10 minutes on full CPB and at the end of surgery before end of CPB. Bland and Altman plots were used to study the agreement between venous saturations.

Eligibility Criteria:
Inclusion Criteria:

* Children in the age from 1-15 years undergoing correction for congenital heart defects with cardiopulmonary bypass

Exclusion Criteria:

* Any chest renal or hepatic problems
Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older at the time of signing informed consent
* Body mass index (BMI) equal to or above 30.0 kg/m\^2 or equal to or above 27.0 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
* History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes mellitus
* A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle


Eligibility Criteria:
Inclusion Criteria:

1. Patients with EOS aged 6-11 years, including idiopathic, syndromic, congenital and low tone neuromuscular diagnoses.
2. Standing x-ray: a single major curve ≤ 8 vertebral segments, 35 to 75 degrees Cobb angle
3. "Normal" or hypokyphotic sagittal contour (T5-T12 ≤ 50⁰ degrees)
4. Primary curve should be reduced to \< 35 degrees Cobb angle on lateral bending/traction/stretch x-ray- the residual rigid segment must be ≤ 35 degrees
5. Patients with ≤ 25 degrees trunk rotation based on Scoliometer measurement
6. Subject in good general health
7. Subject and both subject's guardians/legal representatives are willing to sign a written informed consent form

Exclusion Criteria:

1. EOS with more than one structural curve or a single curve involving more than 8 segments
2. High tone neuromuscular diagnoses
3. Primary curve cobb angle \> 75 degrees
4. Kyphosis \> 50 degrees
5. Previous scoliosis surgery
6. Neural axis abnormality observed by an MRI scan
7. Known allergy to titanium
8. Active systemic disease, such as AIDS, HIV, or active infection
9. Systemic disease that would affect the subject's welfare or overall outcome of the study.
10. Severely mentally compromised
Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears

The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.

This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Eligibility Criteria:
Inclusion Criteria:

* Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
* Failed of conservative treatment for more than 3 months
* Intraoperative arthroscopic confirmed that the tear was Ellman grade II

Exclusion Criteria:

* Previous surgical surgery on the shoulder
* Articular-side or intratendinous rotator cuff tears
* Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
* Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
* The presence of other diseases that affect shoulder function
* Contraindication to arthroscopic surgery or anesthesia
C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population

The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Women aged ≥ 18 years
* Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
* Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
* Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
* Patients are able to read and understand German, English, Turkish or Arabic

Exclusion Criteria:

* Known hypersensitivity to olaparib or any of the excipients of the drug
* Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
* Pregnancy or breast feeding
Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic

Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence.

Aims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR/MPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules.

Methods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.

For further information, please see the attached protocol.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian
* 18 years of age or older
* Literate, can give written or oral consent
* History of severe and/or prolonged trauma, and screen positive for CPTSD
* Reside in any other major city

Exclusion Criteria:

* Imminent risk of suicide, psychotic symptoms, and/or severe alcohol and/or drug abuse
* Have been in therapy before (i.e., completed more than 5-10 sessions of psychotherapy)
Postpartum Weight Loss and Sleep Amongst Obese Women

This study will be a randomized controlled trial involving obese women obtaining prenatal care at an obstetric care clinic. Study subjects will undergo prenatal care in a group setting or prenatal care with a behavioral intervention to improve sleep. Anthropometric measurements, blood draws, questionnaires and at home sleep studies will be completed at three specified times (two antepartum and one postpartum). Primary outcome will be a comparison of postpartum weight loss amongst the intervention and control groups.


Eligibility Criteria:
Inclusion Criteria:

* • Pregnant female patients

  * Currently receiving obstetrical care at the TGH Health Park Genesis Clinic
  * Between in the second trimester at entry into the study
  * Overweight or obese defined as a pre-pregnancy body mass index greater than or equal to 25.0 kg/msquared
  * Over 18 years of age
  * Able to speak and understand as well as give informed consent in English
  * Have access to internet services
  * Have reported nightly sleep duration of \<6.5 hours

Exclusion Criteria:

* • Under 18 years of age

  * Pre-existing type 1 or 2 diabetes mellitus
  * Pre-existing obstructive sleep apnea
  * Current use of sleep medication
  * Serious physical or mental illness or condition that would substantially interfere with participation in, or completion of, the entire intervention
A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole


Eligibility Criteria:
Inclusion Criteria:

* Those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an IRB approved consent before all screening tests
* Healthy Korean male and female volunteers aged 20 to 45
* Those with a body weight of 50 kg or more and less than 90 kg and a body mass index (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2
* CYP2C19 EM or PM

Exclusion Criteria:

* Subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction
* Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug
* Those with a history of substance abuse within the last 2 months
* Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (OTC) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator)
* Those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months
* Those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research
* Those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use)
* Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial
* Those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose
* Those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period
* Screening tests for urine pregnancy (β-hCG) positive or lactating women
* Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* A person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons