cyrilzakka/clinical-trials huggingface dataset:
Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.

A total of 310 patients will be enrolled in about 50 Italian centers.

Patients with resected stage I-III pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.

A total of 310 patients will be enrolled in about 50 Italian centers. All the patients will be followed up during and after the treatment until disease progression and death or for a minimum of 60 months.

Main objective:

To show an increase in disease-free survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.

Secondary objectives:

To show an increase in overall survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.

To show the tolerability of the experimental treatment in this setting.

Principal inclusion criteria:

* histological diagnosis of pancreatic cancer
* surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)
* absence of evidence of metastases (cM0)
* age 18-75
* ECOG performance status 0-1
* adequate bone marrow, liver and renal function
* written informed consent

Principal exclusion criteria:

* evidence of metastases
* CA19.9 higher than 2.5 x ULN (upper limit of normal range)
* precedent chemotherapy or radiotherapy
* coexisting malignancies
* relevant coexisting diseases that could contraindicate the participation to the study
* hypersensitivity/intolerance to the drugs in study
* pregnancy or breastfeeding
* neurotoxicity of grade \> 1
* malabsorption syndrome

Primary end-point:

Disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death.

Secondary end-points:

Overall survival, defined as the time from enrollment to the evidence of death. Toxicity, defined according to NCI-CTC

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of pancreatic cancer
* surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)
* absence of evidence of metastases (cM0)
* age 18-75
* ECOG performance status 0-1
* adequate bone marrow, liver and renal function
* written informed consent

Exclusion Criteria:

* evidence of metastases
* CA19.9 higher than 2.5 x ULN (upper limit of normal range)
* precedent chemotherapy or radiotherapy
* coexisting malignancies
* relevant coexisting diseases that could contraindicate the participation to the study
* hypersensitivity/intolerance to the drugs in study
* pregnancy or breastfeeding
* neurotoxicity of grade \> 1
* malabsorption syndrome
Validation of Questionnaires HAL and HEP

Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia

Validation of the Spanish hemophilia specific questionnaires: HAL and HEP (adult version version version children and parents). To do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A and B
* Parents of children with hemophilia A and B, under 18
* Patients who have previously signed the informed consent document

Exclusion Criteria:

* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
* Patients with cognitive impairment, or oral or written understanding
A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)

The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo.

This is a randomized, placebo-controlled, 4-period study. Eligible patients will undergo a single-blind phase in Period 1, followed by 3 periods during which they will receive low-dose MK-8351, high-dose MK-8351, or matching placebo as a single dose in a random sequence crossover study design.

Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);
* Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;
* Body Mass Index (BMI) \>=17 kg/m\^2 and \<=33 kg/m\^2
* Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;
* History of allergen-induced asthma for at least 6 months prior to enrollment;
* Able to perform reproducible pulmonary function testing;
* Positive methacholine challenge test prior to receiving study medication;
* Allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract;
* Ability to tolerate sputum induction and to produce adequate sputum.

Exclusion Criteria:

* History of clinically significant disease or disorder;
* History of malignancy;
* History of significant multiple and/or severe allergies;
* History of milk or lactose allergies or intolerance;
* History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies;
* History of major surgery within 3 months prior to enrollment;
* Participation in another investigational trial within 4 weeks of screening;
* Lactating females;
* Inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period;
* History of receiving anti-immunoglobulin E (IgE) or immunotherapy;
* History of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication;
* History of hospitalization for asthma-related illness within 3 months of screening;
* History of emergent care more than twice in the last 12 months for asthma-related illness;
* History of life-threatening asthma;
* Consumes \>4 glasses of alcoholic beverage per day;
* Consumes \>6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day;
* History or or current use of illicit drugs within past 24 months.
Aripiprazole Oral Acceptability Trial

The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Stable patients currently receiving aripiprazole or other antipsychotic medications.
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception

Exclusion Criteria:

* •

  * Breast feeding
  * Significant liver and kidney function abnormalities
  * Diabetic patients
  * Colorectal cancer patients
  * Patients with severe UC
  * Patients taking rectal or systemic steroids
  * Patients taking immunosuppressives or biological therapies
  * Addiction to alcohol and / or drugs
  * Known allergy to the studied medications
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:

  * hypertension
  * dyslipidemia
  * obstructive sleep apnea, or
  * cardiovascular disease
* History of of at least one unsuccessful dietary effort to reduce body weight

GOA1 Inclusion Criteria:

* Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month
* Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

GSA1 Inclusion Criteria:

* Previously diagnosed with OSA
* Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
* For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
* If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

GZBJ Addenda (2) inclusion criteria:

* Have completed the final treatment visit of GZBJ Week 80.

Exclusion Criteria:

* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have diabetes mellitus.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis.

GOA1 exclusion criteria

* Have had steroid joint injections within 90 days of screening.
* Have had other joint injections and procedures within 6 months of screening.
* Have joint disease other than osteoarthritis.

GSA1 exclusion criteria

* Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
* Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
* Use a dental appliance or other device to treat OSA other than PAP therapy.

GZBJ Addenda (2) exclusion criteria

* Have had study intervention discontinuation.
* Have had permanent dose reduction.
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique

Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease with new arteriovenous fistula being started for cannulation

Exclusion Criteria:

* End-stage renal disease with grafts
Hypomagnesemia Associated With Proton-Pump Inhibitor Use

Use of proton pump inhibitors has been associated with hypomagnesemia. However, various case-control or prospective studies have found conflicting results with regards to proton pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading to development of hypomagnesemia amongst users of proton pump inhibitors


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with hypomagnesemia (cases)
* Patients prescribed with proton pump inhibitors (controls)

Exclusion Criteria:

* Patients prescribed with less than three months duration of proton pump inhibitors (controls)
Management of Women With Superficial Dyspareunia

Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.

They affect between 3 to 18% of women and are a source of physical and psychological suffering.

Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.

The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.

The main objective is to describe the management of superficial dyspareunia by health professionals.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Superficial dyspareunia, i.e.:

  * Having already had several painful vaginal penetrative sex
  * Having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys)
  * Having persistent and/or recurrent pain (appearing in a manner regular)
* Agreeing to participate in the study

Exclusion Criteria:

* Minors
* Protected by law (guardianship, curatorship, safeguarding of justice)
* Refusing to participate in the study
Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.

OBJECTIVES:

Primary

* Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects.

Secondary

* Study the correlations between the pharmacogenetic and pharmacokinetic parameters.
* Study the predictive value of these parameters on disease-free and overall survival.

OUTLINE: This is a multicenter study.

Patients receive 1 of 4 chemotherapy regimens:

* Regimen 1: Fluorouracil and leucovorin calcium
* Regimen 2: Capecitabine and leucovorin calcium
* Regimen 3: Irinotecan hydrochloride
* Regimen 4: Oxaliplatin Tumor and blood samples are collected before the start of chemotherapy and are examined by pharmacogenetic analysis. Clinical and biological parameters are also studied. Blood samples are also collected during the first course of chemotherapy for pharmacokinetic studies.

After completion of study therapy, patients are followed periodically for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic colorectal cancer

  * Unresectable metastatic disease must be confirmed histologically if \> 2 years since primary diagnosis
* Measurable metastatic disease \> 1 cm by spiral CT scan or \> 2 cm by other methods
* Scheduled to receive first-line chemotherapy for metastatic disease

  * Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin
* No inadequate or unusable tissue as the only tissue available
* No known brain metastases or meningeal disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* No contraindication to chemotherapy
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other severe pathology that is likely to worsen during therapy
* No dementia or severely impaired mental condition
* No geographical or psychological reasons that would preclude treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior therapy for metastatic cancer
* Prior adjuvant chemotherapy allowed
* Concurrent bevacizumab or other monoclonal antibody therapy allowed
Intrinsic Foot Muscle Training With and Without Hip Abductor Muscle Strengthening in Pronation Distortion Syndrome

Pronation distortion syndrome is one of the most common abnormalities in the lower extremity that causes alterations in the structures of the skeletal parts of the foot. The aim of the study will be to compare the effects of intrinsic foot muscle with and without hip abductor muscle strengthening on pain and functional mobility in patients with Pronation Distortion Syndrome.

A Randomized Clinical Trial will be conducted at Nawaz Sharif Social Security Hospital, Multan Road, Lahore through convenience sampling technique on 54 patients which will be allocated using simple random sampling through computer generated method into Group A and Group B. Group A will be treated with intrinsic foot muscle training at the frequency of 4 sets with 15 repetitions and Group B will be treated with hip abductor muscle strengthening at the frequency of 3 sets with 15 repetitions; session would be conducted thrice a week. Outcome measures will be conducted through numeric pain scale and lower extremity functional scale after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Kolmogorov-Smirnov test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Ages 20-30 years
* Both male and female gender
* Foot pronation on observation
* Navicular Drop Test more than 10 mm (measured in weight bearing and non- weight bearing positions distance between ground and navicular tuberosity and difference calculated)
* Increased Q angle : Males: \> 16; females \>18

Exclusion Criteria:

* Other deformities such as tarsal coalition and vertical talus
* Any history of surgery involving both lower extremities
* Neuromuscular disorder
Sit-to-stand Test in Cystic Fibrosis Children and Adolescents

Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis
* Exacerbation-free last month before inclusion

Exclusion Criteria:

* Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
* Other respiratory disease (kyphoscoliosis, asthma ...)
* Exacerbation
* Unability to carry out field tests
No Routine CXR After Bronchoscopy

Most pulmonologist request a routine chest-x-ray after bronchoscopy with transbronchial biopasie to exclude pneumothorax. We published a study in CHEST showing that routine chest-ray might not be necessary. We would like to conduct a propsective study to validate the results of the CHEST-study. Before and after the procedure follwing information will be collected: Age, Sex, Indication for procedure, number of biopsies and segment of biopsie, Saturation, Physical examination, Symptoms suggestive of pneumothorax. If there is no aggravation of the symptoms and/or physical examination after the procedure, as compared to before, routine chest-x-ray will NOT be done. A phone will be made 24 to 48 hours following the procedure to the patient.


Eligibility Criteria:
Inclusion Criteria:

* All patients with bronchoscopy and transbronchial biopsie

Exclusion Criteria:

* No informed consent given
Positive Adjustment Coping Intervention

Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.

About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in Germany, which is experienced as "roller coaster of emotions". The positive effect of "face-to-face" counseling for couples with a desire for children has been proven. However, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling.

In this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design.

For this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention. In the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.In addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques.

Sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported.

No adverse effects or other risks are expected for the study participants.

Eligibility Criteria:
Inclusion Criteria:

All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have

* agreed to participate in the study
* indicated their mobile phone number
* sufficient knowledge of German language.

If one partner is refusing to participate, the other person may be admitted as an individual.

Exclusion Criteria:

* denial of participation
* non-existent smartphone
* insufficient knowledge of German language