cyrilzakka/clinical-trials huggingface dataset:
Incidence of Reflux Esophagitis After Pancreaticoduodenectomy

Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study, the investigators will investigate the incidence of reflux esophagitis after above procedure by the 24-h pH monitoring of esophagogastric junction.

Reflux esophagitis is a common complication following distal gastrectomy. Recently, an Roux-en--Y gastrointestinal reconstruction has been used increasingly to prevent reflux esophagitis; however, reflux esophagitis after pancreaticoduodenectomy (also including distal gastrectomy) has never been studied.

In our preliminary retrospective study of 371 patients having PD (158 standard PD and 213 pylorus-preserving PD) at our hospital, after a median follow-up of 20 months (range, 2-110 months), 40 patients (10.8%) developed reflux esophagitis - 15 (9.5%) in the standard PD group, and 25 (11.7%) in the PPPD group. Multivariate logistic regression analysis revealed the only significant factors related to reflux esophagitis is Roux-en-Y gastrointestinal reconstruction independent of preservation of the pylorus.

To our surprise, there is no significant difference in occurrence of GERD between patients after standard PD (15 of 158 patient) and PPPD (25 of 313 patients, P=0.49). We postulate reflux esophagitis following a PPPD in patients without past history of GERD is most likely caused by disruption of reflux-preventing systems at the gastroesophageal junction, thereby allowing reflux of gastric acid into esophagus. If the postulation is true, GERD after PPPD should be acidic in nature. To test this hypothesis we propose a prospective randomized study to compare preoperative and postoperative parameters, including esophageal morphology, bile acid concentration, trypsin activity of esophageal refluxate, COX2 mRNA expression of lower esophageal mucosa, and 24 hour pH monitor of lower esophagus.

Moreover, to test the effect of a Roux-en-Y reconstruction to prevent GERD after PD, studied patients will be randomized into Roux-en-Y and control groups to study inter-group differences in incidence of GERD and marginal ulcer after PD.

Acidic GERD should be treated with proton pump inhibitor. In contrast, alkaline GERD should be treated with pro-kinetic agent such as primperan and mopride. With this study, we can learn more about the nature of post-PD GERD following various gastrointestinal reconstructions and can give patient more personalized therapy.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years and planned PD for a lesion of either the pancreatic head or the periampullary region

Exclusion Criteria:

* history of abdominal or pelvic radiation
* hepatic dysfunction (Child-Pugh \> 2)
* renal dysfunction (serum creatinine concentration \> 3 mg/L, hemodialysis, or both)
* cardiac dysfunction (New York Heart Association functional class \> III, stroke history)
* pregnancy
* history of intestinal anastomosis of the large bowel without a diverting stoma
Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward

Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.


Eligibility Criteria:
Inclusion Criteria:

* Older (65+ years) persons admitted to a gerontopsychiatric ward

Exclusion Criteria:

* Patients not understanding Dutch or not willing to participate (no informed consent)
Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

This study aims to understand if certain cognitive biases and heuristics are present in patients with knee osteoarthritis being treated with open label placebo (saline injections in the knee). A predefined survey will investigate the affect heuristic and group interviews patients who have responded well or not so well respectively will be used to examine if other cognitive biases or heuristics are present.

Cognitive biases are systematic patterns of deviation from norm or rationality in judgment, while heuristics are tactics, or mental shortcuts to aid in the decision-making process.

Cognitive biases (systematic patterns of deviation from norm or rationality in judgment) and heuristics (tactics, or mental shortcuts to aid in the decision-making process) are increasingly being used in healthcare to facilitate good health decisions, improved care, and in designing new interventions.It has also been shown that cognitive biases influence how patients rate their own health.

Less is known about which specific cognitive biases and/or heuristics that are in play when patients with knee osteoarthritis form their treatment expectations and evaluate their health following an intervention.

This study aims to understand if certain cognitive biases and heuristics are present in patients with knee (OA) being treated with open label intra-articular placebo injections.

Understanding which cognitive biases and/or heuristics that are in play when these patients evaluate their health outcome following open label placebo, allows future treatment context to be designed in a way that actively utilises these cognitive biases and/or heuristics to obtain a greater magnitude of response.

A global predefined questionnaire, evaluating the presence and strength of the affect heuristic, is sent to all participants from the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480). In addition investigators will invite responders and non-responders respectively from the same study to group interviews in order to produce a structured conceptualisation map; the group content mapping method.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)

Exclusion Criteria:

* Have not participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)
Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study

This study will assess the occurrence of multiple symptoms in cancer patients of 5 German university hospitals. Primary goal of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).

Oncology patients experience a variety of symptoms as a result of disease and/or treatment. They often report co-occurrence of symptoms and functional impairments (Miaskowski 2007). To evaluate the prevalence of symptoms and identify symptom clusters and the influence of multiple symptoms on HRQoL, in and out patients of 5 German university hospitals currently undergoing cancer treatment are recruited. These patients are asked to complete the following instruments: Distress thermometer, health related quality of life questionnaire (EORTC QLQ C30) and MD. Anderson Symptom Inventory (MDASI (German version). In a subgroup of two participating hospitals patients, that score ≥ 3/10 (MDASI-subscales for pain, fatigue and/or sleep disorder) are asked to complete additional questionnaires: Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Quality Index (PSQI). The information gained will not be accessible for doctors in charge of the treatment and therefore not influence or alter the participants' treatment regimes.

Primary endpoint of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder). Secondary endpoints are: symptom burden (intensity of symptoms and functional impairments), impact of symptom burden on HRQoL.

The investigators aim to approve the value of standardized assessment of symptoms in clinical cancer care settings as an important precondition of early treatment and supportive care.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients (ICD 10)
* 18 to 80 years of age
* ongoing treatment
* informed consent

Exclusion Criteria:

* not speaking and writing German
The HF-HRV Registry

The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving their first CRT-D
* Patients who sign and date a Patient Informed Consent prior to device implant
* Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled

Exclusion Criteria:

* Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
* Patients who are younger than 18 years of age
* Patients whose life expectancy is less than six-months due to other medical conditions
* Patients with or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
* Women who are pregnant
Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases

A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged above 18 years with histologically or cytologically confirmed NSCLC and contrast-enhanced CT scan or Gadolinium-enhanced MRI confirmed brain metastases who have a performance status of 0 to 2
* No previous radiotherapy, surgery or chemotherapy for brain metastases
* Patients should not have any unstable systemic disease

Exclusion Criteria:

* Serious abnormal laboratory values
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \>2 within 3 months before entry; or presence of cardiac disease that, in the
* Previous randomization of treatment in the present study and/ or current participation in another clinical study
Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery

This study evaluates the effect of a training intervention after thoracoabdominal resection of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery were randomized to an intervention group while the other half a control group.

It is well known that thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications. Earlier trials have shown that respiratory restrictions persist after the operation as well as lower physical function, range of motion in the rib-cage and limitations in activities in daily living. There are, however, only two clinical studies that evaluate postoperative breathing exercises and none evaluating any other rehabilitation interventions.

In other types of extensive surgery that may affect mobility with trauma to muscles and bone structures in the thorax and thoracic spinal column, there is strong evidence that speaks for an active rehabilitation approach in favour of a less active one.

The intervention evaluated was a rehabilitation program including exercises to restore lung function, range of motion in the thoracic spine and shoulders and strength exercises for the back extensors, shoulders and legs.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracoabdominal oesophageal resection
* Ability to perform 90 W during a sub-maximal bicycle test
* Ability to speak Swedish

Exclusion Criteria:

* Serious untreated cardiac disease that may be critical
* Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
The Impact of Past Coronavirus Disease 19 (COVID-19) Infection on the Live Birth Rates of Frozen Embryo Transfer Cycles

This is a prospective observational study. In this study, we aim to investigate the effect of a recent past Covid-19 infection on the live birth rate in the frozen embryo transfer cycles


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization
2. Women have embryos frozen prior to COVID infection.

Exclusion Criteria:

1. Previous COVID infection before oocyte retrieval
2. Recipient of oocyte donation
3. Undergoing preimplantation genetic testing
4. Presence of hydrosalpinx or endometrial polyp which is not surgically treated
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years to 65 years of age
* A diagnosis of an episodic tension-type headache, as defined by the International Headache Society
* A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

Exclusion Criteria:

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)


Eligibility Criteria:
Inclusion Criteria:

1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.
2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2.
4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.

Exclusion Criteria:

1. Nodular lymphocyte predominant Hodgkin lymphoma.
2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
3. Sensory or motor peripheral neuropathy.
4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
5. Known human immunodeficiency virus (HIV) positive.
6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Chemotherapy - Induced Peripheral Neuropathy

The purpose of this study was to examine the efficacy of cryotherapy with frozen gloves for the prevention of the chemotherapy-induced peripheral neuropathy (CIPN) of the hand.

Frozen glove was provided for dominant hand of breast cancer patients while receiving paclitaxel treat, and as the experimental group. In addition, another hand as a control group. The questionnaire was used before chemotherapy and at the fourth, eighth, twelfth, and sixteenth weeks to understand the effectiveness of frozen gloves.

In this study, the cryotherapy interventions were based on previous studies, with the dominant hand wearing the frozen glove set as the experimental group, and the non-dominant hand that was not wearing a frozen glove as the control group. The Elasto-Gel flexible frozen glove (Southwest Technologies, North Kansas City, MO, USA) used in this study lasted for 20 to 40 minutes and was easy to clean.The cold temperature of the refrigerator was measured in advance to be -20.2°C to -22.8°C. The freezing of the gloves lasted for at least three hours, and the gloves were tested with an infrared temperature-measuring instrument before use.

Its temperature range was -24.3°C to -24.7°C. The patient began to wear gloves 15 minutes before the administration of paclitaxel for one hour, and replaced them with new frozen gloves at the 45th minute. The patient continued to wear the gloves until 15 minutes after the end of the chemotherapy drug administration, for a total of 90 minutes. These intervention procedures were used for each treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer diagnosis confirmed by a physician and receiving paclitaxel for the first time.
* Above 20 years of age.

Exclusion Criteria:

* Patients with neurological disease histories.
* Patients with histories of the hand-foot syndrome.
* Patients with distant cancer metastases or skin metastases.
* Patients with nail lesions or the absence of fingers.
* Patients with a low tolerance to cold, and edema.
Re-feeding Gastric Residuals in Preterm Infants

The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).

Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age between 23.0 and 28.6 weeks;
2. Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
3. Written informed consent from the parents

Exclusion Criteria:

1. Major congenital/chromosomal anomalies;
2. Moribund infant with low likelihood of survival, in the opinion of the clinical team
Study of SOM0226 in Familial Amyloid Polyneuropathy

Clinical proof of concept study to evaluate SOM0226 efficacy in TTR Amyloidosis.

This is an open label interventional Phase IIa proof of concept clinical trial designed in two phases separated by a washout period of 6 weeks (± 2 weeks) , to evaluate the TTR stabilization activity of SOM0226 in healthy volunteers (wild type), TTR-FAP patients and asymptomatic carriers.

* Phase A (24 hours): SOM0226 single dose
* Phase B (32 hours): SOM0226 multiple dose

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above at the time of consent
* Two cohorts defined by TTR variant (wild type: healthy volunteers; TTR mutant: asymptomatic carriers with documented mutation in TTR or diagnosed TTR-FAP patients (stage 1 or 2) not undergoing pharmacological treatment with Vyndaqel
* Body Mass Index (BMI) \> 17.5 kg/m2
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 2 month thereafter
* Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the study
* Evidence of history of clinically significant hepatic disease
* An ALT or AST measurement \> 2 times the ULN (Upper Limit of Normal)
* Scheduled elective surgery or other procedures requiring general anaesthesia during the study
* Donation of blood during the study or within the past 4 weeks
* Treatment (during the study or within the past 4 weeks) with a prescription or investigational drug for the treatment of TTR amyloidosis
* Treatment with NSAIDs (nonsteroidal antiinflammatory drug) during the study or within the past 4 weeks. The following NSAID are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethacin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam and sulindac
Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (greater than or equal to 18 years of age)
* Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
* Willing to undergo pre-operative endoscopy
* Consenting to the procedure

Exclusion Criteria:

* Contraindication to abdominal surgery
* Contraindication to general anesthesia or distal pancreatectomy
* Contraindication to upper endoscopy or ERCP
* Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
* Ongoing pancreatitis
* Pancreatic necrosis or abscess
* History of sphincter of Oddi dysfunction
* History of ERCP-induced pancreatitis