cyrilzakka/clinical-trials huggingface dataset:
Effect of Preoperative Pregabalin on Propofol Induction Dose

The primary issue is to determine whether preoperatively administered pregabalin decreases the necessary dose of propofol during induction of general anesthesia. The investigators secondary issue is to test if preoperatively administered pregabalin decreases anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic gynaecologic surgery
* Age 18-40 years
* ASA class I or II
* Body mass index 18-30

Exclusion Criteria:

* Allergic to pregabalin or gabapentin
* Chronic renal failure
* Alcohol or drug abuse
* Chronic analgesic use other than acetaminophen or NSAID
* Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
* Known neurological deficiency
* Suspected difficult intubation or ventilation
* Atypical pseudocholinesterases
p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
* Disease Progression between 6-24 months after a first or second platinum based regimen
* At least a single measurable lesion. Phase II patients only
* Adequate organ function prior to registration
* Toxicities from previous cancer therapies must have recovered to grade 1 (defined by Common Terminology Criteria for Adverse Events \[CTCAE\] 4.0) Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
* ECOG performance status of 0 to 1

Exclusion Criteria:

* Prior exposure to cumulative doses of doxorubicin \>400 mg/m2 or epirubicin \>720 mg/m2
* History of allergic reactions to carboplatin, platinum containing compounds or mannitol and/or hypersensitivity to PLD or to any of the excipients
* Unable to undergo imaging by either CT scan or MRI
* Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
* Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
* Is taking concurrent (or within 4 week prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed
Cognitive Behavioral Therapy for Treatment of Pathological Gambling

This study will determine the effectiveness and cost-effectiveness of three different treatment strategies in reducing gambling behaviors.

The number of pathological gamblers in the United States is steadily growing, leading to significant financial, psychological, and public health consequences. However, studies examining the effectiveness of treatment interventions for pathological gamblers are limited. This study will compare the effectiveness of three different treatment strategies, including referral to Gambler's Anonymous (GA), a self-help manual, and cognitive behavioral therapy (CBT), in reducing gambling behaviors and other problems related to pathological gambling.

This study will last 8 weeks. Participants will be randomly assigned to one of three interventions. Group 1 participants will be referred to GA and 8 weeks of CBT, which focuses on teaching skills to help reduce gambling urges and develop alternative behaviors to gambling. Group 2 participants will be referred to GA and given an 8-week self-help manual. Group 3 participants will be referred to GA alone. Questionnaires will be used to assess participants' gambling behavior and any personal, legal, or health problems they may be experiencing. The questionnaires will be completed at study entry, study completion, and at 6- and 12-month follow-up visits.

Participants will be asked to identify at least one person who knows about their gambling problem and will have regular contact with them during the study and for at least 1 year This person will be interviewed at the beginning of the study, and at Months 2, 6 and 12. Researchers will ask contact persons about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00118391

http://clinicaltrials.gov/show/NCT00618462

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pathological gambling
* 3 or more gambling episodes within 60 days prior to study entry

Exclusion Criteria:

* Inability to read English at the 5th grade level
* Uncontrolled psychiatric condition
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.

Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.

Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.

Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the pancreas
* no prior chemo except adjuvant
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* peripheral neuropathy \</= Gr. 1

Exclusion Criteria:

* Pregnant/lactating females
* Uncontrolled heart disease, diabetes, psychiatric disorder
* Therapeutic doses of Warfarin
Systolic Hypertension in Europe Placebo-Controlled Trial

The Syst-Eur Trial is a concerted action of the European Community's Medical and Health Research Programme. The trial is carried out in consultation with the World Health Organization, the International Society of Hypertension, the European Society of Hypertension and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality. Secondary endpoints include cardiovascular events, such as myocardial infarction and congestive heart failure. To be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The patients are randomized to active treatment or placebo. Active treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos. The drugs (or matching placebos) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and mortality are monitored to enable an intention-to-treat and per-protocol comparison of the outcome in the 2 treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* At least 60 years old.
* Sitting systolic blood pressure on masked placebo, during run-in phase of 160 to 219 mmHg, with a sitting diastolic blood pressure below 95 mmHg and a standing systolic blood pressure of at least 140 mmHg
* Informed consent must be obtained

Exclusion Criteria:

* Systolic hypertension is secondary to a disorder that needed specific medical or surgical treatment.
* Retinal haemorrhage or papilloedema;
* Congestive heart failure
* Dissecting aortic aneurysm
* Serum creatinine concentration at presentation of 180µmol/L or more.
* History of severe nose bleeds.
* Stroke or myocardial infarction in the year before the study.
* Dementia.
* Substance abuse.
* Any disorder prohibiting a sitting or standing position.
* Any severe concomitant cardiovascular or non-cardiovascular disease.
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.


Eligibility Criteria:
Inclusion Criteria:

* define histologic or cytologic diagnosis of non small cell lung cancer.
* determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
* define performance status of 0-1 on ECOG scale
* do not have any prior tumor therapy
* to be suitable for curative resection

Exclusion Criteria:

* to have any treatment within the last 30 days with any investigational drug.
* to get concurrent administration of any other tumor therapy
* to be pregnant
* to have poorly controlled diabetes mellitus
* to have serious concomitant disorders.
IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker

Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.

Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.

In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.

It is a multicenter descriptive study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (sex ratio = 1)
* Aged from 18 to 35 years
* Fasting glycemia \< 6mmol/L
* Total cholesterol \< 7mmol/L
* Triglycerides \< 1.5 mmol/L
* CRPus \< 5 mg/L
* Creatinine clearance \< 80mL/min according to Cockroft formula
* Liver enzymes (ALanine AminoTransférase and ASpartate AminoTransférase) \< 1.5 times normal values

Exclusion Criteria:

* Subject not in compliance with the recommendations of French National Law in force
* Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
* Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
* Blood pressure \> 140/90mmHg
* Tea and coffee consumption more than 5 cups per day
* Subject who smoke more than 5 cigarettes per day
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic renal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic nephrectomy
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Neuropathic Pain and Fabry Disease

Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids in the vascular endothelial cells and many other tissues. An early sign of the disease is painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the X-linked inheritance, male patients are severely affected. Recently attention has been drawn to female patients whether they also show signs of nerve involvement.

The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients. Correlation with X-chromosome inactivation will be attempted. Recombinant human α-galactosidase A is now available for patients. A part of this study is evaluation the long term efficacy of enzyme replacement therapy in female patients with Fabry disease and neuropathy.

Male family members with Fabry disease will be examined.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with confirmed Fabry disease

Exclusion Criteria:

* Patients who cannot cooperate
* Patients who are unable to understand the purpose
Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis.

The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL).

The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Gender/Age: Males or females above 18 years old
* Diagnosis: Cutaneous Dermatomyositis
* Subjects able to give informed consent

Exclusion Criteria:

* Subjects without cutaneous DM
* Penn employees
* Penn students
* Cognitively impaired persons
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome.

The purpose of this study is to :

1. Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
2. Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care

1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks.

2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.


Eligibility Criteria:
Inclusion Criteria:

* All preterm infants with respiratory distress syndrome.

Exclusion Criteria:

* Preterm admitted to NICU for other reasons rather than respiratory distress
* Major congenital anomalies
* spontaneous intestinal perforation
* Endocrinal Dysfunctions
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
* Male or female, age ≥18 years at the screening visit
* Confirmed diagnosis of PBC in line with the AASLD guidelines
* UDCA and anti-pruritic medication use will be allowed if meeting additional criteria
* Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion Criteria:

* Pruritus associated with an etiology other than PBC
* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
* Current symptomatic cholelithiasis or inflammatory gallbladder disease
* History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
* Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
* History of Liver transplantation
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient prescribed the ASSURE wearable cardioverter defibrillator
* Provided written informed consent to participate in the ASSURE Patient Registry

Exclusion Criteria:

* Patients who do not meet the Inclusion criteria
Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This study will measure and compare effects and experiences of two types of birthing rooms.

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This RCT project measures and compares effects and experiences of two types of birthing rooms at one Labour ward in Sweden. A qualitative ethnografic studu will assess how women interact with the birthing rooms and its physical objects.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* Robson 1 classified, i.e. nulliparous, single Pregnancy \>37 weeks, cephalic presentation, sponatanous Labour start
* speak, understand Swedish, English, arabic or somali or have an interpreter present
* Active phase of Labour: 2 of these 3 criteria fulfilled: sponatanous rupture of membranes, 2-3 painful contractions in 10 minutes; cervix dilated \>3-4 cm or effaced and open \>1cm

Exclusion Criteria:

* induced Labour
* planned caesarean section
* multiple gestation
* lack of informed written consent
* not Speaking Swedish, Egmnlish, Arabic or Somali
Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer

To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer

In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years, any gender.
* Pathologically confirmed rectal adenocarcinoma.
* Baseline MR stage T3-4/N+.
* Distance from anal verge ≤12cm.
* No distant metastasis.
* Karnofsky Performance Status ≥70.
* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
* Microsatellite/mismatch repair status MSS/pMMR.
* No prior chemotherapy or any other anti-tumor treatment before inclusion.
* No prior immunotherapy.
* Ability to comply with the study protocol during the study period.
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or lactating women.
* Pathological diagnosis of signet ring cell carcinoma.
* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
* Patients with autoimmune diseases.
* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
* Known deficiency of dihydropyrimidine dehydrogenase (DPD).
* Allergy to any investigational drug components.