cyrilzakka/clinical-trials huggingface dataset:
Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy

Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains. The goal of the present study is to investigate if there is a difference between OA and LA in obese patients. In the present study, Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included. The study participants were assigned to two groups, after their approval: LA and OA. The investigators hypothesized that evaluating the Outcome and Quality of life of laparoscopic appendectomy for the obese patients would be a potential step for standardization of the laparoscopic approach for obese patients who are arranged for appendectomy.

Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains. The investigators' goal is to investigate if there is a difference between OA and LA in obese patients. Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included. The study participants were assigned to two groups, LA and OA. This study aimed to compare LA and OA regarding intraoperative complications, length of hospital stays, post-operative pain, and rate of postoperative complications. Meanwhile, using the SF-36 scoring questionnaire, the quality of life was compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-40 years, with BMI ≥ 30 kg/m2 and diagnosed as acute appendicitis according to Alvarado score i.e., history of right lower quadrant pain or peri-umbilical pain shifting to the right lower quadrant with nausea and/or vomiting, fever of more than 38ºC, right lower quadrant guarding, and tenderness on physical examination and/or leukocytosis above 10,000 cells per ml were included.

Exclusion Criteria:

* The investigators excluded patients with a bleeding tendency., previous lower abdominal surgery, abdominal tuberculosis, mass formation either clinically or by ultrasound, end-stage renal disease (ESRD) patients, and patients who refused to participate in the study
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria
2. PD Hoehn and Yahr stage 2-4
3. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
4. Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed
5. Stable dose of PD medications for at least 4 weeks prior to the study screening.

Exclusion criteria:

1. Atypical or secondary forms of parkinsonism
2. Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)
3. Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS
4. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26
5. Presence of depression defined as the Beck Depression Inventory (BDI) score \>14
6. Untreated hallucinations or psychosis (drug-induced or spontaneous)
7. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed
8. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening
9. Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists
10. Shift work, currently or within the prior 3 months
11. Travel through ≥ 2 time zones within 60 days prior to study screening
12. Hematocrit \<32 mm3
13. Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)
14. Dense cataracts
15. Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)
16. Unstable/serious medical illness.
17. Pregnancy
Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment.

Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.

In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar Disorder according to SCAN interview
* ≥18 years of age
* Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark

Exclusion Criteria:

* Pregnancy
* Lack of Danish language skills
* Patients who previously have received and used the MONARCA I system for self-monitoring
"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects

Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.

Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides

Secondary Study Objective(s):

* Safety (related drug AEs/SAEs and laboratory anomalies G3/4) through 48 w.
* Resistance profile on patients with sustained virological failure
* QOL comparing stopping nucleosides versus continuing therapy
* Pharmaco-economic analysis comparing treatment cost between the 2 study arms.
* Predicting factors of failure in the stopping nucleosides arm

Subject Population: 200 patients

Study Design:

RANDOMIZATION:

Patients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows:

* Stopping nucleosides arm: Lopinavir/r alone.
* Continuing arm: Lopinavir/r + 2 NRTIs

STUDY PROCEDURES: A baseline HIV-RNA, CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. Patients will be followed for HIV-RNA (and CD4) at w1, w4, w8, w16, w24, w 36 and w48. After w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). Routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and HDL/LDL ratio) will be measured at w4, w16, w24, w 36 and w48. A central laboratory will be used for HIV-RNA determinations and to archive plasma/cell samples for further genotype test in case of rebound.

Treatment adherence will be followed with a self-patient report questionnaire (GEEMA study)

All AEs will be collected if suspected relation (possible or probable) to any concomitant ARV drug, and SAEs, related or not, reported within 24h.

Eligibility Criteria:
Inclusion Criteria:

* HIV patients \> 18 years old who provide signed and dated Informed consent.
* HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.
* Plasma HIV RNA \< 50 cop/ml for six months

Exclusion Criteria:

* HIV patients who have stopped a protease inhibitor due to virological failure.
* HIV patients with hepatic or renal insufficiency.
* HIV patients with positive serum HBVAg
* HIV patients who require treatment with a lopinavir/r contraindicated medication.
* HIV pregnant or breastfeeding women.
* Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).


Eligibility Criteria:
Inclusion Criteria:

* \>=18 to 75 years of age, of either gender, and of any race.
* Psoriasis covering at least 10% of total body surface area (BSA) and PASI \>=12 at Screening and Baseline.
* Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
* Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
* Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
* Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
* Screening and Baseline tests (complete blood count \[CBC\], blood chemistry, and urinalysis) must be within protocol-specified parameters.
* Free of significant disease that could interfere with study evaluations.
* Willing to give written informed consent and able to adhere to protocol visits and procedures.
* Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

Exclusion Criteria:

* Standard concomitant psoriasis therapies.
* Active or latent TB.
* History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.
* History of lymphoproliferative disease.
* Malignancy in past 5 years (except treated basal cell carcinoma \[BCC\]).
* Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
* Current drug-induced psoriasis.
* Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
* Previously treated with infliximab.
* Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
* History of chronic or recurrent infectious disease.
* Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
* Have or have had an opportunistic infection within 6 months prior to Screening.
Effects of VR and White Noise During Arthroscopy (VR/WN_ ART)

Background: Today, arthroscopy is widely used in the diagnosis and of treatment intra-articular diseases. Arthroscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure especially spinal anesthesia. Along with physical discomfort during the procedure, it triggers, fear and anxiety in the patient.

Purpose: To examine the effects of virtual rain forest and white noise on patient satisfaction, pain, comfort and vital signs in patients of arthroscopic knee surgery.

Method: The population of the study consisted of all patients who applied to the Dicle University Hospital Orthopedics and Traumatology unit and were scheduled for arthroscopy in the operating room. Based on the sample size of Basak and Sahin's study using similar VR applications, 31 patients were determined for each group total 93 patients with 5% significance level and 80% power(13). G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 31 rain forest video VR group, 31 white noise group and 31 control group. Data will be collected in the in the operating room on weekdays when the procedure is performed.


Eligibility Criteria:
Inclusion Criteria:

18 aged and over, Written and verbal consent to participate in the study, Being conscious (person, place and time orientation), Undergoing colonoscopy for the first time Spinal anesthesia applied, Meniscus surgery will be performed patients.

Exclusion Criteria:

Having vision, hearing and communication problems, Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.), Diagnosed with visual, auditory and / or balance disorders, General anesthesia applied patients.
Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant

As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous patient requiring the placement of one (or more) dental implant (s) in the maxilla or mandibular
* Age ≥ 18 years old
* Good general health (ASA score between \[1-2\])
* Sufficient volume and bone quality (with or without bone graft) to support the implant
* Non-objection of the patient for the collection of his medical data as part of the study

Exclusion Criteria:

* Poor oral hygiene
* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
* Infections and oral inflammation such as active periodontitis, active gingivitis
* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
* Heavy smoker (\> 10 cigarettes / day)
* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
* Patient on prolonged steroid therapy
* Titanium / titanium alloy allergy
* Alcohol or drug abuse
* Pregnant woman (or likely to be pregnant); or breastfeeding
* Difficulty of medical follow-up patients with geographical, social or psychological constraints
* Persons deprived of liberty or guardianship
* Involuntary / patient refusal to participate in the study
Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence

This is a randomized controlled trial comparing two methods of exercise for the treatment of stress incontinence ( loss of urine after physical exertion) in women. We are comparing the Paula method of circular muscle exercise, in which circular muscles controlling sphincters of the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness of circular muscle exercises is equivalent to pelvic floor training among women with this disorder.

Background: Urinary stress incontinence(SI) is defined as involuntary urinary loss which appears during increased intra-abdominal pressure which can be measured objectively. It is an important social and hygienic problem. Its prevalence varies fron 12-55% depending on age, and geography. The economic costs of this condition were estimated to reach 24 billion dollars in the US in 1995. The objectives of this study are to evaluate two non-invasive methods of treatment of stress incontinence.

Methods: 200 women who chosen from the community and suffering from SI will enter the study and will be randomized to one of two arms. The first arm is the Paula method of circular muscle exercises: these women will receive private lessons from a registered Paula instructor. The system is based on activating circular muscles in the body. The second arm will receive instruction in pelvic floor muscle training by a physiotherapist.

The clinical trial will compare the efficacy of the methods for the treatment of SI. The candidates for inclusion in the trial will undergo a gynecological exam and a "Pad Test". The efficacy will be measured in terms of changes in the Pad test (quantity of urinary leakage) and subjective reports of the participants on leakage, quality of life and sexual function.

Eligibility Criteria:
Inclusion Criteria:ambulatory women, aged 20-65, living in Jerusalem area, able to understand instruction in Hebrew or English, suffering from urinary stress incontinence with a positive Pad test of at least 1 gm -

Exclusion Criteria:pregnant,within 12 weeks of delivery,6 weeks since abortion,breastfeeding, illnesses which limit physical activity (cardiac, respiratory, psychiatric and neurological), Pad test \< 1gm,pelvic surgery within last 6 months, genital prolapse Grade 3 or higher, previous surgery for urinary incontinence, previous pelvic radiation therapy

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HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.


Eligibility Criteria:
Inclusion Criteria:

* Women and men who are ≥18 years old at signing of informed consent
* Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
* Provide written informed consent to participate in the study and for circulating tumor DNA screening
* Must be able to provide blood sample(s) for HER2 mutation testing
* Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer
* At least one measurable lesion, as defined by RECIST v1.1

Exclusion Criteria:

* Participants with breast cancer with known HER2-positive or HER2-amplified tumors
* Participants with breast cancer with HR-negative tumors
* Participants who have received HER2-directed TKI
* Participants with previously documented somatic KRAS activating mutation
Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used any anti-IL-17 biologic therapy
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).

This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.

The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.

Eligibility Criteria:
Inclusion Criteria:- Measurable disease by RECIST criteria

* Pathologic diagnosis of renal cell cancer
* Advanced (stage IV) renal cell cancer
* Karnofsky performance status of (KPS\>70)
* Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
* Pregnant women.
* Healthy volunteers.
* Patients participating in other research protocols will be excluded from this study.
* Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.