cyrilzakka/clinical-trials huggingface dataset:
Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer

Participating Surgeons

Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.

Patients Registration

It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.

Each group 128 patients, total 256 subjects will be enrolled.

Randomization

The registration randomization should be done with 1:1 ratio for each researcher.

Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.

Procedure

Operations are performed according to the allocated group.

Eligibility Criteria:
Inclusion Criteria:

Patients are included in the trial if they meet all of the following criteria:

* histologically proven primary gastric adenocarcinoma
* aged 20-80 years old
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
* clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
* location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
* written signed informed consent

Exclusion Criteria:

Patients are excluded if they meet any of the following criteria:

* pyloric deformity because peptic ulcer disease
* previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
* synchronous lesion of early gastric cancer or adenoma in antrum
* prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
* patients who need combined resection (eg. cholecystectomy)
* vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
* participated in another clinical trial within the last six months or currently involved patients
Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

This project aims to include 6 participants, and evaluate the effectiveness and safety of bilateral hippocampal subcortical stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Participants are between the ages of 14 -65 years of age
* Refractory to anti-seizure medications (ASMs).
* Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month.
* After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
* Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
* Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
* Informed consent signed.

Exclusion Criteria:

* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
* Psychogenic non-epileptic seizures within 12 months;
* Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
* Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
* IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
* Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
* Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
* Pregnant, or planning to pregnant within 2 years;
* Participation in another clinical study within 3 months;
* Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).

In this study, the investigators propose to develop a real-time adherence intervention based on SMS (i.e., text messages), wireless adherence monitoring (with the Wisepill device), and engagement of social support that is tailored to rural sub-Saharan Africa. The investigators will build on research by others who have shown SMS reminders improve adherence and viral suppression in Kenya, albeit with relatively small effect sizes and suboptimal virologic failure rates even in the intervention arm. Moreover, little is known about which patients benefit from SMS, why they benefit, and what can be done to further improve adherence and treatment success rates. Understanding the mechanisms of effect will make it possible to design and test evidence-based interventions with the highest likelihood for efficacy.

In a cohort of HIV-infected individuals starting ART and being monitored with Wisepill, the investigators will test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications of 48+hour gaps in adherence to members of social support networks. The investigators will conduct qualitative interviews to learn the experiences of participants and members of their social support networks with the different types of SMS. This staged approach will allow us to fully understand and compare the additive effects and acceptability of SMS-based interventions. The investigators will also determine behavioral effect mechanisms, as well as compare the impact of each type of SMS with a control population receiving only Wisepill monitoring on adherence and HIV RNA.

Eligibility Criteria:
Wisepill Participants:

Inclusion Criteria:

* HIV-infected
* Initiating ART within the next two weeks
* Age 18 years and older
* Owns a cell phone for personal use and has reliable cellular phone reception at home on a network supported by the technology used in this study
* Lives in the Mbarara District (i.e, within 20 km of the ISS Clinic)
* Has at least one person who could be named as a social supporter(see criteria below).

Exclusion Criteria:

* Unable to use SMS
* Unwilling to receive SMS reminders
* Severe mental condition limiting the ability to provide consent
* Cellular phone reception is not reliable

Social supporters (i.e., recipients of the SMS notifications for Wisepill participants in the intervention arms):

Inclusion criteria:

* Knows Wisepill participant has HIV
* Age 18 years or older
* Reports having provided social support to the intervention participant at least once
* Own a cell phone for personal use and have reliable cellular phone reception at home on a network supported by the technology used in this study
* Lives in the Mbarara District

Exclusion criteria:

* Unable to use SMS
* Unwilling to receive SMS notifications regarding interruptions in the intervention participant's adherence
* Severe mental condition limiting the ability to provide consent
Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
* age of \>18 years old

Exclusion Criteria:

* pregnancy or breast feeding
* has emetic episode within 24 hours
* gut obstruction
* uncontrolled brain metastasis
* allergy to or current use of olanzapine
* concomittant moderate or high emetogenic chemotherapy on day 2-5
* Total bilirubin \> 2 mg/dl or creatinine clearance \< 30 ml/min
* unable to swallow drug
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification

* Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
* The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
* This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
* The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
* The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

* Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
* The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
* This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
* The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
* The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

LoBaCoM is a monocentric, exploratory prospective study.

The purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years
* Common low back pain with medical prescription for rehabilitation
* Signed consent
* Be affiliated to a social security scheme
* Be able to perform the lumbar motion control failure tests

Exclusion Criteria:

* Body Mass Index greater than 30 (obesity)
* Person who does not understand French
* Pregnant woman
* Refusal to participate
* Volunteer under guardianship or curatorship
Cologne Placenta Cohort (CPC)

Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* BMI before pregnancy \>= 18
* with \& without gestational diabetes
* c-section at gestational week 35+0 until 41+6

Exclusion Criteria:

* multiple pregnancy
* maternal serious internal disease
* infections before pregnancy (e.g. HIV, hepatitis B)
* pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)
Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent

The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.

Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.

In this registry, data will be collected from approximately 100 consecutive patients who have been treated with the PULSAR® -18 T3 Stent.

Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and will be consecutively included in the registry. Once informed consent is obtained, the required data will be collected.

Eligibility Criteria:
Inclusion Criteria:

I1. Patients with documented PAD from the AFS and/or AP, classified as having intermittent claudication or critical limb ischemia (CLI), with a Rutherford score between 3 and 5.

I2. Age ≥ 55 years. I3. The target lesion consists of one or multiple de novo or restenotic lesions \> 5 cm.

I4. Adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion).

I5. Adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion).

I6. CI signed and dated.

Exclusion Criteria:

E1. Failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow).

E2. Life expectancy \< 12 months.

E3. Any contraindication to the use of antiplatelet therapy and/or heparin

E4. Acute or subacute thrombosis in the target vessel.
Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds

When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring.

Following cutaneous surgical procedures, scar formation is inevitable. Reducing the degree of scar formation and achieving the best aesthetic outcome remains prominent within the dermatological literature.

Wound closure can be achieved by a variety of suturing techniques. After the dermis is closed using deep sutures, the epidermis is closed with a second layer of sutures for additional reinforcement. Approximating the epidermis is commonly performed with running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches.

Running locking sutures are another technique that can achieve secondary layer closure of wounds. Like the running suture, the first anchoring knot is made at one end of the wound, but rather than pulling all of the suture material through after completing the throw, a loop of suture is left from the beginning of the throw, and the needle is then passed through the loop of suture, locking the suture in place. This is repeated until reaching the end of the wound, where the suture material is then tied to the loop using an instrument tie for the final throw. This technique may achieve better hemostasis by improving eversion and providing more equal tension across all loops of the running suture.

To our knowledge, the impact of scar cosmesis and rate of post-operative complications using a running locking suture technique in comparison to using standard running sutures for primary linear repair of surgical wounds has not been studied. This study seeks to determine the effectiveness of an alternative suturing technique for epidermal approximation by using individuals as their own controls in a split-scar model.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure on the head or neck with predicted primary closure
* Willing to return for follow up visit

Exclusion Criteria:

* Incarceration
* Under 18 years of age
* Pregnant Women
* Unable to understand written and oral English
* Wounds with predicted closure length less than 3cm
The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?

The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.

Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.

Eligibility Criteria:
Inclusion Criteria:

* the need for ERCP assessed by a specialist in gastrointestinal surgery

Exclusion Criteria:

* prior sphincterotomy
* age under 18
* age over 90
* contrast media allergy
* inability to give informed consent
Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.

To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.

Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed as ALL.
2. Patients who need hematopoietic stem cell transplantation
3. Age: up to 21 years
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
8. Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
Randomized Controlled Trial of Stress Management Training in HIV

The introduction of highly active antiretroviral therapy (HAART) has dramatically changed the consequences of an HIV infection, which is now viewed as a chronic disease. As in other chronic diseases, emotional distress and depressive symptoms are highly prevalent in HIV-infected patients. Psychological factors such as these have been associated with lower quality of life, lower adherence to therapy and also with a higher risk for mortality and disease progression. Psychosocial interventions, such as group-based cognitive behavioral stress management (CBSM) training, have been shown to reduce distress and psychological symptoms in HIV-infected patients. These psychosocial effects are paralleled by changes in physiological parameters, such as cortisol, DHEA-S, testosterones, catecholamines, and naïve T-cell counts. While these results are congruent with recent evidence of the interaction between psychological, neuroendocrine and immunological parameters in HIV-infected patients, it needs to be shown whether the reported effects hold true in the HAART era. Most importantly, it also needs to be ascertained whether these interventions have an impact on immunological and virological HIV parameters as well as on mortality and morbidity in HIV patients. We propose a randomized controlled one-year prospective evaluation of a group-based CBSM training in 80 HIV-infected patients. Participating patients will be recruited at cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or waiting control group condition. At baseline, post-training and two follow-up (6 and 12 months) assessments, effects of the CBSM on psychological, physiological and clinical out-come variables in HIV-infected patients under HAART will be evaluated. Additionally, the effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected patients will be assessed, thus evaluating a possible direct pathway between emotional distress and physiological HIV-relevant parameters. In conclusion, the planned research project evaluates the effectiveness of a standardized psychosocial intervention as a possible component of a comprehensive disease management in HIV-infected patients under HAART.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 65 years of age
* Sufficient German-speaking abilities to participate in group therapy
* cARTwithin the previous three months,
* CD4 lymphocyte count above 100 cells/mL

Exclusion Criteria:

* Active opportunistic infection at baseline
* Formal psychotherapy within the previous three months
* Intravenous drug users
* Diagnosable current major psychiatric disorder (bipolar affective disorder, psychotic disorders, major depression with melancholia) and diagnosis of antisocial and borderline personality disorders at baseline