cyrilzakka/clinical-trials huggingface dataset:
Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study

the investigator Randomized and compare the efficacy of 3 types of metabolic surgery in the treatment of type 2 diabetes in obese patients, one of them is SASI bypass which is a modification of Santoro's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first comparative clinical trial as regards the clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes.

from 2011 to 2017, investigators Randomized and collect data for the 3 operations SASI bypass , Mini gastric bypass and Sleeve gastrectomy ) about thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude gall stones and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity complications and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetic obese patients

Exclusion Criteria:

* patients age above 65 or below 18 years old
* history of upper laparotomy
* unfit for anesthesia or laparoscopy
* major psychological instability
* drug abuse
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* Male 18 years and older
* Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
* Post radical Primary Prostatectomy
* Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria:

* Prior androgen deprivation therapy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against PCa
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 and ≤75 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function

Exclusion Criteria:

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
2. Received previous anti-tumor therapy: within 21 days of monoclonal antibodies or cytotoxic therapy prior to the first dose of the study drug, or within 14 days of small molecule targeted drugs prior to the first dose of the study drug. Received palliative radiation therapy within 2 weeks prior to the first dose of the study drug, or received radical radiation therapy within 4 weeks prior to the first dose of the study drug;
3. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
The Trauma Recovery and Resiliency Research Project

The overall purpose of this study is the assessment of treatment outcome among traumatized patients seeking individual and/or group therapy at the Victims of Violence Program. The study gathers information from patients using quantitative (self-report) and qualitative (interview-based) approaches, to determine changes in symptom patterns and domains of functioning relevant to psychological trauma.

The focus of the Trauma Recovery and Resiliency Project is primarily the evaluation of treatment outcome among complexly traumatized patients seeking individual and/or group therapy at the Victims of Violence (VOV) Program, a specialty clinic located in the Outpatient Psychiatry Department of the Cambridge Health Alliance and affiliated with Harvard Medical School. The project has two major components: (1) All patients seeking VOV treatment are administered a battery of self-report measures assessing symptoms associated with complex trauma (i.e., interpersonal trauma that is usually repeated and prolonged) (2) A subsample of patients are interviewed using the Multidimensional Trauma Recovery and Resiliency Interview (MTRRI) and its companion rating scale (MTRR; Harvey et al, 1994, 2000, 2003) to assess trauma impact, recovery and resiliency on eight domains of psychological functioning. Data is analyzed using quantitative and qualitative approaches to evaluate treatment effectiveness and elucidate the recovery trajectories of patients receiving VOV treatment. Two subprojects include (a) preparation of a treatment manual documenting the Women's Trauma Recovery Group, and (b) pilot testing a new interview-based measure of complex trauma symptoms, the Symptoms of Trauma Scale (SOTS).

Eligibility Criteria:
Inclusion Criteria:

* In individual or group therapy at VOV program
* Consents to research participation

Exclusion Criteria:

* Insufficient proficiency in English to complete self-report measures and/or interview
* Research participation clinically counterindicated
Laparoscopic Sacropexy With Robot-Assisted Surgical System

The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

Vaginal vault prolapse is a common finding in Gynecology. Many different approaches for vaginal vault prolapse repair are available. During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques.

This prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da Vinci®-System) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. Pre- peri- and post-operative data are collected using the prolapse quantification system (POP-Q) and the German Pelvic Floor questionnaire. The objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

Eligibility Criteria:
Inclusion Criteria:

* vaginal vault prolapse
* recurrence after vaginal prolapse repair
* signed consent

Exclusion Criteria:

* rectocele
* BMI \> 40
Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents

This study examines the effect of self designed school-based interventions on physical activity and psychological outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept, and academic achievement among a community sample of adolescents from Taxila, Pakistan

The main objective of this study is to assess the level of motivation towards physical activity and psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement as assessed through recent grade) among young adolescents and to develop intervention to enhance motivation towards physical activity among young adolescents. Randomized Control Trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes. After assessing their motivation toward physical activity and psychosocial outcomes intervention will given for 10 weeks, in which participants will be asked to participate in 10 minutes exercise activity on regular basis from Monday to Friday during school timings. Assessment will be done to find out that whether the school based intervention will be effective for them in motivation towards physical activity and reduction psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement (as assessed through recent grade)) among adolescents or not. This results of this study will be used in promoting active lifestyle may help the adolescent to develop long-term positive healthy habits and targeting adolescents through encouraging physical activity in school or educational setting and social surrounding. To make decision about effective programs and policies to promote physical activity should be taken in account, by providing empirical support for public health messages that encourage participation in school spots as a mean to reduce the burden of poor mental health. Physical activity programming must align with the predictable developmental changes in adolescent exercise capacity and motor skills, which affect the activities in which they can successfully engage. These programs specifically designed to improve psychosocial outcomes, such as self-concept, social behavior and self-efficacy of adolescents as these are the most important determinants of participation in physical activities.

Eligibility Criteria:
Inclusion Criteria:

* Participants from grade 6th to 8th with in age range of 10-15 years.
* Participants who have lack of physical activity.
* Participants who provide consent to take part in the intervention.

Exclusion Criteria:

* Those participants who do not provide consent to take part in intervention will not be eligible take part in intervention.
* Participants who are having any physical disability or medical condition that compromises their mobility will not take part in intervention.
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap

Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders between 21 to 55 years
2. Dry chronic suppurative otitis media
3. Air bone gap between 15 to 25 Deci bel

Exclusion Criteria:

1. Discharging ear
2. Pediatric population
3. Ossicular Necrosis
4. Previous ear surgery
Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.

A study was designed with a prospective cohort of all patients undergoing urgent surgery for left colon perforation between March 2014 and June 2017 who were treated according to a specific ERAS programme (ERAS group/29 patients). This group was compared with a historic case-matched control group with conventional care (CC group/21 patients). The main endpoints were postoperative 30-day morbidity, length of postoperative hospital stay, rate of readmission within 30 days, and mortality. The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS) between 6-11 points.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS), between 6-11 points.

Exclusion Criteria:

* The exclusion criteria were patients under 18 years old and patients with a high risk of mortality according to a PSS equal to or greater than 12 points.
Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)

Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)


Eligibility Criteria:
Inclusion Criteria Pre-Screening:

* Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). \[...\]
* Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable.
* Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. \[...\]
* Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab.
* At least one measurable site of disease as defined by RECIST v1.1 criteria.
* \[...\]

Inclusion Criteria Screening:

* Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. \[...\]
* Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment.
* Patients must have received 4 cycles (21-day cycles) of chemoimmunotherapy with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1.
* Adequate organ and marrow function

Exclusion Criteria Pre-Screening:

* Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab.
* Radiographic or clinical evidence of progressive disease.
* Negative HRD result in a previous pre-screening in this trial.
* \[...\]

Exclusion Criteria Screening:

* Patients with symptomatic uncontrolled central nervous system (CNS) metastases.
* Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
* History of leptomeningeal carcinomatosis.
* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are:

  1. Alopecia (any Grade)
  2. Vitiligo (any Grade)
  3. Hypothyroidism stable on hormone replacement (Grade ≤2)
  4. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
  5. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor.
  6. ...
Quality of Life in a Representative Swedish Population

Cohort descriptive study of quality of life and body functions in a reference population of Swedish inhabitants from age 30 to age 89. The population was selected to be representative for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.

The population is contacted and asked for informed consent, whereafter a questionnaire of about 200 questions, used in a number of studies in clinical studies and trials, are sent out.

The results will be used as reference values to our patient cohorts

Individuals contacted by letter with information about the study and it's aim. The next step is a telephone contact from the study secretariate where the person can ask for more detailed information and put questions to the reserach nurse. The call leads up to a question to the person, if the questionnaire can be sent. If yes, the questionnaire is posted includeing the consent form and an pre-paid return envelope. After two weeks a thank you/reminder letter is sent out, and if no reply one more phone call is made two weeks further on.

Eligibility Criteria:
Inclusion Criteria:

* list generated by the equivalent to inland revenue ("Skatteverket", Sweden)

Exclusion Criteria:

* unable to read and understand Swedish
* no informed consent
Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up

The aim of this prospective randomized controlled trial was to compare the effectiveness of surgical and conservative treatment in acute lateral ligament injury of ankle. The more detailed aims were to assess the function, physical activity level, re-injuries, objective stability and radiographic changes seen by magnetic resonance imaging in patients randomized to surgery or to functional treatment after a mean of 14 years follow-up.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included positive stress radiographs (in all cases) and arthrography 15 (5 cases) proven fibulotalar anterior (FTA) and fibulocalcanear (FC) ligament injury.
* The positive findings for a lateral ligament injury included a clinically unstable ankle and a radiological talar tilt \>6 degrees or ADS \>5 mm compared with the uninjured opposite ankle.

Exclusion Criteria:

* The exclusion criteria for the study were diabetes, inflammatory arthritis, previous severe trauma, pre-existing instability of joints.
* In addition, patients were excluded from our study if they had previously undergone surgery of the ankle region.
Oxytocin's Effect on the Advantageous- and Disadvantageous-inequity

The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and whether oxytocin has similar effects on them or not.

The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and its underlying neural mechanisms and whether oxytocin has similar effects on them or not. A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 80 healthy males are instructed to self-administrated intranasal spray of oxytocin or placebo. A modified inequity decision-making task starts 45 minutes after treatment with behavioral (fairness rating, preference rating and the choice rate of unequal option) and fMRI data being collected during this task. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before and after the task.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* pregnant,menstruating,taking oral contraceptives
* medical or psychiatric illness.
* excessive head movement (\> 3mm) during scanning
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>/=30 kg/m2
* routine consumption/use of (i) \>/=250 ml of artificially-sweetened beverages per day and/or (ii) \>/=1 gum per day
* willingness and ability to follow the proposed dietary intervention
* informed consent

Exclusion Criteria:

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* working night shifts
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin