cyrilzakka/clinical-trials huggingface dataset:
Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy

Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies.

This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparoscopic nephrectomy

Exclusion Criteria:

* Age \<18 years
* History of previous abdominal surgeries
* Laparoscopic donor nephrectomies
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher
* poor response to previous treatment with metformin for at least 3 months

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

Chronic pain patients receiving a strong opioid in combination with paracetamol in a minimum dose of 1.5 g/day will be randomized to receive either paracetamol in the dose already prescribed (group "paracetamol") or an identically looking placebo (group "placebo") using the same schedule during the first study phase (days 1-7). In the second study phase (days 8-14) paracetamol or placebo will be stopped in both arms to assess the effect of pill withdrawal on pain control.

Next to baseline the patients will be instructed to use a pain diary to rate their pain during the study and also document the required opioid rescue doses. Further assessments will include adverse events, subjective ratings of quality of sleep, overall feeling of functioning and quality of life. At the screening visit, patients will also be asked to rate their expected changes in pain relief as a result of co-treatment with paracetamol. At the completion of the study, patients will be asked about their preference and whether, overall, they felt their pain was more poorly controlled during the study.

Adherence will be checked by pill count and measurement of paracetamol blood concentrations. Genotyping of OPRM1, COMT and relevant CYP enzymes and opioid blood concentrations will be assessed as co-variates for pain control.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day)
* Age ≥ 18 at screening
* Ability to understand the study procedures and to provide written informed consent
* Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days

Exclusion Criteria:

* Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials
* Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation
* Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study
* Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.

Patients will be placed into one of 2 arms.

* Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
* Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.

Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.

Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.

Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage II or III breast cancer
* HER-2 positive tumors
* Older than 18 years of age
* Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
* ANC \> 1,500/mm3
* Hemoglobin \> 9gm/dl
* Platelets \> 100,000mm3
* Creatinine \< 2mg/dl
* Glucose \< 200mg/dl
* Bilirubin \< 1.5 x ULN

Exclusion Criteria:

* Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
* Pregnant or breast-feeding women
* Serious illness, or medical or psychiatric condition
* Uncontrolled infections
* Active or severe cardiovascular or pulmonary disease
* Patients with left ventricular ejection fraction \< 50%
* Peripheral neuropathy of any etiology that exceeds grade 1
* Prior history of malignancy
* Uncontrolled diabetes
Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)

A clinical trial to validate the MCPM (Multi-parameter Combined Physiological Signal-based Monitoring), in estimating physiological activity level, at rest, previous and following stimuli.

The Multi-parameter Combined Physiological Signal-based Monitoring (MCPM) system is a non-invasive multi-parameter physiological monitoring system, intended for continuous . acquisition, analysis and display of physiological signals and a Combined Physiological Activity Index (CPAI).

Subjects who meet the study inclusion and exclusion criteria will be enrolled to the study and their physiological measures, at rest and during exposure to the thermal and stressogenic physical stimuli will be recorded by the MCPM system. All subjects will be recorded according to a standard procedure; subjects will be lying in the supine position and will be instructed to avoid any movements. The experimenter will connect the sensors (MCPM finger probe). During the experimental session, different thermal stimuli will be administrated via the cold pressor test, with 10-20 minutes of non-stimuli interval. The last stimuli is an stressogenic physical preformed by the subject.

1-2 weeks following the first visit, about half of the subjects will be invited to a second visit, identical study visit, to assess the between session test-retest reliability of the signals. During the second visit, CPAI will be measured again under randomize thermal stimuli and an additional 3 Celsius degrees cold stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 \< 65 years old
* Signing an Informed Consent Form (ICF)
* Healthy participant
* No medication/drugs were taken in the last week
* No usage of chronic medication in the last 3 months (except non-pregnancy pills)
* Blood Pressure \< (90,140), Heart Rate \< 100pps at rest
* No alcohol usage during the last 48 hours

Exclusion Criteria:

* Medication/drugs were taken in the last week (not including non-pregnancy pills)
* Alcohol usage during the last 48 hours
* Caffeine and smoking in the last 3 hours
* Pregnant women
* Inability to comply with the study protocol
Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

This study is a prospective comparison between absorbable hemostatic agents as a group and the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus surgery with or without septoplasty.

The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in comparison with physiologic hemostasis after endoscopic sinus surgery. The investigators aim to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of epistaxis observed without therapy and evaluate objective healing parameters.

Eligibility Criteria:
Inclusion Criteria:

-≥18 to \<75 years of age with bilateral chronic or recurrent rhino sinusitis recalcitrant to medical therapy that requires endoscopic sinus surgery

-sinuses should have a similar degree of disease involvement bilaterally.

Exclusion Criteria:

* massive sinonasal polyposis,
* history of underlying immunologic diseases, AIDS, cystic fibrosis, immunoglobulin deficiency, immotile cilia syndrome, and neutropenia,
* known hypersensitivity to the aforementioned agents,
* women who are pregnant or breastfeeding,
* anyone with a known allergy to any of the treatments (potato starch, iodine, shellfish)
* anyone with a known coagulopathy
Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder

The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be between the ages 18-60
* Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
* Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder (Type I or II)
* Be an outpatient receiving a stable dose of mood stabilizing medication(s) for at least one month
* Have a Hamilton Depression Rating Scale (HDRS-17) baseline assessment in the range of 12-25
* Have a Full-Scale IQ of at least 80 as determined by the WTAR
* Be a non-treatment seeking cannabis user
* Evidence of sufficient motivation and effort as measured by a Test of Memory Malingering (TOMM) score of at least 45
* Y-MRS baseline score in the range of 0-15

Exclusion Criteria:

* Meets criteria for abuse or dependence of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine)
* Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine
* Current suicidal or homicidal ideation
* Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
* Treatment seeking for cannabis use
* Head Injury \> 5 minutes LOC
* Exceed upper and lower cut-offs on HSRD-17 and YMRS
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer

The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent
* clinical stage IIA\~IIIC
* histologically proven HR+ invasive breast cancer
* women defined as postmenopausal according to NCCN guideline
* plan to accept the neoadjuvant (pre operational) chemotherapy treatment

Exclusion Criteria:

* clinical evidence of metastatic disease
* bilateral oophorectomy;
* radiation of the ovaries
* patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
* patients who accepted anti-cancer treatment before
* previous hormonal therapy as adjuvant treatment for non-cancer disease
* patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
* previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
* treatment with a non-approved or experimental drug during 1 month before entry into the study
* history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
* leukopenia and/or thrombocytopenia
* history of ocular fundus diseases
* history of thromboembolic diseases
* history of osteoporotic fractures
Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain

Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain that are likely to benefit from a lumbo-pelvic manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result in the same outcome.Purpose: The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.


Eligibility Criteria:
Inclusion Criteria:

1. Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity
2. Oswestry disability score of at least 25%
3. Age greater than 18 years and less than 60 years
4. At least four out of five of the following criteria:

   1. Duration of current episode \< 16 days (judged from the patient's self-report)
   2. No symptoms extending distal to the knee (judged from the pain diagram)
   3. FABQ-W score \<19
   4. At least one hip with \>350 internal rotation range of motion (measured in prone)
   5. Stiffness in the lumbar spine (judged from segmental mobility testing)

Exclusion Criteria:

1. Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
2. Signs consistent with nerve root compression, this includes any one of the following:

   1. Reproduction of low back or leg pain with straight leg raise at less than 450
   2. Muscle weakness involving a major muscle group of the lower extremity
   3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
   4. Diminished or absent sensation to pinprick in any lower extremity dermatome
3. Prior surgery to the lumbar spine or buttock
4. Current pregnancy
5. Past medical history of osteoporosis or spinal compression fracture
6. Inability to comply with treatment schedule (weekly sessions for four weeks)
Investigating the Effect of a Prenatal Family Planning Counseling Intervention Led by Community Health Workers on Postpartum Contraceptive Use Among Women in the West Bank

The purpose of this study is to measure the difference in proportion of postpartum women using contraception after a Community Health Worker (CHW) family planning educational intervention compared to women who receive standard care in the West Bank district of Ramallah and Al-Bireh.

Primary hypothesis: Postpartum contraceptive use will increase in women who receive a dedicated family planning counseling intervention delivered by CHWs during antenatal care compared to women receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* Women attending the MoH Ramallah or Al-Bireh clinic for antenatal care and 34-38 weeks pregnant at enrollment
* Planning delivery at an MoH hospital
* Able and willing to be contacted by phone or home visit

Exclusion Criteria:

* Women less than 34 weeks pregnant or non-pregnant
* Planning delivery at a private or NGO hospital
* Unwilling to be contacted for follow-up after enrollment
Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse

In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM

In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years;
* Diagnosis of multiple myeloma;
* Clinical indication and eligibility for vertebroplasty procedure;
* Performance Status (ECOG) 0-2;
* Life expectancy greater than three months;
* Low-resolution full skeletal CT scan at disease onset and/or at follow-up;
* Spine pain with stiffness and functional impediment pre vertebroplasty;
* Able to express appropriate consent for participation in the study (e.g. Able to understand Italian, patient with intact cognitive abilities)

Exclusion Criteria:

* presence of spinal cord compressions;
* unstable spinal injuries, requiring an orthopaedic back brace;
* risk of spinal cord injury;
* body mass index BMI\>28 kg/m2.
* absence of signed informed consent form
PREvention of Post-mastectomy LYMphoceles by PAdding

Lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. The presence of seromas is therefore associated with discomfort and pain. Seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as obesity, increased post operative drainage of J1 to J3, and arterial hypertension.

Different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility.

Studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. Some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area.

The padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas.

In this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Female gender
* Patients with infiltrating or in situ breast cancer
* Indication of surgical treatment by mastectomy
* Patient providing written informed consent
* Patient with health insurance coverage
* Ability to provide voluntary written informed consent

Exclusion Criteria:

* Informed consent cannot be obtain
* Pregnant or lactating women
* Patients undergoing immediate breast reconstruction
* Patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (BRCA genetic mutations)
* Patients under legal protection or unable to come to a center
* Patients unable to express voluntary consent
* Patients receiving post operative anticoagulants or platelet antiaggregants
* Patients requiring postoperative anticoagulants
* Bilateral mastectomy