cyrilzakka/clinical-trials huggingface dataset:
Intensity-modulated Radiotherapy Protocol in Cervix Cancer

Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial

Radiotherapy

1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)

   * Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks
   * Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week

Eligibility Criteria:
Inclusion Criteria:

1. FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix
2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1
3. Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning
4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL
5. Patients who have signed an approved informed consent and authorization

Exclusion Criteria:

1. Patients with recurrent cervical cancer
2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
3. Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node)
4. Patients with distant organ metastasis
Dual Task Training in Spastic Cerebral Palsy

Cerebral palsy(CP) is a non-progressive disorder, undergoing mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. There could be secondary musculoskeletal problems due to muscle weakness resulting from poor alignment, limited range of motion, and asymmetrical posture. These deformities are negatively affected by biomechanical movements and can affect balance and gait functions. The main goal of rehabilitation in children with cerebral palsy is to restore independent walking. However, children with cerebral palsy have limited mobility, which leads to gait disorders (short steps, slow walking speed, increased swing phase and postural instability). Therefore, it is important to choose an effective training method to improve the balance and gait of children with cerebral palsy. Walking training can help improve muscle tone, postural control and gait function as well as improve muscle strength, endurance, and coordination of the lower extremities. A growing body of evidence supports implementing dual-task gait training for enhancing functional mobility and cognitive performance. This will be a randomized controlled trial, data will be collected from Rising Sun Institute, Mughalpura campus. A study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 to 3 and those who can walk 50 m without mechanical walking aids and maintain standing for more than 5 seconds without falling will be included. Exclusion criteria of this study is low intellectual ability (IQ \< 80) and behavioral symptoms which might affect participation in the protocol, none of the children had surgery or botulinum toxin injections during the year prior to the assessment. Group1 will receive conventional therapy for 30 minutes a day, 3 times a week for 8 weeks. And group 2 will receive conventional therapy with dual-task training for 30 minutes a day, 3 times a week for 8 weeks. For the pre- and post-evaluation of all participants Berg balance scale and Gait outcome assessment list-(GOAL) will be used. Data will be analyzed through SPSS version 23.00.


Eligibility Criteria:
Inclusion Criteria:

* Participant's age will be between 6-12 years.
* Patient should be diagnosed with spastic diplegic cerebral palsy.
* GMFCS I-III

Exclusion Criteria:

* Low intellectual ability (IQ \< 80) and behavioral symptoms which might affect participation in the protocol.
* If patient had any progressive neurological disorder disease.
* If he/she had surgery or botulinum toxin injections during the year prior to the assessment will also be excluded
Berlin-Brandenburg Pregnancy Cohort

This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women after giving informed consent
* pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes

Exclusion Criteria:

* infections
* alcohol and drug abuse
* manifest and chronic diseases
Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD

Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio. Purpose of the study is to learn how mindfulness meditation may be helpful in treating PTSD. Participants will undergo 2 screening sessions, 8 weekly sessions of intervention (MBSR or HWE), 3 laboratory visits that will include completing survey questionnaires, stress test and recording of heart rate, blood pressure and breathing rate.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18-85yo)
* Military veteran
* Experiencing PTSD symptoms
* Reading and speaking in English
* Be able to travel to OHSU for three two-hour lab visits, 8 weekly intervention sessions and one long extended session, and a two- hour focus group

Exclusion Criteria:

* Pregnancy
* Severe untreated depression, cognitive impairment, or active suicidality\*
* Life-threatening or severely disabling medical conditions
* Excessive use of alcohol, nicotine, or cannabis
Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomized order: Tomato, onion and lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup and inulin.

During each feeding study, urine, blood and stool samples will be collected at regular intervals for the duration of 24 hrs after consumption of test food. Participants will be asked to follow a low polyphenol diet for 2 days prior to the feeding study.

Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids.

Eligibility Criteria:
Inclusion Criteria:

• Self-reported healthy adults

Exclusion Criteria:

* Antibiotic use within the last 3 months
* Identified gastro-intestinal diseases
* On prescribed medication other than the contraceptive pill
* Pregnant or breastfeeding.
* Diagnosed as anaemic
* Allergic to paracetamol or any food
Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.

Gynger is a no profit, observational study, composed of a retrospective cohort (A) and a prospective cohort (B). The primary aim of this trial is to describe gene profile of Italian gynecological cancers patients, through the centralization of NGS reports performed in clinical practice or collected in clinical trials, and to correlation them with clinical and pathologic features.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form;
2. Female sex;
3. Age ≥18 years;
4. Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
5. Availability of NGS report performed on solid tumor tissue from primary or recurrent disease or liquid biopsy; data from NGS assays both in-house (academic test) and commercials can be used regardless of the number of genes analyzed

Exclusion Criteria:

* Patients for which the NGS analysis has been performed of germline tissue
Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.

Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours after admission). Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.

The aim of this study is to determine if performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.

Patients who are admitted with bleeding from their rectum and clinical evidence of a significant bleeding episode (elevated heart rate, low blood pressure, or need for blood transfusion) have immediate upper endoscopy (examination of the stomach with a flexible rubber tube with a light and video camera on the end). If this shows no source of bleeding, the patients are randomized (like flipping a coin) to receive a colonsoscopy (examination of the large intestine with a flexible rubber tube with a light and video camera on the end) either as a emergency (within 12 hours) or as a routine procedure (36 hours after admission).

Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.

Eligibility Criteria:
Inclusion Criteria:

Patients who are admitted with rectal bleeding and one of the following high-risk features:

1. HR \> 100/min
2. Systolic blood pressure \<100 mmHg
3. Orthostasis -considered as increase in HR by\> 20/min on assuming erect position as well as by decrease by 20 mmHg in systolic blood pressure
4. Need for blood transfusion
5. Drop in hemoglobin \> 1.5 g/dl or in hematocrit of \> 6% in 6 hours

Exclusion Criteria:

1. Inability to give informed consent
2. Peritoneal signs
3. Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. Participants who underwent transurethral resection for bladder tumor will be included in the study. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with transitional cell non-muscle invasive bladder cancer (NMIBC) pathology
* Patients with a diagnosis of Bladder cancer (NMIBC)
* Patients undergoing transurethral resection for bladder cancer (NMIBC)
* ≥18 years old patients

Exclusion Criteria:

* Non-transitional cell bladder cancers
* Patients with muscle-invasive bladder cancer pathology
* \<18 years old patients
Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.

Objectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.

Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence (ICD-10)

Exclusion Criteria:

* Clinically significant symptoms of alcohol withdrawal
* Significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview)
* Current psychiatric disease demanding special treatment or medication including DSM-IV determined drug dependence other than alcohol or nicotine dependence
* Current use of any opioids within four weeks before screening
* Significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT \> 200)
* Pregnancy, nursing, or women refused to use a reliable method for birth control
Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors

This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.

Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks.

After completion of study treatment, patients are followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pediatric cancer
* Patients 3 months to 1 year after completion of therapy

Exclusion Criteria:

* Patients who are already on antihypertensive or insulin or cholesterol lowering medication
* Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
* Inability to understand program instructions due to language barrier or mental disability
* Unable to participate in the outlined exercise program due to a physical disability
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)

Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis.

The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score\> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities.

Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements.

The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence.

The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.

The design consists in a multicenter national open simple arm trial.

All eligible patients with a lytic bone metastases of the superior femoral epiphysis will be included.

The main objective of this study is to describe the impact of the Y-STRUT® implant on the quality of life of patients with lytic bone metastases of the femoral neck by comparing quality of life scores before and one month after the intervention of implantation of the implant.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* patient with a lytic or mixed matrix bone metastasis of the superior femoral epiphysis visualized in imaging
* MIRELS score ≥8 within 20 days prior to inclusion,
* ECOG-PS 2 or 3 within 20 days prior to inclusion,
* Cervico-diaphyseal angle between 115 ° and 135 ° inclusive,
* Length of the proximal part of the femur greater than or equal to 90 mm
* Patient refusing gamma nail
* Life expectancy greater than 6 months

Exclusion Criteria:

* Act of general anesthesia impossible,
* ECOG \<2 (patients eligible for nailing treatment),
* INR \<0.7 in the 24 hours preceding the intervention,
* Platelets \<70000 / mm3 within 24 hours of surgery,
* Allergy previously known by the patient to PEEK and / or PMMA,
* Patient who previously had a cementoplasty of the target lesion,
* Osteolysis of the target epiphyseal cortex\> 2/3 of the circumference of the epiphyseal cortex,
* Pre-fracture lesions of the underlying ipsilateral diaphysis or ipsilateral acetabulum
* Patient unable or unwilling to give written consent.
Rheumatoid Arthritis Patients in Training

Aim of the study was to investigate the effectiveness (functional ability and physical capacity) and safety (disease activity and damage of the joints) of long-term high-intensity weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be safe and effective.

The 300 patients with RA were randomized into two groups; exercise group and usual care group. The patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and functional ability without detrimental effects on the large joints damage or on disease activity. Only patients with excessive large joint damage at baseline were at risk to develop additional damage when participating in intensive weight-bearing exercises. Patients who exercised were able to delay the decrease of bone mineral density of the hips.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* Prosthesis of a weight bearing joint
To Compare the Efficacy Between 3 Fetal Monitoring Methods

Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.

Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.

study design:

1. signing an informed consent at vas\<3
2. admittance to delivery room.
3. Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases.
4. Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously.
5. Recording fetal heart rate until delivery.
6. Disconnecting the patient from all devices if required according to clinical need.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical indication to insert a scalp electrode for fetal heart rate tracing.
2. Maternal age\>18 years.
3. Reactive fetal heart rate monitoring and BPP (Biophysical Profile) 8/8 at enrollment.
4. Singleton pregnancy.
5. No fetal abnormality or chromosomal defect.
6. Subjects are willing and able to comply with the requirements of the protocol.
7. Fully understand all elements of, and have singed and dated the written informed consent form before initiation of protocol specified procedures, when vas\<3.

Exclusion Criteria:

1. Women who refuse to sign the informed consent form.
2. Maternal age\<18 years.
3. Multiple pregnancy.
4. Women with implanted electronic device of any kind.
5. Women with allergic to silver.
6. Irritated skin or open wound.