cyrilzakka/clinical-trials huggingface dataset:
Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.

All participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin ReTrieve training immediately following an initial assessment, or wait 8 weeks before beginning training.

During the study, participants will have a ReTrieve tactile training system delivered home for use over 6 weeks. Investigators will take three days to teach participants how to use the system. Each week for the remainder of the 6 weeks, participants will use this system for 4+ days per week on their own, and for 1 day supervised. During each supervised day, participants will complete approximately 1 hour of training while supervised over video chat with researchers.

Participants' tactile function will be assessed at three separate time points: once within one week before beginning training, once within one week after completing training, as well as once either 8 weeks before or 8 weeks after the training. This assessment has a required survey component, as well as an optional in-person clinical assessment component.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Be able to communicate and consent for themselves
* Have experienced a brain injury more than 6 months prior to the date of study participation
* Have chronic tactile deficits in at least one hand as a result of their brain injury
* Have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks
* Have sufficient motor ability in their affected hand(s) to raise their arms above their head
* Have sufficient motor ability in their affected hand(s) to hold objects
* Have wireless internet and a laptop or mobile device at home for video conferencing
* Live in the greater Dallas area

Exclusion Criteria:

* Significant cognitive deficits that would preclude them from understanding instructions
* Significant communication deficits that would preclude them from consenting for themselves
Prognostic Score in the Very Old ICU Patients

The two main aims of the study:

1. To investigate the relation of Frailty, Activity of daily life (ADL), Cognitive functions and Co-morbidity on survival at 30 days (and 6 months in a substudy)
2. From the results design a prognostic score that will be validated using a subpopulation of the study cohort

Two secondary aims a

1. Survival at 6 months (in a subpopulation of the study)
2. An inter-rater validation of the Clinical Frailty Score (CFS) (in a subpopulation)

Substudies are planned with regards to the different admission categories, in particular:

* trauma
* acute respiratory failure
* sepsis
* combined respiratory and circulatory failure
* medical neurological conditions In some of the substudies similar groups from the VIP1 study that uses the same admission categories (except planned admissions) will be merged.

Frailty to be registered by the Clinical Frailty Scale (CFS), 1-9 point Activity of Daily life (ADL) with Katz ADL form: 0-6 points Cognition to be described by Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) questionaire, 16 questions to be asked the care-givers Co-morbidity by listing the major comorbidity with Yes or No (Yes= 1 point) and with the number of regular drugs prescribed

Eligibility Criteria:
Inclusion Criteria:

* ≥80 admitted to an ICU as an emergency case

Exclusion Criteria:

* elective admissions
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome

Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.

First, patients will be recruited according to the inclusion criteria and exclusion criteria.

Second, baseline measurements (including menstrual frequency,human chorionic gonadotropin (HCG) stimulation test,physical examination,trans-abdomen ultrasound of the uterus and ovaries, serum levels of sex hormone steroids) will be taken.

Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.

Last, the above baseline measurements will be taken again as soon as the treatment is finished and menstrual frequency will be recorded during the 12 weeks of follow-up after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1) Unmarried women with age between 18 and 28 years and without bearing requirement within 4 months.
* 2) Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligomenorrhea(Menstrual cycle\> 35 days, and less than 8 cycles per year), or amenorrhea (Menstrual cycle\> 90 days) and one of the following two criteria; clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.

Exclusion Criteria:

* 1) Patients with hyperprolactinemia.
* 2) Patients with androgens secrete increased abnormal which caused by adrenal or ovarian tumors.
* 3) Patients with uncorrected thyroid disease\[thyroid-stimulating hormone (TSH) \<0.2 milli-International Unit /milliliter(mIU/mL) or \>5.5 mIU/mL\]except the patients with normal TSH in the past 1 year.
* 4)Suspected Cushing syndrome patients.
* 5)Patients who Received Estrogen, Progesterone or Oral contraceptives Oral contraceptives and hormone medications within the past 1 months. It takes at least one month to Eliminate these medicines, or it will influence the results
* 6) Patients who Received other medications that have influence on Reproductive function. or metabolism within the past 2 months( such as Anti obesity medications，Anti diabetic medications， traditional Chinese medicine and so on).
* 7)Patients who took acupuncture treatment within the past 3 months.
* 8)Patient who are unwilling to give written consent to the study.
Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression

BERTHA study´s primary objective is to characterize Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) progression and to define a combination of biomarkers, genetic and clinical variables capable of identifying patients at risk of RA-ILD progression

BERTHA is a multicentric, observational study that will enroll 100 RA-ILD patients to be followed for 2 years.

Interstitial Lung Disease (ILD) progression will be ascertained by quantitative image analysis and functional parameters. Variables associated with progression with be identified.

Additionally, RA-ILD endotypes will be investigated as well as their association with RA-ILD progression.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive adult patients (aged \>18 years) meeting RA diagnostic criteria in accordance with ACR 2010
2. Presence of interstitial lung disease 2.1 ILD Definition: presence of interstitial alterations in HRCT associated to functional derangements and/or symptoms
3. Patient agrees with having follow-up visits every 6 months for 2 years

Exclusion Criteria:

1. Pregnancy or intending to become pregnant
2. Overlap with other diseases that occurs with ILD (other collagenoses, vasculitis, inflammatory bowel disease)
3. Presence of advanced ILD, characterized by:

   a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
4. Presence of significant Arterial Pulmonary Hypertension:

   1. Evidence of Right ventricular failure evidence by echocardiography
   2. Previous right chamber catheterism showing cardiac index \< 2 liters/min/m²
5. Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
Stress Management Intervention for Living With Epilepsy (SMILE)

The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.

The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy. In the proposed randomized controlled, double blind trial, the investigators will enroll subjects with frequent seizures, especially those who identify stress as a seizure precipitant. There is an observational phase (8-12 weeks) and a treatment phase (12 weeks). During the observational phase, subjects will be monitored multiple times daily via smart phone devices, in order to identify high risk days for seizures. In the treatment phase, subjects will be randomly assigned to one of two groups receiving different focused attention practices. These behavioral interventions will be administered daily with extra interventions applied on days of higher risk.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* English speaking
* Partial epilepsy consistent with ILAE criteria supported by either EEG or MRI data
* Experiencing at least 2 seizures/month
* Reported awareness of all seizures, including seizures in a cluster
* One of the following:

  1. Patient-reported ability to self-predict seizures
  2. Patient-reported awareness of trigger factors, including stress
  3. Patient-reported awareness of premonitory features
* Able to maintain accurate e-diary independently
* Minimum 6th grade reading level as screened by WRAT administration
* Must be on a stable dose of anti-epileptic drugs for at least 30 days prior to study entry
* May be on stable dose of SSRI, SNRI, or atypical antipsychotic for at least 6 months
* May be on a stable dose of benzodiazepines (if so, dose stable for at least 30 days prior to study entry)

For inclusion in clinical trial phase, patient must be/have:

* A minimum of 4 seizures documented in the 8-week baseline phase (or 6 seizures in the 12-week extended baseline phase)
* At least 1 seizure per 4-week period in two of the three 4-week periods in the extended baseline phase
* Diaries satisfactorily completed during baseline phase
* Complied with study requirements during the baseline phase

Exclusion Criteria:

* Non-motor simple partial seizures only
* Concurrent VNS use
* History of suicide attempt within the past 2 years
* Current suicidality
* Not competent to sign consent
* Status epilepticus within the previous 6 months
* Began regularly using behavioral techniques for stress reduction within past 3 months
* Did not benefit from an adequate trial of a valid stress reduction technique
* Progressive neurologic condition that the investigator believes would affect seizure frequency
* Any history of substance abuse within the previous 2 years
* History of poor medication compliance as judged by the investigator
* Psychiatric illness that requires change in medication dose
* Any medical or psychiatric condition that would impair reliable participation in the trial
* Intermittent use of benzodiazepines (if used for sleep, will be determined case by case)
Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery

The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.

Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.

This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum;
* Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic);
* Patients \> 18 years of age;
* Able to provide informed written consent
* Patients capable of completing questionnaires at the time of consent

Exclusion Criteria:

* Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl;
* Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated INR, anticoagulation, patient refusal, etc) or TAP block (patient refusal);
* Urgent or emergent surgery precluding epidural catheter placement or TAP block;
* Systemic Infection contraindicating epidural catheter placement or TAP block;
* Unwillingness to participate in follow up assessments;
* Prisoners
* Pregnant women
Ultrasound Elastography in Patients With Rectal Cancer

The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.

The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
2. T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR \< 5 mm.
3. Life expectancy of more than 3 months.
4. Age ≥18 years.
5. Performance status ≤ 2 according to WHO.
6. Patient able to observe protocol guidelines.
7. Signed informed consent.

Exclusion Criteria:

1. Previous radiation treatment for the pelvis.
2. Known distant metastases.
3. Serious disease contraindicating treatment, including cardiovascular disease.
4. Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
5. Pacemaker
6. other disease making the patient unfit for study participation as assessed by investigator
Effect of Early Posroperative Feeding on Gastrointestinal Function After Cesarean Section

Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital

7. Study Methods

Population of study \& disease condition :

Two hundred women were recruited, with 103 randomized to traditional feeding and 97 to early feeding and compare women satisfaction during discharge from hospital.

Inclusion criteria:

* Maternal age from 20 to 40
* Primigravida and previous one or two cesarean section
* Elective cesarean section
* regional anesthesia .singleton pregnancy.

Exclusion criteria:

* age below 20 years old or above 40 years old
* medical disorders as (hypertension, diabetes , liver or kidney diseases)
* complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
* general anesthesia
* multiple pregnancy

Methodology in details:

1. all Women included in the study have undergo history taking and general examination
2. All patient in the study are randomized in two groups:

Group A:

103 patients will have early postoperative oral fluids and semisolid food after 6 hours of cesarean section irrespective to intestinal sounds ,flatus or stool passage

Group B:

97 patient will start oral fluids 6 hours with no solid or semi solid until after passage of flatus or stool 3_Both groups cesarean section will be held with the same technique:

* spinal anethesia
* pfennenstiel imcision
* lower segment cesarean section
* suturing uterus in two layers while exterionezed
* gentle manibulation
* no towels in gutters will be used 4_ comparison will be held between both groups according:
* postoperative intestinal sounds.
* postoperative nausea and vomiting
* postoprative abdominal distension
* postoperative pain
* postoperative ambulation
* postoperative ileus
* postoperative discharge time from hospital

Eligibility Criteria:
Inclusion Criteria:

* Maternal age from 20 to 40

  * Primigravida and previous one or two cesarean section
  * Elective cesarean section
  * regional anesthesia .singleton pregnancy.

Exclusion Criteria:

age below 20 years old or above 40 years old

* medical disorders as (hypertension, diabetes , liver or kidney diseases)
* complication during surgery as( bleeding, intestinal injury or urinary bladder injury ) .Emergency cesarean section .
* general anesthesia
* multiple pregnancy
A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients, \>/=18 years of age
* Chronic Hepatitis C, Genotype 1 and 4
* HCV RNA \>/=50,000 IU/mL
* treatment-naive

Exclusion Criteria:

* Patients with cirrhosis or incomplete/transition to cirrhosis
* Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair

comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit

* Objective 1: to assess the operative time and surgical field of both choices.
* Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications

Many different secondary procedures have been described in an attempt to restore continence. These may be classified into indirect methods, where the divided sphincter is left unrepaired, and direct methods to repair the sphincter itself. Indirect techniques include construction of circum anal slings of striated muscle or fascia external sphincter reefing procedures" and the use of striated muscle grafts. Direct methods involve identification, mobilization, and suture of the ends of the divided sphincter. Thearliest 'attempts employed an end-to-end

Eligibility Criteria:
Inclusion Criteria:

1. both sex
2. - Traumatic Patients Who Presented by anal Sphincteric Injury
3. accept to participate in the study

Exclusion Criteria:

1. Patient who arrest immediately when arrived trauma unit
2. Obstetric Patients Who Presented by anal Sphincteric Injury
Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State

This study aims to explore the impact of Animal Assisted Therapy (AAT) on brain signal complexity in patients with minimally conscious state (MCS) by analyzing electroencephalogram (EEG) entropy. MCS patients typically exhibit reduced brain entropy compared to healthy individuals, indicating lower brain complexity. The study will assess whether AAT can enhance this complexity, which is crucial for understanding consciousness levels. Entropy, a measure of randomness in brain activity, will be used to evaluate AAT's effectiveness. In addition, electrocardiography (ECG), electrodermal activity (EDA) and behavioral measurements will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients in one of the study sites
* Acquired brain injury resulting from either traumatic or non-traumatic events
* Diagnosis of MCS defined by CRS-R according to the Aspen criteria (Giacino, 2005)
* Informed consent as documented by signature by the patient's legal representative
* Physiologically stable
* Aged 18 or over

Exclusion Criteria:

* Phobia or allergies to any of the involved animals
* Medical contraindications: acute or chronic disease (e.g. chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
* Radical changes in medication (decision made with responsible physician)
Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Half of participants will receive conventional integrated therapy on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF and traditional Chinese medicine colonic dialysis.

Patients who would hospitalized in Nephrology of Guangdong Provincial Hospital of Traditional Chinese Medicine have chance to participate this study. All participates will be divided into two groups depending on their individual treatment interests and the baseline information will be balanced.

Integrated Therapy is routine symptomatic and supportive treatment for CRF,including reducing blood pressure and urine protein, improving anemia，regulating calcium and phosphorus metabolism and so on.The colon lotion used in colonic dialysis is a kind of hospital preparation. It consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The whole treatment lasts about 10 days,as long as a regular drill-and-fill procedure. Before and after the treatment, related body dimensions will be tested.

Eligibility Criteria:
Inclusion Criteria:

* 1.corresponding to diagnosis standards of CKD-5:eGFR≤15ml/min/1.73m2; 2. did not receive kidney replacement therapy; 3. no gastrointestinal diseases (including ulcerative colitis, irritable bowel syndrome, inflammation, cancer, infection, bleeding, etc.) in the past 1 year; 4.not associated with rectal-related disorders (hemorrhoids, anal fistula, rectal cancer, cancer, infection, bleeding, etc.); 5.Sign informed consent.

Exclusion Criteria:

* 1. having used antibiotics, hormones, immunosuppressive, probiotics and laxatives in past three months; 2. pregnant or lactating patients; 3.cannot cooperate or tolerate colonic dialysis treatment; 4.combined with active stage of malignant tumors, cardiovascular, respiratory system, decompensated liver cirrhosis or blood system diseases (including coagulation disorders, hematopoietic dysfunction, etc.) and other serious primary disease; 5. recent merger of patients with infectious diseases; 6.having known to be allergic to some drugs in the study.