cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study Evaluating the ParaPatch System

A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.

* Baseline Period

  o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary.
* Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected.
* Inclusion/exclusion criteria will be rechecked at end of baseline.
* Qol questionnaires will be completed in the office at the end of baseline period.
* Evaluation Period

  o During the evaluation period, the subjects will use the ParaPatch System.
* No medications affecting bladder function will be allowed during the evaluation period.
* Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters.
* Qol questionnaires will be completed in the office at the end of evaluation period.
* Follow-up Period

  o Subjects will be followed for after the evaluation period to check for residual Adverse Events.
* No medications affecting bladder function will be allowed during the follow-up period.
* Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* Women aged from \>18 to \< 75 years old.
* Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires.
* Subject is able to provide written informed consent prior to participation in the study.
* Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence.

Exclusion Criteria:

* Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
* Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits).
* Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months.
* Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator.
* Have an untreated recurrent urinary tract infection (\> 2 times within the past 6 months).
* Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease.
* Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial

There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.

One of the complications of performing the colorectal anastomosis is the anastomotic leak, which sometimes entails the need for reinterventions and stoma formation (provisional or definitive). In recent decades, the improvement in surgical techniques together with the knowledge of the causes that predispose to the anastomotic failure have allowed to reduced the rates.

The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine (liquid or air) has been proposed as a factor that could influence the healing between intestines.

In studies carried out in other centers, with the same characteristics as the present one, differences have been shown in the probability of anastomotic leakage, but these results are not conclusive and do not allow us to know the effectiveness of this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing scheduled laparoscopic, robotic or laparotomic colorectal cancer surgery who undergo colorectal anastomosis.
* Both mechanical and manual colorectal anastomosis with or without diverting ileostomy.
* Negative intraoperative air-leak test.
* Height of the anastomosis: promontory or distal to it.
* Age≥18 years.
* Histology of Adenocarcinoma with or without prior neoadjuvant treatment.
* Any T, any N, any M.
* Informed consent signed by the patient and by the researcher.

Exclusion Criteria:

* No performance of colorectal anastomosis.
* Colorectal tumor with histology other than adenocarcinoma or adenoma.
* Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of surgery.
* Inability to read or understand any of the informed consent languages (Catalan, Spanish).
* Emergency surgery.
* Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
Open Label Study of Octreotide Implant in Patients With Acromegaly

To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.

An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30 male and female patients with acromegaly. Eligible patients received 1 implant, either hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone (GH), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with acromegaly
* Must be at least 18 years old
* Confirmed diagnosis of a growth hormone -secreting tumor
* Must be either a full or partial responder to octreotide demonstrated by historical laboratory values

Exclusion Criteria:

* Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control
* Patients with liver disease
* Patients with symptomatic cholelithiasis
* Patients receiving radiotherapy for their pituitary tumor at any time before Screening
Obesity and Endogenous Oxalate Synthesis

The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones.

The study will recruit adult participants without history of kidney stones. Participants will

* Ingest fixed diets containing low amounts of oxalate for 4 days
* Collect 24-hr urine samples during the fixed diet

In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, in individuals of varying body sizes without history of kidney stones. The 24-hr urinary oxalate excretion on such a low-oxalate normal calcium fixed diet is determined to be an appropriate surrogate for endogenous oxalate synthesis.

Screening phase. The study will enroll 60 individuals without history of kidney stones (30 males/30 females) at the University of Alabama at Birmingham (UAB).

Screening will include blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.

Dietary phase Participants will ingest a low-oxalate (\<60 mg/day), normal calcium (1000 mg/day) fixed diet for 4 consecutive days, collect three 24-hr urines after 1 day of dietary equilibration and have a fasted blood draw on day 5.

Eligibility Criteria:
Inclusion Criteria

Age 19-70 yrs Body Mass Index \> 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets

Exclusion Criteria

Chronic Kidney Disease, estimated glomerular filtration rate \< 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes
Investigation of the Relationship Between Core Muscles Functions and Symptoms of Patients with Abdominal Bloating/Distension

The aim of this study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension. The main questions it aims to answer are:

Does symptoms in individuals with abdominal bloating/distension have an effect on core muscles? How do core muscles change based on an increase or decrease in these symptoms?

In studies on individuals with abdominal bloating/distension in the literature, the diaphragm, abdominal muscles, and pelvic floor muscles have been examined separately. There is no study that examines all core muscles together in such cases. Additionally, there is no study examining the relationship between core muscle function and symptoms. Therefore, the aim of our study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of abdominal bloating/distension made by a physician according to the Rome IV Criteria
* Be female between 18 and 65 years of age
* Volunteer to participate\&#34;

Exclusion Criteria:

* Having a serious neurological, pulmonary, systemic, orthopedic, or metabolic disease accompanying bloating-distension
* Being under 18 or over 65 years of age
* Being pregnant
* Having any organic cause for bloating and distension (such as celiac disease or other absorption disorders, intestinal dysmotility, and chronic intestinal pseudo-obstruction)
* Having alarm symptoms (weight loss, rectal bleeding, or anemia)
* Having a Body Mass Index (BMI) ≥40
* Having a history of gastrointestinal (GI) or abdominolumbopelvic surgery
Biomarkers of Traumatic Brain Injury With Tbit System

A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Presents to the Emergency Department with suspected traumatic brain injury
* Prescribed a non-contrast CCT as part of routine emergency care within 24 hours from injury
* Blood sample collected for Tbit™ System within 12 hours of injury
* Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria:

* Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
* Subject suspect of need of craniotomy for the acute trauma for this event
* External signs compatible with a depressed skull fracture based on ED exam
* Subject requiring administration of blood transfusion after injury and prior to study blood draw
* Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
* Subject with a condition precluding entry into the CT scanner
* Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
* Known or suspected to be pregnant
* Prisoner or under incarceration
* Participating in another clinical research study prior to this study completion
A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients

Objectives:

Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia.

Design:

A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.

Subjects:

Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a subgroup of them will be included according to specific inclusion criteria tailored for indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).

Method:

Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be treated during a single session, and real/sham SNAG will be applied from a sitting position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a validated kinematic spine model will be used and recorded with an opto-electronic device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic with for factors; time and groups.


Eligibility Criteria:
Inclusion Criteria:

* non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy

Exclusion Criteria:

* specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied
A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC

The aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's overall survival (OS) is superior to placebo.

This is a multicenter, randomized , double-blind Phase II trial and the aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With Abiraterone and Docetaxel whether the patient's overall survival (OS) is superior to placebo. The Stage I part is a dose-escalation and -expansion study. Approximately 18\~24 patients in Stage I will receive fixed-dose of orally SHR3680 and only one of two dose levels of orally SHR3162. The Primary endpoints of the Stage I are incidence of adverse events(AE) and recommended phase 2 dose(RP2D). The Stage II part is a randomized , double-blind study. Approximately 90\~120 patients in Stage II will receive SHR3162 combined with SHR3680, in which one fixed-dose levels of SHR3162 will be selected based on the result of the Stage I.The Primary endpoint of the Stage II is overall survival(OS).

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
3. Radiographic evidence of metastasis;
4. Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
6. Adequate hepatic, renal, heart, and hematological functions;
7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
8. Patient has been treated with Abiraterone and treatment failed（Treatment failure is defined as the progression of disease during treatment）
9. Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening.

Exclusion Criteria:

1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
2. Planned to initiate any other anti-tumor therapies during the study;
3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
4. Clinically significant cardiovascular diseases;
5. History of seizure or certain conditions that may predispose to seizure;
6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Evaluation of the Patient's Experience in Medical Studies for Cholangiocarcinoma

The main reason for conducting this research is to gain a better understanding of why some people with cholangiocarcinoma are not able to participate in or complete clinical trials. Historically, certain groups of people have been more likely to participate in clinical trials, but there hasn't been much research to understand why this is the case.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future cholangiocarcinoma patients during clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Participant has a diagnosis of Cholangiocarcinoma
* Patient has self-identified as planning to enroll in an interventional Cholangiocarcinoma clinical trial
* Patient must provide written informed consent

Exclusion Criteria:

* No diagnosis of Cholangiocarcinoma confirmed
* Inability to perform regular electronic reporting
* Women who are pregnant, intend to become pregnant, or are lactating
* Patient does not understand, sign, and return consent form
Improving Voice Production for Adults With Age-related Dysphonia

The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.


Eligibility Criteria:
Inclusion Criteria:

* Adults in age range who volunteer
* Can understand and complete directions presented in English
* People with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux.

Exclusion Criteria:

* Laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, Parkinson disease)
* Known history of stroke, brain injury, or other neurological disorder
Ultrasound Guided Artificial Insemination

The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* The woman's inclusion criteria in our IUI program were at least one patent tube, normal cavity, basal FSH \< 10 mU/mL and age under 40 years.
* IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%).
* In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4).

Exclusion Criteria:

* Previous infertility treatments had been carried out.
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.

The purpose of this proof-of-concept study is to evaluate ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutations and other rare genetic epilepsies. After establishing baseline seizure frequency, qualifying subjects will enter the study and be treated with open-label ganaxolone for up to six months.

Eligibility Criteria:
Key Inclusion Criteria:

1. Have parent or legal guardian available and willing to give written informed consent.
2. Male and female outpatients between 2 and 18 years of age years of age at time of consent.
3. Have any of the following epilepsy syndromes: PCDH19; CDKL5; Dravet Syndrome; Lennox Gastaut Syndrome (LGS); Continuous Spikes and Waves during Sleep (CSWS)
4. Have uncontrolled cluster seizures and/or non-clustered seizures.
5. Subjects should be on a stable regimen of anti-epileptic medication, and generally in good health.
6. Parent or guardian is able and willing to maintain an accurate and complete daily written seizure calendar.
7. Able and willing to take study medication with food, two or three times daily.

Key Exclusion Criteria

1. Have had previous exposure to ganaxolone.
2. Known sensitivity or allergy to any component in the study drug, progesterone, or other related steroid compounds.
3. Exposure to any investigational drug or device \< 90 days prior to screening, or plans to participate in another drug or device trial at any time during the study.
4. Concurrent use of vigabatrin, tiagabine, or ezogabine is not permitted.
5. Have any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to: clinically significant cardiac, renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
6. Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.
7. Have Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels \> 3 times upper limits of normal (ULN), or total bilirubin \>1.5 time ULN at the screening and baseline visits.