cyrilzakka/clinical-trials huggingface dataset:
Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests

This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of less than or equal to 63 days
* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
* Willing to use the MLPT at home
* 11-56 years old
* Willing and able to comply with study procedures
* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria:

-
Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children

The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.


Eligibility Criteria:
Inclusion Criteria:

1. Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
2. Children who needed caudal block for postoperative analgesia

Exclusion Criteria:

1. if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
2. patients scheduled for penile surgery
Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms.


Eligibility Criteria:
Inclusion Criteria:

* a score \>5 on the PHQ-9 OR a score \>5 on the GAD-7
* patient at Lurie Division of Adolescent and Young Adult Medicine
* provider agreement that this would be an appropriate intervention
* age between 13 and 25
* comfort speaking and reading in either English or Spanish

Exclusion Criteria:

* inability to speak and understand English or Spanish
* imminent risk for suicide as indicated by a "Yes" response to questions #5 on the Ask Suicide Questions (ASQ) Screener
Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community

The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).

The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.

The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 years or older
2. Advanced COPD

Exclusion Criteria:

1. Permanent tracheostomy
2. Heart failure with significant left-ventricular dysfunction
3. Severe other chronic disease
4. Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
5. No telephone or permanent address
6. Bedridden
7. Refusal to use telemonitoring equipment
8. Participation in another clinical trial
Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol

Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.

In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.

This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength...) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Lateral hip pain lasting more than 3 months.
* Greater trochanteric pain syndrome compatible with changes on MRI.
* Clinical examination correlation: one of the following tests must be positive: FADER test, FABER test, hip adduction (ADD) test in side-lying position (DL), isometric contraction test in the ADD position, or single-leg stance test for 30 seconds.
* Pain/sensitization upon palpation of the trochanter.

Exclusion Criteria:

* Radicular pain due to lumbar pathology.
* Osteoarthritis.
* Pelvic pathology that could refer pain to the hip.
* Needle phobia.
* Hip injection performed less than 6 months ago.
* Dry needling performed less than 1 month ago.
* Surgery or pathology of the lower limb that prevents single-leg support.
* Systemic diseases that could interfere with the pathological process.
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity


Eligibility Criteria:
Inclusion Criteria

* Participants must have a multiple sclerosis (MS) diagnosis.
* Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
* Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.
* Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.

Exclusion Criteria

* Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
* Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.
* Participants must not have a history of any substance abuse disorder.
* Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
* Participants must not have used cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Low-Intensity Focused Ultrasound for Cocaine Use Disorder

This study aims to understand the role of Low-Intensity Focused Ultrasound on craving levels for cocaine as evidenced by diagnostic imaging of the dorsal anterior insula (dAI) and subjective ratings. Data analysis will serve to show if 1) LIFU is safe and effective and to 2) examine the effects of LIFU on dAI BOLD activity and craving in response to cocaine cue-exposure. The study will screen 60 individuals with Cocaine Use Disorder (CUD) to arrive at 30 enrolled subjects, based on a 2:1 screen/randomization ratio.

This is a randomized single-blind, active, sham-controlled study.

This study will enroll thirty (30) individuals, aged 18 years and older, that meet the criteria for CUD. Participants will be recruited from the general population and will be asked to complete cognitive testing and measures, self-reported craving measures, and diagnostic exams including magnetic resonance imaging (MRI) and Computed Tomography (CT). Participants will also undergo functional MRI which entails being shown cocaine-related photos at regular intervals.

All participants will receive LIFU and sham interventions, but will be randomized to one of two sessions, and will return one month after the second session for an in-person follow-up. In total, there are five (5) in-person visits and two (2) phone calls to assess for adverse events, conducted over eight (8) weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older with a history of cocaine use disorder
* Have a current (past 6 months) DSM-5 diagnosis of cocaine use disorder (4 or more symptoms) assessed using the MINI neuropsychiatric interview
* Have a blood alcohol content by breathalyzer, equal to 0.000 when informed consent document is signed
* Ability to abstain from cocaine use at key points during study
* Willingness and ability to comply with scheduled visits and study procedures
* Ability to lie down for extended periods of time for imaging tests
* Will have reliable transportation throughout study
* Will have a stable residence during the 2 weeks prior to randomization and not be at risk of losing housing in next 2 months
* Must meet criteria to have magnetic resonance imaging (MRI)

Exclusion Criteria:

• Please contact PI or Study Coordinator for more details.
Efficacy and Safety of Empagliflozin in GSD-Ib Patients

Empagliflozin Treatment of GSD-1b patients

Glycogen storage disease type Ib (GSD-Ib) is a type of genetic disease with a prevalence of approximately 1 in 500,000. In addition to phenotypes common to GSD-I such as hypoglycemia, hypoglycemia, lactatemia, hyperlipidemia, hyperuricemia, and hepatomegaly, GSD-Ib patients also experience neutropenia and dysfunction, causing infections and inflammatory bowel disease (IBD). At present, the only available treatment for neutropenia in GSD-Ib patients is subcutaneous injection of granulocyte-colony stimulating factor (G-CSF). G-CSF increases the number of neutrophils, but does not improve neutrophil dysfunction, and is also associated with the risk of concurrent splenomegaly and malignancy.

The most recent research findings demonstrated that substantial accumulation of 1,5-anhydroglucitol-phosphate is the cause of neutropenia and neutrophil dysfunction in GSD Ib patients. Empagliflozin, an SGLT2 inhibitor, is an efficient and secure approach of treating neutropenia in these patients by inhibiting renal glucose and 1,5-anhydroglucitol reabsorption. Our study's objective is to assess the efficacy and safety of empagliflozin (Jardiance®) in patients with GSD Ib.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with glycogen storage disease type Ib (genetically diagnosed) aged ≥ 1 year and ≤ 50 years;
2. Patients meet the diagnostic criteria for Crohn's disease (CD) based on Expert consensus on the diagnosis and treatment of inflammatory bowel disease in Chinese children (2019) or Consensus opinion on the diagnosis and treatment of inflammatory bowel disease in China (2018), or patients meet the diagnostic criteria for recurrent respiratory tract infection based on Clinical diagnosis and treatment for recurrent respiratory tract infection in Chinese children (2022);
3. Subjects and their guardians/clients (\< 18 years old) or subjects (≥ 18 years old) signed the informed consent form.

Exclusion Criteria:

1. Patients with chronic kidney disease (eGFR \< 60 ml/min/1.73 m\^2) or cirrhosis (Metavir F4);
2. Experiencing symptomatic or severe hypoglycemia within 1 month before the start of this trial;
3. Absolute neutrophil count continued ≥ 1.5 × 10\^9/L (≥ 3 tests, each interval ≥ 5 days);
4. Current active urinary tract infection (until urine routine twice negative);
5. Participating other clinical investigators in the past 1 month;
6. Pregnancy, breast-feeding and having a pregnancy plan;
7. Presence of contraindications to empagliflozin therapy (hypersensitivity to empagliflozin, current or history of gangrene, history of recurrent urinary or genital infections);
8. Patients who are not suitable for participating in the clinical investigator or with low compliance in the investigator 's opinion.
Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression

The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Eligibility Criteria:
Inclusion Criteria:

* A primary DSM-5 diagnosis of depressive or anxiety disorder
* At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
* Age 18-65 years
* Sufficient knowledge of the German language
* Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period

Exclusion Criteria:

* Increased suicidality
* Substance abuse or dependency
* Borderline personality disorder
* Pervasive developmental disorder
* Psychotic disorder
* Eating disorder
* Bipolar disorder
* Severe physical illness
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach

Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.

The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old), male or female ,
* Persons able to understand and object to the information provided (at the discretion of the investigator)
* Patient affiliated to social security
* Patient agreeing to sign the informed consent form
* patient having presented at least one renal colic attack before inclusion

Exclusion Criteria:

* Pregnant or breastfeeding woman.
* Persons deprived of liberty,
* Adults under legal protection guardianship, or curators or unable to express their consent.
* Patient refusing to participate in the study
* Patient in an emergency situation
A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male vulunteers aged 18 and above.
* The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
* Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
* Participation in another clinical trial within 3 months.
* Smoking more than 5 cigarettes per day during the 3 months prior to screening.
* Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
* Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.
Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients

This clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using T-piece.

We project to test the effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients. Patients will be randomly assigned to undergo a spontaneous breathing trial in one of two ways: with a T-piece therapy or with high flow oxygen therapy. Primary end-points are rate of weaning failure and rate of reintubation within 48 hr of extubation. Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation. Secondary end-points are ICU mortality, in-hospital mortality, ICU length of stay, time to reintubation after extubation. Study sample was calculated to detect ability of high flow oxygen therapy to reduce weaning failure from 42 to 15 percent, at two-tailed alpha error of 5% and power of 85% and 98 patients are needed in each arm.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or more, both gender
* Receiving endotracheal intubation and mechanical ventilation for more than 12 hours
* Recovery from the precipitating illness
* Weaning readiness according to the following criteria :

  1. Respiratory criteria :

     1. PaO2:FIO2 \>150 with FIO2 ≤0.4, PEEP \<8 cm H2O
     2. Arterial pH \>7.35
     3. Rapid shallow breathing index (RSBI) \< 105
     4. Maximum inspiratory pressure (MIP) \< -20 cm H20
  2. Clinical criteria :

     1. Absence of electrocardiographic signs of myocardial ischemia
     2. No vasoactive drugs, or vital signs are stable with using vasoactive drugs
     3. Heart rate \<140/min,
     4. Hemoglobin \>8 g/dL
     5. Temperature \<38°C
     6. No need for sedatives, or mental status are stable with sedatives
     7. Presence of respiratory stimulus, and appropriate spontaneous cough
     8. Absence of excessive tracheobronchial secretions

Exclusion Criteria:

* Tracheostomy status
* Decision to stop life-supportive therapies before enrollment
Deep Brain Stimulation (DBS) for Alzheimer's Disease

Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.

Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.

Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 to 80 years old, who
* Satisfy the diagnostic criteria for probable AD,
* Have received the diagnosis of AD within the past 2 years,
* Have a CDR of 0.5 or 1.0, and
* Score between 20 and 28 on the Mini Mental State Examination

Exclusion Criteria:

* Pre-existing structural brain abnormalities,
* Other neurologic or psychiatric diagnoses, or
* Medical comorbidities that would preclude them from undergoing surgery