cyrilzakka/clinical-trials huggingface dataset:
PsylliumRx Dietary Fiber Study

The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).

For this 3-month clinical pilot trial to test the effects of dietary fiber, 120 healthy obese adolescents and young adults, age 12-21 (\>97th percentile of BMI-for-age) will be recruited to participate in this study.

Recruitment outreach will begin with an email invitation. Parents will be encouraged to call a toll-free number for study information and answer via email. One email will be sent to potential study participants. If there is no response to the email, research staff will call parents up to 5 times and leave 3 messages to introduce the study. Once a parent or potential participant has been reached over the phone, research staff will explain the study and determine interest in participating. If member is interested in participating, research staff will email member the informed consent form (ICF). Participants will sign ICF using Adobe e-Sign web server.

Intervention: Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Using a mobile application, participants will be asked to track bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.

Liquid meal challenge test: The metabolic test will be conducted as two sessions lasting 180 minutes each, before and after the dietary fiber intervention (week 0 and 12). Subjects will participate in the metabolic tests after an overnight fast. Subjects will consume 250 ml of a standard liquid meal replacement shake with sugar added to 75 g of total sugar per meal (equivalent to oral glucose tolerance test used in clinical care). Blood draw will be done through an indwelling catheter in the antecubital vein and blood samples collected into 3 mL Ethylenediaminetetraacetic acid (EDTA) containing tubes at -15, 0, 30, 60, 90, 120, and 180 minutes after administration of the test meal. An additional 5 mL serum tube and urine will be collected at time -15 min. Total blood draw volume for the entire test is 26 mL.

Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Southern California (KPSC) member for at least 12 months.
* KPSC members ages 12 to 21 years old.
* KPSC member with \>97th percentile of BMI for age.
* Minors with parents whose preferred language is English.
* 18 to 21 year old members whose preferred language is English.

Exclusion Criteria:

* Has diagnosis of serious mental illness and/or cognitive impairment.
* Provider has concerns over participation.
* Minors with parent whose preferred language is not English.
* 18 to 21 year old members whose preferred language is not English.
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Type of Study This is a single center, prospective case series

Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation.

Study Population Patients (\> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.

Study Design This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.

Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario.

Endpoints of the study The main study endpoints consist of

1. Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay.
2. Quality of Life - EORTC Thyroid specific Health related quality of life

These endpoints will be compared to historical age/indication controls for analysis.

Eligibility Criteria:
Inclusion Criteria:

- Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma.

* Total thyroid size is 7-8 cm (no more than 10 cm)
* Their age is ≥18 years and ≤80 years
* Able to give written consent

Exclusion Criteria:

* - History of neck surgery or neck radiotherapy
* Recurrent thyroid disease
* Lymph node metastases
* Presence of intraoral infections
* Presence of extrathyroidal or substernal extensions
* Smoking
* Morbid obesity
* Contra-indication to general anesthesia with nasotracheal intubation
* Previous mediastinal surgery
* Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle)
* Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
tDCS for Treatment of Depression in Parkinson's Disease

Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.

We aim to investigate the effects of transcranial direct current stimulation (tDCS) as treatment for depression in patients with Parkinson's Disease. We have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tDCS during 1 week (3 sessions a day, with 30 minutes interval in between). Subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). The collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. Subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome.

We aim to enroll 50 subjects, 25 for each arm. The sample size calculation took into consideration previous clinical trials using tDCS for depression in different settings.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease
* Geriatric Depression Scale - 15 higher that 5
* Major Depression Disorder

Exclusion Criteria:

* CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke)
* Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia)
* Previous neurosurgical intervention (i.e. DBS)
* Current use of antidepressant drug
* High suicidality risk
* Limited capacity of understanding written and spoken Portuguese
Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia

A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.

Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.

In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.

Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in video-assisted thoracoscopic lobectomy. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in lung cancer patients who have undergone video-assisted thoracoscopic lobectomy.

This prospective study will discover the efficacy and differences between two methods.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* American Society of Anesthesiologists (ASA) I-III class
* Video-assisted thoracoscopic lobectomy

Exclusion Criteria:

* previous history of allergy to local anesthetics
* psychological disorder
* chronic analgesics or sedatives use
* coagulopathy
* The presence of systemic infection or local infection at injection site
* Pregnancy
Effects of Walking and Respiratory Muscle Training on Pulmonary Function and Functional Exercise Capacity in PD

The purpose of this randomised and controlled study is to investigate the effects of walking training combined with respiratory muscle training on pulmonary function, respiratory muscle strength, and functional exercise capacity.

Although respiratory dysfunction has been recognized as a cause of morbidity and mortality in patients with Parkinson's disease (PD), most of the patients were not aware of their respiratory problems due to restriction in their activities.

Respiratory dysfunction in patients with PD has not been well characterized. However, there are many studies showing restrictive or obstructive type respiratory disorders and decreased respiratory muscle strength in the literature. Ineffective cough due to decreased respiratory muscle strength may cause to secretion retention and secondary infections in PD patients who have severe symptoms. Therefore, the assessment and rehabilitation of these respiratory problems is important in PD patients treatment. There are studies in the literature showing that respiratory muscle training is effective in PD.

Walking difficulty is seen as a common problem in PD. Typically, walking is slow despite adequate Levodopa therapy. It is known that exercise capacity may be affected by respiratory impairment, walking difficulties and personal exercise habits in patients with PD. Respiratory and walking problems lead to limitation of physical activity in PD, which leads to a decrease in exercise capacity. In a recently published article reported that walking is a good example of exercise.

Although walking training is important for PD patients, there is no studies what happens to pulmonary function and functional exercise capacity when walking training is combined with respiratory muscle training in patients with Parkinson's disease. Therefore, this study planned to investigate the effects of walking and respiratory muscle training on pulmonary function and functional exercise capacity in PD.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed according with PD to the clinical criteria of the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria
* being in phase 1-3 according to the Hoehn-Yahr (H-Y) scale,
* being under anti-parkinson's treatment, and
* being in the "on"period.

Exclusion Criteria:

* • dyskinesia, (which may be obstacles to the tests),

  * chronic respiratory disease,
  * dementia,
  * co-operation difficulty,
  * cognitive impairment (mini-mental test score \<24), and
  * other neurologic, cardiovascular or musculoskeletal problems that impede walking.
Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase

Screening Wizard (SW). Primary Care Providers (PCPs) are often uncertain about how to best refer adolescents who screen positive for depression or suicidality. Screen-positive youth who are either not in treatment, or express dissatisfaction with current treatment will be consented by an on-site research assistant (RA). Those parents and patients receiving SW will answer additional questions: adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania; perceived barriers; and preferences about treatment. SW generates recommendations for PCPs reflecting patient clinical needs and preferences.

Screening Wizard will be delivered by Primary Care Providers (PCPs) at well child visits, beginning with screening occurring within the waiting room which will yield decision support guidance delivered and followed by the PCP at that same visit.

This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.

Hypothesis: The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).

Eligibility Criteria:
Inclusion Criteria:

* Youth aged 12-26 yo
* Biological or adoptive parent is willing to provide informed consent for teen to participate
* Youth speaks and understands English

Exclusion Criteria:

* Non English speaking
* No parent willing to provide informed consent
* Is currently experiencing acute mania or psychosis, evidence of an intellectual or developmental disorder (IDD), life threatening medical condition that requires immediate treatment, or other cognitive or medical condition preventing youth from understanding study and/or participating.
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.

This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.


Eligibility Criteria:
Inclusion Criteria:

* childhood and adolescent patients aged \>/=6 months to 18 years of age
* metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
* adequate bone marrow function
* adequate renal and liver function
* adequate blood clotting

Exclusion Criteria:

* previous malignant tumors
* tumor invading major blood vessels
* prior systemic anti-tumor treatment
Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.

The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.


Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis in the distal interphalangeal joint
* require surgical treatment
* patient aged 18 years and over
* signed written informed consent

Exclusion Criteria:

* posttraumatic osteoarthritis
* rheumatoid disease
* pregnant woman
* any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* legal incompetence
* no knowledge of German
Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis

The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* patients who provided informed consent
* patients who were diagnosed with RAS by CTA, MRA, or Doppler ultrasonography
* patients who were aged 18 years or older
* patients whose intervened renal arteries were not completely occluded (confirmed by DSA)
* the stenosis percentage exceeding 70%
* patients who had uncontrolled blood pressure or impaired renal function
* paitents whose affected kidney did not have total loss of function

Exclusion Criteria:

* were pregnant
* had a history of renal transplantation or renal artery bypass surgery
* were allergic to iodine contrast medium
* had other contraindications of endovascular treatment
* contraindications of MRI examinations
* had technical failure in the endovascular treatment.
Hearing Study: Sensitivity to Features of Speech Sounds

The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.

The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.

Eligibility Criteria:
Inclusion Criteria:

* Normal hearing, mild or moderate symmetric sensorineural hearing loss.

Exclusion Criteria:

* Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
* Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.


Eligibility Criteria:
Key Inclusion Criteria:

* Has ESRD and has been on hemodialysis 3 times per week for at least 3 months;
* Not currently taking opioid medication;
* If female, is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

• Has a concomitant disease or a history of any condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements; Past or present diseases, which as judged by the Investigator, may affect the outcome of this study.
Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning

  * Written informed consent
  * No uncontrolled infections

Exclusion Criteria:

* Severe organ dysfunction defined as:
* Cardiac left ventricular ejection fraction (LVEF) of less than 35%
* diffusing lung capacity (DLCO) of less than 40%
* total lung capacity (TLC) of less than 40%
* forced expiratory volume (FEV1) of less than 40%
* total bilirubin \>3mg/dl
* creatinine-clearance of less than 40 ml/min
* pregnancy or breast feeding
* participation in other experimental drug trials