cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Head-point Acupuncture on Insomnia

The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled. The aim of the study is to assess the therapeutic effect of head-point acupuncture for the treatment of insomnia.

The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled, and will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 acupuncture treatment for 4 weeks.

The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.

The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).

Eligibility Criteria:
Inclusion Criteria:

1. aged 20\~80 years,
2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
3. experienced insomnia at least three times a week for more than a month
4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.

Exclusion Criteria:

1. a pregnant or lactating woman
2. the patient's insomnia is caused by mental disorders other than mild anxiety,
3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
6. the patient with cardiac pacemaker
7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
8. the patient has a history of sleep apnea
Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).

The SPIRIT study is interventional, national, prospective, open, multicentric each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting a non-traumatic acute-subacute hemiplegia. The primary endpoint is defined by the patient's ability to perform the 10 MWT with the Atalante system.

The study will include at least 12 patients and takes place in three french rehabilitation centers.


Eligibility Criteria:
Inclusion Criteria:

* Patient with non-traumatic vascular hemiplegia in acute subacute phase (15 days to 6 months) hospitalized in rehabilitation center,
* Patients presenting a FAC score of 0, 1 or 2,
* Patient with ischemic or hemorrhagic stroke of which etiological evaluation is complete,
* Adult patient ≥18 years old,
* Patient able to verticalize on a daily basis and having a stabilized blood pressure,
* Patient with stable medical condition at the time of inclusion in the study (absence of infectious and cardiorespiratory events),
* Patient's height is at least 1m55,
* Lengths of patient's lower limb are in the following intervals:

  * Thigh (distance gluteus maximus - patella): 56.8 and 64.8 cm,
  * Distance between the ground and the joint space of the knee (to be measured while wearing the shoes the patient intends to wear with Atalante):

    * 45.7-60.7 cm for patient with an ankle dorsiflexion ≥ 16°
    * 45.7-57.7 cm for patient with an ankle dorsiflexion \&gt; 13° et \&lt; 16°
    * 45.7-56.7 cm for patient with an ankle dorsiflexion \&gt; 10° et ≤ 13°
    * 45.7-55.7 cm for patient with an ankle dorsiflexion ≥ 0° et ≤ 10°
  * Intertrochanteric distance lower or equal to 46.0 cm when seated,
* Maximum weight: 90 kg,
* Patient able to read and write French and who have signed an informed consent form.

Exclusion Criteria:

* Ranges of motion below:

  * Hip: 90° flexion, 5° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation
  * Knee: 5° extension, 110° flexion
  * Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
* Patient whose joint centers cannot be aligned Atalante's system,
* Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
* Pregnant or lactating women,
* Medical history of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis,
* Patient with a cardiac contraindication to physical exertion,
* Evolutive intercurrent disease: venous thrombosis, hypotension,
* Patient unable to deliver his/her consent,
* Patient under legal protection,
* Patient participating at the same time in another study.
Robotic Seed Implantation for Prostate Cancer Brachytherapy

A robotic brachytherapy device will be used to assist physicians in performing seed implantation to the prostate. EUCLIDIAN is the first robotic system designed to allow automatic placement of radioactive seeds by robot and thus reduce operator dependence. The clinical study is designed to evaluate the dosimetric quality, accuracy and patient self-reported quality of life scores after robotic brachytherapy.

EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing)

The dose-volume histogram parameters of robotic brachytherapy will be compared to historical controls of the study institution. Short-term (\<1 yr) health-related quality of life (HRQoL) and changes will be assessed using FACT-P and IPSS self-report questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T2b, NX, N0, M0.
* Zubrod status 0-1.
* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration
* No prior pelvic radiation or chemotherapy for any reason; induction hormonal therapy beginning \< or = 6 months prior to registration is acceptable.
* Prostate volume \< or = 65 cc prior to registration, or planned use of LHRH agonist therapy for reduction of prostate volume. If LHRH agonist therapy is used to reduce prostate volume, then prostate volume must be \< or = 65 cc on the routine pre-implant volume study to be eligible for the study.
* Gleason score 6, or Gleason Score 7 if both , or = 33% of biopsy cores contain cancer and PSA level is \< or = 10 ng/mL.
* AUA voiding symptoms score \< or = 15.
* Prostate specific antigen (PSA) prior to study entry (and prior to any hormone treatment if given); must be \< or = 20 ng/ml.
* Patients must sign a study-specific consent form prior to registration (Standard of care: only the standard consent form must be signed).
* Patient must be \> or = 40 years old.

Exclusion Criteria:

* Stage T2c, T3 or T4 disease.
* Lymph node involvement (pathological N1)
* Evidence of distant metastases (M1)
* Gleason score 8-10.
* Prostate specific antigen (PSA) prior to study entry \> 20 ng/mL.
* AUA voiding symptoms score \> 15.
* Radical surgery for carcinoma of the prostate.
* Previous hormonal therapy beginning \> 6 months prior to registration
* Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease- free for \> or = 5 years.
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up and/or completion of HRQoL questionnaires (not a condition for ineligibility in Standard of care).
* Prior TURP
* Hip prosthesis
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers

We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.

As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* sporadic cigarette smoking (\<9 cigarettes per month)

Exclusion Criteria:

* Any form of cardiovascular disease
* Any form of pulmonary disease like asthma or COPD
* Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
* Active allergy within 4 weeks of the study
* Symptoms of infection or inflammation within 4 weeks of the study
* Pregnancy
Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH

The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 75 years of age.
* Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
* Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.

Exclusion Criteria:

Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:

* Cirrhosis or current unstable liver or biliary disease.
* Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
* Known weight loss of ≥5% within 3 months prior to Screening.
* Weight reduction surgery or procedures within 2 years of Screening.
* Any contraindication to undergoing liver biopsy.
* Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.
Novel Endoluminal Clinical TreAtment of Reflux

This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.


Eligibility Criteria:
Inclusion Criteria:

1. History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
2. History of GERD symptoms of at least six months despite continuous PPIs.
3. GERD-HRQL score ≥15 after discontinuing PPI therapy.
4. GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
5. A minimum GERD-HRQL score while on PPIs of 2.
6. Pathologic acid exposure time, a baseline pH \<4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
7. Twenty two years of age or older.
8. Life expectancy of at least two years.
9. Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
10. Is capable of understanding clinical study procedures and giving informed consent.

Exclusion Criteria:

1. Unable to tolerate an endoscopic procedure
2. Presence of esophageal or gastric varices
3. Presence of erosive esophagitis (LA Classification of C or D)
4. Presence of a hiatal hernia \> 2 cm
5. Presence of Barrett's esophagus
6. Presence of esophageal motility disorder
7. History of or known esophageal stricture or gross esophageal anatomic abnormalities
8. Symptoms of dysphagia more than once per week within the last six months
9. Obesity (BMI ≥ 35)
10. Gastric or esophageal cancer undergoing active treatment
11. Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites
12. Had an ablation procedure in the lower esophageal sphincter area
13. Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder
14. Enrolled in a concurrent clinical trial
15. Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator)
16. Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months
17. Prior gastric or GERD surgery
A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.

Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.

Eligibility Criteria:
Inclusion Criteria:

* Age \>19 years
* Gestational age \> 37 weeks
* Booked elective cesarean section

Exclusion Criteria:

* Gestational age \< 37 weeks
* Premature rupture of membranes
* Onset of labor prior to procedure
* Evidence of maternal sepsis; maternal fever \> 38.5C
* LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction
Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study

To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather adequate tissue for cancer stem cell quantification.


Eligibility Criteria:
Inclusion Criteria:1. Patients with malignant tumors seen at the Stanford University Cancer Center. Eligible patients will have a diagnosis of squamous cell carcinoma (HNSCC) and will have been seen in the Stanford Head and Neck Oncology Program. A decision to undergo surgery at Stanford will have been made, prior to recruiting patients for the study, and prior to obtaining the samples during surgery. (Histological confirmation of the diagnosis need not be made prior to obtaining consent.) 2. A definitive resection of a malignant tumor is planned. 3. Surgeon judgment that the definitive procedure will not be compromised by including

* FNA
* Core needle biopsy
* Cup forceps or punch biopsy of\<4mm. 4. Informed consent documented prior to procedure
Transitional Rehabilitation in CABG Patients

The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.

Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease. The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning. The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery. Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* 50-80 yrs of age
* ambulatory
* scheduled for coronary artery bypass graft surgery
* able to provide informed consent

Exclusion Criteria:

* rheumatoid arthritis or other inflammatory/autoimmune disease
* cancer, excluding non-melanoma skin cancer
* exercise limiting peripheral vascular disease
* neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
* body mass index \>38 kg/m2
* valvular heart disease not corrected surgically
* lower extremity blood clot or implantable cardioverter-defibrillator
AI-assisted Preoperative Planning Technology for THA for DDH

In this study, the investigators retrospectively collected DDH case data of THA assisted by AI 3D planning and THA assisted by traditional planning. The compliance between preoperative planning and the type of prosthesis used in the operation, the position of the acetabular prosthesis, the correction of LLD and the postoperative joint function score were analysed to evaluate the short-term effect of AI combined with preoperative 3D planning in THA for DDH.


Eligibility Criteria:
Inclusion Criteria:

* DDH was diagnosed by clinical signs and imaging examination, and a primary THA was planned;
* the patient had persistent unilateral hip pain, which seriously affected their quality of life;
* the standard posterolateral approach was used;
* the contralateral hip was normal or had received THA;
* the proximal femoral Dorr classification was type A or B;
* The acetabular classification was Crowe type Ⅰ, Ⅱ, Ⅲ or IV;
* all patients were treated with the bioartificial hip joint PINNACLE® cup or SUMMIT® stem, developed by Johnson \& Johnson Biological.

Exclusion Criteria:

* preoperative and postoperative imaging examinations did not meet the evaluation criteria (non-standard double-hip anteroposterior film, acetabular angle and LL length could not be accurately measured);
* severe osteoporosis, tumour or metabolic disease around the affected hip joint;
* spinal deformity by other causes or a history of lumbar internal fixation;
* external deformity of the affected hip joint in the lower extremity;
* neuromuscular insufficiency (with hip abduction weakness and poliomyelitis);
* severe disease with intolerance to surgery.
Macroalgae Consumption - a Pilot Study

In this study, the aim is to investigate the food safety of macroalgae. There will be an analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and iodine in macroalgae, as well as measure the status of these elements in consumers. An investigation of the thyroid function of macroalgae consumers and the use of metabolomics to explore which biological changes occur when consuming seaweed and kelp and when the consumer excludes macroalgae from their diet will be performed.

A group of consumers of macroalgae will be recruited to investigate their macroalgae intake and iodine, cadmium, and inorganic arsenic status and thyroid function. Iodine, cadmium, and inorganic arsenic have been selected since these elements have been described as relatively high in a previously published report from Norway. The goal is to recruit consumers of brown algae - especially kelp, and certain types of red algae, as these were the species with the highest content of iodine, cadmium, and arsenic, described in a previous publication. The participants will be asked to abstain from macroalgae for 6 weeks and again examine iodine status, cadmium and arsenic exposure, and thyroid function after the cessation period. A withdrawal period of 6 weeks has been chosen on the basis that it is calculated 6-8 weeks after Levaxin treatment for hypothyroidism before a new equilibrium can be expected and the effect of treatment on TSH can be assessed.

This study will provide new insight into the status of iodine, cadmium, and inorganic arsenic that macroalgae consumers have in urine and thyroid function after regular macroalgae consumption and after cessation of macroalgae intake. In addition, the study will provide descriptive data on macroalgae consumption, how it is eaten, how often, and how much. This can provide critical knowledge to the national and European authorities for food safety and public health advisers to evaluate the food safety of macroalgae.

Eligibility Criteria:
Inclusion Criteria:

* adults
* weekly consumer of macroalgae

Exclusion Criteria:

* pregnant
* known disease