cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain

The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.

This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (TTS) Durogesic® D-Trans in patients with non-cancer pain. The patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). The study will be conducted for 12 weeks. The efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. All participants will use the patch at least once during the study. The drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. The overall safety will be assessed based on the adverse events reporting.

Eligibility Criteria:
Inclusion Criteria:

* spine related and extremity pain lasting for 3 months or longer
* pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
* good overall health condition based on the medical history and clinical laboratory tests
* participants using appropriate contraception in case of childbearing potential during the study period.

Exclusion Criteria:

* history of hypersensitive reaction to narcotic analgesics
* history of narcotic abuse
* serious psychotic disorder
* unable to use transdermal analgesics due to a dermatological condition
* history of CO2 retention (e.g., chronic obstructive pulmonary disease)
* surgery in the area with pain within 7 days prior to initiation of the clinical study.
Effectiveness and Safety of Single-session Endoscopic Stone Extraction

This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.

Acute cholangitis is an acute inflammation caused by obstruction of the bile duct, of which choledocholithiasis is the most common cause. Without timely removal of the obstruction or control of the infection, cholangitis can get worse and even become life-threatening. Therefore, timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis. Endoscopic retrograde cholangiography (ERCP) is used as the first-line treatment for choledocholithiasis-associated acute cholangitis. Previous guidelines recommended two-session endoscopic therapy. Endoscopic biliary drainage as the initial treatment, followed by endoscopic stone extraction after cholangitis improved. In recent years, studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment. Meanwhile, single-session endoscopic lithotomy can avoid the second ERCP intervention, which can relieve the pain of patients, reduce medical costs and shorten the length of hospital stay. However, there is still insufficient evidence on the effectiveness and safety of early single-session ERCP lithotomy. The aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis, so as to provide reference of clinical treatment.

In a prospective study, approximately 64 patients with acute cholangitis accompanied with choledocholithiasis will be involved. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old and ≤90 years old
* 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis
* 3. Imaging examination confirmed the presence of choledocholithiasis

Exclusion Criteria:

* 1. Common bile duct with benign or malignant stenosis
* 2. Changes in the anatomical structure of the stomach or duodenum
* 3. Patients with common biliary duct or pancreatic duct stent
* 4. Patients complicated with acute pancreatitis
* 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission
* 6. Patients with cardiac failure, respiratory failure or consciousness disorder can not tolerate endoscopic operation
* 7. Patients who have coagulation dysfunction or are taking anticoagulation and antiplate drugs
* 8. Imaging examination showed that the maximum diameter of choledocholithiasis was more than 1.5cm
Tolerance & Responsiveness Improvement for Metformin (TRIM)

The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).


Eligibility Criteria:
Inclusion criteria

1. Male (M)
2. African American (AA) race
3. Age 20-70 years
4. BMI 28-59 kg/m2
5. T2D
6. A1c 6.5 - 8.9%
7. eGFR =/\> 30
8. Drug-naïve or use Glipizide or newly started on Metformin (within 2 weeks).

Exclusion criteria

1. Chronic kidney disease stage 3b, 4 and 5 (eGFR \< 30)
2. Insulin use
3. Oral steroids use (inhalers and creams are allowed)
4. Antibiotic use within the last month
5. Artificial heart valves
6. Hospitalization for chronic condition within 6 months prior to the study
7. History, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
8. Use of other antidiabetic drugs (except glipizide and metformin).
9. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Additional Exclusion criteria for subjects who previously used Metformin:

1. Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
2. Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
3. Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.
End-range Mobilization on Pressure Pain Threshold

Pain in knee osteoarthritis (OA) represents increased pain intensity due to peripheral and central sensitivity. Pressure pain threshold (PPT) is a widely applied (used) method for measuring the magnitude of peripheral and central sensitivity in knee OA. Among several manual therapy techniques increasing PPT in knee OA, the effect of end-range mobilization has not been evaluated so far. The aim of this study was to investigate the immediate effect of end-range mobilization compared to placebo on increase of PPT and some function-related measures.

Knee osteoarthritis (OA) is the most common form of arthritis contributing to a major cause of disability worldwide. Although many mechanisms may contribute to knee pain severity, the patient-reported hyperalgesia can be attributed to peripheral and central sensitivity in knee OA. Pressure pain threshold (PPT) measurement is a simple and commonly applied method for measuring somatosensory function in musculoskeletal disorders, just as in knee OA. Many trials have shown a lower PPT value in knee OA underlining the presence of peripheral and central sensitivity compared to healthy controls.

Manual therapy techniques, as a preferred treatment option, may not only alleviate pain, but also increase pain tolerance to locally applied mechanical pressure. Positive results of different manual therapy techniques on increase of PPT has been reported in knee OA. End-range manual therapy is an option for the decrease of sensitivity in knee OA; however, the effect of end-range mobilization has not been evaluated so far in knee OA.

Eligibility Criteria:
Inclusion Criteria:

* the clinical classification criteria of knee OA according to the American College of Rheumatology
* Categorization of patients as End Of Range Problem based on Maitland manual therapy
* female patients aged between 60 and 80 years
* uni/bilateral moderate-to-severe symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale 2 or 3
* pain during weight-bearing activities at least within 6 months
* at least 90° knee flexion
* sufficient mental status.

Exclusion Criteria:

* acute inflammation of the knee
* total knee replacement in the opposite side
* severe degenerative lumbar spine disease (e.g. spondylolisthesis)
* systemic inflammatory arthritic or neurological condition
* physiotherapy/balneotherapy attendance or manual therapy within 3 months
* intraarticular injections in the prior 12 months
* use of walking aids
* contraindication for manual therapy
* complex regional pain syndrome
* cognitive impairment
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL .

OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of OnabotA X in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States.

Participants will receive one dose of OnabotA X administered as 5 injections on Day 1.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines.
* Participant has severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.

Exclusion Criteria:

* History of known immunization to any botulinum toxin serotype.
* History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
* Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotA X or interfere with the study evaluation, including:

  * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
  * History of facial nerve palsy
  * Infection or dermatological condition at the site of study drug injection
  * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
  * Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator
Impact of Educational and Professional Supportive Interventions on Nursing Home Quality Indicators

Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality indicators is not well-established.

The main objective: The main purpose of the IQUARE study was to examine the impact of two types of audit and feedback interventions on NH quality indicators and on residents dependence levels in a 18-month follow-up.

Study hypothesis: We hypothesised that audit and feedback associated to educational and professional supportive interventions are more efficacy in improving NH quality indicators than audit and feedback only.

Secondary objectives: Investigate the impact of the interventions on

1. Residents:

   * Functional decline rate
   * Drug prescriptions (quantity and quality)
   * Prevalence of adverse health outcomes (e.g., falls)
2. NHs:

   * Planning and implementation of therapeutic measures

IQUARE is a multicentric individually-tailored controlled trial comparing two types of audit and feedback interventions:

* audit and feedback associated to cooperative work meetings between hospital geriatricians and nursing home (NH) staff in a 6-month intervention (strong intervention)
* audit and feedback only (light intervention) Power statistics and sample size calculations indicated that each group should be composed of at least 2 500 individuals. The strong intervention will last 6 months and is composed of two face-to-face cooperative meetings (hospital geriatricians and NH staff). Data will be collected at baseline and in a 18-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Nursing homes (NH) voluntarily accepted to participate in the study.
* NH residents of both sex
* Residents living in the NH for ≥ 30 days
* Residents and their general practitioner (GP) having received information about the study
* NH residents do not voluntarily decline to participate in the study

Exclusion Criteria:

* NH currently participating in another interventional study
* GP of NH residents refused participation in the study.
A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough

Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that Desflurane can reduce the extubation time when compared to Sevoflurane. This potential benefit of Desflurane can be especially attractive in short ambulatory cases performed with general anesthesia with a laryngeal mask airway.

Although some studies have not shown a difference on perioperative cough and laryngospasm between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the literature that Desflurane causes cough4 and many providers avoid using Desflurane with a LMA (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate, as a secondary outcome, the presence and severity of perioperative cough and laryngospasm.

Previous investigators have demonstrated a more rapid resumption of normal daily activities after ambulatory surgery in patients anesthetized with Desflurane when compared with Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality of recovery as a secondary outcome using a validated instrument.

Significance:

1. A more rapid awakening, especially, in a fast and high turnover cases that are performed with LMA can lead to a more cost effective utilization of operating room time
2. It has been reported that Desflurane causes more cough than Sevoflurane and Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that there is no difference.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Female patients undergoing outpatient gynecologic and breast surgery
* Under general anesthesia using an LMA
* ASA I,II,

Exclusion Criteria:

* Patients on CNS depressants
* Chronic opioid use
* Corticosteroid
* Pregnant patients
* Full stomach
* Morbidly obese (BMI \>35kg/m2)
* Hepatitis B
* Hepatitis C
* Coronary artery disease
* Liver disease
* Renal disease
* Seizure disorder

Dropout criteria:

* Need for endotracheal tube
* Surgeon or patient request
* Hospital admission
Nutrition and Pregnancy Intervention Study

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery.

The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated.

Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.


Eligibility Criteria:
Inclusion Criteria:

* pregnant, less than 17 gestational weeks
* overweight
* healthy

Exclusion Criteria:

* Diabetes (type 1 or 2)
* Coeliac disease
* Increased bleeding tendency
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
* Corrected serum calcium level is \> 11.3 mg/dL at screening.

Exclusion Criteria:

* Patients receiving cinacalcet hydrochloride within 2 weeks before screening
* Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
* Severe heart disease
* Severe hepatic dysfunction
* Uncontrolled hypertension and/or diabetes
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count

This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in 40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25 ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed, Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum, Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit, Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and morphology. Secondary Outcome measure is to see the impact on the harmone level.

METHODOLOGY OF PROPOSED RESEARCH:

I. Preclinical study II. Clinical study

I. PRECLINICAL STUDY:

Standardization Of The Study Drug

1. Botanical Identification
2. Chemical Identification
3. Preparation of the study drugs:

   Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168 (Approved sastric book as per drugs \& cosmetic act 1940.
4. Chemical methods of testing
5. Pharmacological study : A. Spermotogenic Activity
6. Toxicological study : A. Acute Toxicity B. Long term Toxicity

II. CLINICAL STUDY

Conducted as per the guidelines of GCP accepted by Ayush adapted from the ICH.

A. Pilot study B. Main study

Eligibility Criteria:
Inclusion criteria:

* Male infertile Patients with age between 21-45 yrs
* Marriage history for \>1 year
* Abnormal Sperm count 1-15 million/ml
* Patients with normal Liver \& Renal function test
* Willing to give specimen of semen before \& at the end of the clinical trial
* Informed patients giving written consent

Exclusion criteria:

* Azoospermia - complete absence of sperm cells in the ejaculate
* Aspermia - complete lack of semen
* Necrospermia- Spermatozoa in semen are either immobile or dead.
* Clinical diagnosis of Varicocele \& Hydrocele
* History of Undescended testis
* Inguinal hernia on physical examination
* Male accessory gland infection
* History of DM, Hypertension and Cardiac disease
* Any recent medical or surgical illness
* Underwent treatment for promoting Spermatogenic fertility in last 3 months
* Other Systemic disease requiring specific therapies
* Known Thyroid disease
* Past history of Renal, Hepatic or any other chronic illness in the Patient
Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

Subject must be eligible for a diagnostic or surgical procedure and

* Suffers from OSA (apnea/hypopnea index \>10 event/h sleep) based on history and a physical exam.
* Is a surgical candidate.
* Is willing and capable of providing informed consent.
* Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
* Is willing to participate in the designated follow-up visits.
* Must be in good general health.
* Is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
* Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria:

* Has Body Mass Index above 35 kg/m2.
* Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
* Has significant co-morbidities making them unable or inappropriate to participate in this POC study.
Retrospective Femoral Nerve Block Study

This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients that had reconstructive knee surgery between July 2009 to the present.

Exclusion Criteria:

* None