cyrilzakka/clinical-trials huggingface dataset:
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

* Male and female 18 to 65 years of age (inclusive)
* Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
* Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.

Group B: Healthy subjects

* Male and female 18 to 65 years of age (inclusive)
* Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
* Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures

Exclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
* Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
* Severe hepatic encephalopathy
* Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
* Hepatocellular carcinoma, HIV, hepatitis B/C
* Significant renal dysfunction
* Solid organ or bone marrow transplantation
* History of regular alcohol consumption, drug abuse or regular smoking

Group B: Healthy subjects

* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* History of regular alcohol consumption, drug abuse or regular smoking
Evaluating a New Gonadotoxic Risk Stratification System

The primary objective of this study is to assess if there is an association between a newly described gonadotoxic risk stratification system and post-treatment ovarian reserve as determined by FSH and AMH.

The Investigator will test the amount of agreement between the two ordinal variables using a kappa statistic at each time point in the first two years of follow up. The Investigator will perform ordinal logistic regression accounting for repeated measures data for participants who are not using contraception. The Investigator will assess participant characteristics to see if the Investigator need to adjust for other covariates including age, race, ethnicity and body mass index (BMI).

Since contraception can mask an elevated FSH surge from gonadal failure, the Investigator will perform a similar model for participants on contraception using AMH only.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ages 8 - 39 years of age
* Seen in CHCO or AMC outpatient clinics for any of the following reasons:

  * At risk for fertility problems (Z91.89)
  * Encounter for fertility preservation counseling (Z31.62)
  * Primary ovarian insufficiency
  * Premature ovarian failure/premature menopause
  * Diminished ovarian reserve
* At least 12 months post-completion of chemotherapy and/or radiation
* History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to:

  * Any type of cancer/malignancy
  * Rheumatoid arthritis
  * Systemic lupus erythematosus
  * Aplastic anemia
  * Fanconi anemia
  * Diamond-Blackfan syndrome
  * Hurler syndrome
  * Other autoimmune conditions

Exclusion Criteria:

* Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.)
* History of bilateral oophorectomy
* Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy
* Inability to consent/assent
Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder

Adhesive capsulitis, is a common problem characterized by the insidious onset of glenohumeral pain and limitation of shoulder motion in all planes. Clinically, frozen shoulder could be divided into freezing, frozen and thawing stage. The treatments of frozen shoulder are mainly conservative, including non-steroidal anti-inflammatory medications and physiotherapy. Due to debilitating pain at a certain stage and protracted clinical course, intra-articular corticosteroid injection in the early stages of idiopathic adhesive capsulitis has long been used to treat adhesive capsulitis with satisfactory result. However, intra-articular steroid injection still raise some controversy and is still considered too invasive for some patients.

Low-level laser therapy (LLLT) is a safe and non-invasive alternative. LLLT can employ photo-biomodulation effects to help normalize cellular functions and is considered to have partial effect in many shoulder soft tissue disorders. Possible mechanisms include increasing adenosine triphosphate production, fibroblast activity and collagen synthesis. One prospective cohort study has shown that LLLT can be effective in the management of the early phase (less than 6 weeks of disease onset) of adhesive capsulitis of the shoulder in elderly who failed to respond to conventional physical therapy and nonsteroidal anti-inflammatory medications and improvement was found maintained up to 2 years.

To this date, no randomized controlled study has been made to establish the possible role of LLLT as an adjuvant therapy on adhesive capsulitis. Also, no study has researched the effect of LLLT on patient with later stage/chronic phase of adhesive capsulitis. The objective of this paper is to report the clinical result of a study on the efficacy of LLLT as an add-on therapy in the management of adhesive capsulitis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 to 85 years old
* Diagnosed with adhesive capsulitis clinically. Painful restriction of both active and passive flexion less than 120° and 50% restriction of the external rotation aside the body
* Visual analog scale of shoulder motion pain greater than 3 on a scale of 10
* No fracture, dislocation, or arthritis in shoulder region

Exclusion Criteria:

* History of or scheduled shoulder or chest surgery
* Significant shoulder trauma within the previous 2 years
* Presence of cervical radiculopathy or other central or peripheral neurologic deficits of the upper limb
* Known shoulder tendon tear or active tendinitis or bursitis as confirmed with US
* Contraindication of low-level light therapy

  1. Pregnancy, cancer, patient with pacemaker, high bleeding tendency, or longterm corticosteroid use.
  2. Poor consciousness state, or patients with sensory impairment
  3. Patients hypersensitive to light
  4. Severe circulatory system disorder
Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2

CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.

This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows their detection with an ambulatory monitoring system.

The benefit for patients is to improve the diagnosis of their diseases by better characterizing their seizures.

CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.

The project is planned in three phases:

* Installation of 3-D accelerometric and magnetic sensors acquisition systems on the hospital (extension of a preceding study CAPAMETRIM).
* Collection of data on epileptic patients. Sensors will be positioned on the right and left hands and on the head. A 3-D analysis of movements will be done according to the collection by tagging data with visual analysis made on video.
* Development of a motor pattern classification system used for seizure detection.

Eligibility Criteria:
Inclusion Criteria:

* Adult or children (\>= 6 years)
* Written inform consented from the patient or its legal representative
* Presurgical investigation of pharmaco-resistant partial epilepsy
* Motor manifestations during seizures

Exclusion Criteria:

* Proved generalized epilepsy
* No motor manifestations during seizures
* Pregnant women
* Subjects deprived of freedom by an administrative or judicial decision
Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.

Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.

Exclusion Criteria:

* Patients were excluded if they had: medical conditions preventing pneumo-peritoneum
* Patients with medical conditions hindering proper ventilation during general anesthesia.
* Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.
* Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a DSM-5 diagnosis of OUD (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 5 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after the XR-BUP injection.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults aged 18 and above.
* DSM-5 diagnosis of opioid use disorder.
* Self-reporting use of illicit opioids in \>21 days in the prior 30 days.
* Provide urine toxicology testing positive for fentanyl at baseline.

Exclusion Criteria:

* Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
* Received buprenorphine or methadone treatment in prior 30 days.
* Current DSM-5 diagnosis of alcohol or sedative/hypnotic use disorder.
* Physical dependence on alcohol or sedative/hypnotics.
* Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed Consent.
* Requiring treatment with opioids for acute or chronic pain.
* History of hypersensitivity or allergy to buprenorphine or fentanyl.
* Pregnant or breastfeeding.
FMT for Postop Crohn's Disease

People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.

This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.

Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign informed consent form
* Age 18 or older
* English speaking
* Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
* Prior ileocecal resection for CD
* Stable medications for 30 days
* Women of reproductive age: Agree to remain abstinent or use effective birth control
* Able and willing to comply with all study procedures

Exclusion Criteria:

* Antibiotic therapy within 15 days
* Probiotic therapy within 15 days
* Adenomatous polyps that have not been removed
* Anticipated antibiotic use over the study period
* Subtotal or total colectomy
* Current ostomy (ileostomy or colonoscopy)
* Anticipated surgical procedure over study period
* Pregnancy
* Severe food allergy
* Diagnosis of end stage liver disease or cirrhosis
* Absolute neutrophil count \< 500 cell / uL
* Life expectancy \< 6 months
Anecortave Acetate Risk-Reduction Trial (AART)

The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Dry AMD in study eye, Wet AMD in non-study eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 50;
* Other protocol-defined exclusion criteria may apply.
Treating Thought Problems in Patients With Schizophrenia

This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia.

Many schizophrenia patients have serious difficulties that affect their quality of life. Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or environmental supports, is tailored to each individual and is based on executive functioning levels and other factors.

Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits will be slowly reduced to once a month. For the remaining 12 months of treatment, patients receive CAT only once a month.

Participants assigned to the MES group receive a generic set of supplies and equipment (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each month, the supplies are replenished as necessary during the patient's scheduled clinic visit.

In all groups, assessments of adaptive function and quality of life occur at study start and at 3, 6, 9, 18, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Treatment with an atypical antipsychotic medication
* Stable living environment
* Able to read, understand, and complete rating scales and neuropsychological testing
* Willing to participate in psychosocial treatments for schizophrenia that may involve home visits

Exclusion Criteria:

* History of significant head trauma, seizure disorder, or mental retardation
* Alcohol or drug abuse that could interfere with participation in the study
* Treatment by an ACT team
* History of violence in the past year
* Score \> 80 on the SOFAS
* Hospitalized in the past year
Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty

Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.

Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.

Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Total knee arthroplasty

Exclusion Criteria:

* BMI\>35
* liver, kidney, and advanced heart failure,
* routine use of analgesics and
* having used analgesics in the last 24 hours,
* having neuropathic pain,
* refusal to participate in the study
Multimodal Data-assisted Primary Screening for Allergic Rhinitis Based on Voice Recognition and Face Recognition

Collect facial images and voice and audio of patients with rhinitis in the department of otolaryngology, and collect the examination results of patients with rhinitis who have received electronic fiber nasopharyngoscopy. Skin prick test to a standard panel of aeroallergens or by using the ImmunoCAP Phadiatop test for detecting immunoglobulin E antibodies against various common inhalant allergenswere detected, and a prediction model for the type of rhinitis was finally established.

The incidence of allergic rhinitis is high and the progression of the disease is serious, but public awareness of the disease is limited. Mistaking allergic rhinitis for the common cold or other respiratory illnesses and purchasing non-specific medications for its treatment not only delays proper diagnosis and treatment, but may also lead to further aggravation of the disease and complications. Such omission, misdiagnosis and mistreatment of allergic rhinitis not only affects the management and control of the disease, but may also result in unnecessary wastage of healthcare resources and increased treatment costs.

In this study, the investigators propose to capture face photographs and audio files of rhinitis patients coming to the otolaryngology clinic using a work cell phone to determine whether the patients are allergic or non-allergic rhinitis by using an allergy detection test. The face photos, audio files and basic clinical information were multimodally fused to construct a prediction model, and the effectiveness of the model was evaluated.

Ultimately, it is expected that the predictive model can simply identify and screen for allergic rhinitis, improve public awareness and understanding of allergic rhinitis, and take proper treatment measures.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects understood the purpose and procedure of the trial and signed an informed consent form, and voluntarily participated in this study;
2. Subjects were initially clinically diagnosed with chronic rhinitis;
3. Subjects were aged 8-80 years old, limited to Chinese nationality, and were able to perform basic examinations and cooperate with face photography and voice collection.

Exclusion Criteria:

1. Those who received systemic immunotherapy, used systemic or local glucocorticoids as well as leukotriene receptor antagonists within one month;
2. Those who suffer from immune system diseases, autoimmune diseases, allergic diseases or allergies and have a history of food allergy;
3. Other serious systemic diseases, such as active tuberculosis, rheumatic heart disease, congenital heart disease, arthritis, nephritis, hypertension, psychosis, dermatitis, epilepsy and so on;
4. Women during lactation and pregnancy;
5. History of upper respiratory tract infection or more serious infectious diseases within three months;
6. Those who are currently participating in another clinical study or have participated in another clinical study within 90 days;
7. Other patients who, in the judgment of the clinician, are not suitable for inclusion in the study.