cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain.

Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:

Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.

Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:

Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 years of age or older.
* Patients with chronic non-cancer pain that necessitates the use of non- injectable opioid analgesics.
* Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
* Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced Constipation (OIC) is defined as follows:

less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:

1. Hard or very hard stools
2. sensation of incomplete evacuation
3. straining while having a bowel movement

Exclusion Criteria:

* 1. Who are receiving opioids for abdominal pain or connective tissue disorders.
* Planned discontinuation of opioids during the study
* Who underwent major surgery within 3 months prior to screening.
* With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
* With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
* With a previous use of tegaserod within 3 months prior to baseline.

Other protocol-defined inclusion/exclusion criteria may apply
SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.

This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.


Eligibility Criteria:
Inclusion Criteria:

* Complete ACL rupture
* Injured knee range of motion \>= 75% of contralateral knee
* MCL tear grading \<= 2
* Sign informed consent.

Exclusion criteria:

* Prior ACL reconstruction
* Complete PCL tear
* Locked bucket handle tear or complex tears of the menisci.
* Contralateral knee ligament injury
* Known joint disease
* Known allergy to silk
* Active drug or alcohol abuse
* Pregnant
Effect of Vestibular Rehabilitation in Patients With Bilateral Vestibular Hypofunction

Bilateral vestibular function is a heterogeneous chronic condition characterized by bilaterally decreased or absent function of vestibular organs, vestibular nerves, or both.1 Patients present with various symptoms such as oscillopsia, imbalance, visual vertigo, cognitive deficits, autonomic symptoms, and impaired spatial orientation. The aim of this study is to investigate the effectiveness of vestibular rehabilitation on balance, dynamic visual acuity and quality of life in patients with bilateral vestibular hypofunction. Twenty patients diagnosed with bilateral vestibular hypofunction by videonystagmography were included in the study. Balance Tests, Visual Analogue Scale, Dynamic Visual Acuity, Dizziness Disability Inventory for quality of life, computer modified for Sensory Interaction in Balance Clinical Test (MCTSIB) tests and Limits of Stability test, which provides evaluation of body movements, which are an important part of balance, in all directions. Evaluations were made at 3 and 6 months before treatment. Physiotherapy sessions were given at two-week intervals. According to the development of the patients, they were asked to perform a home exercise program with 10 repetitions 3 times a day.

After the initial evaluations, the patients included in the study were included in the rehabilitation program. The rehabilitation program consisted of two phases. The first phase included patient education. All patients were planned to receive a verbal training for 30 minutes by the physiotherapist, including the definition of unilateral vestibular hypofunction, its importance, risk factors, ways of prevention, and recommendations for preventing falls. The second phase consisted of the vestibular exercise program. In this phase, vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.

Eligibility Criteria:
Inclusion Criteria:

1. To be diagnosed with bilateral vestibular hypofunction by Videonystagmography test
2. To be between the ages of 18-75
3. To have communication and cooperation skills
4. To have no problems originating from the central nervous system
5. To have previously had ear infections, not having undergone surgery

Exclusion Criteria:

1. Having cognitive dysfunction
2. Presence of temporal bone pathologies detected by magnetic resonance imaging
3. Presence of other inner ear disorders that may cause dizziness and imbalance as determined by audiogram, tympanogram, and acoustic reflexes
4. Previous lower extremity injuries
5. The presence of central findings in Videonystagmography results
Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy male and female (of not childbearing potential), ages 18-45 years, inclusive
* BMI 18 to 32 kg/m2, inclusive

Exclusion Criteria:

- Any significant acute or chronic medical illness
Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

This study is being done to discover if there is a link between estrogen exposure and the severity of Fuchs Endothelial Corneal Disease. We are trying to understand if the decrease in estrogen levels in post-menopausal women may be a reason why FECD is seen more often in women than men.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals with FECD grade 1-2/7 (mild) or 5-6/7 (severe) in one or both eyes
2. Age ≥ 55
3. Phakic and pseudophakic individuals will be included. Pseudophakic patients must have evidence of routine cataract surgery (posterior chamber intraocular lens in-the-bag without clinical evidence of damage to any intraocular structures).

Exclusion Criteria:

1. Females are excluded if not post-menopause.
2. Pseudophakic patients with a history of complex cataract surgery or other intraocular surgery (e.g. have an anterior chamber lens, sulcus lens, or poorly positioned posterior chamber lens, aphakia, iris damage, glaucoma surgery) will be excluded due to risk of iatrogenic damage to the corneal endothelium.
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth

The investigators seek to adapt, implement and evaluate a randomized controlled trial of an evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk, targeting Apache adolescents. Specific study objectives include:

1. To perform formative research through focus groups and individual interviews on attitudes, practices and intervention preferences among Apache adolescents and community stakeholders.
2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the formative research, components of Protection Motivation Theory, and input from a community advisory board.
3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized intervention trial measuring behavior change at 6- and 12- months follow-up.
4. To determine the feasibility of gathering biological specimens via self-administered swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and future studies.

The general format of the study consists of a randomized controlled trial delivered through the medium of an 8-day basketball camp. Intervention activities will consist of the daily delivery of a youth HIV/AIDS prevention curriculum over the course of 8 days.

Eligibility Criteria:
Inclusion Criteria:

* American Indian ethnicity and primary residence and/or employment within the White Mountain Apache (Fort Apache) Reservation. Participants must be aged 13-19 years and have parent/guardian consent for youth under 18 years old.

Exclusion Criteria:

* Youth that are unable to fully participate in the evaluation assessments or intervention components will be excluded. In addition, individuals age 16 or older that are listed on either the Federal or Tribal sexual offender registries will be excluded from participation.
Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

The objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.

Specific Aim I:

To determine if patients undergoing arthroscopic rotator cuff repair prefer the traditional abduction sling vs the novel sling.

Specific Aim II:

To determine if patients undergoing total shoulder arthroplasty prefer the traditional abduction sling vs the novel sling.

Specific Aim III:

To determine if short term follow-up (2, 4, 6 weeks), subjective patient-reported outcomes are superior in patients utilizing the novel sling compared to patients utilizing the traditional, abduction sling.

Specific Aim IV:

To determine if longer term follow-up (6 weeks, 14 weeks, 6 months, and 12 months), validated patient-reported outcomes are similar (non-inferior) in patients utilizing the novel sling compared to a historical control cohort of patients that only utilized the traditional, abduction sling. The purpose of this aim is to ensure that patients that utilize the novel novel sling for 2 to 4 weeks (with the traditional sling used for the rest of the 6 week period) do not have inferior outcomes compared to patients that have worn the traditional sling for a total of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
* Dominant extremity undergoing surgery

Exclusion Criteria:

* Patients undergoing revision surgery
* Patients with a history of significant cervical spine disease, peripheral neuropathy, or concomitant wrist or elbow disorders
* Patients that do not understand English
* Patients unwilling to participate or follow up for the study protocols
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female patients ≥18 years of age who are HLA-A\*02+ (performed during screening locally or centrally, or based on documented historic test results)
* Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
* Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
* At least 1 measurable lesion according to RECIST 1.1
* Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Baseline and on Cycle 2 Day 8 (+/- 3 days)
* Patients must agree to venous access for the leukapheresis and be willing to have a central line inserted if venous access is an issue
* Adequate organ function and bone marrow reserve performed within 14 days prior to the leukapheresis

Exclusion Criteria:

* Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis
* Systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
* Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the Sponsor
* Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
* Patients with \>Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
* Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
* History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
* Has known active central nervous system metastases
* History of interstitial lung disease requiring steroids
* Major surgery within 2 weeks of leukapheresis
Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)

One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients., The investigators hypothesise that blue- enriched light improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65;
* diagnosis of Seasonal affective Disorder, winter type according to DSM-IV;
* SIGH SAD rating higher then or equal to 18 on day 1;
* no other treatments for mood disorder during the study
* stay in the Netherlands during the study

Exclusion Criteria:

* other Axis 1 disorder according to DSM-IV
* acute suicide risk
* use of psychotropic drugs or photosensitizing drugs
* eye diseases other then usual effect of aging
* diabetes or epilepsy
* regular shift work
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI between 27 and 45 kg/m2
* Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
* Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits

Exclusion Criteria:

* Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
* Are pregnant or plan to become pregnant in next 2 years
* Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
* Are participating in or plan to participate in another weight loss program in the next 2 years
IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION

The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.

Objective assessment of the effect of environmental and occupational factors on fertility is difficult to establish due to the lack of relevant exposure biomarkers for reporting multi-exposures.

The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.

Subsequently, the results of this study will make it possible to personalize and evaluate the effectiveness of the preventive measures put in place upstream of the MPA route by allowing To identify a relationship between PAH exposure and sperm DNA gamete quality in humans, serum AMH concentration and ovarian response to gonadotropic stimulation for IVF in women.

To highlight a relationship between individual exposures to complex PAH mixtures and infertility.

The methodology based, on the feminine side, on the analysis of follicular cells makes it possible to study cells close to female gametes within the cumulo-oocyte complex, without losing the chance of pregnancy for the couple.

Eligibility Criteria:
Inclusion Criteria:

* Couples whose wife is under 36 and the man under 45 at the time of IVF
* Regular cycles of 27 to 33 days in women
* Management of classical IVF (without the use of micro-sperm injection)
* 1st or 2nd attempt of IVF
* Signature of informed consent by both partners of the couple
* Affiliation to a social security scheme or equivalent for both partners of the couple.

Exclusion Criteria:

* Refusal to participate in the study of one or both members of the couple
* No fluency in French
* History likely to alter the ovarian reserve, endometriosis
* Uterine or systemic antecedents, likely to affect implantation
* Andrological antecedents likely to alter fertilization rates
* History of chemotherapy / radiotherapy
* Positive plasma viral load for HIV, HCV or HBV in the year prior to inclusion in one of the members of the couple
Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor

Pregnancy promotes respiratory system's restrictive component. This study observes the generation of atelectasis during labor.

Pregnancy causes restriction of diaphragm movements as well as higher resistive component to the respiratory system. Spirometry studies have shown that the supine position increases risks of hypoxemia. There seems to be only casual observation regarding the generation of atelectasis during labor.

Eligibility Criteria:
Inclusion Criteria:

* post-anesthesia recovery

Exclusion Criteria:

* hemodynamic disorder during labor
Use of NIRS in Preterm Population Born at Altitude

Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.


Eligibility Criteria:
Inclusion Criteria:

* Infant must be \<32 weeks' gestational age at time of delivery.
* Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
* Infants that require blood transfusions during the monitoring time may be included.

Exclusion Criteria:

* Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
* Infant born after placental abruption or concern for extreme blood loss immediately after birth.
* Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
* Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
* Mothers/guardians that are \<18 years of age will not be approached for consent.
* Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study.
* Any infant that is planned to be placed for adoption
* Infant is greater than 24 hours of age at time of consent.
Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).


Eligibility Criteria:
Inclusion Criteria:

* clinically significant primary mitral regurgitation
* patient underwent M-TEER
* echocardiography data at baseline, procedure and follow-up
* follow-up of at least 12 months

Exclusion Criteria

* age under 18 years