cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment

  * Body mass index (BMI) of greater than or equal to (\>=)18.0 to less than (\<) 40.0 kilogram per square meter (kg/m\^2)
  * Stable renal function as pre-defined in the protocol
* Cohorts 2 and 4: Matched Healthy Participants

  * Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)

Key Exclusion Criteria:

* Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment

  * Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening
* Cohorts 2 and 4: Matched Healthy Participants

  * Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis
* All Cohorts:

  * History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
  * Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..

The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are

* AIM 1: Refine the Take a Break mHealth tool and implementation program.
* AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.
* AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.

Eligibility Criteria:
Inclusion Criteria:

* For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.

Exclusion Criteria:

* Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.

Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.
Rehabilitation in Lumbar Disc Herniation

The aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life.

45 symptomatic lumbar disc herniation patients, who are in chronic period and aged between 18-65 years, will be included. The participants will be randomised into three groups. 15 patients will be included in the written home exercise group,15 patients will be in video based home exercise group and 15 patients in the control group. In the written exercise group and video based exercise group, exercise programs will be 8 weeks. In the control group, the exercise protocol will not be performed during 8 weeks.

The outcomes will include the quality of life, pain level, functional capacity, kinesiophobia. In the exercise groups, the evaluations will be made in the first interview (before exercise program), at the end of 8 weeks of exercise (when the exercise program is completed) and in 12th weeks (4 weeks after the exercise program completion). Evaluations in the control group will be carried out at the first interview, at the 8th week, 12th weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged between of 18-65 years
* Having been diagnosed with a lumbar disc herniation
* No need for surgery due to lumbar disc herniation
* Having pain in the lower back or leg for at least 12 weeks
* Not using corticosteroids
* To be oriented and cooperative
* To be volunteer to participate in the study

Exclusion Criteria:

* Having undergone lumbar spine surgery
* Having undergone lower extremity, upper extremity, spine surgery in the last 1 year
* Presence of lumbar stenosis
* Analgesic addiction, or any addiction
* Presence of tumor
* Presence of metastases
* Presence of rheumatological diseases
* The presence of scoliosis, congenital deformity
* Presence of leg length discrepancy
* Being pregnant
* To have uncontrolled hypertension
* To have exercise-dependent angina
Effects of Dietary Folate and Phytate Zinc Absorption: Zinc Amino Acid Complexes vs. Zinc-chloride

The purpose of this study is to determine the effects of consuming a small breakfast of juice and toast with added phytate or with taking a folic acid supplement on the absorption of a small amount of zinc that is either bound to amino acids or to chloride or picolinate. The results of this study will provide new information on how components of diet (e.g., phytate, and folic acid) affect the absorption of different forms of dietary zinc (e.g., zinc bound to amino acids, zinc chloride, and zinc picolinate).


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men (i.e., have no current health issues requiring medications or a specific diet), 19 to 50 years of age, with a body mass index between 18 and 30 kg/m2, and willing to eat only the foods provided by the study for 17 days

Exclusion Criteria:

* Those reporting current chronic or acute diseases or HIV diagnosis, food allergies, smoking tobacco or marijuana, alcohol abuse, any contraindication to venipuncture such as bleeding disorders or use of blood thinners; use of illicit drugs; regular consumption of medications, micronutrient supplements, or both. Vegetarians, or those unable to eat meat, are also excluded since the foods for the study contain meat.
Orchidopexy Randomized Clinical Assessment

This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).


Eligibility Criteria:
Inclusion Criteria:

* Boys age 4 months to 36 months
* Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate.

Exclusion Criteria:

* Age \> 36 months
* Age \< 4 months
* Bilateral cryptorchidism
* Solitary testis
* Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated
* Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels.
* Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.
Competence-feedback and Therapy Outcome

In a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions. The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior. The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU).

Psychotherapeutic competencies are considered to be an important factor for therapy success. However, empirical studies which have investigated the competence-outcome relationship were only based on correlational analyses. Therefore, these studies are inappropriate for the investigation of causal relationships. In previous studies, feedback on therapists' competencies was found to be suitable for enhancing such competencies. Therefore, in the current research project, competence-feedback should be used to enhance therapeutic competencies systematically, in order to investigate the causal impact of these competencies on therapy outcome. Using a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions. The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior. The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU). In order to ensure comparability of both treatment conditions (regarding an observation situation), the therapists in the TAU condition should also receive feedback, but only after the treatments are finished. We hypothesize that the feedback-group is superior to the TAU-group and that their treatments lead to significantly better therapy outcome. Moreover, we use mediator analysis to analyze whether the group-outcome relationship is mediated by therapeutic competencies or by the quality of the therapeutic alliance. The results are highly relevant for clinical process research, psychotherapy training and for the dissemination of treatment approaches in routine care.

Eligibility Criteria:
THERAPISTS

Inclusion Criteria:

* Having successfully completed the interim Audit
* Having started to treat ambulant patients

Exclusion Criteria:

---

PATIENTS

Inclusion Criteria:

* Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)
* Informed consent

Exclusion Criteria:

* Suicidal tendency
* Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder
* Clinical diagnosis of personality disorder cluster A (odd disorders) and B (dramatic, emotional or erratic)
Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis

The prevalence of knee osteoarthritis has been increasing in recent decades as the number of obese people has increased. Various interventions are used to improve the functional condition of patients, but it is still not clear which one is most effective. The primary aim of this study was to determine and compare the effects of kinesio taping and sham taping on the knee functional mobility.

The investigators assigned 30 adult participants (26 women, 4 men; mean age 58,1±3,9 yrs) from Lithuania. Participants were assigned to one of three groups: control group (CON) (n = 10), sham taping + exercise (STE) (n = 10), and kinesio taping + exercise (KTE) group (n = 10). Participants performed all necessary tests according to the study protocol one week before the intervention. A second set of tests was performed one week after the intervention. The intervention duration was 1 week. Exercise, sham and kinesio taping were applied by Physical Therapist. All the study groups did exercise training.

Eligibility Criteria:
Inclusion Criteria:

* clinical and radiography diagnosis of osteoarthritis of the knee joint
* patients with different degrees of severity of the knee osteoarthritis
* consent to participate in the study.

Exclusion Criteria:

* rheumatoid arthritis
* systemic connective tissue disease
* knee joint oedema
* surgery intervention in recent 6 months
* wearing of knee braces
* skin problems
* previous total or partial knee replacement surgery
* inability to perform physical examination tests
* oncology
* use of medications, infection
* previous experience of kinesio taping intervention.
Effects of Telephone Consultations on Discharged Liver Cancer

The aims of this three-year study are to:

1. From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA
2. Develop a telephone follow-up and consultation program and examine its effect on self-efficacy, anxiety, depression and quality of life in liver cancer patients receiving non-surgical treatment.

In the first year, a longitudinal mixed method with quantitative and qualitative method will be used. The Distress Management Tool, the Hospital Anxiety and Depression Scale, and the Short Form-12 quality of life will be used to assess patients' care needs, anxiety, depression, and quality of life in the quantitative method. Data will be analyzed by descriptive, Pearson's Correlation, and Stepwise Regression for each time point. Tape-recorded and in-depth interviews with semi-structured interview guidelines will be used in qualitative method to interview the cancer patients who are scheduled to be discharged after treatment. Content analysis will be used to analyze the interview content.

In the second and third year, randomized control trial will be used to recruit eligible subjects from inpatients in oncology wards in one medical center in Taipei. The eligible subjects will be randomized into a control or experimental group. The patients in the control group will receive usual care and those in the experimental group will receive seven instances of telephone follow-up or face-to-face education (the day before discharge and during the first, second, third, fourth, sixth, and eighth weeks after discharge).Data will be analyzed by independent t-test, one-way analysis of variance, and generalized estimating equations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cancer in non-surgical treatment
* Aged above 18
* Those who are wiling to participate in the research

Exclusion Criteria:

* None
Outcome of Sub-inguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchilagia With Normal Semen

varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.

Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.

This study will focus on the effect of operation on the semen postoperatively .


Eligibility Criteria:
Inclusion Criteria:

1. Primary varicocele.
2. Patient's age more than 20 years.
3. Scrotal pain (after exclusion of other causes).
4. Normal semen analysis

Exclusion Criteria:

1. Secondary varicocele.
2. Recurrent varicocele.
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. To address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.

Motivational deficits have emerged as a critical determinant of functional disability in schizophrenia (SZ). Despite significant advances in our understanding and treatment of the illness, effective therapeutic strategies for motivational deficits have remained elusive. This has ultimately hindered our ability to promote recovery for individuals with SZ so that they can return to their premorbid level of functioning. An emerging therapeutic approach in SZ has utilized computerized remediation strategies, with recent efforts focused on cognitive deficits. To date, however, such a therapeutic strategy has not been developed for the critical motivational deficits in SZ. In light of the detrimental functional consequences of motivational deficits in SZ, there is a clear need for effective therapeutic strategies for the treatment of these motivational deficits experienced by affected individuals. To address this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a novel virtual reality-based motivation rehabilitation program in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 35 years old;
2. DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
3. Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks;
4. Minimum Apathy Evaluation Scale (AES) score of 34.

Exclusion Criteria:

1. Diagnosis of other DSM-IV Axis I disorders;
2. History of active substance abuse or dependence in the past 6 months, with the exception of nicotine;
3. History of neurological disease;
4. History of head trauma with loss of consciousness \>30 minutes
5. Presence of significant akathisia (a rating of \>2 on the Barnes Akathisia Rating Scale (BARS) Global item); or
6. Presence of significant extrapyramidal symptoms (a rating of \>2 on \>2 items of the Simpson Angus Rating Scale (SARS))
7. Any MRI contraindications.
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* Antiretroviral-naive
* CD4 cell count below 100 cells/mm3

Exclusion Criteria:

* Pregnancy
* Current opportunistic infection requiring parenteral therapy
* Current malignancies requiring parenteral chemotherapy
* Any contraindication to the study drugs
An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

The purpose of this study is to investigate the feasibility, acceptability and preliminary efficacy of an internet delivered cognitive behavior treatment (ICBT) for people with prolonged grief disorder (PGD) compared to a face-to-face intervention for PGD.

Grief is an intense emotional reaction to the loss of a loved one. It produces feelings of regret and longing that usually decrease over time. However, some people have difficulty adapting to the loss and develop Prolonged Grief Disorder (PGD). An open clinical trial will be conducted to investigate the feasibility \[initial efficacy and acceptability\] of an Internet delivered cognitive behavior treatment (ICBT) for adult people diagnosed with prolonged grief disorder (PGD). There will be at least 24 participants that will be randomly assigned to experimental group (internet-based treatment for PGD) or active control group (traditional face- to-face intervention for PGD). Four assessment moments will be included (pre-treatment, post-treatment, 3 months follow-up and 12 months follow-up). The present study aims to improve knowledge about the feasibility, acceptability and preliminary efficacy of an ICBT for PGD and conduct a preliminary comparison between two intervention conditions (internet-based intervention vs. traditional face-to-face intervention). Also, the investigators aim to collect information that can help to improve the efficacy and acceptability of Internet-based interventions in general.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Meeting diagnostic criteria for PGD
* Sign an informed consent
* Ability to understand and read Spanish
* Ability to use a computer and having access to the Internet
* Having an e-mail address

Exclusion Criteria:

* Presence of risk of suicide or self-destructive behaviors
* Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia o bipolar disorder)
* Presence of severe personality disorder
* Presence of a medical condition whose severity or characteristics prevent the performance of treatment
* Receiving other psychological treatment during the study for PGD
* An increase and/or change in the medication during the study period
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.


Eligibility Criteria:
Inclusion Criteria:

Unilateral breathing impairment due to septal deviation